[Ip-health] Novartis decision simplified
b.baker at neu.edu
Mon Apr 1 07:43:07 PDT 2013
The Novartis judgment is a long one. It combines a meticulous examination of the legislative context within which India passed its amended Patents Act in 2005 and a painstaking analysis of the claims and disclosures in the original patent application on Glivec's base ingredient, imatinib, the details of its regulatory filing when it first sought product registration in the US and in India, and its subsequent application on the beta crystalline form of imatinib mesylate. It also clarifies the interrelationship between standards for invention found in section 2(1)(j) and (ja) of the Act and section 3(d) addressing the patentability of previously known substances including medicines.
In terms of the successive patent applications, the Supreme Court held that the original patent application, filed in the United States in 1994 before the effective date of India's amended Patents Act (the so-called Zimmerman patent), had claimed and had covered the imatinib mesylate as well as imatinib (paragraphs 133, 157). It held further that the second application, filed in India's "patent mailbox" in 1998, on the beta crystalline form was a rough cut and paste version of the original patent (paragraph 164). It found that Novartis's application for approval of Glivec/Gleevec in the United States had claimed that the active pharmaceutical ingredient was imatinib mesylate rather than only the beta crystalline form thereof (paragraphs 116-120), that Novartis' exclusive marketing rights application in India had been based on imatinib mesylate as well (paragraph 193), and that all of the pharmaceutical properties of the beta crystalline form were equally possessed by imatinib in free base form or its salt (paragraph 163). In terms of properties, the Court found that the beta crystalline form had better flow properties, was more termodynamically stable, and was less hygroscopic (paragraph 172), but none of these characteristics were relevant to the section 3(d) analysis which focuses on increased efficacy in term of treatment (paragraph 187). It found that there was no evidence that the beta crystalline form had better bioavailability than the imatinib mesylate itself, the relevant comparison (paragraph 170).
It terms of its legal ruling, the Supreme Court clarified several important points. First, by examining the legislative context and history, the Court confirmed that India's amended Patents Act was intended to prevent evergreening patents (paragraphs 75-86). Second, it confirmed that India had incorporated strict standards of patentability, especially with respect to medicines, and that section 3(d) encapsulated that intent and was a clarification of basic standards of invention and inventive step found in section 2(1)(j) and (ja) of the Act (paragraph 104). Third, it held that Novartis' attempt to differentiate the "coverage" of a patent from what is "disclosed" in patent claims and specifications was unacceptable and that there should be no significant gap between the two (paragraphs 136-156). Finally, it confirmed an interpretation of section 3(d) that focuses on the therapeutic impact of modifications rather than simply physical properties such as solubility, flow, or stability (paragraphs 158-187). It rejected an interpretation that section 3(d) requires that the full therapeutic efficacy of the original compound be known and demonstrated at the time of filing and stated further that evidence of increased bioavailability alone would not necessarily show increased therapeutic efficacy (paragraph 188-189). The Court declined to further specify the exact meaning of increased efficacy even while acknowledging divergent opinion offered by counsel (paragraphs 182-186).
At the end, the Court summarized the legal standard that should be applied in assessing secondary patent applications:
"Section 2(1)(j) defines “invention” to mean, “a new product or …”, but the new product 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”. 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." (Paragraph 192.)
The Court was quite patient with the "creative" arguments advanced by Novartis' high priced lawyers. But in the end, it found the case incredibly easy to decide: the beta crystalline form failed both tests of invention found in section 2(1)(j) and (ja) and standards of patentability further set forth in section 3(d). The Court further stated that "the case of the appellant [Novartis] appears in a rather poor light and the claim for a patent for the beta crystalline form of Imatinib Mesylate would only appear as an attempt to obtain patent for Imatinib Mesylate, which would otherwise not be permissible in this country." (Paragraph 194.)
Professor Brook K. Baker
Health GAP (Global Access Project)
Northeastern U. School of Law
Program on Human Rights and the Global Economy
400 Huntington Ave.
Boston, MA 02115 USA
Honorary Research Fellow, University of KwaZulu Natal, Durban, S. Africa
b.baker at neu.edu
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