Novartis Clinical

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 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. 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 on “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 demonstrated by appropriate bioavailability studies.

The 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 evergreening in Canada and Australia, available at: < http://law. anu. edu. au/StaffUploads/236Art%20ANZHP%20Linkage%20Evergreening.pdf> (last visited 31 August, 2011). ( See Carlos Correa “Guidelines for Examination of Pharmaceutical Patents”, available at: (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: (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 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 drug outweigh the risks. ”9 Safety of a drug is assessed relative to risks and 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 6 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, 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 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 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. 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). 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 efficacy? 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 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 receptordrug 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 19 See 21CFR Sec 320. 24. 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. 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. 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 20 Supra note 1 at 243-244.

Orphan Drug Regulations, 57 Fed. Reg. 62,078, See supra sub part Orphan Drug Act at 8-9. 21 11 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. 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 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 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. 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?

24 Supra note 1, at 256. 13 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. 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. 25 Synthon BV v. SmithKline Beecham plc [2006] RPC 10. 14 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.

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