Novartis AG vs Union of India - 2013 Supreme(SC) 292

Judicial Analysis Court Copy Headnote Facts Arguments Court observation

2013 Supreme(SC) 292

Supreme Court of India
AFTAB ALAM & RANJANA PRAKASH DESAI, JJ.
Novartis AG & Others - Appellants
Versus
Union of India & Others - Respondents
CIVIL APPEAL Nos. 2706-2716 OF 2013 (ARISING OUT OF SLP(C) Nos. 20539-20549 OF 2009) WITH CIVIL APPEAL No. 2728 OF 2013 (ARISING OUT OF SLP(C) No. 32706 OF 2009) AND CIVIL APPEAL Nos. 2717-2727 OF 2013 (ARISING OUT OF SLP(C) Nos. 12984-12994 OF 2013) SLP(C)………../2011 CC Nos.6667-6677
Decided On : 01-04-2013

Headnote:
Constitution Of India,1950 -Article 6 - Patents Act, 1970 - section 5 - Atomic Energy Act, 1962 - section 20 - committee came to be appointment - appellant claims - Court was urged to strike a balance between the need to promote research and development in science and technology and to keep private monopoly (called an ‘aberration’ under our Constitutional scheme) at the minimum. Arguments were made about India’s obligation to faithfully comply with its commitments under international treaties and counter arguments were made to protect India’s status as “the pharmacy of the world”. The Court was reminded of its duty to uphold the rights granted by the statute, and the Court was also reminded that an error of judgment by it will put life-saving drugs beyond the reach of the multitude of ailing humanity not only in this country but in many developing and under-developed countries, dependent on generic drugs from India. We will advert to these and a number of other arguments at their proper place but we must first take note of the facts that give rise to the above questions and provide the context for the debate –Held, appellant that the beta crystalline form of Imatinib Mesylate has 30 per cent increased bioavailability as compared to Imatinib in free base form. If the submission of Mr. Grover is to be accepted, then bioavailability also falls outside the area of efficacy in case of a medicine. Leaving aside the submission of Mr. Grover on the issue, however, the question is, can a bald assertion in regard to increased bioavailability lead to an inference of enhanced therapeuticposition that emerges is that just increased bioavailability alone may not necessarily lead to an enhancement of therapeutic efficacy. Whether or not an increase in bioavailability leads to an enhancement of therapeutic efficacy in any given case must be specifically claimed and established by research data. In this case, there is absolutely nothing on this score apart from the adroit submissions of the counsel. No material has been offered to indicate that the beta crystalline form of Imatinib Mesylate will produce an enhanced or superior efficacy (therapeutic) on molecular basis than what could be achieved with Imatinib free base in vivo animal modelproduct in chemicals and especially pharmaceuticals may not necessarily mean something altogether new or completely unfamiliar or strange or not existing before. It may mean something “different from a recent previous” or “one regarded as better than what went before” or “in addition to another or others of the same kind” [The New Oxford Dictionary of English Edition 1998]. However, in case of chemicals and especially pharmaceuticals if the product for which patent protection is claimed is a new form of a known substance with known efficacy, then the subject product must pass, in addition to clauses (j) and (ja) of section 2(1), the test of enhanced efficacy as provided in section 3(d) read with its explanation – appeal allowed

Judgement Key Points

Based on the provided legal document, here are the key points regarding the case of Novartis AG & Others vs. Union of India & Others, focusing on the patentability of the beta crystalline form of Imatinib Mesylate:

1. Legislative Context and Objectives * The Patents Act, 1970 was amended in 2005 to comply with the TRIPS Agreement, introducing product patents for pharmaceuticals. * Parliament introduced Section 3(d) specifically to prevent "evergreening" (repetitive patenting of minor changes to known substances) while encouraging genuine inventions, balancing international obligations with public health interests (!) (!) (!) (!) . * The amendment to Section 3(d) explicitly states that a "mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance" is not an invention (!) . * The Explanation to Section 3(d) clarifies that salts, esters, ethers, polymorphs, etc., are considered the same substance unless they differ significantly in properties with regard to efficacy (!) .

2. Facts of the Invention * Prior Art: The drug Imatinib (free base) was invented by Jürg Zimmermann and covered under US Patent No. 5,521,184 (Zimmermann Patent), which disclosed its salts, including Imatinib Mesylate, and their therapeutic uses (!) (!) (!) (!) (!) . * Market History: The drug Gleevec (Imatinib Mesylate) was approved by the FDA and marketed globally starting in 2001, based on the Zimmermann Patent (!) (!) (!) . * Appellant's Claim: Novartis claimed the beta crystalline form of Imatinib Mesylate as a new invention. They argued it involved two stages of invention: creating the mesylate salt and then the specific beta crystal form (!) (!) . * Conduct of Appellant: Novartis previously obtained patent term extensions for the Zimmermann Patent regarding Gleevec and successfully sued competitors (e.g., NATCO Pharma) for infringement based on the Zimmermann Patent covering Imatinib Mesylate, acknowledging that the free base and its salts were part of the original patent (!) (!) (!) (!) (!) .

3. Analysis of Patentability (Section 2(1)(j) and (ja)) * Novelty and Inventive Step: The Court held that Imatinib Mesylate is a "known substance" fully disclosed in the Zimmermann Patent, including its pharmacological properties (!) (!) . * Disclosure vs. Coverage: The Court rejected the argument that "coverage" of a patent (claims) differs from "disclosure" (teaching). A patentee cannot claim a genus for which the species were not enabled or disclosed at the time of filing (!) (!) (!) . * Finding: Since Imatinib Mesylate was known and disclosed in the Zimmermann Patent, it does not qualify as a "new product" or an "invention" under Section 2(1)(j) and (ja) (!) .

4. Analysis of Patentability (Section 3(d)) * Applicability: Even if the beta crystalline form is considered a "new form" of a known substance (Imatinib Mesylate), it falls squarely under Section 3(d) because it is a polymorph of a known substance with known efficacy (!) . * Enhanced Efficacy Test: The Court emphasized that for polymorphs/salts, the test is whether there is an enhancement of therapeutic efficacy (!) (!) . * Physical Properties vs. Efficacy: Properties such as flow characteristics, thermodynamic stability, and lower hygroscopicity are beneficial for processing and storage but do not constitute "therapeutic efficacy" (!) . * Bioavailability: The appellant claimed a 30% increase in bioavailability compared to the free base. However, the Court noted: * Bioavailability is a pharmacokinetic property, distinct from pharmacodynamic efficacy (!) . * Increased bioavailability alone does not automatically prove enhanced therapeutic efficacy (!) . * The appellant failed to provide research data proving that the beta form produces superior therapeutic results on a molecular basis compared to the known substance (!) . * Comparison Error: The appellant compared the beta form to the free base, but the immediate preceding substance is Imatinib Mesylate (non-crystalline). No data was provided to show enhanced efficacy over the non-crystalline mesylate form (!) (!) .

5. Final Determination * The beta crystalline form of Imatinib Mesylate fails the test of "invention" under Section 2(1)(j) and (ja) because it is a known substance disclosed in the Zimmermann Patent (!) . * It also fails the test of "patentability" under Section 3(d) because it does not demonstrate an enhancement of the known therapeutic efficacy of Imatinib Mesylate (!) . * Held: The appeal for patent protection for the beta crystalline form of Imatinib Mesylate is dismissed (!) .

Judgment :-

Aftab Alam, J.

1. Delay condoned.

2. Leave granted in all the special leave petitions.

3. What is the true import of section 3(d) of the Patents Act, 1970?

How does it interplay with clauses (j) and (ja) of section 2(1)? Does the product for which the appellant claims patent qualify as a “new product” which comes by through an invention that has a feature that involves technical advance over the existing knowledge and that makes the invention “not obvious” to a person skilled in the art? In case the appellant’s product satisfies the tests and thus qualifies as “invention” within the meaning of clauses (j) and (ja) of section 2(1), can its patentability still be questioned and denied on the ground that section 3(d) puts it out of the category of “invention”? On the answer to these questions depends whether the appellant is entitled to get the patent for the beta crystalline form of a chemical compound called Imatinib Mesylate which is a therapeutic drug for chronic myeloid leukemia and certain kinds of tumours and is marketed under the names “Glivec” or “Gleevec”.

4. These questions were debated at the bar intensely and at great length. The debate took place within a very broad framework. The Court was urged to strike a balance between the need to promote research and development in science and technology and to keep private monopoly (called an ‘aberration’ under our Constitutional scheme) at the minimum. Arguments were made about India’s obligation to faithfully comply with its commitments under international treaties and counter arguments were made to protect India’s status as “the pharmacy of the world”. The Court was reminded of its duty to uphold the rights granted by the statute, and the Court was also reminded that an error of judgment by it will put life-saving drugs beyond the reach of the multitude of ailing humanity not only in this country but in many developing and under-developed countries, dependent on generic drugs from India. We will advert to these and a number of other arguments at their proper place but we must first take note of the facts that give rise to the above questions and provide the context for the debate.

5. Jürg Zimmermann invented a number of derivatives of N-phenyl-2- pyrimidine-amine, one of which is CGP 57148 [4-(4-methylpiperazin-1–ylmethyl)-N-[4-methyl-3-(4-pyridin-3- yl)pyrimidin-2-ylamino)phenyl] benzamide.] in free base form (later given the International Nonproprietary Name ‘Imatinib’ by the World Health Organisation). These derivatives, including Imatinib [Ibid], are capable of inhibiting certain protein kinases, especially protein kinase C and PDGF (platelet-derived growth factor)-receptor tyrosine kinase and thus have valuable anti-tumour properties and can be used in the preparation of pharmaceutical compositions for the treatment of warm-blooded animals, for example, as anti-tumoral drugs and as drugs against atherosclerosis. The N-phenyl-2-pyrimidine-amine derivatives, including Imatinib, were submitted for patent in the US. The application was made on April 28, 1994 and patent was granted on May 28, 1996 under US Patent No. 5,521,184 (hereinafter referred to as ‘the Zimmermann Patent’). The Zimmermann compounds (i.e., derivatives of N-phenyl-2-pyrimidine-amine) were also granted a European patent under Patent No. EP-A-0 564 409.

6. The appellant claims that beginning with Imatinib [Ibid] in free base form (as the ‘e-duct’), in a two-stage invention they first produced its methanesulfonic acid addition salt, Imatinib Mesylate, and then proceeded to develop the beta crystalline form of the salt of Imatinib. According to the appellant, starting from Imatinib free base they could reach to the beta crystal form of Imatinib Mesylate in two ways: one “by digesting another crystal form, especially the alpha crystal form, or an amorphous starting material of the methanesulfonic acid addition salt of compound of formula I …”; and second “by dissolving another crystal form, especially t

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