shamnad basheer's written submissions
TRANSCRIPT
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 court in evolving a framework and a set of
propositions for resolving patent disputes, particularly disputes around
pharmaceutical patents and section 3(d). Being an academic, the interests of the
intervenor lie in the robust development of sound patent jurisprudence for India
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 inventions: The following are not inventions within the
meaning of this Act….
(d) the mere discovery of a new form of a known substance which does not
result in the enhancement of the known efficacy of that substance or the
mere discovery of any new property or new use for a known substance or of
1
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.
Explanation: For the purposes of this clause, salts, esters, ethers,
polymorphs, metabolites, pure form, particle size, isomers, mixtures of
isomers, complexes, combinations and other derivatives of known substance
shall be considered to be the same substance, unless they differ significantly
in properties with regard to efficacy.
In essence, section 3(d) stipulates that a new form of a known substance would
be patentable only when the said new 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 does “efficacy” mean?
2. Does increased bioavailability qualify as enhanced “efficacy”?
3. What is the standard of proof required to establish “efficacy”?
4. When must proof of efficacy be produced?
5. What is the meaning of the term “known substance” under section 3(d)?
A. Meaning of “Efficacy”
The term “efficacy” is central to interpreting the scope and ambit of section 3(d).
More specifically, the issue is whether or not efficacy ought to be interpreted
narrowly to mean only “therapeutic” 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 High Court held that “efficacy” meant only “therapeutic” efficacy and
not every advantageous property claimed for the new drug derivative in
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
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 3(d). However,
one important caveat needs to be borne in mind; section 3(d) is not limited to
pharmaceutical technology alone. Rather, it applies also to chemicals (such as
paints) and agro-chemicals (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 therapeutic efficacy in the
pharmaceutical context, it would 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 conformity with prevailing patent
jurisprudence in countries such as the US and EU which have been known to
interpret facially neutral patent standards in a 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
pharmaceutical derivatives would be considered the same “substance”, unless
“they differ significantly in properties with regard to efficacy.”
The above clause refers to only those “properties” that have some bearing on
2 Novartis AG & Anr. v. Union of India & Othrs., (2007) 4 MLJ 1153 at para 13 also available at <http://www.indiankanoon.org/doc/1111498/> (last visited 12 August, 2011).
3 Supra note 1 at internal page 244.
4 See Dan L Burk and Mark A Lemley, Policy Levers in Patent Law 89 Va. L Rev. 1575, 1662 (2003). See Also Dan L Burk and Mark A Lemley, Is Patent Law Technology– Specific? 17 Berkeley Tech. L.J. 1155, 1184 (2002).
3
“efficacy” and not all properties. If "all 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."
Therefore, not all advantageous properties of a new form (such as improved
processability or flow characteristics, storage potential etc) ought to qualify
under section 3(d), but only those properties that have some bearing on efficacy.
Although this precise line of argument pointing to the phrase “properties with
regard to efficacy” does not appear to have been explicitly made by either the
Madras High Court or the IPAB to support their conclusion, it is one that
compellingly supports a restrictive interpretation of the term “efficacy”.
This interpretation is further buttressed by the objectives of the Act, which
suggests that section 3(d) was introduced to prevent ever-greening.5 The Madras
High Court states in this regard:6
“…We have borne in mind the object which the Amending Act wanted to
achieve namely, to prevent ever-greening; 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…”
5 See Transcript of Parliamentary Debate, March 22, 2005, where Shri Kurup makes a statement indicating that the section is being brought in to prevent ever-greening. See also statements of Madras High Court in this regard.
6 Para 19 of the judgement.
4
Although the term ever-greening does not have a scientific definition as yet, it is
widely understood to mean an inappropriate extension in patent monopoly
which does not convert to a significant benefit for the patient.7
Put another way, it is a patenting strategy “consisting of acquiring patents on
minor, often trivial, modifications of existing pharmaceutical products or
processes in order to indirectly extend the period of patent protection over
previously patented compounds.”8
B. Exploring the Contours of Therapeutic Efficacy
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 overall
scheme of the Act and the links between Section 2(j), Section 2(ja) and Section 3.
In terms of the link with drug regulatory concepts, it is important to note that
section 3(d) borrows extensively from a EU 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 same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been
7 'Ever-greening' is not a formal concept of patent law. It is best understood as a social idea used to refer to the myriad ways in which pharmaceutical patent owners utilise the law and related regulatory processes to extend their high rent-earning intellectual monopoly privileges, particularly over highly profitable (either in total sales volume or price per unit) 'blockbuster' drugs. T. A. Faunce & J. Lexchin, 'Linkage' pharmaceutical ever-greening in Canada and Australia, available at: < http://law.anu.edu.au/StaffUploads/236-Art%20ANZHP%20Linkage%20Evergreening.pdf> (last visited 31 August, 2011).8
? See Carlos Correa “Guidelines for Examination of Pharmaceutical Patents”, available at: <http://www.iprsonline.org/resources/docs/Correa_Patentability%20Guidelines.pdf> (last visited 31 August, 2011). See Also A. Kesselheim, Intellectual Property Policy in the Pharmaceutical Sciences: The Effect of Inappropriate Patents and Market Exclusivity Extensions on the Health Care System, available at: <http://www.aapsj.org/view.asp?art=aapsj0903033> (last 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.”).
5
demonstrated by appropriate bioavailability studies. The different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in properties with regard to safety and/or efficacy. In such cases, additional information providing proof of the safety and/or efficacy of the various salts, esters or derivatives 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 regimes are distinct. While the patent system is meant to
grant protection to inventions that demonstrate technical/technological merit
with a view to incentivizing innovation, a drug regulatory 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 provide
protection to those inventions providing a genuine advantage to patients (as
opposed to ever-greened varieties), efficacy ought to be defined as any
“therapeutic advantage” and not just “efficacy” as strictly understood in a drug
regulatory sense.
It is pertinent to note in this connection that under most 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 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
6
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 section 3(d) ought
to be interpreted to mean any “therapeutic advantage” including one that flows
from significantly reduced toxicity.
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 to help incentivise the 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 that pharmaceutical companies generally shy away from research on
orphan drugs, owing to the lack of large markets for such drugs, the ODA was
brought into existence to grant additional incentives for creating such drugs to
benefit minority patient 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 costs and also make a healthy profit during this period of exclusive
protection. Contrast this with regular data exclusivity regimes, which grant drug
originators a period of exclusivity lasting only 5 years from the date of their
approval. Further, such exclusivity is limited to preventing the use of and
reliance upon “data” submitted by the drug originator to regulatory authorities,
9 Susan Thaul, How FDA Approves Drugs and Regulates Their Safety and Effectiveness, CONGRESSIONAL RESEARCH SERVICE, 5 (Jun., 2012), available 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.”)
11 21 USC §360ee(b) (2) (1994).
7
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 submitted. In other
words, the protection is against all follow-on drug manufacturers, who cannot
enter the market, even if they repeat the clinical trials and are able to submit
independently generated data.13
Complete market exclusivity, as opposed to mere data exclusivity, would mean
that no follow-on manufacturer can make or 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 to
provide a significant therapeutic advantage over and above that provided by an
approved 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
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).
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.
8
drug makes a major contribution to patient care in "unusual cases."16
It bears noting that the ODA norms above mentioned are not strictly “regulatory”
in nature. Rather, they act as incentives for innovation in a manner similar to
patents. Therefore these norms 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 3(d) context however, the old 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 beta crystalline).
Further, in some cases where patent 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 developed as
a drug and submitted to the drug regulator for regulatory approval.
It is therefore submitted that the standard of proof required to demonstrate
significant therapeutic advantage cannot be as onerous as that expected for drug
regulatory regimes such as the ODA, an aspect dealt with in a later section.
C. Does increased bioavailability amount to significantly enhanced
15 The terms therapeutic advantage and clinical superiority are interchangeable. 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 (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. §. 316.3 (b) (3) (iii) (1999).
9
efficacy?
It is humbly submitted that the short answer to this is 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 has to be assessed on a case-by-case
basis; the answer cannot be a blanket yes or no.
Bioavailability means “the rate and extent to which the active drug ingredient or
active moiety is absorbed from a drug product and becomes available at the site
of drug action”.17 It is usually determined by measuring the concentration of a
substance 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
Bioavailability in short relates to “absorption”. The IPAB 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 Parthasarathy, learned counsel appearing also on behalf of R 6 & R 7. Shri Parthasarathy explained that the drug action process which broadly be divided into three categories – absorption, binding 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 therapeutic response. After the active ingredient was absorbed by the body, for it to act, it must bind with the relevant reception of the target cell. This binding was the crucial step that determined effect, where there were less number of receptor sites, increased availability of the active ingredient did not produce any therapeutic response. Therefore, binding and not absorption was the key to healing the disease. Subsequently, after the receptor- drug binding occurs, the subsequent response could be measured. The response was typically in the form of increase or decrease of some parameter (in this case the white blood cell count). Bio-availability was related to the absorption and not the binding stage of the drug action and therefore was not a measure of the efficacy of drug. 19
17 See 21 CFR Section 320.1(a).
18 See 21CFR Sec 320.24.19 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
10
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 be independently
established, without assuming that an increase in bioavailability automatically
translates to enhanced efficacy.
Illustratively, in few cases, a new form with increased bio-availability might
confer significant benefits in terms of reduced toxicity. Assume that the earlier
known substance had to be administered at 10gm to be therapeutically effective,
but that this 10 gm 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 at all, this is a significant clinical 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 regard that the regulations in relation
to the ODA state that a “diminution in adverse reactions may be sufficient to
allow a finding of clinical superiority."21
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% increase in bio-availability.
However, this by itself 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.
5/2007/ PT/CH, at 51, June 26, 2009.
20 Supra note 1 at 243-244.
21 Orphan Drug Regulations, 57 Fed. Reg. 62,078, See supra sub part Orphan Drug Act at 8-9.11
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 regarded as effective. However a
determination that a drug product is bio-available is not in itself a determination
of effectiveness.22
D. Proving Efficacy
When it comes to evidentiary requirements, it is submitted 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 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 that the drug is developed and tested
through a series of clinical trials and finally brought into the market after
procuring regulatory approval. The time gap between discovering a drug
molecule and developing it into a marketable drug can take several years. This is
borne out by the present case itself, where the parent molecule (Imatinib) was
first discovered in 1993, but the final 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 be
irrational and even unethical to insist on clinical trial evidence only for the
purpose of satisfying patentability requirements under section 3(d).23 For any
such clinical trial testing would involve testing a less than optimal substance (the
known substance) against its allegedly superior derivative.
2242 FR 1640 (1977). Cf. Moffitt, Jane, Appropriateness of Bioavailability and Bioequivalency as Pre-Market Clearance Considerations, 34 Food Drug Cosm. L.J. 640 (1979).
23 Supra note 1 at 255-256.
12
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 performed only if the importance
of the objective outweighs the inherent risks and burdens to the research
subjects. Subjecting 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 applicant has to demonstrate a reasonable correlation between the efficacy claimed and the data provided in support of this. Such reasonable evidence of the correlation can be established by relying on, inter alia, statistically relevant data documenting the activity of the new form and/or known substance, documentary evidence (e.g. articles 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 can proof of efficacy be submitted?
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.
24 Supra note 1, at 256.13
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 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 court to a
British case, Synthon BV v. SmithKline Beecham.25 In Synthon, the appellant
Synthon BV applied to revoke Smith Kline’s patent for a particular crystalline
form of the blockbuster drug paroxetine, based on Synthon's own earlier patent
application. 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 issue of “enablement”, Lord Hoffmann observed that enablement means
‘that the ordinary skilled person would have been able to perform the invention
which satisfies the requirement of disclosure’. Enablement in the context of
novelty, according to Lord Hoffman was the same as enablement for the purpose
of determining sufficiency. 25 Synthon BV v. SmithKline Beecham plc [2006] RPC 10.
14
It is important to note that disclosure and anticipation are distinct requirements,
and proof needs to be submitted on both. In assessing disclosure, no aspect of
trial or error is permitted. In assessing whether or not the disclosure is enabled,
a reasonable degree of experimentation can be expected and is permissible.
Depending on the concept under consideration, the role of 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 the prior
art may have meant, but rather, whether 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 several admissions
made by the Petitioner in various documents including its patent applications,
(including wording such as preparation of salts “known per se”), the amorphous
form of Imatinib Mesylate could be made by a person skilled in the art as on
2007 (the priority year of the application pertaining to the beta crystalline form)
by referring to the disclosures 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).
15
WRITTEN SUBMISSIONS ON BEHALF OF THE INTERVENOR
(PART II)
II. CONCEPTUALIZING SECTION 3(d): BUILDING A BRIDGE?
16
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 treat section 3(d) criterion as separate and distinct from traditional
patentability criteria, such as novelty, inventive step and utility.
2. To create a bridge between section 3(d) and the traditional 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
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. INDEPENDENT PATENT STANDARD UNDER SECTION 3(d)
This choice is easier to implement than its alternative, in that the patent office is
at liberty to qualify an alleged invention 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 case and the advantage is that one need not go out of the way to
interpret section 3(d) in consonance with other criteria.
However, this choice might open India up to a potential TRIPS challenge. Article
27 of TRIPS reads as below:
17
“…patents shall be available for any inventions, whether products or
processes, in all fields of technology, provided that they are new, involve
an inventive step and are capable of industrial application. Subject to
paragraph 4 of Article 65, paragraph 8 of Article 70 and paragraph 3 of
this Article, patents shall be available and patent rights enjoyable
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
patentability criteria i.e. a pharmaceutical 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 violates the mandate under TRIPS to grant patents to inventions that
are new, 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
Given that the term “invention” is not defined under TRIPS, member states have
some degree of flexibility in defining this term.
27 See also Panel Report on Canada- Patent Protection of Pharmaceutical Products, 17 March 2000, WT/DS114/R.
18
Practice of member states reveal that the term “invention” does not admit of a
precise meaning. An English judgment is illustrative 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 satisfactory, all-embracing definition and I do 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 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 technology’ makes this nexus even
more evident. The Indian patent act also veers towards this suggestion by its use
of the term “technical advance” in section 2(ja).
Peter Prescott J again tellingly notes: “….If something is an invention…… we can
call it "technology" for short’.”30
28 See Peter Prescott J’s ruling in In the Matter of Patent Applications GB 0226884.3 and 0419317.3 by CFPH LLC, [2005] EWHC 1589 (Pat) available at <http://www.bailii.org/ew/cases/EWHC/Patents/2005/1589.html> (26 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 a particular technical problem using particular technical means. It is on this understanding of the term "invention" that the patent granting practice of the EPO and the jurisprudence of the Boards of Appeal are based.
See Basic Proposal for the Revision of the European Patent Convention 13 October 2000. <http://patlaw-reform.european-patent-office.org/epc2000/documents/mr/_pdf/em00002a.pdf>.
30 See CFPH LLC v Comptroller-General of Patents, Designs and Trade Marks [2005] EWHC 1589 (Pat), at para. 92.
19
Owing to this definitional difficulty, most member states resort to a ‘negative’ or
exclusionary definition.31 Thus for example, in Europe, ‘invention’ is defined to
exclude the following: discoveries, scientific theories and mathematical methods;
literary, dramatic, musical and artistic works, and any other aesthetic creations
whatsoever; 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 law follows a similar format and section 3 excludes from the ambit of
patent protection a diverse range of subject matter. It reads as below:
2. What are not Inventions: Evaluating Section 3
The following are not inventions within the meaning of this Act,—
a. an invention which is frivolous or which claims anything obviously contrary to well established natural laws;b. an invention the primary or intended use or commercial exploitation of which could be contrary to public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment;] c. the mere discovery of a scientific principle or 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 which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new
31 See NRDC (n Error: Reference source not found) 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 Electronic Access (CLEA) database) for a similar list of exclusions. <http://www.wipo.int/clea/en/index.jsp> (14 September 2005).
20
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.
Explanation : For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy;]
e. a substance obtained 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 mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way;g. Omitted by Patents (Amdt.) Ad, 2002 h. a method of agriculture or horticulture;i. any process for the medicinal, surgical, curative, prophylactic 1[diagnostic, therapeutic] or other treatment of human beings or any process for a similar treatment 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 micro-organisms but including seeds, varieties 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 algorithms; l. a literary, dramatic, musical or artistic work or any other aesthetic creation whatsoever including cinematrographic works and television productions;m. a mere scheme or rule or method of performing mental act or method of playing game;n. a presentation of information; o. topography of integrated circuits;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 rationales
underlying them. Some exclusions flow from the meaning of the term
“invention” (hereafter “definitional exclusions”). Thus, one might argue that the
21
term invention connotes a man made creation within the technical or the
technological field.
The exclusion of literary works (such as poems) under section 3(l) of the patents
act comports well with this rationale. As an 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 considered to be an 'invention' under patent law.’33.
Similarly, a mere discovery of a scientific principle or a natural product (as
excluded under section 3(c)) will fall outside the purview of the term
“invention”. For one has not “created” or “invented” anything new by human
intervention: but merely discovered something that was not known earlier.34
This is best expressed in the language of Lord Kenyon in Hornblower v Boulton35:
“…having now heard 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:
33 Peter Prescott J’s ruling in In the Matter of Patent Applications GB 0226884.3 and 0419317.3 by CFPH LLC [2005] EWHC 1589 (Pat) available at <http://www.bailii.org/ew/cases/EWHC/Patents/2005/1589.html> (26 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).35
? 101 Eng. Rep. 1285
36 Id., at 1288.
22
“Courts in the United States, as well, have emphasized on the human
intervention aspect of an invention. Illustratively, in Morton v New York Eye
Infirmary37, the New York Circuit Court expressed the opinion that,
“In its naked ordinary sense, a discovery 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 domain of discovery, and has laid hold of the 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. Sever the force or principle discovered from 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, in order to constitute an invention, one might argue that the subject
matter must necessarily be new, inventive and useful. The Indian Patents Act
explicitly recognizes this definitional component and articulates it in section 2(j),
which defines invention as “a new product or process involving an inventive step
and capable of industrial application.”
Some of the section 3 exclusions draw from this definitional component and
categorically exclude certain subject matter from the purview of patentable
inventions.
Section 3(e) encapsulates such a rationale by suggesting that merely combining
existing substances (when the combination does not yield a result greater than
37 5 Blatchf. 116, 17 F.Cas. 879 (1862)
38 Id., at 881. See also, Kewanee Oil Co. v. Bicron Corp., 416 U.S. 470, 476 (1974) (stating that “discovery is something less than invention”)
23
the sum total of the additions) is not patentable. It excludes “a substance
obtained by a mere admixture resulting only in the aggregation 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 “policy” based
exclusions). The subject matter may be an “invention” from the definitional
standpoint, having a significant 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 could be contrary to public order or morality
or which causes serious prejudice to human, animal or plant life or health 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.
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 similar exceptions, see Richard Gold & Yann Joly, The Patent System and Research Freedom: A Comparative Study, in Exclusions from Patentability and Exceptions and Limitations to Patentees’ Rights , (Report prepared by Bentley et al. for WIPO Standing Committee on the Law of Patents, SCP/15/3, 2010), available at < http://www.wipo.int/edocs/mdocs/scp/en/scp_15/scp_15_3-annex1.pdf>. 40
24
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 section 3(d) is treated as separate and distinct from other patentability criteria
and not a species of the inventive step test, then it qualifies as an exclusion made
for policy reasons. The key question then is: to what extent can member states
carve out exclusions from the term “invention” based on policy reasons?
Prima facie, TRIPS appears to carve out very specific cases where one might
bring in a policy based exclusion. Article 27.2 and 27.3 3 states:
2. Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law.
3. Members may also exclude from patentability:
(a) diagnostic, therapeutic and surgical methods for the treatment of humans or animals;
(b) plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, Members 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 this subparagraph shall be
? Indian Patent Act, 1970, S3(h) excludes from patentability, “a method of agriculture or horticulture.”
25
reviewed four years after the date of entry into force of the WTO Agreement.
One might argue that any further policy exclusions are 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 terms41 and if the term “invention” is understood to
mean something of a technical or technological nature, then new forms of known
chemical substances under section 3(d) would qualify 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 risk of a TRIPS challenge and a
finding of contravention, should section 3(d) be divorced from regular
patentability criteria and be seen as an independent stand alone test for
patentability.
It also bears noting that if this line of reasoning were adopted (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.
41 See Petros C. Mavroidis (2009), Chapter 3 Licence to Adjudicate: A Critical 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 6), Emerald Group Publishing Limited, pp.73-90 where he notes that WTO appellate body (AB) has “traditionally followed an (overly) textualist interpretative approach. This attitude is probably consistent with the incentive structure of a risk averse agent who can always turn back and request from its principals to write a more complete contract next time.”
26
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 “inventive step”
or non-obviousness. Such technologically 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 evolved a specific obviousness test that bears close similarly to
section 3(d). Courts have held that structural similarities between a
pharmaceutical substance that is sought to be patented and an earlier known
substance trigger off a presumption of prima facie obviousness.42 This
presumption can be dislodged only if the patent applicant demonstrates that the
applied for substance exhibits “unexpected or surprising results.” 43
Although unexpected results are ordinarily not limited to “therapeutic”
advantages alone,44 courts have been known to discount advantages that are 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 one must also demonstrate that there is some motivation to 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. Cir. 2007), where the court relied on two of its earlier 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 similar properties and therefore chemists of ordinary skill would ordinarily 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
27
mere physical advantages. Illustratively, in Pfizer v Apotex45, the CAFC (Court of
Appeals for the Federal Circuit) strikes a distinction between therapeutic
properties and other properties (physical properties such as process-ability) of a
pharmaceutical substance and appears to give the latter relatively much less
weight while assessing non-obviousness. The court holds:
“Finally, we do not see the trial court’s finding that amlodipine besylate had adequate physicochemical characteristics as sufficient to uphold the court’s ultimate holding of unexpected superiority…... At most, then, Pfizer engaged in routine, verification testing 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 stronger, cheaper, cleaner, faster, lighter, smaller, more durable, or more efficient . . . to enhance commercial opportunities . . . is universal—and even common-sensical.”
A scholar notes in this regard:
“The Pfizer opinion repeatedly emphasized that the besylate part of the claimed compound was merely a drug delivery vehicle that did not improve amlodipine’s therapeutic effect. “Because the Federal Circuit 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
structurally similar new form demonstrates unexpected properties (such
properties relating specifically to “efficacy”).
“therapeutic efficacy”, but was a more advantageous dosage form/drug delivery mechanism.),45
? 480 F.3d 1348 (2007)
46 See JM Mueller, Chemicals, Combinations, and ‘Common Sense’: How the Supreme Court's KSR Decision is Changing Federal Circuit Obviousness Determinations in Pharmaceutical and Biotechnology Cases 35(3) N. Ky. L. Rev. 281 (2008)
28
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 as a short cut for determining
whether or not something is inventive.
A patent office faced with an alleged invention which potentially claims a new
form of an existing substance would do well to therefore use section 3(d) as a
short cut to determining inventive step. If the alleged new form fails the test of
section 3(d), that is evidence enough of the fact that it is not “inventive”. To 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
“inventive step” test. Rather, it might so happen that even despite the existence
of significantly enhanced therapeutic 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 amlodipine besylate exhibits unexpectedly superior results, this secondary consideration does not overcome the strong showing of obviousness in this case. Although secondary considerations must be taken into account, they do not necessarily control the obviousness conclusion.
…patentability is not imparted where ‘the prior art would have suggested to one of ordinary skill in the art that this process should be carried out and would have a reasonable likelihood of success.’”
29
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 artisan would have had a reasonable expectation of success with the besylate salt form of amlodipine at the time the invention was made.”
In other words, after using section 3(d) as a short cut for determining whether
or not a claimed new chemical 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 article47:
“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 art”, a requirement that the invention involve a ‘technical advance’ or have an ‘economic significance’ of some sort has been added.
This change in the standard seems odd, given that the 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 no doubt achieved in an optimal manner by the simple test of whether the invention, though novel, is non-obvious to a person skilled in the art.
….Contrary to suggestions by some commentators, the addition of ‘technical advance’ or ‘economic significance’ to the ‘non obviousness’ test does not dilute the ‘inventive step’ requirement…..48
47 See Shamnad Basheer, India’s Tryst with TRIPS: The Patents (Amendment) Act, 2005, 1 Ind. J. L. Tech. 15 (2005).
48 Id., at 22.
30
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 specific assessment, and
evaluative analysis, making 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 may opt for a stricter standard. The
Indian 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,
Sildenafil Citrate, sold as Viagra by Pfizer, was the first effective oral treatment
for MED (male erectile dysfunction), with up to 82% of patients experiencing
benefits.49 At the time of this path-breaking discovery, Sildenafil Citrate was
already a known substance and was being tested by Pfizer for its ability to cure
angina (blood pressure) and a specific form of heart ailment. Upon discovering its
potential new use as a cure for MED, Pfizer immediately filed a patent.50
49 See Darren R. Flower, Molecular Informatics: Sharpening Drug Design’s Cutting Edge (2002), 17, available at http://www.rsc.org/ebooks/archive/free/bk9780854048168/bk9780854048168-00001.pdf.
50 Sildenafil Citrate essentially works by inhibiting an enzyme that retards the relaxation of the penile 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
31
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 included an article by Rajfer et al. and
published patents,52 that would have prompted the person skilled in the art to
evaluate the possibility of using Sildenafil Citrate, for the treatment of MED.53
Famously, the court noted that it was worth a try.
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
PDE inhibitors.
51 See Lilly Icos Llc v. Pfizer Ltd [2002] EWCA Civ. 1 where the Court of Appeal in the U.K. upheld the High Court decision delivered by Laddie, J., in this 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 number of other chemicals, proposing their use for a number of medical 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 See Lilly Icos Llc v. Pfizer Ltd. [2002] EWCA Civ. 1, ¶ 54 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 Relaxation of the Corpus Cavernosum in Response to Nonadrenegic, Noncholinergic Neurotransmission, (1992) 326 NEW ENG. J. MED. 90).
54 Compare Pfizer Canada Inc. v. Apotex Inc. (F.C.A.), 2009 FCA 8, [2009] 4 F.C.R. 223,¶ 28-31 available at http://reports.fja.gc.ca/eng/2009/2009fca8/2009fca8.html (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), with Apotex Inc. v. Sanofi-Synthelabo Canada et al 2008 SCC 61 available at http://scc.lexum.umontreal.ca/en/2008/2008scc61/2008scc61.pdf (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 probabilities that it was more or less self-evident to try to obtain the invention. Mere possibility that something might turn up is not enough.”)
32
The divergent conclusions on obviousness discussed above 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 inventive step threshold that would have found in
favour of the patentability of a larger number of inventions than the UK regime.56
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. MAKING SENSE OF THE PATENT TERMINOLOGY
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
ii) product
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 at http://www.patentlyo.com/patent/2007/05/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 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 this avenue “worthwhile” to pursue (Pfizer Ltd., at paragraph 107, as quoted at paragraph 42 above). As such, a solution may be “worthwhile” 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, was expressly rejected by the Supreme Court in Sanofi-Synthelabo, at paragraph 66.”
33
iii) process
iv) substance
v) entity
vi) pharmaceutical substance
vii) pharmaceutical product
Most patent regimes including TRIPS uses the terms: invention, product and
process. Product and process have fairly standard connotation and are often
used in contradistinction to each other57
The Indian Patent Act also uses these terms in the following sections:
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 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, selling or importing for those purposes the product 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
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 in the field of technology. An invention may relate to a product or a process.”)
34
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 gets protection
as a product. In other words, a new form qualifies as a patentable product (and a
new substance) only when it demonstrates significantly enhanced efficacy. As to
the kind of protection that a product is entitled to, Merrel Dow vs Norton59 is
illustrative:
“The scope of the monopoly conferred by a product 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 whether for disposal or otherwise." For this purpose it does not matter how the product is made or what form it takes. The monopoly covers every method of manufacture and every form which comes within the description in the claim”.60
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 example in the context of a particular activity), then a claim to the physical entity per se lacks novelty”.61
58 See section 2(o) which defines "patented article" and "patented process" to mean respectively an article or process in respect of which a patent is in force;
59 [1995] UKHL 14.
60 Id., at para 13.
61 Id., at para 14. (quoting Decision G02/88 MOBIL/Friction reducing additive [1990] EPOR 73)
35
Needless to add the very process of creating the new form may itself be
patentable independently, if it is demonstrated to be “new” and “inventive”.
Whither Section 2(ta)?
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) as “any new entity involving one or more inventive steps”. Defined in such a broad way, one is forced to query: would a mobile 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 even more perplexing about this definition is the fact that the term ‘pharmaceutical substance’ 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 legislature, in all its wisdom, did not see it fit to clarify this concept.”63
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
manufacturing capabilities, uses the term ‘pharmaceutical products’. However
this term is used in a different sense than ‘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.62 See Shamnad Basheer, India’s Tryst with TRIPS: The Patents (Amendment) Act, 2005, 1 Ind. J. L. Tech. 15 (2005).
63
? Id., at 23.36
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 3(d) is a species of the inventive step test, as
applied specifically to the pharmaceutical arts.
The definition of pharmaceutical substance as a new entity involving one or
more inventive steps essentially means that in order to constitute a new
pharmaceutical substance, an allegedly new form must necessarily entail one or
more inventive steps.
III. INHERENT ANTICIPATION AND APPOINTMENT OF EXPERT
The key issues are:
1. Was the beta crystalline version of imatinib mesylate effectively enabled
by the 1993 patent and subsequent 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 if it was not enabled by the prior art, could the beta crystalline form
have been said to be obvious to a skilled person from the prior art?
If the person skilled in the art attempting to produce imatinib mesylate (as per
the disclosure in 1993 patent and other relevant prior art existing up to July
1997) would necessarily produce the beta crystalline version (since the
compound naturally 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 submitted that in such cases, the beta crystalline form is anticipated under
the doctrine of inherent anticipation, a doctrine explicated well in Schering Corp.
v. Geneva Pharmaceuticals, Inc.64
64 339 F.3d 1373, 1382 (Fed.Cir. 2003).
37
In this case, Schering had a patent covering loratadine, an antihistamine
marketed as Claratin. Schering subsequently filed a second patent on
descarboethoxyloratadine (“DCL”) that is naturally produced by the human body
as a metabolite of loratadine.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
or recognized at the time of the 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 be held to be 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, the
intervenor requests that this Hon’ble Court suggest 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. PATENTS, PUBLIC ORDER AND EXCESSIVE PRICING
65 Id. at 1375.
66 Supra note 38 at 1378-80
38
The IPAB held that the beta crystalline form of imatinib mesylate was not eligible
for a patent under section 3(b), since a drug corresponding to the patent had
been priced excessively. Section 3(b) currently reads as under:
“3. What are not inventions: The following are not inventions within the meaning of this Act…
(b) an invention the primary or intended use or commercial exploitation of which could be contrary to be public order or morality or which causes serious prejudice to human, animal, plant life or health or to the environment
According to the IPAB, the excessive price of Glivec would create public disorder
and was therefore ineligible for a patent under section 3(b) of the Indian patents
act. In the words of the IPAB
“…But as per information furnished in its written 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 havoc to the lives of poor people and their families 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 us, we observe that the Appellant’s alleged invention 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 section 3(d)of the Act, but also for its possible disastrous consequences on 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?
39
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 given point in time,67 an exception based on ‘public ordre’
and ‘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, Article 27.2 of
the TRIPS applies only if a prohibition against the commercial exploitation of the
invention is necessary to protect ordre public or morality and only if the
exclusion from patentability will likewise contribute to the protection of that
ordre 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 a law
which prevents the commercial exploitation of the particular product.70 Or one
must at least show the existence of circumstances necessitating such a law or
ban.71 Under such an interpretation, unless India bans the sale of Glivec or shows
67 Basheer, Purohit and Reddy, “Patent Exclusions that Promote Public Health Objectives” Report by Bentley et al “Exclusions from Patentability and Exceptions and Limitations to Patentees’ 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_3-annex1.pdf>.
68Patents: Ordre Public and Morality, Resource Book on TRIPS and Development, available at <http:// www.iprsonline.org/unctadictsd/docs/RB2.5_ Patents _2.5.3_update.pdf >.
69 Charles R. McManis, Patenting Genetic Products and Processes: A TRIPS Perspective, available at <http://law.wustl.edu/faculty_profiles/documents/Kieff/HGPIP/Final/GEN_50_CH5.pdf> (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.
71Dan Leskien & Michael Flitner, Intellectual Property Rights and Plant Genetic Resources: Optionsfor a Sui Generis System (Issues in Genetic Resources No. 6 June 1997), International Plant
40
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
Therefore, any measure taken is justified only if no reasonable alternative is
available to a Member. Here, as stated above, alternatives such as compulsory
licensing, price control mechanisms are ‘reasonably available’. Hence in this 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.
Genetic 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, for the purposes of these provisions, exclusions must be objectively 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.
41
42