Biotech firms want changes in patent law

The Biotechnology Industry Association (BIA), the representative body of international biotech product makers, has expressed concern over the patent criteria norms prescribed under the Indian Patent Act.

In a representation to the office of the US Trade Representative (USTR) on February 11, the association has demanded that India be kept under the priority watch list of USTR due to inadequate intellectual property (IP) compliance.

BIA represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centres and related organizations in the US and 31 other countries. In addition to healthcare, BIA members cover sectors like agriculture, industrial and environmental biotechnology products and services.

BIA feels that Indian laws are unclear on whether biomolecules like polypeptides and nucleic acids are eligible for patents in India. It is worried about specific clauses in the Indian Patent Act that disallows patents for known products unless they result in significant enhancement of the known efficacy.

The organisation also expressed apprehensions about India's preparedness in incorporating data protection clauses for medicines.

Taking note of the Indian rules that requires applicants to disclose the source and geographical origin of biological materials used for invention, which is the subject of a patent application, BIA said these special disclosure requirements impose unreasonable burdens on patent applicants, subjecting valuable patent rights to uncertainty.

"Each patent applicant is responsible for tracing the "history" of all naturally-derived biological materials contributing to the invention, even if the applicant obtained the material from a commercial supplier and the material has been available from secondary sources for decades. The failure to identify the geographical source of a biological material used in the invention may be the basis for opposition or revocation proceedings. Such requirements pose unacceptable risks for patent applicants and would undermine the incentives of the patent system to promote innovation in biotechnological inventions," the BIA said.

Pharmaceutical Research and Manufacturers of America (PhRMA), the representative body of the US drug makers, has for long been voicing for more industry-friendly IP laws in India. Swiss multinational drug major Novartis had even taken the government to court on IP issues.

The BIA move is a reiteration of the stand taken by multinational corporations that Indian patent laws do not favour large-scale patent monopoly for incremental innovations on known substances.

Incidentally, India is not the sole target of the BIA. Countries like China, Thailand, Brazil, the Philippines, Argentina, Chile, Egypt, Israel and Ukraine have also been blamed for inadequate IP protection measures.