The Indian Patents Amendment Act 2005- Pt 1

One of the more significant developments in the Indian Pharmaceutical Industry in recent times being the Patents Amendment Act 2005, amending the Patents Law of 1970, and extending Patent Protection to Pharmaceutical products – as opposed to processes as was the case before. This being to satisfy the deadline set by the WTO’s Trade-Related Aspects of Intellectual Property Rights agreement (TRIPS), which made patent protection on both products and processes compulsory for 20 years. The new statute forced recognition not only of new patents but also any patents filed after 1st January 1995.

Key provisions in the statute are as follows:

*a) Extension of product patent protection to all fields of technology (i.e., drugs, foods and chemicals);

b) Deletion of the provisions relating to Exclusive Marketing Rights (EMRs) (which would now become redundant), and introduction of a transitional provision for safeguarding EMRs already granted;

c) Introduction of a provision for enabling grant of compulsory licence for export of medicines to countries which have insufficient or no manufacturing capacity, to meet emergent public health situations (in accordance with the Doha Declaration on TRIPS and Public Health);

d) Modification in the provisions relating to opposition procedures with a view to streamlining the system by having both Pre-grant and Post-grant opposition in the Patent Office;

e) Addition of a new proviso in respect of mailbox applications so that patent rights in respect of the mailbox shall be available only from the date of grant of patent, and not retrospectively from the date of publication;

f) Strengthening the provisions relating to national security to guard against patenting abroad of dual use technologies;

g) Rationalisation of provisions relating to time-lines with a view to introducing flexibility and reducing the processing time for patent applications, and simplifying and rationalising procedures.

* Source http://www.indianembassy.org/

Of particular significance to the Pharmaceutical Industry was Section 3 and of even more specific interest to the on-going question of Patent protection and the WTO-TRIPS regime is Section

(3)d.

The wording of Section 3(d) is thus: “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 of 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” The section is further explained thus: “ For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pre 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 regards to efficacy”

The application of this Law was tested in two cases in the New Delhi High Court namely In Re Novartis and Roche v Cipla.

In Re Novartis- this case being based on a Claim filed by Novartis in the New Delhi High Court, challenging refusal of a Patent application for its product Glivec. The Claim being for a Declaration that Section 3 (d) of the Patents Amendment Act 2005 was unconstitutional and non-compliant with India’s obligations under WTO/TRIPS. Novartis was unsuccessful in its claim, with the court deciding that S.3(d) was not unconstitutional as contended by Novartis, further deciding that the Claim was more appropriately addressed to the WTO’s dispute resolution mechanism.

In Roche v CIPLA- Roche registered the patent for the API - Erlonitib- of its Drug Tarceva last year, CIPLA however launched a generic version of the Drug. Roche naturally brought action against CIPLA who claimed that the Patent was invalid being that Erlotinib is a derivative of an earlier Molecule Gefatinib, hence it wasn’t original. Roche sought an order of Interim Injunction restraining CIPLA from further infringement of its Copyright, which was refused by the Delhi High Court on the basis that there is a serious triable issue as to the originality of the API; hence a case had not seriously been made out for the grant of an Injunction. The case being ground-breaking in that the Court whilst determining the application, placed substantial emphasis on public interest- whilst still applying the American Cyanamid v Ethicon principles.

A simple summary of CIPLA's argument being that the patent suffered from invalidity as it wasn’t new, obvious and didn’t involve an inventive step as it was

i. A modified version of a pre-1995 drug- and hence not eligible for patent protection in India;

ii. There was no evidence of improved efficacy as per S.3(d) in addition the application had not disclosed that the drug was a mixture of two polymorphs, or drug derivatives, which would have been ineligible for patent protection, since the efficacy test was not satisfied.

iii. That the Roche claim be denied and fundamentally that the court rule in favour of a regime of public interest, i.e lower cost drugs (the comparative cost of Roche/Cipla drugs being 4800 Rs/1600 Rs respectively). It is necessary to clarify that Roche' contention is that the actual cost of the drug is 3200 Rs, however the court was minded to accept Cipla's account of cost- as it contended to be found on the packaging.

This case is now currently being heard by the Indian Court of Appeal based on appeal from the High Court by Roche.

Viewpoint:

a. There are still unanswered questions as to the efficacy of the new Patent regime engendered by the Patents Amendment Act 2005, which is presently in a state of uncertainty pending a final determination on the subject both by the Indian Supreme Court and indeed the WTO Tribunal, on India’s compliance with its obligations under TRIPS. The key questions being to determine what constitutes “enhanced efficacy” as per S.3(d) and the larger question being whether Section 3 (d) satisfies the threshold of compliance espoused by TRIPS.

b. The perspective of Multi-national Pharmaceutical companies on the application of India’s responsibilities under TRIPS differs substantially from that of Indian Pharmaceutical establishment as succinctly defined by Komal Shah of InnovarIP “the matter really pertains to the obviousness criteria and the scope of patentability…. In the U.S., obviousness is assessed based on various criteria including commercial success, motivation to combine, long-felt need, praise and skepticism, or unexpected results. In Europe, patentability is judged by applying the problem-solution approach”

One-dimensional Case Law seems in my view be wholly insufficient to resolve the issues inherent in S3(d), since the very breadth and implications of the section lends itself to amorphous applications of its content. The way forward? Difficult to say, Class action/WTO Tribunal? These may only answer part of the question, Legislative intervention? Still not a comprehensive answer, since fresh amendment may only throw up further questions. The only real finality may come - as stated above- from authoritative interpretation by the Supreme Court of India. The world waits.

© Edward C Keazor