The Background:
As a previous British colony, India had inherited its intellectual property regime from Britain. However, after gaining independence in 1947 product patents were removed from protection under the patent laws. During the 1990’s, India needed to adapt its patent legislation to be TRIPS compliant. Therefore, in 1999 India allowed for transitional filing of product patents with retrospective effect from 1995, and full product patent protection was re-introduced from 2005, when transitional regulations ended.
The Case:
During the 1990’s, Novartis filed a series of patent applications in the US, initially for a drug containing “imatinib”. This patent application covered pharmaceutically acceptable salts and was subsequently granted. Novartis then filed a patent application for the “beta crystalline” form of the imatinib mesylate salt, which was subsequently granted in the US. The US Food and Drug Administration (FDA) approved the active ingredient imatinib mesylate for use as a magical cancer drug, in the form of Novartis marketed drug “Gleevec”. It is used to treat chronic myeloid leukemia. Several patents were obtained for the beta crystalline form of imatinib mesylate in other countries.
At the time, India did not allow protection for product patents, and no patent protection for imatinib was obtained in India. Thereafter, as India’s patent laws changed, Novartis sought patent protection for the beta crystalline form of imatinib mesylate in 1998. The application was processed in 2005 once the law allowed for product patents, however, the application was rejected in 2006 on the grounds that it failed to satisfy novelty and non-obviousness requirements. Novartis lodged appeals before the Madras High Court, which was then transferred to the then newly formed Intellectual Property Appellate Board. The Appellate Board modified the previous decision, stating that novelty and non-obviousness were present in the application (i.e. the invention of the beta crystalline form of imatinib mesylate is new and inventive), however further stating that the patent application had to be rejected on the grounds that the invention was not a new substance but an amended form of a known compound and that Novartis was unable to show increase in efficacy as laid down in section 3(d) of the Indian Patents Act[1]. Novartis then appealed directly to the Supreme Court through a Special Leave Petition, due to urgency, as the patent if granted on appeal would expire by 2018.
Novartis had applied for a patent application for protection of the beta crystalline form rather than imatinib in free base form or imatinib mesylate, and thus needed to prevent prior literature on imatinib and imatinib mesylate from being regarded as prior art against the beta crystalline form. Novartis’s argument was that the beta crystalline form was one polymorph of imatinib mesylate and inventors therefore had to research it further, and that the beta crystalline form had enhanced efficacy in comparison to imatinib and imatinib mesylate. In terms of efficacy, it was stated that the beta crystalline form had more beneficial flow properties, better thermodynamic stability, lower hygroscopicity and increased bioavailability.
On the basis of the documents presented , the Court concluded that the prior patents and literature did count as prior art against the beta crystalline form of imatinib mesylate, and it therefore did not meet the requirements of an “invention” as laid down in the Indian Patents Act.[2]
The Court then turned to the argument of efficacy in order to pass the test of s 3 (d). The Court held that “the test of efficacy would depend upon the function, utility or the purpose of the product under consideration...in the case of a medicine that claims to cure a disease, the test of efficacy can only be ‘therapeutic efficacy’...With regard to the genesis of section 3(d), and more particularly the circumstances in which section 3(d) was amended to make it even more constrictive than before, we have no doubt that the ‘therapeutic efficacy’ of a medicine must be judged strictly and narrowly”.[3] The Court then held that the claimed flow properties, thermodynamic stability and hygroscopicity, whereon Norvartis relied on to overcome s 3 (d), had nothing to do with therapeutic efficacy. With regard to Novartis’s claims of increased bioavailability, on the facts, the Court found that the increase in bioavailability of the beta crystalline form was not in comparison to the known and previously marketed mesylate salt form of the drug which was soluble, but rather in comparison to the free base form which was not marketed as it was not highly soluble. On the facts, increased bioavailability was not proven, and the efficacy test of s 3(d) was therefore not met. The Court therefore rejected the Novartis patent application. The Court held that the purpose behind s 3(d) is specific i.e. “The amended portion of s 3(d) clearly sets up a second tier of qualifying standards for chemical substances/pharmaceutical products in order to leave the door open for true and genuine inventions but, at the same time, to check any attempt at repetitive patenting or extension of the patent term on spurious grounds..” [4]
Evergreening:
It was stated that the primary purpose of s 3(d) as evidenced from the legislative history, was to prevent “evergreening”. “Evergreening is a term used to label practices that have developed in certain jurisdictions wherein a trifling change is made to an existing product, and claimed as a new invention. The coverage/protection afforded by the alleged new invention is then used to extend the patentee’s exclusive rights over the product, preventing competition”.[5]
It can thus be seen that some critics, as was argued in the case at hand, claim that incremental improvements to existing medicines are trivial, provide minimal medical advancement and form the basis of the “evergreening” strategy. Incremental innovation occurs when medicines are improved by possibly increasing treatment options, dosage options, discovering new uses or improving properties on existing medicines. However, it can also be said that an incremental improvement does not affect the patent term of the existing medicine, as the patent on the first medicine and the patent on the improved medicine are independent of each other. Thus, once the term of the patent(s) on the original product expires, any generic manufacturer may begin production and marketing of that original medicine.
Whilst incremental innovation has been disregarded as trivial by critics, most innovation is incremental by nature as progression of technology, especially in the pharmaceutical sector, occurs in steps. What should be borne in mind is that there is a difference between incremental innovations that confer real advantages and those that offer no therapeutic improvements. It is important to differentiate between the two and avoid patents being used as strategic instruments in competitive practices. The question to be asked is, “When does an incrementally improved invention of a first patented invention become eligible for a separate patent?” In this regard, each invention will have to be examined on its merits based on the usual patenting criteria of novelty and inventiveness, and should be able to withstand the scrutiny thereafter. As was seen in the Novartis case, the Supreme Court held that novelty was not proven on the facts, and the drug would have failed the patentability test on this basis alone. Some, as was seen with the Indian legislature’s intention, believe that additional criteria such as therapeutic efficacy should be used during this examination for patentability. However, it may be worthwhile to note that intention of defensive strategy against competitors in the patenting process is not relevant during the patent grant process or validity of the patent. Post-grant procedures such as licensing etc may be employed to deal with undesirable competitive practices.
The goal of any patent regime is to promote innovation by rewarding the inventor for disclosing his invention to the public through the award of exclusive rights for a period of time, thereby disseminating knowledge and improving the welfare of society. Intellectual property protection is of greater importance to the pharmaceutical industry as the research and development process is both costly and time-consuming. The importance of striking a balance between research and development and access to healthcare for the public is once again highlighted.
