Summary
The Novartis decision by the Indian Supreme Court clarified that Section 3(d) of the Patents Act requires enhanced therapeutic efficacy for new forms of known substances, significantly impacting patent law in India. This principle, though tested on pharmaceuticals, has implications for genetic inventions such as gene sequence patents. The post analyses the treatment of cDNA and gDNA patents in India, highlighting that both are patentable, unlike in some other jurisdictions. However, it questions whether genetic inventions can meet the enhanced efficacy standard required by Section 3(d). The author discusses the resulting legal complexities and the potential challenge for genetic and biotechnology patents in India.
The Supreme Court of India’s decision rejecting patentability of the cancer drug Imatinib Mesylate in its beta crystalline form (commonly called Glivec) has been widely commended for its emphasis on public interest and access to healthcare. The ruling removed the last possible barrier to patients accessing the drug at roughly one-tenth of its branded price, which was around Rs. 1, 20, 000/- per month. The central issue turned on Section 3(d) of the Patents Act, which prohibits patents on new forms of a known substance unless enhanced efficacy is demonstrated. The Court held that, for pharmaceutical substances, enhanced efficacy means therapeutic efficacy, and that specific physico-chemical properties of a form cannot be considered unless they translate into an objective and enhanced therapeutic effect in treating a disease.
Scope of Section 3(d) Beyond Pharmaceuticals
The application of Section 3(d) is not confined to pharmaceutical and chemical inventions as clarified in the Novartis case; it extends to other categories of inventions as well. One field that has attracted significant patent controversy is genetics and genetic engineering. The breast cancer patent case then pending before the United States Supreme Court had brought forward a range of public policy questions on the patentability of genes, from the product of nature doctrine to issues of healthcare access.
Gene Sequence Patents in India
Isolated sequences — both gDNA (naturally existing DNA sequences) and cDNA (products of reverse transcription) — have been treated as patentable in India. Approximately 393 cDNA patents and 74 gDNA patents had been granted in India, and 1203 cDNA applications and 364 gDNA applications had been published as of 8th May 2013. In India, neither cDNA nor gDNA sequences are treated as products of nature, which is a common obstacle to gene sequence patents in other jurisdictions. Not coincidentally, most of the top ten filers of gene sequence patents in India are multinational corporations, including Hoffmann-La Roche, Merck, Eli Lilly and Novartis. Given that gene sequence patents have a direct correlation with healthcare — particularly in diagnostics, as demonstrated by the breast cancer patent dispute — there is a reasonable basis for drawing parallels between pharmaceutical substances and genetic substances for patent analysis.
Applying Section 3(d) to Genetic Substances
As with the cancer drug in the Novartis case, which was priced at a level that rendered it inaccessible to many patients, the breast cancer genetic test was similarly priced at levels that restricted access. The pharmaceutical applications of gene sequences make them susceptible to Section 3(d) scrutiny in the same manner as chemical compounds. In most gene-sequence inventions, the primary contribution, aside from identifying the exact sequence, lies in characterising the sequence’s function. Since the complete sequence already exists in the human body or in genome libraries, gDNA sequences may be considered as the same form as the naturally occurring molecule, while cDNA sequences may be considered a new form because they lack introns (non-coding regions) relative to their natural counterparts.
For cDNA sequences to pass the test of Section 3(d), they would need to possess enhanced efficacy in performing their biological function. That, however, is structurally impossible: cDNA sequences, when compared with their natural counterparts, possess either the same or reduced efficacy in performing their function and not greater efficacy. Extending this analysis further, a protein produced using recombinant DNA technology would be substantially the same as the naturally extracted protein, differing perhaps only in purity. Such a substance would not be able to satisfy the therapeutic efficacy standard articulated by the Supreme Court.
Implications for Genetic and Biotechnology Inventions
The analysis raises a difficult question for the future of genetic inventions in India. Two possible paths present themselves: either genetic inventions are exempted from the scope of Section 3(d) by restricting the section’s application to chemical inventions, or they are brought within its scope with specific judicial exceptions carved out on the basis of the nature of the invention. The second approach is structurally complex for a judiciary with limited experience in patent law, while the first would expose India to challenges under the Agreement on Trade-Related Aspects of Intellectual Property Rights. The question of what becomes of genetic, biotechnology, and related inventions in the light of Section 3(d) therefore remains to be addressed by the legislature or the courts.
Disclaimer: This article is for general information and does not constitute legal advice. Readers should consult a qualified attorney before acting on any matter discussed here.