Novartis vs. Union of India

In this post (which I wrote long back), I have summarized the landmark judgment delivered by the Supreme Court.

Here it goes - The Novartis Patent Saga 

The Zimmerman patent in 1993 - disclosed the imatinib free base – this patent was not granted in India because India did not provide for pharmaceutical patents prior to 1995;

A publication in 1996, which referenced imatinib mesylate;

The 1998 patent application (Application No.1602/MAS/1998) before the Indian Patent Office which claimed the beta-crystalline form of imatinib mesylate. What is claimed- beta crystalline form, better thermodynamic stability, lower hygroscopicity (comparison was made to alpha crystalline form)

Application lay dormant – mailbox procedure – since patent law was in transition – appellant made an application for grant of EMR u/s 24A of the Act – EMR granted Nov. 10, 2003

Jan 1, 2005 – Application taken out of mailbox - attracted five pre-grant oppositions in terms of section 25(1) of the Act - Applicant filed four affidavits of experts in response to these oppositions- two of which stating higher bioavailability of beta crystal form of Imatinib Mesylate as compared to Imatinib in free base form. (Para 10)

Asst Controller heard – Dec 15, 2005 under Rule 55 of Act – rejected grant – reasons – anticipated by prior publication; obvious; disallowed by S. 3(d) and July 18, 1997, the Swiss priority date, was wrongly claimed as the priority date for the application in India, since On July 18, 1997, Switzerland was not one of the “Convention Countries” as defined under section 2 (1)(d) read with section 133 of the Act - notified as a convention country on November 30, 1998 (Para 14, 15).

Appellant challenged controller’s orders before Madras HC – in writ petition. Another writ petition to declare 3(d) unconstitutional since violated A. 14 and not in compliance with TRIPS

Five writ petitions challenging the five orders of Controller transferred from the HC to IPAB by order dated April 4, 2007

IPAB reversed findings of controller – saying invention novel and non obvious and entitle to said priority date – but hit by S. 3(d) – requirement of higher standard of inventive step in pharma – further held – appellant could not be denied process patent

Challenging order of IPAB – Appellant to SC under Article 136 (Special Leave Petition)

Supreme Court didn’t find any evidence that the beta-crystalline form of imatinib mesylate is anticipated (Para 158)

Novartis had tried to argue - that the beta-crystalline form of imatinib mesylate should be compared with imatinib. However, the generics wanted the comparison to be with imatinib mesylate, since that would make it more difficult for Novartis to prove a significant increase in efficacy.

In order to establish this argument, the generics had to first establish that imatinib mesylate was “known” in the period intervening the ’93 Zimmerman patent for imatinib and the beta-crystalline form of imatinib mesylate.

There Court accepted the argument that there was significant prior art, including a judgement from the U.S. Board of Patent Appeals, which reportedly held that imatinib mesylate was directly anticipated from the ’93 patent.

The court thus came to the conclusion that at least imatinib mesylate was anticipated by the prior art documents.

Court then moved to evaluate the patentability of the beta-crystalline form of “imatinib mesylate” w.r.t. S. 3(d) – Analysis

Novartis - Section 3(d) would not apply, since it required a comparison of the claimed invention with a ‘known substance’ having known ‘efficacy’ and that neither imatinib nor imatinib mesylate had any known efficacy.

Novartis keen to have the imatinib free base identified as the ‘known substance’ instead of imatinib mesylate since it would be easier to prove greater efficacy vis-à-vis the imatinib free base. In support, Novartis tried to reason that the beta crystalline form of imatinib mesylate was derived directly from imatinib and not imatinib mesylate. (Para 170)

The Supreme Court dismissed this argument on the following grounds

That the Zimmerman patent of 1993, identified the tumor treating potential of the imatinib free base and its derivatives, such as imatinib mesylate.

That prior art documents like the article published in Cancer Research clearly identified the in-vivo experiments carried out with imatinib mesylate.

SC - ‘efficacy’ in Section 3(d) means only therapeutic efficacy (Para 180) - rejects the arguments by Novartis for a more broad based interpretation of efficacy which would have included even non-therapeutic efficacy such better storage and ease of administration

SC - an increase in bioavailability can qualify for protection under 3(d) - if evidence is provided to establish that such an increase leads to greater therapeutic efficacy.

Increased bioavailability (30%) alone may not necessarily lead to an enhancement of therapeutic efficacy. In this case - 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. (Para 189)

SC- None of the three properties claimed (flow properties, better thermodynamic stability and lower hygroscopicity) would qualify under a Section 3(d) analysis since they would not contribute to an increased therapeutic efficacy (Para 173).