'Preventing Companies from Getting Fresh Patents for Making Minor Changes to Existing Medicines: Revolutionary Treatment vs. Incremental Improvement. India's Drug Research Market in Danger?

Supreme Court of India, April 1st 2013.

ABSTRACT

The Supreme Court of India has rejected a plea by Novartis to patent a prima vacie updated version of a cancer drug Glivec. The court ruled that the new version was only slightly different (practice known as 'evergreening') from the initial one. This decision will allow generic drug-makers to continue to sell copies of the drug at far lower prices and ... saving lives.

On the second page of the ruling, the Court was at pains to discuss the 'tension' presented in the case, i.e. 'to strike a balance between the need to promote research and development in science and technology and to keep private monopoly (called an ‘aberration’ under our Constitutional scheme) at the minimum. Arguments were made about India’s obligation to faithfully comply with its commitments under international treaties and counter arguments were made to protect India’s status as “the pharmacy of the world"'.  

FACTS

Since 2006, the Swiss drug giant Novartis has fought in India to patent a new version of 'Glivec' (also known as 'Gleevec' in the US), used in the treatment of multiple cancers, such as leukemia and gastrointestinal cancer, and rare tumors  It has to be noted that the initial cancer drug was not patented in India, whereas the newer form of 'Glivec' has been patented in nearly 40 countries including the United States, Russia and China. The story of the patent begins with Jurg Zimmerman’s invention of derivatives of N-phenyl-2- pyrimidine-amine, one of which in freebase form was called 'Imatinib', and together constituted a U.S. patent application (No. 5,521,184) granted on May 28, 1996 (the Zimmermann patent). Subsequently, a European patent was also acquired (No. EP-A-0 564 409).

Later, in the US, a patent application was filed for the beta crystalline form of Imatinib Mesylate (the subject in dispute) on January 18, 2000 (The US patent for beta crystalline form of Imatinib Mesylate was granted to the appellant about five and a half years later on May 17, 2005 following the order of the US Appellate Court dated November 23, 2003). The filings for new drug approval, submitted in April 1998, was for Gleevec, and a filing for original drug approval in February 2001 was for Imatinib Mesylate. The judgment highlights this to establish that Imatinib Mesylate was covered by the Zimmerman patent and that Gleevec was its market name ('This application leaves no room for doubt that Imatinib Mesylate, marketed under the name Gleevec, was submitted for drug approval as covered by the Zimmermann patent', said the Court).

RULING

In a 112 page-ruling, the Bench of Justices Aftab Alam and Ranjana Desai concluded that 'the patent product, the beta crystalline form of Imatinib Mesylate, fails in both the tests of invention and patentability (...)' laid out under Sections 2(1)(j), 2(1)(ja) and 3(d) of the 1970 Patents Act (as last amended by the 2005 Patents (Amendment) Act:

2(1)(j) - "invention" means a new product or process involving an inventive step and capable of industrial application.

2(1)(ja) - "inventive step" means a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in the art.

3 - 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.

In other words, Novartis failed to establish either that the compound Imatinib Mesylate was a new product invented beyond the existing Zimmermann patent (derivatives of N-phenyl-2-pyrimidine-amine), or that its beta crystalline form enhanced therapeutic efficacy. The Bench states that 'Imatinib Mesylate is a known substance from the Zimmermann patent itself. Not only is Imatinib Mesylate known as a substance in the Zimmermann patent, but its pharmacological properties are also known in the Zimmermann patent'.

FUTURE PERSPECTIVE

India is a fast-growing pharmaceutical market where many patented drugs are unaffordable for most of its 1.2 billion people. A victory for the Swiss drugmaker would have limited access to important medicines for millions of poor people around the world and for cancers sufferers, would have made a big price difference between life and death. This latest ruling will definitely not make 'easier' for foreign firms engaged in ongoing disputes in India, such as Pfizer's cancer drug Sutent and Roche Holding AG's hepatitis C treatment Pegasys, to win back patent protection after they lost it last year.

Novartis can file a review petition within 90 days. However, the Bench made it clear that they 'do not wish the law of patent in this country to develop on lines where there may be a vast gap between the coverage and the disclosure under the patent; where the scope of the patent is determined not on the intrinsic worth of the invention but by the artful drafting of its claims by skillful lawyers, and where patents are traded as a commodity not for production and marketing of the patented products but to search for someone who may be sued for infringement of the patent'.

Getting fresh patents for making only minor changes to existing medicines doesn't seem to have a future in India. Pharmaceutical multinational companies need to focus research on new drug (genuine inventions) rather than those which are slightly different from existing medicines. They may consider other ways to do business, such as licensing agreement with local firms to offer cheap versions of branded drugs. Depending on the next disputes, including Pfizer and Roche Holding, India's research market might well change in the future. For now, this judgment just reaffirms the importance of the need for substantial innovations (revolutionary treatment) before new patents are issued on medicines.