PHARMACEUTICAL PATENTING IN INDIA - BREAKING MYTHS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NOVARTIS AG VS. UNION OF INDIA (UOI) AND ORS.[3] 

By way of a special leave petition filed before the Supreme Court of India, Novartis appealed the decision of the IPAB of rejecting the patent application[4] “Crystal Modification of a N- Phenyl-2-Pyrimidineamine derivative, processes for its manufacture and its use” on the ground that the subject matter claimed in the patent application was non-patentable under the provision of Section 3(d) of the Act.

 

Though the Supreme Court rejected the patent application and upheld the decision of the IPAB, the findings in the matter are pertinent to be noted for applicants of pharmaceutical inventions.

 

One imperative clarification made by the Hon’ble Court is with respect to incremental inventions. The Court clarified that the provision of Section 3(d) of the Act should not be interpreted to bar patent protection for all incremental inventions of pharmaceutical substances. The Court held that, “We have held that the subject product, the beta crystalline form of Imatinib Mesylate, does not qualify the test of Section Atomic En of the Act but that is not to say that Section Atomic En bars patent protection for all incremental inventions of chemical and pharmaceutical substances. It will be a grave mistake to read this judgment to mean that Section Atomic En was amended with the intent to undo the fundamental change brought in the patent regime by deletion of Section 5 from the Parent Act. That is not said in this judgment”.

Further, the Hon’ble Court clearly and repeatedly clarified that the findings of the Court were based on the material/ data provided before it by the Applicant, said material/ data failing to substantiate the therapeutic efficacy of the claimed invention. It is imperative to note that the Hon’ble Court did not deny or disregard the fact that increase in bioavailability may lead to an enhancement of therapeutic efficacy, but on the other hand, held that much like any other claim of enhancement of therapeutic efficacy, such claims must be supported by research data. Since the Applicant was unable to substantiate its claim that the beta crystalline form of Imatinib Mesylate has 30 percent increased bioavailability as compared to Imatinib in free base form by way of any research or evidence, the Court did not find the claimed invention as disclosing enhanced therapeutic efficacy. Accordingly, the Hon’ble Court held that, “… the position 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 model.

Thus, in whichever way Section Atomic En may be viewed, whether as setting up the standards of "patentability" or as an extension of the definition of "invention", it must be held that on the basis of the materials brought before this Court, the subject product, that is, the beta crystalline form of Imatinib Mesylate, fails the test of Section Atomic En, too, of the Act”.

Thus, to understand the above judgment as being discouraging with respect to pharmaceutical related inventions would have a contrary result as that intended by the Hon’ble Court. Since 2013 i.e. post the Glivec judgement, the IPO as well as the Indian Courts have time and again upheld the sanctity of Section 3(d) of the Act, while at the same time maintaining the interests of innovators. The below decisions are reflective of the pro-patent and pro-innovation stand taken by the IPO and the Indian Courts alike, while deciding upon pharmaceutical related inventions.

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[3] Civil Appeal Nos. 2706-2716 of 2013 (Arising out of SLP (C) Nos. 20539-20549 of 2009)

 

[4] Indian Patent Application number: 1602/MAS/1998

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