The Novartis Decision - A Primer

On April 1, 2012, the Supreme Court of India delivered its first ever much-awaited decision involving a pharmaceutical product/drug, namely beta crystalline form of Imatinib Mesylate (let’s call it BCIM in short), sold by Novartis AG. The drug is used to treat chronic forms of cancer such as myeloid leukemia. In this series of posts, I will attempt to cover the significant aspects of this decision, keeping the legal jargon to the minimum. Those interested in a detailed comprehensive analysis of the decision can visit the blog “The Demanding Mistress“, which is dedicated to reportage and analysis of Indian innovation and corporate laws.

Background to the Supreme Court’s Decision

In 1998, the Swiss global pharma giant Novartis AG applied for a patent in India through its application numbered 1602/MAS/1998. The application was for a patent on “Crystal Modification of N-Phenyl-2-Pyrimidineamine derivative processes for its manufacture and its use“. Clearly, the application was for a patent on a pharmaceutical derivative (product), the method of its manufacture (process) and the use of the product.

Until the year 2005, India’s patent law, the Patents Act, 1970, did not permit grant of “product patents” to pharmaceutical substances. In other words, until 2005, patents could be sought only over pharmaceutical “processes” or methods of manufacture, but not on the very pharma product being manufactured. This was with a view to safeguard public health concerns and to provide a breather period during which Indian pharma companies could prepare themselves for competition with global majors.

During this period and until 2005, people interested in filing for product patents used to file “mailbox applications”. Under this procedure, the applications for product patents would be taken up for consideration after 2005 when India was scheduled to introduce pharma product patents. Until such time, if the applicant requested, he would be granted Exclusive Marketing Rights (EMR) after examination by the Patent Office. This was the case with Novartis’s application on BCIM as well. On November 10, 2003, Novartis was granted an Exclusive Marketing Right over BCIM.

In the year 2005, the Patents Act was amended to permit grant of “product patents” to pharmaceutical substances, along with which certain other safeguards were also introduced in the Act to prevent grant of patents to trivial innovations to pharma substances. One such significant safeguard is Section 3(d) of the Act, which reads as follows:

3. What are not inventions: The following are not inventions within the meaning of this Act–

…(d) the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.

Explanation: For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy;

In 2005, when Novartis’s application was taken up for examination for grant of product patent on BCIM, 5 parties filed their oppositions to the application, effectively saying that Novartis ought not to be granted a patent for BCIM. These parties were Cancer Patients Aid Association, Natco Pharma Limited, Cipla Limited, Ranbaxy Laboratories Limited, and Hetero Drugs Limited.

On January 25, 2006, the Indian Patent Office agreed with a host of objections of these opponents, and refused to grant a patent to Novartis on BCIM. Here is the link to one of the decisions passed in the oppositions (the contents of the decisions in all 5 oppositions were nearly identical). The primary grounds for rejection of the BCIM Application were:

1. BCIM lacked novelty. In other words, there was nothing new about the invention compared to what was known prior to the patent application.
2. Section 3(d) barred the grant of patent to BCIM.

Following are the relevant observations from the decision of the Patent Office on Section 3(d):

“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 these 5 decisions of rejection by 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.

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, to which India is a party. 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.

It was on these 5 SLPs that the Supreme Court delivered its decision on April 1, 2013, holding the following:

1. That BCIM is not a “new product” and therefore it did not deserve the grant of a patent.
2. That BCIM is not an “invention” under the Act since it was squarely covered by the prohibition under Section 3(d) of the Act.

I will undertake a detailed analysis of the Supreme Court’s decision in the next few posts.