Even with the second amendments, the Indian Patent Act remains unclear on several provisions as far as pharmaceutical sector is concerned. The last amendments effected in the Indian Patent Act in 2002, which was notified on May 20, 2003, has its own chunk of grey areas, said noted patent expert Prof. Dr. Prabuddha Ganguli.

Dr. Ganguli was speaking at the recently organized seminar on Indian IPR titled "Intellectual Property Rights and Patent Act Amendments" organized by Healthcare & Industry Information Centre in Mumbai. According to Dr Ganguli, although the Indian Patent Office's intention to make amendments in the country's patent law was good, many points in the law was still unclear and had protectionist intent. In his presentation titled "Intellectual Property Systems in India: A focus on Patents especially for the Pharma Sector," Dr. Ganguli pointed out several provisions which are yet to be modified and made clear. This includes, Sec 57 (3), where advertising any amendment to a patent application in the official gazette has been made discretionary "in the opinion of the controller is substantive," makes the system non-transparent.

An essential requirement of the Patent Law, which states that any products of biotechnological, biochemical and microbiological processes are not patentable in India, putting the inventors of products in these advancing fields to a disadvantage.

Under Section 25/64, the grounds of opposition will include "knowledge that is oral or otherwise available within local communities in India or elsewhere". "How does one authenticate oral knowledge, without any benchmarks provided," he said.

Section 39 has been reintroduced with respect of inventions relevant to defence purposes (DP) and atomic energy (AE). "Here definition for DP and AE are either loose or outdated, leading to further confusion," said Ganguli.

Section 83(b) continues to state, "that patents are not granted merely to enable patentees to enjoy a monopoly for importation of the patented article". This is contradictory to the 24C, which was introduced, in the first Patents Amendment related to compulsory licenses which states "working of patents shall be deemed to be selling or distributing of the article or substance" and "patents" shall be deemed to be reference to "right to sell or distribute." "A correct definition on the working of patents has not been included in the notification," he said. The Section, which deals with the general principles applicable to the working of patented inventions has been expanded to include several conditions especially mentioning "that patents are granted to make the benefits of the patented invention available at reasonably affordable price to the public".

Linking price and affordability to conditions for compulsory licenses is too restrictive. A strong competition law or clauses as in most anti-trust laws would be welcome to control monopolistic practices and overuse of the protection given by patents, he said.

Additional clauses in Section 90 regarding compensation to the patentee after compulsory licensing have been unfair to him, he said. It states "The royalty and other remuneration, if any, reserved to the patentee or other person beneficially entitled to the patent, is reasonable, having regard to the nature of the invention, the expenditure incurred by the patentee in making the invention or in developing it and keeping in force and other relevant factors."

Special provisions (national emergency) in Section 92 (1)(ii) "in setting the terms and conditions of a licence granted under this section, the Controller shall endeavour to secure the articles manufactured under the patent shall be available to the public at the lowest price consistent with the patentee deriving reasonable advantage from their patent rights.

Section 100 of the Principal Act is now substituted by "Provided that in the case of any such use of any patent, the patentee shall be paid not more than adequate remuneration in the circumstances of each case taking into account the economic value of the use of the patent."

Section 90(1)(ii) "Settling the terms and conditions for CL that the patented invention is worked to the fullest extent by the person to whom the licence is granted and with reasonable profit to him." Are these points really fair to the original patent holder questioned Dr. Ganguli.

The National Biodiversity Board (NBB) has been made an agent, scrutinising every move of the patentee. For e.g. as per the National Biological Act - Chapter II. e.g. Sections 3, 4, 5 & 6 of BD Act 2002, Biodiversity Application for IPR cannot be made without approval of NBB, results of R&D cannot be transferred without its approval, exceptions for collaborative research projects, applications for IPR cannot to be made without the approval of NBB.

Nevertheless, the positive points in the amendment include - increasing the term of patents to 20 years, inclusion of microorganisms as patentable, inclusion of software as patentable if it satisfies conditions of patentable inventions, making a provision for the non-patentability of an invention which in effect is traditional knowledge or is an aggregation or duplication of known properties of traditionally known component or components, making it mandatory to deposit the biological material which is a subject matter of a patent to any of the depository centres as required by the Budapest Treaty, making disclosure of the source and geographical origin of the biological material in the specification when used in an invention mandatory, making a formal request for examination of the patent application by the applicant within a specified period shortening of some of the time-scales for the actions during patent prosecution mandatory, formation of an appellate board to look after IPR violation cases, reversal of the burden of proof in case of infringement of process patents, the deletion of Sections 86, 87, and 88 of the Indian Patents Act 1970 related to "Licences of Right", which will ensure that all patent applications will be published after 18 months from the date of filing. "It is a welcome concept provided it is implemented with appropriate caution and speed. However there should have been a special appellate board for patents as it is a highly specialized area coupling it with the Trade Marks Appellate Board may not serve the purpose even though the appellate board is supposed to have the technical member to handle matters dealing with patents," said Dr. Ganguli.

Rajeev Ranjan, Director, Department of Industrial Policy and Promotion was the chief guest at the seminar. The other key speakers at the seminar were Ranjit Shahani, President, OPPI, Swati Piramal, Director, Nicholas Piramal, and Krishna Sarma were the other keynote speakers at the event. The symposium was organized by Healthcare & Industry Information Centre and co-sponsorred by Assocham, IMC, TPDC, CropLife India and Interpat.