Novartis Case : An Insight

Novartis Case: A landmark judgment from 
Supreme Court of India

Supreme Court of India has given a landmark judgement in latest Novartis case, covering the vital aspects of Section 3(d), Section 2(1)(j) and Section 2(1)(ja)  of the Patent Act, 1970 and protecting the interest of the public at large against costly medicines.

This case is associated with the Patent Application bearing number 1602/MAS/1998 filed by the Novartis (“a leading pharmaceutical drug manufacturer MNC”) for granting of patent for beta crystalline forms of “Imatinib Mesylate”, a drug used for curing cancer and tumors. Before getting in depth of the judgment and points ruled by the Apex Court lets go through the major aspects of the case.

In backstage, Jurg Zimmermann, an inventor at Swiss pharmaceutical company Novartis, invented a number of derivatives of N-phenyl-2-pyrimidine-amine including a derivative known as “Imatinib” (Non-proprietary name by WHO). “Imatinib” - a drug having properties to cure chronic myeloid leukemia, a special sort of blood cancer caused due to white blood cells, and also used in cure of tumor. It is to be noted that the Imatinib was founded in free base form.

The N-phenyl-2-pyrimidine-amine derivatives, including Imatinib, were submitted for patent in the US. The application was made on April 28, 1994 and patent was granted on May 28, 1996 under US Patent No. 5,521,184 (“the Zimmermann Patent”). The Zimmermann compounds (i.e., derivatives of N-phenyl-2-pyrimidine-amine) were also granted a European patent under Patent No. EP-A-0 564 409.

Later on the Imatinib was further refined in form of beta crystalline. For the clarity it is pertinent to mention that Crystalline form of any substance refers to the degree of structural order in a solid. In a crystal, the atoms or molecules are arranged in a regular, periodic manner. A free base Imatinib was changed in form of crystal through the method as explained well in the application. It will be cumbersome to discuss the method in detail as it consist the technical jargons.

The product, “Imatinib mesylate” comes into existence which was marketed as “Gleevec” by Novartis.

Novartis filed patent application in India on July, 1998, however, the Patent Laws were in transitional stage and the application was put down in “mailbox”. Novartis on the other hand made application for Exclusive Marketing Right for the Imatinib Mesylate in India. The case remain silent till 2005, when India enunciated Patent Amendment act 2005 and repealed Section 5 which puts bar over the products patents.

On 15^th December, 2005, assistant controller of patent rejected the registration on the following grounds:

i.                     The application is anticipated by the prior patent of Zimmermann

ii.                   The process is obvious to the person skilled in the art.

iii.                  The product is a mere discovery of known product Imatinib.

iv.                 Contention of priority date is not acceptable as Switzerland was not a convention country as on 17^th July, 1998.

Novartis, appealed against the order of Controller to Madras High Court, whereas matter was shifted to IPAB (Intellectual Property Appellate Board). The Board accepted the novelty in process but refuse to grant patent on the product based on the grounds contained in Section 3(d).

Novartis filed writ petition before the Apex Court contending the order of IPAB is invalid and Section 3(d) is unconstitutional as it violates Article 14 and also contravenes the TRIPS Agreement.

Mr. Gopal Subramanium and Mr. Andhyarujina, learned senior advocate presenting the case for Novartis have given some very fine arguments in favor of the registration of patent.

The Supreme Court of India considering the international treaties and the interest of public at large refused the registration and dismissed the appeal with cost on the grounds as follows:

1.       The contention that Patent Laws violate the TRIPS Agreement and Article 14:

The reason for making amendment in the Patent Act in 2005 was to make the patent laws in consonance with the TRIPS Agreement and to provide the necessary and adequate safeguards for protection of public interest, national security, bio-diversity, traditional knowledge to the country. The amendment was also done to allow the patent of pharmaceutical product and agricultural chemical substance in India which was not allowed prior to 2005. In the context of the same it shall:

a.       Limit the scope of patentability to only new chemical entities.

b.      Prevent patent for new usage or dosage of known drugs

c.       Provide simple procedure within the time limit for granting compulsory license.

d.      Protect the generic drugs available in market

e.      Ceiling on the royalty paid to the pharmaceutical company.

Moreover, the Novartis was granted exclusive marketing right for its product Gleevec to sell the drugs in India at Rs. 1,20,000 whereas the generic drugs of the same are avalble in Rs. 8,000 to Rs. 10,000. The Act can’t be said as contravening any provision of Article 14 of the Constitution of India.

2.       There has been a lot of similarity between the Imatinib patent of Zimmermann and Imatinib Mesylate patent as filed by Novartis.

3.       Zimmermann patent teaches any person skilled in the art how to use Imatinib, or a pharmaceutically acceptable salt thereof, in a pharmaceutical composition for treating tumors or in a method of treating warm-blooded animals suffering from tumoral disease.

4.       Further, Novartis send legal notices to NATCO for marketing a drug in UK having similar capabilities of Imatinib Mesylate on the basis of old Zimmermann patent. It directly confers that the new application is basically based upon old Zimmermann patent. Hence, it is only a new form of known drug and cannot be patented as per Section 3(d) of the Patent Act, 1970.

5.       The Imatinib mesylate was discussed in an issue of January, 1996, of a journal called Cancer Research, titled as “Inhibition of the Abl Protein – Tyrosine Kinase in Vitro and in Vivo by a 2 – Phenylaminopyrimidine Derivative” and was also published in Nature Medicine Magazine of the year 1996, titled as “Effects of a selective inhibitor of the Abl tyrosine kinase on the growth of Bcr- Abl positive cell.” The Supreme Court opined that the Imatinib Mesylate cannot be said as new product, having come into being through an “invention” that has a feature that involves technical advance over the existing knowledge and that would make the invention not obvious to a person skilled in the art.

6.       Imatinib Mesylate is a known substance from the Zimmermann patent itself.

This case apparently shows the concern of Indian Judiciary towards the weaker sections, not only of India bur to those countries whom India supplies the generic drugs…. I personally anticipate some more landmark judgment from Apex Court which will help the public at large and create a hope in judiciary.

Note: The facts produced here have been selected from the judgment available with Supreme Court of India. Please refer CIVIL APPEAL Nos. 2706-2716 OF 2013, (ARISING OUT OF SLP(C) Nos. 20539-20549 OF 2009). The contents produced in this Article are meant solely for information purposes and author does not intends to report anything causing harm to any business, directly or indirectly.