IN THE SUPREME COURT OF INDIA CIVIL APPELLATE JURISDICTION I. A. NO. _____ OF 2011 IN S.L.P. (C) NO. 20549/2009 IN THE MATTER OF:
NOVARTIS AG
…PETITIONER
VERSUS UNION OF INDIA & ORS.
…
RESPONDENTS AND IN THE MATTER OF:
SHAMNAD BASHEER
…INTERVENOR
WRITTEN SUBMISSIONS ON BEHALF OF THE INTERVENOR
The intervenor seeks to assist the the court in evolving a framework and a set of propos propositi itions ons for resolv resolving ing patent patent disput disputes, es, partic particula ularly rly disputes around pharmaceutical patents and section 3(d). Being an acad academ emic ic,, the the int inter eres estts of the int inter erv veno enor lie lie in the the robust bust deve develo lopm pmen entt
of
soun sound d
pat patent ent
jur jurisp isprude ruden nce
for for
India ndia
that that
appropriately balances the competing interests of drug originators against that of generic companies and patients. I
THE SECTION 3(d) STANDARD
Section 3(d) currently reads as under: “3. What are not invention inventions: s: The following following are not invention inventions s within the meaning of this Act….
1
(d) the mere discovery of a new form of a known substance whic which h does does not not resu result lt in the the enha enhanc ncem emen entt of the the know known n efficacy of that substance or the mere discovery of any new property or new use for a known substance substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant. Explan Explanati ation: on: For the purpos purposes es of this this clause clause,, salts salts,, esters esters,, ethers ethers,, polymo polymorph rphs, s, metabo metabolit lites, es, pure pure form, form, partic particle le size, size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same same substa substance nce,, unless unless they they differ differ sig signif nifica icantl ntly y in properties with regard regard to efficacy.
In esse essenc nce, e, sect sectio ion n 3(d) 3(d) stip stipul ulat ates es that that a new new form form of a know known n subs substa tanc nce e woul would d be pate patent ntab able le only only when when the the said said new new form form demonstrates significantly enhanced efficacy when compared with the known substance.1 The key issues in interpreting the scope and ambit of section 3(d) are: 1. What What does does “eff “effica icacy” cy” mean mean? ? 2. Does increased increased bioavai bioavailabili lability ty qualify as enhanced enhanced “efficacy” “efficacy”? ? 3. What is the stand standard ard of proof proof required required to establi establish sh “efficacy”? “efficacy”? 4. When must must proo prooff of efficacy efficacy be produce produced? d? 5. What What is the the mean meanin ing g of the the term term “kno “known wn subst substan ance” ce” under under section 3(d)? A.
Meaning of “Efficacy”
1
Section 3(d) of the Indian Patents Act, 1970. For an elaborate discussion of this provision, see Shamnad Basheer and Prashant Reddy, The “Efficacy” of Indian Patent Law: Ironing out the Creases in Section 3(d), Volume 5, Issue 2, Script-ed, August 2008.
2
The term “efficacy” is central to interpreting the scope and ambit of section 3(d). More specifically, the issue is whether or not efficacy ough oughtt to be inte interp rpre rete ted d narr narrow owly ly to mean mean only only “the “thera rape peut utic ic” ” efficacy or whether it ought to be broadened out to include any kind of advantageous property attributable to the new form in question. The
Madras
“the “thera rape peut utic ic” ”
High
Court
held
that
not not
ever every y
effi effica cacy cy and and
“efficacy”
meant
only
adva advant ntag ageo eous us prop proper erty ty
claimed for the new drug derivative in question. 2 The IPAB endorsed this interpretation. The intervenor submits that, based on the history of the section 3(d) and its current structure, this appears to be a correct reading of section section 3(d). However, However, one importa important nt caveat needs needs to be borne in mind mind;; sect sectio ion n 3(d) 3(d) is not not limi limite ted d to phar pharma mace ceut utic ical al tech techno nolo logy gy alone. Rather, it applies also to chemicals (such as paints) and agrochemicals (such as pesticides), for which therapeutic efficacy cannot be an appropriate standard.3 A nuanced interpretation of efficacy would therefore suggest that it be defined in a technologically specific way i.e. while it would mean ther therap apeu euti tic c effi effica cacy cy in the the phar pharma mace ceut utic ical al cont contex ext, t, it woul would d translate to an ability to destroy pests in a pesticide context. In other words, efficacy has to be construed in accordance with the predominant
function/utility/purpose
of
the
claimed
substance/invention in question. This function is often adduced from the patent specification itself, where the alleged utility is cited. Such an
interpretation
is
in
conformit mity
with
prevailing
patent
jurisprudence in countries such as the US and EU which have been known
to
interpret
facially
neut eutral
patent
standards
in
a
2
Novartis AG & Anr. v. Union of India & Othrs., (2007) 4 MLJ 1153 at para 13 also available at > (last visited 12 August, 2011). 3
Supra note 1 at internal page 244.
3
technologically specific way.4 The structure of section 3(d) as also its legislative history supports a narrow reading of the term “efficacy”. Illustratively, the Explanation to section 3(d) clearly states that all phar pharma mace ceu utica ticall
der derivat ivativ ives es
would uld
be
con conside siderred
the
same ame
“substance “substance”, ”, unless unless “they “they differ differ sig signif nifica icantl ntly y in proper propertie ties s with with regard to efficacy.”
The above clause refers to only those “properties” that have some bearing bearing on “efficacy” “efficacy” and not all propertie properties. s. If "all properties" properties" were to qualify, it would effectively render the term "efficacy" redundant. Had Parliament intended “any property” to qualify under section 3(d), the Explanation would simply have stated "unless they differ significantly in properties". And the main part of section 3(d) would have been rephrased as "the mere discovery of a new form of a known substance which does not result in the enhancement of the known "properties" of that substance." Therefor Therefore, e, not all advantageo advantageous us properties properties of a new form (such (such as improved improved processab processability ility or flow character characteristics istics,, storage storage potential potential etc) ought to qualify qualify under under section section 3(d), but only those those propertie properties s that have some bearing on efficacy. Altho Althoug ugh h this this prec precis ise e line line of argu argume ment nt poin pointi ting ng to the the phra phrase se “properties with regard to efficacy” does not appear to have been expl explic icit itly ly made made by eith either er the the Ma Madr dras as High High Co Cour urtt or the the IPAB IPAB to supp suppor ortt thei theirr conc conclu lusi sion on,, it is one one that that comp compel elli ling ngly ly supp suppor orts ts a restrictive interpretation of the term “efficacy”. 4
See Dan L Burk and Mark A Lemley, Policy Levers in Patent Law 89 Va. L Rev. 1575, 1575, 1662 (2003). (2003). See Also Dan L Burk and Mark A Lemley, Is Patent Patent Law Technology– Specific? 17 Berkeley Tech. L.J. 1155, 1184 (2002).
4
This interpretation is further buttressed by the objectives of the Act, which suggests that section 3(d) was introduced to prevent evergreening.5 The Madras High Court states in this regard: 6 “…We have borne in mind the object which the Amending Act want wanted ed to achi achiev eve e name namely ly,, to prev preven entt ever ever-g -gre reen enin ing; g; to provide easy access to the citizens of this country to life saving drugs and to discharge their Constitutional obligation of providing good health care to its citizens…”
Alth Althou ough gh the the term term ever ever-g -gre reen enin ing g does does not not have have a scie scient ntif ific ic definition as yet, it is widely understood to mean an inappropriate exte extens nsio ion n in pat patent ent mono monopo poly ly which hich does does not not con conver vert to a significant benefit for the patient. 7 Put another way, it is a patenting strategy “consisting of acquiring patents
on
mino inor,
often
trivial,
modifications
of
existing
pharmaceutical products or processes in order to indirectly extend the
period
of
patent
protection
over
previously
patented
compounds.”8 5
Transcrip riptt of Parlia Parliamen mentar tary y Debate Debate,, Ma March rch 22, 22, 2005, 2005, where where Shri Shri Kurup Kurup See Transc makes a statement indicating that the section is being brought in to prevent evergreening. See also statements of Madras High Court in this regard.
6
Para 19 of the judgement.
7
'Ever-greening' is not a formal concept of patent law. It is best understood as a social social idea idea used used to refer refer to the myriad myriad ways ways in which which pharma pharmaceu ceutic tical al patent patent owners utilise the law and related regulatory processes to extend their high rentearning intellectual monopoly privileges, particularly over highly profitable (either in total sales volume or price per unit) 'blockbuster' drugs. T. A. Faunce & J. Lexchin, 'Linka 'Linkage' ge' pharma pharmaceu ceutic tical al ever-g ever-gree reenin ning g in Canada Canada and Aus Austra tralia lia, available at: < http://law.anu.edu.au/Sta http://law.anu.edu.au/StaffUploads/236-Art% ffUploads/236-Art%20ANZHP%20L 20ANZHP%20Linkage inkage %20Evergreening.pdf > (last visited 31 August, 2011). 8
Carlos Correa Correa “Guidelines “Guidelines for Examinatio Examination n of Pharmaceut Pharmaceutical ical Patents”, Patents”, See Carlos available at: (last (last visite visited d 31 August August,, 2011). 2011). See Als Kesselheim,, Also o A. Kesselheim Inte Intell llec ectu tual al Prop Proper erty ty Polic Policy y in the the Phar Pharma mace ceut utic ical al Scie Scienc nces es:: The The Effe Effect ct of Inappr Inappropr opriat iate e Paten Patents ts and Market Market Exclus Exclusivi ivity ty Extens Extension ions s on the Health Health Care Care availa labl ble e at: at: (last System, avai
5
B.
Expl Ex plor orin ing g the the Cont Contou ours rs of Ther Therap apeu euti tic c Effi Effica cacy cy
Sectlon 3(d)’s lineage can perhaps be said to embody concepts of both patent law and drug regulatory norms. I will examine the patent concept linkage later while discussing the over overal alll sche scheme me of the the Act Act and and the the link links s betw between een Sect Sectio ion n 2(j) 2(j),, Section 2(ja) and Section 3. In terms of the link with drug regulatory concepts, it is important to note note that that sect ection ion 3(d) (d) bor borrows ows ext extensi ensive vely ly fro from a EU drug drug regulatory directive. Article 10(2)(b) of Directive 2004/27/EC defines a ‘generic medicinal product’ as: “a medicinal product which has the same qualitative and quantitative composition in active substances and the th e sa sam me ph phar arm mac aceu euti tica call for orm m as th the e ref efer eren ence ce medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriat appro priate e bioav bioavailabi ailability lity stud studies. ies. The diffe different rent salts salts,, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance shall be consid con sidere ered d to be the sam same e act active ive sub substa stance nce,, unl unless ess they the y dif differ fer sig signif nifica icantl ntly y in pro proper pertie ties s wit with h reg regard ard to saffet sa ety y an and/ d/o or ef effi fica cacy cy.. In such ca case ses s, ad add dit itio iona nall information providing proof of the safety and/or efficacy of the various salts, esters or derivativ ive es of an authorised active substance must be supplied by the applicant.
Given this history, there is a real danger in interpreting the provision in a strictly drug regulatory sense, which might prove problematic within a patent ecosystem. It is therefore submitted that the drug regulatory meaning must not be transposed wholly to the patent context, without suitable adaptation. For the purpose of these two visited 31 August, 2011) “patent ever-greening,” is the patenting of nonessential features of products, including aspects of their formulation, their metabolites, or methods of administration.”).
6
regimes are distinct. While the patent system is meant to grant protection protection to inventions inventions that demonstra demonstrate te technical/ technical/techn technologi ological cal merit merit with with a view view to incent incentivi ivizin zing g innova innovatio tion, n, a drug drug regula regulator tory y regime seeks to ensure that only “safe” and “effective” drugs are sold to consumers. Firstly, given that the intention behind section 3(d) appears to be to prov provid ide e
prot protec ecti tion on
to thos those e
inve invent ntio ions ns prov provid idin ing g
a
genu genuin ine e
adva advant ntag age e to pati patien ents ts (as (as oppo oppose sed d to ever ever-g -gre reen ened ed vari variet etie ies) s),, efficacy ought to be defined as any “therapeutic advantage” and not just “efficacy” as strictly understood in a drug regulatory sense. It is pert pertin inen entt to note note in this this conn connec ecti tion on that that unde underr most most drug drug regulatory regimes, the notion of “efficacy” is used quite distinctly from that of “safety”. It is a truism that almost all allopathic drugs are blessed with toxicity. A regulator’s job essentially entails a risk: benefit analysis i.e. determining whether or not the costs/risks of toxicity are clearly outweighed by the benefits offered by efficacy of the drug in question. In its review of a New Drug Drug Application (NDA), the American Food and Drug Administration (FDA) considers inter alia “[w]hether the drug is safe and effective in its proposed use,
and whether the benefits of the drug outweigh the risks.” 9 Safety of a drug is assessed relative to risks and benefits. 10 The intervenor therefore submits that the term efficacy under sect sectio ion n 3(d) 3(d) ough oughtt to be inte interp rpre rete ted d to mean mean any any “the “thera rape peut utic ic advant advantage age” ” includ including ing one that that flows flows from from signif significa icantl ntly y reduce reduced d toxicity. 9
Susan Susan Thaul, Thaul, How How FDA FDA Ap Appr prov oves es Drug Drugs s and and Regu Regula late tes s Thei Theirr Safe Safety ty and and Effectiveness, CONGRESSIONAL RESEARCH SERVICE, 5 (Jun., 2012), avai availa labl ble e at http://www.fas.org/sgp/crs/misc/R41983.pdf 10
See Cynthia Ho, From Conception to Commercial Success, in ACCESS TO MEDICINE IN THE GLOBAL ECONOMY: INTERNATIONAL AGREEMENTS ON PATENTS AND RELATED RIGHTS 6,13(2011) (“Although it would be optimal for all drugs to be completely safe, in most cases safety is assessed relative to risks and benefits.”)
7
An Illustration – The Orphan Drug Act, 1983
The Orphan Drug Act (ODA) is illustrative in this regard and could be used to delineate the contours of “therapeutic advantage”. The ODA was enacted by the US Congress Congress to help incentivise incentivise the creation creation of what are known as “orphan drugs” i.e. any drug used to treat a rare disease or condition that affects fewer than 200,000 patients in the US or for which there is no reasonable expectation that the cost of developing the drug for a disease will be recovered from sales. 11 Given Given that that pharma pharmaceu ceutic tical al compan companies ies genera generally lly shy away away from from research on orphan drugs, owing to the lack of large markets for such drugs, the ODA was brought into existence to grant additional ince incent ntiv ives es for for crea creati ting ng such such drug drugs s to bene benefi fitt mino minori rity ty pati patien entt populations. The incentive is in the form of a seven year marketing exclusivity to drug originators, so that they are able to recover their R&D cost costs s and and also also make make a heal health thy y prof profit it duri during ng this this peri period od of exclus exclusive ive prote protectio ction. n. Contra Contrast st this this with with regula regularr data data exclus exclusivi ivity ty regimes, which grant drug originators a period of exclusivity lasting only only 5 year years s from from the the date ate of their heir appr appro oval. val. Furt urther her, such uch exclusivity is limited to preventing the use of and reliance upon “data” submitted by the drug originator to regulatory authorities, such that no follow-on drug manufacturer’s drug can be approved using this very same data during the time of protection. However, follow-on manufacturers are free to conduct their own clinical trials and procure drug marketing approval during this time period. 12 On the other hand, the ODA which offers complete and absolute “market” exclusivity, independent of the clinical trial data that is 11
21 USC §360ee(b) (2) (1994).
12
Robert A. Bohrer and John T. Prince, A Tale of Two Proteins: The FDA's Uncertain Interpretation of the Orphan Drug Act , 12 Harv. J. L. & Tech. 365, 370 (1999).
8
submit submitted ted.. In other other words, words, the prote protecti ction on is agains againstt all follow follow-on -on drug drug manufa manufactu cturer rers, s, who canno cannott enter enter the market market,, even even if they they repe repeat at the the clin clinic ical al tria trials ls and and are are able able to subm submit it inde indepe pend nden entl tly y generated data.13 Complete market exclusivity, as opposed to mere data exclusivity, woul would d mean mean that that no foll follow ow-o -on n manu manufa fact ctur urer er can can make make or sell sell a version containing the same active ingredient or claiming the same “indication” or “use”, even if they are able to generate their own data for the same. However, the issue of “sameness” has been a highly contentious one under the ODA. The FDA regulations on this count suggest that “clinical superiority” would render a structurally similar drug molecule “different” from the original drug entitled to orphan drug exclusivity.14 The regulations define a "clinically superior" drug as one that "is shown shown to provid provide e a signif significan icantt therap therapeut eutic ic advant advantage age over over and above that provided by an approved a pproved orphan drug . . . ." Therapeutic advantage, or clinical superiority15, can be shown in one of three ways: (1) greater effectiveness; (2) greater safety; or, (3) demonstration that the drug makes a major contribution to patient care in "unusual cases." 16 13
Unlike other types of exclusivities for new drugs, the law provides complete market exclusivity for orphan drugs for a seven-year period, thereby preventing a competitor from entering the market, even if it were able to generate its own data. See Orphan Drug Act, 1983. 14
"With regard to macromolecular drugs, clinical superiority by itself will render a subsequent drug different." See Orphan Drug Regulations, 57 Fed. Reg. 62,076, 62,081 (1992) at 62,078. This "clinical differences" standard was based on the principle that the market exclusivity should not create a barrier to needed patient therapies. See Joseph A Levitt & John V Kelsey, The Orphan Drug Regulations and Related Issues 48 Food & Drug L.J. at 528-29. 15
The terms therapeutic therapeutic advantage advantage and clinical clinical superiority superiority are interchange interchangeable. able. Therapeutic advantage is demonstrated when clinical testing of a drug demonstrates it to be superior in an important dimension. See 21 C.F.R. §. 316.3 316.3 (b) (3) (iii) (1999). 16
The FDA intends this to be "a narrow category," such as, for example, "the development of an oral dosage form where . . . only a parenteral dosage form" had existed previously.. See 21 C.F.R. §.
9
It bears noting that the ODA norms above mentioned are not strictly “regulatory” in nature. nature. Rather, they act as incentives for for innovation in a mann manner er simi simila larr to pate patent nts. s. Ther Theref efor ore e thes these e norm norms s seem seem appropriate for providing guidance in a patentability context, such as in interpreting efficacy under section 3(d). However, a key limitation must be noted in this regard: In order to evaluate “sameness” under the ODA, one is always likely to have two drugs i.e. the drug which is protected for 7 years under the ODA and the new drug which is allegedly similar to the old “known” drug under protection. In a section section 3(d) context context however, the old substance substance against which the therapeutic advantage comparison is made, may not be a drug (as is the case with imatinib or imatinib mesylate in a form other than than beta beta crys crysta tall llin ine) e).. Furt Furthe her, r, in some some case cases s wher where e pate patent nt applications are filed to claim new forms, such a new form may not be a fully developed drug at the time that the patent application is filed. In fact, in most cases, it is likely that the point of time at which a new form is claimed as a patent is prior in time to its being deve develo lope ped d as a drug drug and and subm submit itte ted d to the the drug drug regu regula lato torr for for regulatory approval. It is ther theref efor ore e subm submit itte ted d that that the the stan standa dard rd of proo prooff requ requir ired ed to demo demons nstr trat ate e
sign signif ific ican antt
ther therap apeu euti tic c
adva advant ntag age e
cann cannot ot be as
onerous as that expected for drug regulatory regimes such as the ODA, an aspect dealt with in a later section.
C.
Does Does incr increa ease sed d bioa bioava vail ilab abil ilit ity y amoun amountt to signi signifi fica cant ntly ly
316.3 (b) (3) (iii) (1999).
10
enhanced efficacy?
It is humb humbly ly subm submit itte ted d that that the the shor shortt answ answer er to this this is this this:: it depends. As noted earlier, efficacy ought to be interpreted to mean a definite “therapeutic advantage”. As to whether or not a showing of increased bioavailability also converts to an added therapeutic advantage advantage has to be assessed assessed on a case-by-cas case-by-case e basis; basis; the answer answer cannot be a blanket yes or no.
Bioavailabi Bioavailability lity means “the rate and extent extent to which the active drug ingredient or active moiety is absorbed from a drug product and beco become mes s avai availa labl ble e at the the site site of drug drug acti action on”. ”.17 It is usua usuall lly y dete determ rmin ined ed by meas measur urin ing g the the conc concen entr trat atio ion n of a subs substa tanc nce e in biological fluids as a function of time, or by excretion of a substance as a function of time, or by acute pharmacology effect. 18
Bioavailabi Bioavailability lity in short relates relates to “absorpt “absorption”. ion”.
The IPAB decision decision
reproduced a submission from one of the counsels that captured this aspect quite well.
“The drug action process in the body was explained by Shri Shri Partha Parthasar sarath athy, y, learne learned d counse counsell appear appearing ing also also on behalf behalf of of R 6 & R 7. 7. Shri Parthasar Parthasarathy athy explained explained that the drug action action proces process s which which broadl broadly y be divide divided d into into three categories categories – absorption, absorption, binding and and response. The absorption related to the amount of active ingredient that had been absorbed by the body. However, this absorption did not automatically translate into therap therapeut eutic ic respo response nse.. After After the active active ingred ingredien ientt was absorbed by the the body, for it to act, it must must bind with the relevant reception of the target cell. This binding was was the crucial step that determined effect, where there were less 17
18
See 21 CFR Section 320.1(a ).
See 21CFR Sec 320.24.
11
number number of recept receptor or sites, sites, increa increased sed availa availabil bility ity of the acti active ve ingr ingred edie ient nt did did not not prod produc uce e any any ther therap apeu euti tic c response. Therefore, binding binding and not absorption was was the key key to heal healin ing g the the dise diseas ase. e. Subs Subseq eque uent ntly ly,, afte afterr the the receptor- drug binding occurs, the subsequent response could be measured measured.. The response response was typically typically in the form of of increase or decrease of some parameter parameter (in this case case the white white blood blood cell cell count) count).. Bio-av Bio-avail ailabi abilit lity y was related to the absorption and not the binding stage of the drug drug acti action on and and ther theref efor ore e was was not not a meas measur ure e of the the 19 efficacy of drug.
The intervenor wishes to adopt the above proposition, with the caveat that it is theoretically possible for increased bioavailability to result in increased enhanced efficacy in some cases. However, this must must be inde indepe pend nden entl tly y esta establ blis ishe hed, d, with withou outt assu assumi ming ng that that an increa increase se in bioava bioavaila ilabil bility ity autom automati atical cally ly transl translate ates s to enhanc enhanced ed efficacy.
Illustratively, in few cases, a new form with increased bio-availability migh mightt conf confer er sign signif ific ican antt bene benefi fits ts in term terms s of redu reduce ced d toxi toxici city ty.. Assume that the earlier known substance had to be administered at 10gm 10gm to be ther therap apeu euti tica call lly y effe effect ctiv ive, e, but but that that this this 10 gm was was significantly toxic to the patient. If the new form now enables 5 gm to deliver the same therapeutic impact with greatly reduced or no toxicity toxicity at all, this is a significant significant clinical clinical advantage advantage in so far as the patient is concerned. Such enhanced patient advantage ought to count as “efficacy” under section 3(d).20 It is pertinent to note in this rega regard rd that that the the regu regula lati tion ons s in rela relati tion on to the the ODA ODA stat state e that that a “diminution in adverse reactions may be sufficient to allow a finding of clinical superiority."21 19
Novartis AG v Union of India & Ors., Intellectual Property Appellate Board, M.P. Nos 1 to 5/2007 in TA/1 to 5/2007/PT/CH , M.P.No.33/2008 IN TA/1/2007/PT/CH, and TA/1 TO 5/2007/ PT/CH, at 51, June 26, 2009.
20
21
Supra note 1 at 243-244.
Orphan Orphan Drug Regulatio Regulations, ns, 57 Fed. Fed. Reg.
62,078, 62,078, See supra sub part Orphan
12
In other cases, it is possible that an increase in bio-availability does not convert to any significant therapeutic advantage at all.
In the specific facts of the case under dispute before this Hon’ble Court, the Petitioner sought to establish that when compared with the Imatinib free base, the beta crystalline form demonstrates a 30% increa increase se in bio-av bio-avail ailabi abilit lity. y. Howev However, er, this this by itself itself does does not demonstrate any therapeutic advantage in relation to the patient. Such advantage has to be independently established and has not been done in this case.
A commentator rightly notes: “It is not the intent of a bio-availability study to demonstrate effectiveness, but to determine the rate and extent of absorption. If a drug product is not bio-available, it cannot be regard regarded ed as effect effective ive.. Howev However er a determ determina inatio tion n that that a drug drug pro product duct is bio bio-av -availa ailab ble is
not not
in itse itself lf a
deter etermi mina nattion ion
of
effectiveness.22
D.
Proving Efficacy
When When it comes comes to eviden evidentia tiary ry requir requireme ements nts,, it is submit submitted ted that that section 3(d) ought not to be interpreted in the same way as a regulatory standard. The drug innovation process could be broadly divided into two phases, namely “drug discovery” and “drug development”. Patents Drug Act at 8-9. 22 42 FR 1640 1640 (1977 (1977). ). Cf. Mo Moffi ffitt, tt, Jane, Jane, Appropriateness of Bioavailability and Bioequivalency as Pre-Market Clearance Considerations, 34 Food Drug Cosm. L.J. 640 (1979).
13
are typically filed at the upstream drug discovery stage, when all that the applicant has is a potentially viable drug molecule. It is only later later that that the the drug drug is deve develo lope ped d and and test tested ed thro throug ugh h a seri series es of clinic clinical al trials trials and finall finally y brough broughtt into into the market market after after procu procurin ring g regula regulator tory y approv approval. al.
The time time gap betwee between n discover discovering ing a drug drug
molecule and developing it into a marketable drug can take several years. This is borne borne out by the present case itself, where the parent molec molecul ule e (Ima (Imati tini nib) b) was was firs firstt disc discov over ered ed in 1993 1993,, but but the the fina finall regulatory approval for a drug based on this molecule issued only in the year 2001. Therefore, in many cases, it is unlikely that at the patenting (drug discovery) stage, the applicant would possess any clinical trial data at all. It would would be irrational irrational and even unethica unethicall to insist on clinical clinical tria triall evid eviden ence ce only only for for the the purp purpos ose e of sati satisf sfyi ying ng pate patent ntab abil ilit ity y requirements under section 3(d). 23 For any such clinical trial testing would would involv involve e testin testing g a less less than than optima optimall substa substance nce (the (the known known substance) against its allegedly superior derivative. One might even argue that insisting on clinical trial type proof under section 3(d) would contravene the Helsinki Declaration, principle 21 of which states that trials and other experiments on humans can be perfor performed med only only if the impor importan tance ce of the object objective ive outwe outweigh ighs s the inhere inherent nt risks and burdens burdens to the researc research h subjec subjects. ts.
Subjec Subjectin ting g
human subjects to clinical trials for the sole purpose of crossing the threshold of section 3 (d) is unethical and unwarranted. One suggestion for the standard of proof could be as under: “The applicant need not prove “efficacy” under section 3(d) as a matter of statistical certainty. Nor does the applicant have to provide actual evidence of trials in humans. Instead, the applic applicant ant has to demons demonstra trate te a reason reasonabl able e correl correlatio ation n 23
Supra note 1 at 255-256.
14
betw betwee een n the the effi effica cacy cy clai claim med and and the the data data prov provid ided ed in support of this. Such reasonable evidence of the correlation can can be esta establ blis ishe hed d by rely relyin ing g on, on, inte interr alia alia,, stat statis isti tica call lly y relevant data documenting the activity of the new form and/or known known su subst bstanc ance, e, docum document entary ary eviden evidence ce (e.g. (e.g. article articles s in scientific journals), data generated using in vitro assays, or from testing in an animal model, other preclinical test data or any combination thereof”.24
E.
When hen ca can pr proo ooff of of eff effic icac acy y be be sub submi mitt tte ed?
In so far as pharmaceutical patent applications were filed prior to the introduction of the 2005 Patent Amendments, the patent office must
permit
patent
applicants
an
opportunity
to
file
documentation/evidence in support of section 3(d) at the time that it reviews the application for the first time. This is only fair and just, as the patent applicant could not have known of the future existence of section 3(d) at the time of filing her patent application. However, in so far as applications filed after the coming into force of the Patents (Amendment) Act, 2005 are concerned, no such opportunity need be provided. In such cases, if the filed specification does not contain any evidence of increased efficacy, the patent office is entitled to reject the application.
F.
What is the known substance for the purpose of
section 3(d)?
For an appropriate determination under section 3(d), the primary issue is: what is the “known substance” against which the enhanced “efficacy” comparison ought to be made? It is submitted that the standard for determining “known” substance 24
Supra note 1, at 256.
15
under section 3(d) ought to be the same as that used for determining novelty and anticipation under traditional patent law i.e. whether substance X that is claimed in a patent application is already part of the prior art and therefore anticipated? The test thus far employed in US and EU suggests that X is anticipated only if the prior art teaches a person skilled in the art to reproduce X without undue experimentation. In this regard, the intervenor wishes to draw the attention of the cour courtt to a Brit Britis ish h case case,, Syntho Synthon n BV v. Smith SmithKli Kline ne Beecha Beecham. m.25 In Synthon, the appellant Synthon BV applied to revoke Smith Kline’s pate patent nt for for a part partic icul ular ar crys crysta tall llin ine e form form of the the bloc blockb kbus uste terr drug drug paroxe paroxetin tine, e, based based on Syntho Synthon's n's own own earlier earlier patent patent applic applicati ation on.. Although Synthon was successful at the first instance, the court of appeals reversed the decision. Synthon accordingly appealed to the House of Lords. The leading opinion of the House of Lords was given by Lord Hoffman, who held that anticipation required proof of two distinct matters (1) the invention had been disclosed (2) the invention had been enabled viz. an ordinary skilled man would have been able to perform the disclosed invention if he attempted to do so by using the disclosed matter and common general knowledge. On the the issu issue e of “ena “enabl blem emen ent” t”,, Lord Lord Hoff Hoffma mann nn obse observ rved ed that that enable enablemen mentt means means ‘that ‘that the ordin ordinary ary skille skilled d person person would would have have been able to perform the invention invention which satisfies the requireme requirement nt of disclosure’. Enablement in the context of novelty, according to Lord Lord Hoff Hoffma man n was was the the same same as enab enable leme ment nt for for the the purp purpos ose e of determining sufficiency. It is important to note that disclosure and anticipation are distinct req re quir uiremen ements ts,, and and proof oof need needs s to be subm submit itte ted d on both both.. In assess assessing ing disclo disclosur sure, e, no aspect aspect of trial trial or err error or is permit permitted ted.. In 25
Synthon BV v. SmithKline Beecham plc [2006] RPC 10.
16
assessing whether or not the disclosure is enabled, a reasonable degree degree of experi experimen mentat tation ion can be expect expected ed and is permis permissib sible. le. Depe Depend ndin ing g on the the conc concep eptt unde underr cons consid ider erat atio ion, n, the the role role of the the skilled person is different. In assessing disclosure, the skilled person is attempting to discern what the author of the prior document art meant. In assessing enablement, the skilled person is not concerned with what what the the prio priorr art art may may have have mean meant, t, but but rath rather er,, whet whethe herr the the invention disclosed by the prior art could be made to work. As such, disclosure is an inquiry as to construction. Enablement is an inquiry as to what the skilled man would or would not be able to achieve. The importance of the separation of these two concepts is evident particularly in cases of simple “low-tech” inventions, where a simple disclosure of an invention will probably be enough to enable it, but in cases of high-tech inventions, the basic assertion of the existence of an invention may disclose it, but it may well require additional detailed description to enable a skilled person to perform it. 26
On the facts of the present case, it would appear based on the severa severall admis admissio sions ns made made by the Petiti Petitione onerr in variou various s docum document ents s incl includ udin ing g its its pate patent nt appl applic icat atio ions ns,, (inc (inclu ludi ding ng word wordin ing g such such as prep prepar arat atio ion n of salt salts s “kno “known wn per per se”) se”),, the the amor amorph phou ous s form form of Imatinib Mesylate could be made by a person skilled in the art as on 2007 2007 (the (the prior priority ity year year of the applic applicati ation on pertai pertainin ning g to the beta beta cry crystal stalli line ne for form) by re refe ferrring ing to the the disc disclo losu surres in the ’93 Zimmerman patent and the 1996 articles authored by Zimmerman and using common general knowledge.
26
See A Sharples and D Curley, ‘Experimental Novelty: Synthon v. SmithKline Beecham’ , 28(5) E.I.P.R 308-311 (2006); See Also A. Batteson, Patents: Enabling Disclosures 28(2) E.I.P.R 28 (2006).
17
WRITTEN SUBMISSIONS SUBMISSIONS ON BEHALF OF THE INTERVENOR (PART II)
II. II.
CONC CONCEP EPTU TUAL ALIZ IZIN ING G SEC SECTI TION ON 3(d) 3(d):: BUIL BUILDI DING NG A
BRIDGE? 18
While the intent behind Section 3(d) is laudable in that it seeks to impose a rigorous patentability threshold to prevent ever-greening (within the chemical arts) such that only truly meritorious inventions are granted patents, its execution leaves much to be desired. It is submitted that from an interpretative perspective, this Hon’ble court is left with two broad choices:
1. To trea treatt sect sectio ion n 3(d) 3(d) crit criter erio ion n as sepa separa rate te and and dist distin inct ct from from traditional patentability criteria, such as novelty, inventive step and utility.
2. To crea create te a brid bridge ge betw betwee een n sect sectio ion n 3(d) 3(d) and and the the trad tradit itio iona nall patent criteria, namely novelty, inventive step and utility. Under this approach, section 3(d) would be seen as a species of the general “inventive” step or non-obviousness non-obviousness test. test. In this sense, an invention that flunks the section 3(d) test would not amount to an “invention” within the meaning of section 2(j).
Each of these choices are explicated below.
A.
INDE INDEPE PEND NDEN ENT T PAT PATEN ENT T STA STAND NDAR ARD D UND UNDER ER SECT SECTIO ION N 3(d 3(d))
This choice is easier to implement than its alternative, in that the pate paten nt offic ffice e is at lib liber ertty to quali ualify fy an alle allege ged d inve inven ntio tion as “inventive”, whilst at the same time holding that it flunks the 3(d) test. This is precisely what the IPAB did in the present present case and the the adva advant ntag age e is that that one one need need not not go out out of the the way way to inte interp rpre rett 19
section 3(d) in consonance with other criteria. Howe Howeve ver, r, this this choi choice ce migh mightt open open Indi India a up to a pote potent ntia iall TRIP TRIPS S challenge. Article 27 of TRIPS reads as below: “…patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that that they they are are new, new, invo involv lve e an inve invent ntiv ive e step step and and are are capable of industrial application. Subject to paragraph 4 of Article 65, paragraph 8 of Article 70 and paragraph 3 of this this Artic Article, le, patent patents s sh shall all be availa available ble and patent patent rights rights enjoyable enjoyable without without
discrimination
as to the place of
invention, the field of technology and whether products are imported or locally produced.” 27
One might argue that section 3(d) amounts to the imposition of a new patentabil patentability ity criteria criteria i.e. a pharmaceut pharmaceutical ical derivative, derivative, which qualifies as an invention and is new, inventive and useful is now subjected to a further test, namely whether or not it satisfies the requirements of section 3(d). This therefore therefore violates the mandate under TRIPS to grant grant patents patents to inventions inventions that are new, inventive inventive and useful.
However, one might counter this by suggesting that those claims falling within the scope of section 3(d) are not really “inventions”.
1.
The ‘Invention’ Definition
Give Given n that that the the term term “inv “inven enti tion on” ” is not not defi define ned d unde underr TRIP TRIPS, S, 27
See also Panel Report on Canada- Patent Protection of Pharmaceutical Products, 17 March 2000, WT/DS114/R.
20
member states have some degree of flexibility in defining this term.
Practice of member states reveal that the term “invention” does not admit of a precise precise meaning. An English English judgment is illustrativ illustrative e in this regard, where Peter Prescott J held as below: 28
“How, then, does the law define what is an 'invention'? The answer is that nobody has ever come up with a sati satisf sfac acto tory ry,, allall-em embr brac acin ing g defi defini niti tion on and and I do not not suppose anybody will. By its very nature, therefore, the subject cannot be reduced to a precise verbal formula. It is, indeed, something of a moving target, because the progress of technology technology continues apace.”
At best, the term could be understood to mean something having a ‘technical’ or ‘technological’ character of some sort. 29 The fact that Article 27 uses this term in close conjunction with the phrase ‘fields of techno technolog logy’ y’ makes makes this this nexus nexus even even more more eviden evident. t. The Indian Indian patent act also veers towards this suggestion by its use of the term “technical advance” in section 2(ja). 28
See See Pete Peterr Pres Presco cott tt J’s J’s rulin ruling g in In the the Ma Matt tter er of Pate Patent nt Applic Applicat atio ions ns GB 0226884. 0226884.3 3 and 0419317.3 0419317.3 by CFPH LLC, [2005] [2005] EWHC 1589 (Pat) (Pat) available available at ml> (26 August August 2005).. See also NRDC's Application [1961] RPC at 162, where their Honours said in relation to the term ‘invention’: ‘To attempt to place upon the idea the fetters of an exact verbal formula could never have been sound…’ 29 Comments made in relation to the 2000 European Patent Convention (EPC) revision are illustrative in this regard: Nevertheless, the point must be made that patent protection is reserved for creations in the technical field. This is now clearly expressed in the new wording of Article 52(1) EPC. In order to be patentable, the subject-matter claimed must therefore have a "technical character" or to be more precise - involve a "technical teaching", i.e. an instruction addressed to a skilled person as to how to solve solve a partic particula ularr techn technica icall proble problem m using using partic particula ular r tech techni nica call mean means. s. It is on this this unde unders rsta tand ndin ing g of the the term term "invention "invention"" that the patent granting granting practice of the EPO and the jurisprudence of the Boards of Appeal are are based. See Basic Proposal for the Revision of the European Patent Convention 13 October 2000. . 00002a.pdf>.
21
Pete Peterr Pres Presco cott tt J agai again n tell tellin ingl gly y note notes: s: “….I “….Iff some someth thin ing g is an invention…… we can call it "technology" for short’.”30
Owing to this definitional difficulty, most member states resort to a ‘negative’ or exclusionary definition. 31 Thus for example, in Europe, Europe, ‘invention’ is defined to exclude the following: discoveries, scientific theories and mathematical methods; literary, dramatic, musical and arti artist stic ic work works, s, and and any any othe otherr ae aest sthe heti tic c crea creati tion ons s what whatso soev ever er;; schemes, rules and methods for performing a mental act, playing a game
or
doing
business,
and
programs
for
a
computer;
presentations of information; and methods of medical treatment. 32
Indian Indian law follows a similar similar format and section section 3 excludes excludes from the ambit ambit of patent patent prote protecti ction on a divers diverse e range range of subje subject ct matter matter.. It reads as below:
2.
What are not Inventions: Evaluating Section 3
The following are not inventions inventions within the meaning of this Act,— a. an inve invent ntio ion n whi which ch is friv frivol olou ous s or or whi which ch cla claim ims s any anyth thin ing g obviously contrary to well established natural laws; 30
See CFPH CFPH LLC LLC v Comp Comptr trol olle lerr-Ge Gene nera rall Marks [2005] EWHC 1589 (Pat) , at para. 92.
of Pate Patent nts, s, Desi Design gns s
and and
Trad Trade e
31
See NRDC (n 28) 28) which states that ‘… in telling us about patentable inventions, the Patents Act 1977 does not try to define what is an 'invention'. Instead, it contains a list of things that are not inventions.’
32
Art 52(2) of the European Patent Convention, 1977 (hereafter ‘EPC’). See also Article 15 of the Andean Community law (Decision 486-Common Provisions on Industrial Property (14 September 2000), available at WIPO Collection of Laws for Elec Electr tro onic nic Acces ccess s (CLEA CLEA)) data databa bas se) for a simi simila larr list list of exc exclus lusions ions.. (14 September 2005).
22
b. an inve invent ntio ion n the the prim primar ary y or or int inten ende ded d use use or com commerc mercia iall exploi exploitat tation ion of which which could could be contra contrary ry to public public order order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment;] c. the the mere mere disc discov over ery y of a sc scie ient ntif ific ic prin princi cipl ple e or the the formulation of an abstract theory [or discovery of any living thing or non-living substance occurring in nature;] d. the mere discovery of a new form of a known substance whic which h does does not not resu result lt in the the enha enhanc ncem emen entt of the the know known n efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant. Expl Explan anat atio ion n : For For the the purp purpos oses es of this this clau clause se,, salts, salts, esters, esters, ethers, ethers, polymor polymorphs, phs, metaboli metabolites, tes, pure form, particle size, isomers, mixtures of isom isomer ers, s, comp comple lexe xes, s, comb combin inat atio ions ns and and othe other r der derivat ivativ ives es of know known n subst ubstan ance ce shall hall be considered to be the same substance, unless they differ differ sig signif nifica icantl ntly y in proper propertie ties s with with regard regard to efficacy;] e. a substance obtain ained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance; f. the the mer mere e arr arran ange geme ment nt or re-a re-arr rran ange gem ment ent or or dup dupli lica cati tion on of know known n devi device ces s each each func functi tion onin ing g inde indepe pend nden entl tly y of one one another in a known way; g. Omitted by by Pa Patents (A (Amdt.) Ad Ad, 20 2002 h. a met meth hod of ag agricu ricult ltu ure or hor horti ticu cult ltu ure; re; i. any any proc proces ess s for for the the medi medici cina nal, l, su surg rgic ical al,, cura curati tive ve,, 1 prophylactic [diagnostic, therapeutic] or other treatment of huma human n bein beings gs or any any proc proces ess s for for a simi similar lar trea treatm tmen entt of animals to render them free of disease or to increase their economic value or that of their products. j. plants and animals in whole or any part thereof other than than micr microo-or orga gani nism sms s but but incl includ udin ing g seed seeds, s, vari variet etie ies s and and species and essentially biological processes for production or propagation of plants and animals; k. a mathematical or business method or a computer program per se or or algorithms; l. a literary, dramatic, musical or artistic work or any other aesthetic creation whatsoever including cinematrographic works and television productions; m. a mer mere e sch schem eme e or or rul rule e or or met metho hod d of of per perfo form rmin ing g men menta tall act or method of playing game; n. a presentation of information; o. topography of of in integrated ci circuits;
23
p. an invention which, in effect, is traditional knowledge or which is an aggregation or duplication of known properties of traditionally known component or components.
The Definitional Exclusions
A careful evaluation of these various exclusions reveal a diversity of rati ration onal ales es unde underl rlyi ying ng them them.. meaning
of
the
term
Some Some excl exclus usio ions ns flow flow from from the the
“invent ention”
(hereafter
“defi efinitional
excl exclus usio ions ns”) ”).. Thus Thus,, one one migh mightt argu argue e that that the the term term inve invent ntio ion n con connote notes s a man made ade cre creatio ation n with ithin the the tech techni nica call or the the technological field.
The exclusion of literary works (such as poems) under section 3(l) of the patent patents s act compor comports ts well with this ration rationale ale..
As an English English
judge notes: ‘Some kinds of ideas cannot be patented at all – even if new and very ingenious. For example, you could not patent the plot of a detective story. It would not be cons consid ider ered ed to be an 'inv 'inven enti tion on'' unde underr pate patent nt 33 law.’ .
Simila Similarly rly,, a mere mere discov discovery ery of a scient scientifi ific c princi principle ple or a natura naturall product (as excluded under section 3(c)) will fall outside the purview of the term “inventi “invention”. on”. For one has has not “created” “created” or “invente “invented” d” anyt anythi hing ng new new by huma human n inte interv rven enti tion on:: but but mere merely ly disc discov over ered ed something that was not known earlier. 34 This is best expressed in the language of Lord Kenyon in Hornblower v Boulton35: 33
Peter Prescott Prescott J’s ruling in In the Matter Matter of Patent Applications Applications GB 0226884 0226884.3 .3 and and 0419317 9317.3 .3 by CF CFPH PH LLC [2005 005] EWHC EWHC 1589 (Pat) Pat) avai availa labl ble e at ml> (26 August August 2005) 34
See Linda J. Demaine and Aaron Xavier Fellmeth, Reinventing the Double Helix: A Novel and Nonobvious Reconceptualization of the Biotechnology Patent , 55 Stan. L. Rev. 303, 373 (2002-03). 3 35
101 Eng. Rep. 1285
24
“…having “…having now heard heard everything everything that can be said on the subject, I have no doubt in saying, that this is a patent for a manufacture, which I understand to be something made by the hands of man.”36
And later, he states:
“Cou “Court rts s in the the Unit United ed Stat States es,, as we well ll,, have have emph emphas asiz ized ed on the the human intervention aspect of an invention. Illustratively, in Morton v New York Eye Infirmary 37, the New York Circuit Court expressed
the opinion that, “In its its naked aked ord ordinar inary y sen sense, se, a disc disco over very is not patentable. A discovery of a new principle, force, or law operating, or which can be made to operate, on matter, will not entitle the discoverer to a patent. It is only where the explorer has gone beyond the mere doma domain in of disc discov over ery, y, and and has has laid laid hold hold of the the new new principle, force, or law, and connected it with some particular medium or mechanical contrivance by which, or through which, it acts on the material world, that he can secure the exclusive control of it under the patent laws. He then controls his discovery through the means by which he has brought it into practical action, or their equivalent, and only through them. It is then an invention, although it embraces a discovery. Seve Severr the the forc force e or prin princi cipl ple e disc discov over ered ed from from the the means or mechanism through which he has brought it into the domain of invention, and it immediately falls out of that domain and eludes his grasp. It is then a naked discovery, and not an invention.38”
Secondly, Secondly, in order to constitute constitute an invention, invention, one might argue that the subject matter must necessarily be new, inventive and useful.
36
Id., at 1288.
37
5 Blatchf. 116, 17 F.Cas. 879 (1862)
38
U.S. 470, 476 (1974) Id., at 881. See also, Kewanee Oil Co. v. Bicron Corp., 416 U.S. (stating that “discovery is something less than invention”)
25
The Indian Patents Act explicitly recognizes this definitional component and articulates it in section 2(j), which defines invention as “a new new prod produc uctt or proc proces ess s invo involv lvin ing g an inve invent ntiv ive e step step and and capable of industrial application.”
Some Some of the the sect sectio ion n 3 excl exclus usio ions ns draw draw from from this this defi defini niti tion onal al component and categorically exclude certain subject matter from the purview of patentable inventions.
Sect Sectio ion n 3(e) 3(e) enca encaps psul ulat ates es such such a rati ration onal ale e by sugg sugges esti ting ng that that merely combining existing substances (when the combination does not yield a result greater than the sum total of the additions) is not patentable. It excludes “a substance obtained obtained by a mere mere admixture resulting
only
in
the
aggregati ation
of
the
properties of
the
components thereof or a process for producing such substance. This is a kind of “inventive step” or non-obviousness test.
The Policy Based Exclusions
The second broad category of section 3 exclusions are those that are made for “policy” reasons, whether explicit or implicit (hereafter “po “policy licy” ”
based ased excl exclus usio ions ns). ). The The
subj subjec ectt
matte atterr may may
be
an
“inven “inventio tion” n” from from the defini definitio tional nal stand standpoi point, nt, having having a signif significan icantt nexus with technology and being new, inventive and useful. Yet, it may be denied patents for reasons of policy.
Section 3(b) is an excellent illustration of this, where subject matter is inventive, new and useful is still excluded since it is “immoral” in some way. This section excludes from patentability, “an invention the primary or intended use or commercial exploitation of which 26
could be contrary to public order or morality or which causes serious prej prejud udic ice e to human uman,, anim nimal or plan plantt life life or hea ealt lth h or to the environment.” Examples might include a new and inventive device that aids in theft.
Similarly, section 3(i) excludes methods of medical treatment from the scope of patentability for policy reasons. 39 Section 3(h) is also illustrative of this, where the act deems a new and inventive method of agriculture of a process of treatment to be a non invention and therefore not patentable. 40.
This is a clear “deeming” provision under the law, where although technically the said subject matter may amount to an invention, the law deems them to be non inventions and therefore not patentable.
If sect sectio ion n 3(d) 3(d) is trea treate ted d as sepa separa rate te and and dist distin inct ct from from othe otherr patentability criteria and not a species of the inventive step test, then it qualifies as an exclusion made for policy reasons. The key ques questi tion on then then is: is: to what what exte extent nt can can memb member er stat states es carv carve e out out exclusions from the term “invention” based on policy reasons?
Prima facie, TRIPS appears to carve out very specific cases where 3 39
This exception is not unique to India. Illustratively, Art. 53(c) of the European Patent Convention contains a similar exception. For a list of other countries with simi simila larr exce except ptio ions ns,, see see Rich Richar ard d Gold Gold & Yann Yann Joly Joly,, The The Pate Patent nt Syst System em and and Research Research Freedom: Freedom: A Comparati Comparative ve Study , in Exclusions from Patentability and Exceptions and Limitations to Patentees’ Rights , (Report prepared by Bentley et al. al. for for WIPO WIPO Stan Standi ding ng Co Comm mmit itte tee e on the the Law Law of Pate Patent nts, s, SCP/1 SCP/15/ 5/3, 3, 2010 2010), ), < http://www.wipo.int/edocs/mdocs/scp/en/scp_15/scp_15_3available at annex1.pdf >. >. 4 40
Indian Indian Patent Patent Act, Act, 1970 1970,, S3(h) S3(h) exclud excludes es from from patent patentabi abilit lity, y, “a method method of agriculture or horticulture.”
27
one might bring in a policy based exclusion. Article 27.2 and 27.3 3 states: 2.
3.
Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protec protectt ordre ordre public public or moral morality ity,, includ including ing to protect human, animal or plant life or health or to avoi avoid d seri seriou ous s prej prejud udic ice e to the the envi enviro ronm nmen ent, t, provided that such exclusion is not made merely becaus because e the exploi exploitat tation ion is prohi prohibit bited ed by their their law.
Members ers ma may al also ex exclude fr from pa patentabi ability:
(a) diag diagno nost stic ic,, ther therap apeu euti tic c and and sur surgical ical met meth hods ods for for the treatment of humans or animals;
(b) plants and ani animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and micro microbio biolog logical ical proces processes ses.. Howeve However, r, Member Members s shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof. The provisions of t h is subparagraph shall be reviewed four years after the date of entry into force of the WTO Agreement.
One One migh mightt argue gue that any furt furthe herr poli policy cy excl exclu usio sions ar are e not sustainable under TRIPS. Therefore, a Section 3(d) type exclusion, if viewed as a policy based exclusion, might run foul of TRIPS. Panels are known to hew close to overly textual meanings of treaty terms 41 41
See Petros Petros C. Mavroi Mavroidis dis (2009 (2009), ), Chapte Chapterr 3 Licenc Licence e to Adjudi Adjudicat cate: e: A Critic Critical al Evaluation of the Work of the WTO Appellate Body So Far, in James C. Hartigan (ed.) Trade Disputes and the Dispute Settlement Understanding of the WTO: An Interdisciplinary Assessment (Frontiers of Economics and Globalization, Volume Emeral ald d Grou Group p Publ Publis ishi hing ng Limi Limite ted, d, pp.7 pp.733-90 90 wher where e he note notes s that that WT WTO O 6), Emer appellate body (AB) has “traditionally followed an (overly) textualist interpretative approach. This attitude is probably consistent with the incentive structure of a risk
28
and if the term “invention” is understood to mean something of a tech techni nica call or tech techno nolo logi gica call natu nature re,, then then new new form forms s of know known n chemical
substances
under
secti ction
3(d)
would
qualif lify
as
“inventions” within the meaning of TRIPS.
However, as one cannot predict with absolute certainty the outcome of a TRIPS challenge, given the fact that there is no consensus on what the term “invention” means. Suffice it to suggest that there is some some risk risk of a TRIP TRIPS S chal challe leng nge e and and a find findin ing g of cont contra rave vent ntio ion, n, should section 3(d) be divorced from regular patentability criteria and be seen as an independent stand alone test for patentability.
It also also bear bears s noti noting ng that that if this this line line of reas reason onin ing g we were re adop adopte ted d (namely that the only kind of policy based exclusions compatible with TRIPS are those that are explicitly carved out in Article 27.2 and 27.3), then 3(h) which excludes a method of agriculture from patentability may also be held to contravene TRIPS.
B.
THE
ALTERNATIVE:
BRIDGING
SECTION
3(d)
AND
INVENTIVE STEP
The second alternative is to interpret section 3(d) as nothing than a specific adaptation of the inventive step test to suit the specificities of chemicals/pharmaceuticals.
To this extent, it is seen as a species of the broader genus called averse agent who can always turn back and request from its principals to write a more complete contract next time.”
29
“inventive “inventive step” or non-obvio non-obviousnes usness. s. Such technolog technologically ically specific specific applications of general patentability standards and the evolution of sector specific tests are common in leading patent jurisdictions such as the US. Within the chemical arts, courts in the US and EU have evolve evolved d a speci specific fic obviou obviousne sness ss test test that that bears bears close close simila similarly rly to section section 3(d). 3(d). Courts Courts have held that structural structural similarities similarities between a pharma pharmaceu ceutic tical al substa substance nce that that is sought sought to be patent patented ed and an earlie earlierr known known substa substance nce trigge triggerr off a presu presumpt mption ion of prima prima facie facie obviousness.42 This presumption presumption can be dislodged dislodged only if the patent patent appl applic ican antt demo demons nstr trat ates es that that the the appl applied ied for for subs substa tanc nce e exhi exhibi bits ts “unexpected or surprising results.”
Alt Althoug hough h
unex unexpe pect cted ed
resu esults lts
43
are ar e
“therapeut “therapeutic” ic” advantages advantages alone, alone,44 discount
adv advantages
that
are
ordin dinar aril ily y
not
lim limited ited
to
cour courts ts have have been been know known n to mere
physical
advantage ages.
Illustratively, in Pfizer v Apotex 45, the CAFC (Court of Appeals for the Federal Circuit) strikes a distinction between therapeutic properties 42
In earlier cases, the presumption arose as soon as the structural similarity was established. In subsequent cases however (most notably Dillon), the court held that that one must also also demons demonstra trate te that that there there is some some motiva motivatio tion n to make make the claimed structurally similar substance. See In Re Diane M. Dillon, 919 F.2d 688 (Fed. Cir. 1990). 43
For a recent application of the US standard, see Takeda v Alphapharm, 480 F.3d 1348 (Fed. (Fed. Cir. 2007), 2007), where the court relied on two of its earlier decisions: decisions: In re Dillon, 919 F.2d 688, 692 (Fed. Cir. 1990), which held that “structural similarity between claimed and prior art subject matter, proved by combining references or otherwise, where the prior art gives reason or motivation to make the claimed compositions, creates a prima facie case of obviousness.” And In re Deuel (51 F.3d 1552, 1558 (Fed. Cir. 1995), where the court held that “A known compound may suggest its homolog, analog, or isomer because such compounds “often have simila similarr proper propertie ties s and theref therefore ore chemis chemists ts of ordina ordinary ry skill skill would would ordina ordinaril rily y contemplate making them to try to obtain compounds with improved properties.” Id page 9. 44
See Eli Lilly and Company v Premo Pharmaceutical Laboratories, Inc., 630 F.2d 120 (1980), where the court upheld the patentability of an oral antibiotic that was superior in terms of its mode of administration (it could be taken in tablet form, when compared with its predecessor that had to be taken intravenously). To this extent, the drug did not strictly exhibit increased “therapeutic efficacy”, but was a more advantageous dosage form/drug delivery mechanism.),
4 45
480 F.3d 1348 (2007)
30
and other properties (physical properties such as process-ability) of a pharmaceutical substance and appears to give the latter relatively much much less less weight weight while while assess assessing ing non-obv non-obviou iousne sness. ss.
The The court court
holds: “Fin “Final ally ly,, we do not not see see the the tria triall cour court’ t’s s find findin ing g that that amlo amlodi dipi pine ne besy besyla late te had had adeq adequa uate te phys physic icoc oche hemi mica call char charac acte teri rist stic ics s as suff suffic icie ient nt to upho uphold ld the the cour court’ t’s s ultimate holding of unexpected superiority…... At most, then, then, Pfizer Pfizer engage engaged d in routi routine, ne, verifi verificat cation ion testin testing g to optimize selection of one of several known and clearly suggested pharmaceutically-acceptable salts to ease its commercial manufacturing and marketing of the tablet form of the therapeutic amlodipine. Creating a “product or process that is more desirable, for example because it is strong stronger, er, cheape cheaper, r, cleaner cleaner,, faster faster,, lighte lighter, r, small smaller, er, more durable, or more efficient . . . to enhance commer commercia ciall oppor opportun tuniti ities es . . . is univer universal sal—an —and d even even common-sensical.” A scholar notes in this regard: “The “The Pfiz Pfizer er opin opinio ion n repe repeat ated edly ly emph emphas asiz ized ed that that the the besylate part of the claimed compound was merely a drug delivery vehicle that did not improve improve amlodipine amlodipine’s ’s ther therap apeu euti tic c effe effect ct.. “Bec “Becau ause se the the Feder ederal al Cir Circuit cuit discounted the physical properties of improved stability and tablet processing, Pfizer was unable to rebut the prima facie case of obviousness based on the prior art.” 46
Therefore, one might argue that section 3(d) simply asks whether or not a struct structura urally lly simila similarr new form form demons demonstra trates tes unexpe unexpecte cted d properties (such properties relating specifically to “efficacy”).
To this extent, it is nothing more than a species of the overall inventive step test laid down in section 2(ja). One might also see it 46
See JM Muelle Mueller, r, Chemic Chemicals als,, Combin Combinati ations ons,, and ‘Commo ‘Common n Sense’ Sense’:: How the Supr Suprem eme e Cour Court' t's s KSR KSR Deci Decisi sion on is Chan Changi ging ng Fede Federa rall Circ Circui uitt Obvi Obviou ousn snes ess s Determinations in Pharmaceutical and Biotechnology Cases 35(3) N. Ky. L. Rev. 281 (2008)
31
as a shor shortt cut cut for for dete determ rmin inin ing g whet whethe herr or not not some someth thin ing g is inventive.
A patent office faced with an alleged invention which potentially clai claims ms a new new form form of an exis existi ting ng subs substa tanc nce e woul would d do we well ll to therefore use section 3(d) as a short cut to determining inventive step. If the the alleged new new form fails fails the test of of section section 3(d), 3(d), that is evid eviden ence ce enoug enough h of the fact that that it is not not “inv “inven enti tive ve”. ”.
To this this
extent, one would avoid the incongruous ruling such as the one handed down by the IPAB and potentially avoid a TRIPS challenge as well.
However, it bears noting that section 3(d) alone is not dispositive of the “inven “inventiv tive e step” step” test. test. Rather Rather,, it might might so happen happen that even even desp despit ite e
the the
exis existe tenc nce e
of
sign signif ific ican antl tly y
enh enhance anced d
ther therap apeu euti tic c
efficacy, the new form was “obvious to try” with some reasonable expectation of success (it followed an “obvious” train of thought or came out of trial and error and fairly routine experimentation by the skilled person).
In such a case, the new form does not merit a patent, despite satisfying section 3(d).
In Pfizer vs Apotex, the court noted: “Alternatively, we hold that even if Pfizer showed that amlo amlodi dipi pine ne besy besyla late te exhi exhibi bits ts unex unexpe pect cted edly ly su supe peri rior or results, this secondary consideration does not overcome the strong showing of obviousness in this case. Although secondary secondary consideration considerations s must be taken into account, account, they hey do not nece neces ssar sarily ily cont contrrol the the obvio bviou usn snes ess s conclusion.
32
…patentability is not imparted where ‘the prior art would have suggested to one of ordinary skill in the art that this this proc proces ess s sh shou ould ld be carr carrie ied d out out and and woul would d have have a reasonable likelihood of success.’” Merck, 874 F.2d at 809 (quoting In re Dow Chem. Co., 837 F.2d 469, 473 (Fed. Cir. 1988)). For these reasons, we hold that Apotex introduced clear and convincing evidence that a skilled arti artisa san n woul would d have have had had a reas reason onab able le expe expect ctat atio ion n of success with the besylate salt form of amlodipine at the time the invention was made.”
In other ther wor words, ds, aft after usin using g sect sectio ion n 3(d) (d) as a shor hort cut cut for for dete determ rmin inin ing g whet whethe herr or not not a clai claime med d new new chem chemic ical al form form is inventive, the patent office would still need to subject the claimed form to the inventive step test in section 2(ja), which reads as below:
“ ‘inventive step’ means a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in the art;”
As I had noted earlier in an article 47:
“As can be seen from this definition, while the fundamental yardstick for measuring an ‘inventive step’ remains that which is “not obvious to a person skilled in the ar art” t”,, a req equ uir irem emen entt tha hatt th the e in inv ven enti tio on in inv vol olve ve a ‘technical ‘tech nical advance’ or have an ‘econ ‘economic omic significance’ significance’ of some sort has been added. This ch This chan ange ge in th the e st stan anda dard rd se seem ems s od odd, d, gi give ven n th that at th the e very purpose of the ‘inventive step’ criterion is to determine whether an invention sufficiently advances the technical arts so as to warrant an exclusive right. This is 47
See Shamnad Basheer, India’s Tryst with TRIPS : The Patents (Amendment) Act, 2005 , 1 Ind. J. L. Tech. 15 (2005).
33
no do doub ubtt ac achi hiev eved ed in an op opti tima mall ma mann nner er by th the e si simp mple le test of whether the inven enttion, though novel, is nonobvious to a person skilled in the art. ….Contra ….Con trary ry to sug sugges gestio tions ns by som some e com commen mentat tators ors,, the addition of ‘technical advance’ or ‘economic significance’ to the ‘non obviousness’ test does not dilute the ‘inventive step’ requirement… requirement….. ..48
In other words, given that the term “invention” relates essentially to technological arts (as earlier discussed), any alleged invention that represents a sufficient leap from the prior art will ipso facto amount to a “technical advance”.
It bears noting that a determination of inventive step, considered as the key patentability filter, is prone to a high degree of fact spec specif ific ic
ass assessm essmen entt,
and and
eval evalu uativ ative e
anal analys ysis is,,
mak akin ing g
for for
considerable variation in results.
WTO member states are free to devise appropriate standards and principles for determining inventive step, since the term is not defined under TRIPS. While some countries may opt for a lower threshold and permit a greater range of inventions to be patented, others others may opt opt for a strict stricter er standar standard. d.
The Indian Indian Patent Patent Act
1970, premised on the Ayyangar Report in large part, arguably supports a much higher threshold, particularly for pharmaceutical technology, as made evident by section 3(d).
The Viagra example is illustrative in this regard. The chemical substance, substance, Sildenafil Sildenafil Citrate, sold as Viagra Viagra by Pfizer, was the first effective oral treatment for MED (male erectile dysfunction), with up
48
Id., at 22.
34
to 82% of patients experiencing benefits. 49 At the time of this pathbreaking discovery, Sildenafil Citrate was already a known substance and was being tested by Pfizer for its ability to cure angina (blood pressure) pressure) and a specific specific form of heart ailment. Upon discovering its pote potent ntia iall new new use use as a cure cure for for MED, MED, Pfiz Pfizer er imme immedi diat atel ely y file filed d a patent.50
The U.K. courts, however, invalidated the patent on the ground that the new use would have been obvious to a person skilled in the art. 51 The court based its reasoning on the ground that the prior art includ included ed an articl article e by Rajfer Rajfer et al. and publis published hed patent patents, s,52 that would have prompted the person skilled in the art to evaluate the possib possibili ility ty of using using Silden Sildenafi afill Citrat Citrate, e, for the treat treatmen mentt of MED. MED.53 Famously, the court noted that it was worth a try.
49
See Darren R. Flower, Molecular Informatics: Sharpening Drug Design’s Cutting (2002), 17, Edge available at http://www.rsc.org/ebooks/archive/free/bk9780 http://www.rsc.org/ebooks/a rchive/free/bk97808540481 854048168/bk97808 68/bk978085404816 54048168800001.pdf . 50
Sildenafil Citrate essentially works by inhibiting an enzyme that retards the relaxat relaxation ion of the penile penile muscle muscle.. The relaxation of penile smooth muscle is traceable to chemicals called cyclic adenosine monophosphate or cAMP and cyclic guanosine monophosphate or cGMP. cGMP and cAMP are rendered ineffective by the action of a PDE enzyme. Viagra helps restore the potency of cGMP and cAMP by inhibiting the PDE enzyme with the help of certain other chemicals called PDE inhibitors. 51
See Lilly Icos Llc v. Pfizer Ltd [2002] EWCA Civ. 1 where the Court of Appeal in the U.K. upheld upheld the High Court decision decision delivere delivered d by Laddie, Laddie, J., in this regard regard (Pfizer Ltd v. Lilly Icos Llc [2000] EWHC Patents 49). 52
Two earlier Pfizer patent applications, namely EP 0463 756 and EP 0526 004, referred to respectively as Bell I and Bell II, covered Sildenafil Citrate, along with a numb number er of othe otherr chem chemic ical als, s, prop propos osing ing thei theirr use use for for a numb number er of medi medica call applications, but not the treatment of MED specifically. However, these patents disclosed the use of Sildenafil Citrate as a PDE inhibitor for the treatment of such complaints as angina and hypertension. 53
Lilly y Icos Icos Llc Llc v. Pfiz Pfizer er Ltd. Ltd. [200 [2002] 2] EWCA EWCA Civ. Civ. 1, ¶ 54 available See Lill available at http://www.bailii.org/ew/cases/EWCA/Civ/2002/1.html (last visited Jan. 18, 2011) (citing the key prior art evidence as Rajfer J. et al., Nitric Oxide as a Mediator of Rela Relaxa xati tio on of the the Corp Corpus us Cave Cavern rno osum sum in Res Respons ponse e to Non Nonadre adrene negi gic, c, Noncholinergic Neurotransmission, (1992) 326 N EW ENG. J. MED. 90).
35
However, the Federal Court of Appeals in Canada rejected the above line of reasoning and held that a mere “worth a try” possibility did not preclude inventiveness. Rather, the claimed invention would be obvious, only when the “try” was a matter of routine and required no significant thinking or effort. 54
The divergent conclusions on obviousness obviousness discussed above stem stem not only from a differential subjective assessment of the same facts, 55 but also due to a difference in legal standards. As can be seen from the above discussion, Canada preferred a lower non-obviousness or invent inventive ive step step thresh threshold old that would would have have found found in favour favour of the patentability of a larger number of inventions than the UK regime. 56 54
Compare Pfizer Canada Inc. v. Apotex In c . (F.C (F.C.A .A.) .),, 2009 2009 FC FCA A 8, [200 [2009] 9] 4 F.C.R F.C.R.. 223, 223,¶ ¶ 28-3 28-31 1 available at http://rep http://reports. orts.fja.g fja.gc.ca/ c.ca/eng/2 eng/2009/ 009/2009 2009fca8 fca8/200 /2009fca 9fca8.ht 8.html ml (last visited Jan. 18, 2011). (following the standard laid down by the Canadian Supreme Court in an earlier pharmaceutical case, Apotex Inc. v. Sanofi-Synthelabo Canada et al 2008 SCC 61), 61), with 2008 SCC SCC 61 with Apotex Apotex Inc. Inc. v. Sanofi Sanofi-Sy -Synth nthela elabo bo Canada Canada et al 2008 http://scc.lexum.umontreal.ca/en/2008/2 l.ca/en/2008/2008scc61/2 008scc61/2008scc61.pdf 008scc61.pdf avai availa labl ble e at http://scc.lexum.umontrea (last visited Jan. 18, 2011), (holding that: “For a finding that an invention was ‘obvious to try’, there must be evidence to convince a judge on a balance of prob probab abil ilit itie ies s that that it was was more more or less less self self-e -evi vide dent nt to try try to obta obtain in the the invention. Mere possibility that something might turn up is not enough.”)
55
The US and other leading patent jurisdictions hold non-obviousness or inventive step to be a question of law, albeit one is that predicated heavily on underlying facts. See In re Kubin, 561 F.3d 1351, 1355 (Fed. Cir. 2009) ( “Obviousness is a question of law based on underlying findings of fact.”) See also Professor Chris Cotropia, KSR and the Line between Fact and Law, (May, 2007), available available at http://www.patentlyo.com/patent/2007/05 http://www.patentlyo.com/p atent/2007/05/ksr_and_the_lin.html /ksr_and_the_lin.html (last visited Jan. 19, 2011) (“Owing to the highly intensive fact specific nature of the enquiry and the subjectivity of the assessment, it is evident that courts may come to differing conclusions on the facts of the same case.”)
56
See Pfizer Canada Inc. V . Apotex Apotex Inc., 2009 FCA 8, [2009] 4 F.C.R. 223, where the court noted: ““….the test applied by Mr. Justice Laddie appears to be met if the prior art indicates that something may work, and the motivation is such as to make make this this avenue avenue “wort “worthw hwhile hile” ” to pursue pursue (Pfize (Pfizerr Ltd., Ltd., at paragr paragraph aph 10 107, 7, as quoted quoted at paragr paragraph aph 42 above) above).. As such, such, a soluti solution on may may be “worth “worthwhi while” le” to pursue even though it is not “obvious to try” or in the words of Rothstein J. even though it is not “more or less self-evident” (Sanofi-Synthelabo, at paragraph 66). In my view, this approach which is based on the possibility that something might work, work, was was expres expressly sly reject rejected ed by the Suprem Supreme e Court Court in Sanofi Sanofi-Sy -Synth nthela elabo, bo, at paragraph 66.”
36
India is free to therefore devise her own standard for obviousness or inventive step without necessarily toeing the US, EU or any other country on this count.
C.
MAKI MAKIN NG SEN SENSE SE OF THE THE PAT PATEN ENT T TER TERM MINO INOLO LOGY GY
The Patent Act is creased in several parts, particularly in the aftermath of the 2005 amendments. Some of these creases can be ironed out by interpreting terms by drawing meaning from other provisions in the Act.
The Act uses the following terms: i)
invention
i i)
product
i i i)
process
iv)
substance
v)
entity
v i)
phar arm mace aceutical substanc ance
vii) vii)
phar pharm maceu aceuti tica call pro rod duct uct
Most Most patent patent regime regimes s includ including ing TRIPS TRIPS uses uses the terms: terms: invent invention ion,, produc productt and proces process. s.
Produc Productt and proces process s have have fairly fairly standar standard d
connotation and are often used in contradistinction to each other 57
The Indian Patent Act also uses these terms in the following sections:
57
See WIPO, Fields of Intellectual Property Protection, in WIPO: INTELLECTUAL PROPERTY HANDBOOK : POLICY, LAW & USE 16, 17 (““Invention” means a solution to a specific problem problem in the field of technolo technology. gy. An invention invention may relate relate to a product product or a process.”)
37
Section 2(j): "invention" means a new product or process involving an inventive step and capable of industrial application;
Section 48 stipulates that: ….a patent granted under this Act shall confer upon the patentee— (a) where the subject matter of the patent is a product, the exclusive right to prevent third parties, who do not have his consent, from the act of making, using, offering for sale, selling or importing for those purposes that product product in India: (b) where the subject matter of the patent is a process the exclusive right to prevent third parties, who do not have his consent, from the act of using that process, and from the act of using, offering for sale, sellin selling g or import importing ing for those those purpo purposes ses the produ product ct obtained directly by that process in India:
Therefore the registrability of a patent and its rights really apply to only two broad categories: “product” and “process”. And one has to fit in all claimed subject matter within these terms. To this extent, terms such as “substance”, article, 58 entity, etc., have to be read in conformity with these terms.
Section 3(d) outlines what is a patentable invention: any new form that demonstrates significantly enhanced efficacy is an invention and and gets gets prot protec ecti tion on as a prod produc uct. t. In othe otherr word words, s, a new new form form qualifies as a patentable product (and a new substance) only when it demonstrates significantly enhanced efficacy. As to the kind of 58
See section 2(o) which defines "patented article" article" and "patented "patented process" process" to mean respectively an article or process in respect of which a patent is in force;
38
protection that a product is entitled to, Merrel Dow vs Norton59 is illustrative:
“The “The sc scop ope e of the the mono monopo poly ly conf confer erre red d by a prod produc uct t claim is defined by section 60(l)(a), which provides that where the invention is a product, a person infringes the patent if, without the consent of the proprietor, he "makes, disposes of, offers to dispose of, uses or imports the product or keeps it wheth ether for disposal or otherwise." For this purpose it does not matter how the product is made or what form it takes. The monopoly covers covers every every metho method d of manuf manufact actur ure e and every every form form 60 which comes within the description in the claim”.
And later: “It is generally accepted as a principle underlying the EPC that a patent which claims a physical entity per se, confers absolute protection upon such physical entity; that is, wherever it exists and whatever its context. ... It follows that if it can be shown that such physical entity (that is, a compound) is already in the state of the art (for (for exampl example e in the contex contextt of a partic particula ularr activi activity) ty),, then a claim to the physical entity per se lacks novelty”.61
Needless to add the very process of creating the new form may itse itself lf be pate patent ntab able le inde indepe pend nden entl tly, y, if it is demo demons nstr trat ated ed to be “new” and “inventive”.
Whither Section 2(ta)?
59
[1995] UKHL 14.
60
Id., at para 13.
61
ara 14. (quo quoting ing Id., at para additive [1990] EPOR 73)
Decisi Decision on
G02/88 G02/88 MOBIL/ MOBIL/Fri Fricti ction on
reduci reducing ng
39
The term pharmaceutical substance has been defined in section 2(ta) to mean: "pharmaceutical substance" means any new entity involving one or more inventive steps.”
This is a rather curious definition, since the term does not find mention anywhere else in the Act. As noted in an earlier article: 62
“The term ‘pharmaceutical substances’ has been rather strangely defined in section 2(1)(ta) 2(1)(ta) as “any new entity involving one or more inventive steps”. Defined in such a br broa oad d wa way, y, on one e is fo forc rced ed to qu quer ery: y: wo woul uld d a mo mobi bile le phone that deploys advanced technology be a pharmaceutical substance if it is shown that such entity is new and involves one or more inventive steps? What is ev What even en mo more re pe perp rple lexi xing ng ab abou outt th this is de defi fini niti tion on is the fact that the term ‘pharmaceutic ‘pharmaceutical al subs substance’ tance’ does not find mention anywhere else in the Patents Act. 25 In the absence of such a term in the Act, one wonders why the th e le legi gisl slat atur ure, e, in al alll it its s wi wisd sdom om,, di did d no nott se see e it fi fitt to 63 clarify this concept.” It is pertinent to note in this regard that Section 92A, which deals with compulsory licenses in the context of exports to countries with minimal minim al manuf manufactur acturing ing capab capabilitie ilities, s, uses the term ‘phar ‘pharmaceu maceutical tical prod pr oduc ucts ts’. ’. Ho Howe weve verr th this is te term rm is use sed d in a di diff ffer eren entt se sens nse e th than an ‘pharmaceutical substances’, as is made evident by the fact that it is defined in section 92A itself. The absurd definition in section 2(1)(ta) cannot therefore apply to ‘pharmaceutical products’ under section 92A. If one were keen on investing some meaning in this insertion of a term that finds no mention anywhere else in the act, one might argue that it offers some support for the proposition that section 62
See Shamnad Basheer, India’s Tryst with TRIPS: The Patents (Amendment) Act, 2005 , 1 Ind. J. L. Tech. 15 (2005). 6 63
Id., at 23.
40
3(d) is a species of the inventive step test, as applied specifically to the pharmaceutical arts. The definition of pharmaceutical substance substance as a new entity involving one on e or mo more re in inve vent ntiv ive e st step eps s es esse sent ntia iall lly y me mean ans s th that at in or orde derr to constitute a new pharmaceutical substance, an allegedly new form must necessarily entail one or more inventive steps.
III. II I.
INHE IN HER REN ENT T ANTI TIC CIPAT ATIO ION N AND APPOI OIN NTMEN ENT T OF
EXPERT The key issues are: 1. Wa Was s
the
beta
crystalline
version
of
imatinib
mesylat late
effe effect ctiv ivel ely y enab enable led d by the the 1993 1993 pate patent nt and and subs subseq eque uent nt literature that preceded the priority date of the 1998 patent application covering the beta crystalline version (the priority date for the 1998 application is 18 July, 1997) 2. Even Even if it was not enabl enabled ed by the the prio priorr art, art, could could the beta beta crys crysta tall llin ine e form form have have been been said said to be obvi obviou ous s to a skill skilled ed person from the prior art?
If the the pers person on skil skilled led in the the art art atte attemp mpti ting ng to prod produc uce e imat imatin inib ib mesylate (as per the disclosure in 1993 patent and other relevant prior art existing up to July 1997) would necessarily produce the beta crystalli crystalline ne version version (since (since the compound compound naturally naturally expresses expresses itself in this form), then the beta crystal will be found to have been anticipated. Such a conclusion holds good even if such a skilled person obtaining the beta crystalline form is unable to characterize it as a beta crystalline form.
It is subm submit itte ted d that that in such such case cases, s, the the beta beta crys crysta tall llin ine e form form is 41
anticipated under the doctrine of inherent anticipation, a doctrine explicated well in Schering Corp. v. Geneva Pharmaceuticals, Inc.64 In this this cas case, Sch Scher erin ing g had a paten atentt cove coverring ing lor loratad atadin ine, e, an antihistamine marketed as Claratin. Schering subsequently filed a second patent on descarboethoxyloratadine (“DCL”) that is naturally prod produc uced ed by the the huma human n body body as a meta metabo boli lite te of lora lorata tadi dine ne.. 65 Notwithstanding the lack of any prior art teaching of DCL, or any other metabolite of loratadine, the Court held that Schering’s prior art patent claiming loratadine inherently anticipated its subsequent patent. This is because DCL was “necessarily and inevitably” formed upon the metabolism of loratadine. Inherent anticipation does not require that the inherent feature be appreciated appreciated or recognized recognized at the time of the earlier earlier patent, as long as the disclosure is a "necessary and inevitable" consequence of the earlier invention.
66
Based on the above, if the beta crystalline version automatically results from the teachings of the prior art, it is anticipated, even if the skilled person is unable to identify or characterize it.
Conversely, if the beta crystalline version does not automatically result from the teachings of the prior art, it cannot be held to be anticipated. However, it may still still be held to be obvious obvious to a person skilled in the art, in the light of prior art. In order to optimally resolve such complicated technical issues for the future, future, the intervenor intervenor requests requests that this Hon’ble Hon’ble Court Court suggest suggest 64
339 F.3d 1373, 1382 (Fed.Cir. 2003).
65
Id. at 1375.
66
Supra note 38 at 1378-80
42
that lower courts and tribunals appoint independent experts under section 115 of the Patents Act. In the case at hand, such an expert could, at the very least, have been tasked with helping determining whether or not the prior art would have rendered Imatinib Mesylate inherent.
IV.
PATENT PATENTS, S, PUBLI PUBLIC C ORD ORDER ER AND EX EXCE CESSI SSIVE VE PRICI PRICING NG
The IPAB held that the beta crystalline form of imatinib mesylate was was not not elig eligib ible le for for a pate patent nt unde underr sect sectio ion n 3(b) 3(b),, sinc since e a drug drug corresponding to the patent had been priced excessively. Section 3(b) currently reads as under: “3. What “3. What are are not not inve invent ntio ions ns:: The The foll follow owin ing g are are not not inventions within the meaning of this Act… (b) (b) an inve invent ntio ion n the the prim primar ary y or inte intend nded ed us use e or commercial exploitation of which could be contrary to be publ public ic orde orderr or mora morali lity ty or whic which h caus causes es seriou serious s prejud prejudice ice to human, human, animal animal,, plant plant life life or health or to the environment
According to the IPAB, the excessive price of Glivec would create publ public ic diso disord rder er and and was was ther theref efor ore e inel inelig igib ible le for for a pate patent nt unde underr section 3(b) of the the Indian patents act. In the words words of the IPAB “…But as per per info inforrmatio ation n furni urnish shed ed in its its writ writte ten n counter–argument by R 3 that when the Appellant was holding the right as EMR on GLEEVEC it used to charge Rs. 1, 20,000/- per month for a required dose of the drug from a cancer patient, not disputed by the Appellant, which in our view is too unaffordable to the poor cancer patients in India. Thus, we also observe that a grant of product patent on this application can create a havo havoc c to the the live lives s of poor poor peop people le and and their their fami famili lies es affected with the cancer for which this drug is effective. This will have disastrous effect on the society as well. Considering all the circumstances of the appeals before
43
us, we observ us, observe e that that the Appell Appellant ant’s ’s allege alleged d invent invention ion won’t be worthy of a reward of any product patent on the basis of its impugned application for not only for not satisfying the requirement of of section 3(d)of the Act, but also also for its possib possible le dis disast astrou rous s conseq consequen uences ces on such such grant as stated above, which also is being attracted by the provisions of section 3(b) of the Act which prohibits grant of patent on inventions, exploitation of which could create public disorder among other things”
It is submitted that this is a wrong legal proposition. Under current Indian patent law, the excessive price of a drug cannot be a ground for denying a patent to an invention underlying the said drug. The key issue at the time of granting a patent is whether the invention represents a good enough technical/scientific advance to merit a twenty year monopoly?
Any potential for patent abuse is redressable through a number of ex-post (prospective) mechanisms such as compulsory licensing and
price control and ought not to factor in during the stage of grant of a patent, not least because very often, there is no product at the stage of grant of a patent.
Secondly, such an additional patentability criterion could fall foul of TRIPS. Under Article 27 of TRIPS, all inventions (barring those mentioned in paragraphs 2 and 3 of that Article) are patentable. Although the terms ordre public or morality are fairly subjective and dependent on the particular socio-cultural mores of a country at a give given n poin pointt in time time,,67 an exce except ptio ion n base based d on ‘pub ‘publi lic c ordr ordre’ e’ and and 67
Basheer, Purohit and Reddy, “Patent Exclusions that Promote Public Health Objectives” Report by Bentley et al “Exclu “Exclusio sions ns from from Patent Patentabi abilit lity y and Except Exception ions s and Limita Limitatio tions ns to Patent Patentees ees’’ Rights”, WIPO Standing Committee on the Law of Patents, SCP/15/3, September 2010, available at < http://www.wipo.int/edocs/mdocs/scp/en/scp_15/scp_15_3http://www.wipo.int/edocs/mdocs/scp/en/scp_15/scp_15_3annex1.pdf>.
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‘morality’ in Article 27.2 can be applied only when it is necessary to prevent the “commercial exploitation” of the invention. 68 In other words, words, Article 27.2 of the TRIPS applies only if a prohibition prohibition against the commercial exploitation of the invention is necessary to protect ordre public or morality and only if the exclusion from patentability
will will likewi likewise se contri contribut bute e to the prote protecti ction on of that that ordre ordre public public or morality.69 This could suggest, as some have argued, that in order to justify a patent as immoral or against public order, one must first have have a law law whic which h prev preven ents ts the the comm commer erci cial al expl exploi oita tati tion on of the the particular product. 70 Or one must at least show the existence of circum circumsta stance nces s necess necessita itatin ting g such such a law or ban. ban. 71 Under such an interpretation, unless India bans the sale of Glivec or shows that Glivec is otherwise harmful, it cannot exclude a patent covering it on the grounds of public order or morality.
Thirdly, Article 27.2 appears to be predicated on a “necessity test” to assess whether protection of an overriding social interest is justified.72 Ther Theref efor ore, e, any any meas measur ure e take taken n is just justif ifie ied d only only if no 68
Patents: Ordre Public and Morality, Resource Book on TRIPS and Development, available at . 69
Charle Charles s R. McMani McManis, s, Patent Patenting ing Geneti Genetic c Produc Products ts and Proces Processes ses:: A TRIPS TRIPS available at Perspective, (citing Nuno Pires de Carvalho, The TRIPS Regime of Patent Rights 170-173 (2003)). 70
Nuno Pires De Carvalho, The TRIPS Regime of Patent Rights, 2nd edn. Kluwer Law International,Hague 2005 at 209.
71
Dan Leskien & Michael Flitner, Intellectual Property Rights and Plant Genetic Resources: Optionsfor a Sui Generis System (Issues in Genetic Resources No. 6 June 1997), In ternational Plant Genetic Resources Resources Institute. 72
Though TRIPS constitutes the lex specialis for dealing with patent issues in the WTO framework, the GATT/WTO jurisprudence on Article XX of GATT is likely to play a role in the interpretation of the said Article. [Citing India- Patent Protection for Pharmaceutical and Agricultural Chemical Products case (WT/DS50)]. Article XX (a) and (b) of GATT have a similar structure to Article 27.2, and it is clear that,
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reasonable alternative is available to a Member. Here, as stated above, above, altern alternati atives ves such such as compul compulsor sory y licens licensing ing,, price price contro controll mechan mechanism isms s are ‘reaso ‘reasonab nably ly availa available ble’. ’. Hence Hence in this this case, case, one might argue that the conditions of Article 27.2 of TRIPS have not been satisfied.
For all the above reasons, it is submitted that the rejection of a patent based on excessive price of the final patent product has no basis in Indian patent law.
for the purposes of these these provisions provisions,, exclusions exclusions must be objective objectively ly justified. justified. [GATT Analytical Index , Vol. I, p. 518 et seq.]. Applying principles of the GATT that interpret similar provisions in Article XX, the necessity test must be applied to determine whether a) it is necessary to public morals, and b) that it is necessary to protect human, animal or plant life.
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