A few features of the amendments in the Indian Patent Act and its overall impact on the Indian Patent system is discussed . The Act now provides for two different stages of patent opposition: pre-grant, upon the publication of the application; and post-grant, upon the grant of a patent. All 11 grounds for pre-grant opposition have been restored in Section 25 of the Patents Act. The new legislation would create a new IPR culture in India. India's IPR policy is aimed at boosting development of research and technology and also attract foreign investments.
Salient features of the legislation-Post 2005
*Extension of product patent protection to all fields of technology (i.e., drugs, foods and chemicals);
*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; The Act now provides for two different stages of patent opposition: pre-grant, upon the publication of the application; and post-grant, upon the grant of a patent. All 11 grounds for pre-grant opposition have been restored in Section 25 (1) of the Patents Act. While an interested person can initiate post-grant opposition, the Act allows any person to institute a pre-grant opposition on the same grounds as the post-grant opposition.
*Changes in Section 3: (Section 3 lists out the exceptions to patentability).With regards to what is not patentable, the Act dropped the earlier provision contained in the Ordinance; that provision created the possibility for the grant of a patent on a second medical use of a known drug. The amended Section 3(d) reads thus:
(d) 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 for a known substance or the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least employs one new reactant.
Explanation- For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, and 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 regard to efficacy. It follows from the above statements that patents would not be available on the following grounds:
*the mere discovery of a known substance which does not result in the enhancement of the known efficacy of that substance.
* the mere discovery of any new property or new use for a known substance.
* the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least employs one new reactant.
One can argue that a minor alteration to an existing drug molecule, resulting in "enhancement of its known efficacy" could lead to the grant of a patent on that molecule. The word "mere" has been deleted from qualifying "new use," patents available only in instances where the discovery is not mere.
With reference to the lengthy explanation accompanying the above provision, the Act states that patents would not be available on new forms of a known substance unless it "differ[s] significantly in efficacy." Efficacy will thus be the important deciding factor for grants of patents on drug molecules. This would help both domestic and foreign pharmaceutical companies secure patents on "genuine innovations" only, and would reduce the opportunity for companies to extend their patent monopoly through minor modifications around a drug molecule. While the onus of passing the "efficacy" test has been put on the patent applicant, a lot would depend upon the specifications and the claims therein.
*Introduction of a provision for enabling grant of compulsory license 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);
*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.
*Strengthening the provisions relating to national security to guard against patenting abroad of dual use technologies;
*Rationalization of provisions relating to time-lines with a view to introducing flexibility and reducing the processing time for patent applications, and simplifying and rationalizing procedures.
*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;
Impact of Pre-grant Opposition
India's pre-grant opposition procedure permits opposition to potentially frivolous patent applications, protecting consumers against high prices on non-innovative pharmaceutical products under consideration for patent protection. The amended Patents Act would erode the level of transparency and civil society involvement in pre-grant opposition.
The timeline for filing a pregrant opposition is within 6 months from the publication of patent application or till the grant of patent. Ideally the proceeding of pre grant opposition and examination of patent application should occur synchronous. Thus besides patent office an opponent also could bring out the relevant prior art for judging the novelty and inventive step. Thus the patent application would be properly scrutinized which would filter the frivolous patents and only the genuine inventions would be granted.
There was a reported filing of 6989 patent applications during the period 1995 to 2004 in India in the mail box category out of which 3646 relates to product 1198 relates to composition 1296 relates to process 206 relates to crystal form 218 relates to combinations and 425 relates to method of use.
It was pleaded that the grounds of pre-grant opposition under the Law of 2005 was weak and cited the case of Canada and UK where the grounds of pre-grant opposition were much stronger. It was presented that pre-grant opposition is an important tool to prevent grant of trivial and frivolous patents without litigation. Litigation it was pointed out is long drawn, expensive and not affordable by most Indian companies.
It was asserted that the strengethening of the grounds of pre-grant opposition would not be contrary to TRIPS. GlaxoSmithKline's application for EMR for rosiglitazone maleate was rejected as it was a pre-95 molecule and a derivative of a known substance which does not qualify for EMR. GlaxoSmithKline had filed a case in the Delhi High Court against the government's decision not to grant an EMR to GSK for its anti-diabetic drug rosiglitazone. The corresponding patent application is also undergoing a pre-grant opposition.
There are several examples of drugs which are the extensions of the basic patent and filed in India to increase the life for additional periods and to prevent generics from entering the market.
There is some anomaly of procedure at the different patent offices in respect of pre-grant oppositions. Some of the controllers are of the opinion that the pre-grant opposition is merely an extension of a third party representation while a post-grant opposition is full-fledged opposition. Some controllers however are conducting a pre-grant opposition as a full swing opposition.
If one looks at the provision then a pre-grant opposition also has to be a full-fledged opposition because the law aims at preventing grant of patents for inventions which attract any of the grounds of opposition. Once a doubtful application is allowed to proceed to grant the patent holder will have the right to take recourse to legal action which may be an unnecessary burden on a small industry.
New IPR Culture
The product patents and related processes which were in the pipeline until January 1, 2005 are currently under examination and the patents would get granted in the very near future and most likely before the end of 2008. India will then experience a load of litigations in respect of pharmaceutical products and processes and one has to wait and see how and what these litigations actually protect the innovators and strike a balance between good trivial and frivolous patents. The patent holders and the generic industry both have to keep their fingers crossed.
Indian pharmaceutical firms are beginning to benefit from IP protection for their own products. Stronger product patent protection will encourage this development.There are several products, which are competitively sold which would attract infringement actions as soon as the patent applications in the pipeline start getting gran-ted. The industry should review each such product to save smaller local players from being exposed to harsh litigations. It is also important to review the processes in respect of process patents especially in the backdrop of the doctrine of equivalence or the doctrine of purposive construction. While a manufacturer could be of the impression that his process is different from the patented process but he could get seriously trapped under these doctrines. As a matter of policy, the industries should conduct a thorough due diligence of all product which relate to the Trips regime.
The Indian government is responding to the need for development of IPR infrastructure. A major modernization programme is underway for patent office operations. This includes computerization, networking of the 4 offices, new buildings, improved facilities including online search capabilities and also the training of IP personnel.
(The author is faculty, Academy of Intellectual Property Studies & patent attorney, S.Majumdar & Co, Mumbai)