[Case Brief] Novartis AG v/s Union of India & Others – Supreme Court of India

Case name Novartis AG v/s Union of India & Others
Case number Civil Appeal Nos 2706-2716 of 2013
Court Supreme Court of India
Bench Justice Aftab Alam and Justice Ranjana Prakash Desai
Author of the Judgment Justice Aftab Alam
Decided on 1st April, 2013
Relevant Act/Sections Patents Act, 1970 – Section 2(1)(j), Section 2(1)(ja), Section 3(b), Section 3(d)
Author of the case brief Aditya Gor

The present case concerned itself with the following issues

  • What is the true import of Section 3(d) of the Patents Act, 1970?
  • What is the interplay between Section 3(d) and Section 2(1)(j) read with Section 2(1)(ja)?
  • Does the product on which the appellant claims patent qualify as a new product which comes by through an invention?
  • In case the appellants product satisfies the tests and thus qualifies as “invention” within the meaning of Section 2(1)(j) and Section 2(1)(ja), can its patentability still be questioned and denied on the ground that Section 3(d) puts it out of the category of “invention”?
  • 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 marketed under the names Glivec or Gleevec?

The appellant claims to have identified an invention

As per facts, Jürg Zimmermann invented a number of derivatives of N-phenyl-2- pyrimidine-amine, one of which is Imatinib in free base form. These derivatives, including Imatinib, are capable of inhibiting certain protein kinases and thus have valuable anti-tumour properties and can be used in the preparation of pharmaceutical compositions for the treatment of warm-blooded animals. These derivatives were granted a European patent.

The appellant claims to have identified an invention to produce Imatinib Mesylate from Imatinib. An application was filed for the grant of the patent at the Chennai Patent Office on July 17, 1998. After the application was made and before it was taken up for consideration, a number of amendments were introduced in the Indian Patents Act, 1970, which brought about fundamental changes in the patent law of the country.

The appellant was, however, fully aware of these changes in the law and, in order to reinforce its claim for patent for the subject product and to bring its claim within the four corners of the changed law, it filed four (4) affidavits of certain experts, two of which stated that the beta crystal form of Imatinib Mesylate has much higher bioavailability as compared to Imatinib in free base form.

In 1997, when the appellant filed its application for patent, the law in India with regard to product patent was in a transitional stage and the appellant’s application lay dormant under an arrangement called the mailbox procedure. The appellant’s application for the patent was taken out of the mailbox for consideration only after amendments were made in the Patents Act, with effect from January 1, 2005.

Can Patent be granted on the applicant’s invention?

The Assistant Controller of Patents and Designs heard all the parties on December 15, 2005, as provided under rule 55 of the Patent Rules, 2003, and rejected the appellant’s application for grant of a patent to the subject product on January 25, 2006.

Appeals were thus filed against this order which were heard and dismissed by the IPAB by a long and detailed judgment dated June 26, 2009. The IPAB reversed the findings of the Assistant Controller on the issues of anticipation and obviousness. It also referred to the pricing of the drug Gleevec by the appellant while it enjoyed EMR over it, and held that the patentability of the subject product would also be barred by section 3(b) of the Act. IPAB declined the product patent to the appellants but, however, granted them with the process patent for preparation of Imatinib Mesylate in beta crystal form.

Against this, the matter reached the Honourable Supreme Court through a writ petition.

The Court observed that between January 1, 1995, and January 1, 2005, the Patents Act, 1970, underwent wide-ranging changes, but the single most important change brought about in the law of patent in India as a result of the country’s obligations under the international agreement was the deletion of section 5 from the Act. The time-frame for this set of amendments was most crucial as any slippage in meeting the January 01, 2005 deadline had the potential of inviting retaliatory action under the WTO disputes mechanism.

It is significant to note that section 5 in chapter II of the Act expressly excluded product patents for substances intended for use and capable of being used as food or as medicine or drug, and substances prepared or produced by a chemical process, and made these substances non- patentable. Through the Patents (Amendment) Ordinance, 2004, section 5 of the Patents Act, 1970, was done away with, opening the doors for grant of patents to, amongst others, pharmaceutical products.

Is Imatinib Mesylate a part of the Zimmermann patent?

On facts, the present application for patent leaves no room for doubt that Imatinib Mesylate, marketed under the name Gleevec, was submitted for drug approval as covered by the Zimmermann patent. Since the grant of the Zimmermann patent, the appellant has maintained that Gleevec (that is, Imatinib Mesylate) is part of the Zimmermann patent. The inventor of Imatinib Mesylate, be it Zimmermann or anyone else, would also be entitled to get patent for Imatinib Mesylate, but in case the inventor was anyone other than Zimmermann, he would require Zimmermann’s permission for marketing Imatinib Mesylate since Imatinib had the protection of the Zimmermann patent.

The finding that Imatinib Mesylate is a known substance from the Zimmermann patent is not based on the conduct of the appellant alone but the finding has been arrived at on an objective consideration of all the material facts and circumstances. On the basis of this observation, the Court rejected the appellant’s case that Imatinib Mesylate is a new product and the outcome of an invention beyond the Zimmermann patent. It was found that Imatinib Mesylate is a known substance from the Zimmermann patent itself.

Moreover, the solvent and the emulsifier were not secrets and they were ordinary market products. On facts also it was unable to accept that Imatinib Mesylate or even Imatinib was not a known substance with known efficacy. All the pharmacological properties of a beta crystalline form of Imatinib Mesylate are equally possessed by Imatinib in free base form or its salt and thus there is no question of the subject product having any enhanced efficacy over the known substance of which it is a new form. It was also held that there is no clarity at all as to what is the substance immediately preceding the subject product, the beta crystalline form of Imatinib Mesylate.

Through the application, it was observed that the beta crystalline form of Imatinib Mesylate is derived directly from Imatinib free base. The Court thus held that the beta crystalline form of Imatinib Mesylate certainly cannot be said to possess enhanced efficacy over Imatinib Mesylate within the meaning of section 3(d) of the Act. It was also seen that all the pharmacological effects of Imatinib Mesylate in beta crystalline form are equally possessed by Imatinib in free base form. Further, 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.

In view of these findings, it was held that the patent product fails in both the tests of invention and patentability as provided under clauses (j), (ja) of section 2(1)and section 3(d) respectively. Thus, the appeals filed by Novartis AG failed and were dismissed with cost.

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