Tuesday, April 2, 2013

A Brief Primer on the Novartis Case

Yesterday, I had blogged on the pronouncement of the decision of the Supreme Court on the Novartis case. In the next few posts, I will discuss various significant aspects of the decision in detail. Before I do so, I thought it fit to provide a brief factual summary of the case to set the context.

Facts leading to the Supreme Court Decision
Title of the Patent:  Application number 1602/MAS/1998- “Crystal Modification of a N-Phenyl-2-Pyrimidineamine derivative, processes for its manufacture and its use”- Beta Crystalline Form of Imatinib Mesylate (“BCIM”)
July 18, 1997: Swiss basic application filed
July 17, 1998: Indian Application filed claiming priority from the Swiss application
November 10, 2003: Exclusive Marketing Rights (EMR) granted
January 25, 2006: Patent office refuses to grant patent after 5 pre-grant oppositions are filed by Cancer Patients Aid Association, Natco Pharma Limited, Cipla Limited, Ranbaxy Laboratories Limited, and Hetero Drugs Limited. 

The primary grounds for rejection of the Application by the Patent Office were:
1.       BCIM lacked novelty. 
2.       BCIM fell within the ambit of Section 3(d).

On Section 3(d), the Patent Office observed thus:

“9. The Opponent (Cipla) said that the application claims only a polymorphic form of the known substance, imatinib mesylate. There is no enhancement of known efficacy as required under Section 3(d) of the Patents Act. Moreover the present specification states that all the inhibitory and pharmacological effects are also found with the free base, or other salts thereof.

10. Countering the arguments of the Opponent, the Applicant (Novartis) said that the crystal form of imatinib mesylate is an invention and not a more discovery. They further said that, a discovery graduating into a patentable invention solely on the basis of efficiency defies logic and, therefore, Section 3(d) may be unable to stand legal scrutiny. The Applicant submitted that this aspect of Section 3(d) is against the tenets of our patents act and well established principles of jurisprudence and therefore, the said Section cannot be used against the subject application.

11. I do not agree with the contention of the Applicant that this application claims a new substance. It is only a new form of a known substance. As regards efficacy, the specification itself states that where're crystals are used the imatinib free base or other salts can be used. Even the affidavit submitted by the Applicant states that "the proviso to the Section 3(d) is unique to India and there is no analogous provision in the law of any other country of the world".

As per the affidavit the technical expert has conducted studies to compare the relative bioavailability of the free base with that of crystal form of imatinib mesylate and has said that the difference in bioavailability is only 30 per cent and also the difference in bioavailability may be due to the difference in their solubility in water. The present patent specification does not bring out any improvement in the efficacy of the crystal form over the known substances rather it states the base can be used equally in the treatment of diseases or in the preparation of pharmacological agents wherever the crystal is used.

Even the affidavit submitted on behalf of the Applicant does not prove any significant enhancement of known efficacy. It is found that this patent application claims only a new form of a known substance without having any significant improvement in efficacy. Hence, I conclude that the subject matter of this application is not patentable under Section 3(d) of the Patents Act, 1970 as amended by the Patents (Amendment) Act, 2005.”

Against the rejection of the Patent Office, Novartis filed a batch of 5 Writ Petitions before the Madras High Court. All the 5 petitions were converted to appeals and were transferred in 2007 to the then newly-constituted Intellectual Property Appellate Board (IPAB).

By an order dated June 26, 2009, the IPAB upheld the rejection of Novartis’s application by the Patent Office essentially relying on Section 3(d). Here is a link to the decision of the IPAB.  In contrast to the Patent Office, the IPAB held that BCIM was novel, but rejected it citing Section 3(d).

Apart from the above appeals, Novartis had also filed 2 other Writ Petitions before the Madras High Court challenging the constitutionality of Section 3(d). Novartis alleged that Section 3(d) of the Patents Act was violative of Article 14 of the Constitution of India and was also violative of TRIPS. Both the writ petitions challenging the constitutionality of Section 3(d) were dismissed by the Madras High Court in 2007. Here is a link to the decision of the Madras High Court. There was no further challenge to the decision of the Madras High Court on the constitutionality of Section 3(d).

Novartis then proceeded to file Special Leave Petitions (SLPs) against the decision of the IPAB in its 5 appeals.

Decision of the Supreme Court 
It was on these 5 SLPs that the Supreme Court delivered its decision yesterday, 2013, holding the following: 
A.      That BCIM is not a “new product” and therefore it did not deserve the grant of a patent.  
B.     That BCIM is not an “invention” under the Act since it was squarely covered by the prohibition under Section 3(d) of the Act.

More on the decision in the next few posts. 

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