While the Union Government issued Patents Ordinance fulfilling obligations and commitments under the TRIPS Agreement, which has opened the product patent regime in pharmaceuticals, food and agro-chemicals, the country's pharmaceutical industry including large, medium and small sectors is disappointed to find that some crucial points have either been left out or have been treated in a half hearted manner in the Ordinance.
Expressing the industry concerns on the discriminately drafted Patents Ordinance, the representative bodies of the sector, the Indian Drug Manufacturers Association (IDMA) and the Indian Pharmaceutical Alliance (IPA) have stated that it was necessary to highlight the very important points, which were missed in the Patents Ordinance, so that when the Patents Third Amendment Bill comes up before the Parliament during the Budget session (Ordinance's life remains only for 6 months), the government would be able to correct these deficiencies.
The IPA, which represents the top Indian pharma companies, stated that though the Ordinance claims the existing law does not provide for 'evergreening' of patents, as it prohibits patents on mere new use for a known substance, obtained by mere admixture, it leaves definition of patentability vague. "It does not clarify that patents intended to delay entry of generics and patents for polymorphs, hydrates, isomers, metabolites, substantially pure, particle size, blood levels, etc., will not be patented. It would lead to litigations and the government seemed to have abdicated its responsibility to jurisprudence," the IPA sources said.
While IDMA pointed out that some claims made by the government such as a 3-month period for an appealable Pre-Grant Opposition, insistence on local working etc do not appear in the Ordinance, the IPA said, "as far as Section 25 of the Bill that deals with opposition to grant of patent is concerned, the Ordinance is silent on the hearing and the 'composite order' and mentions only of representation, which is in contrary to the public statements in the press and record of discussions at the meetings of the Group of Ministers."
Nevertheless, the IDMA suggests that making a clear provision that to state salts, esters, polymorphs, hydrates, isomers, metabolites, or changes in purity level, particle size, blood levels, etc. are not patentable as being not substantially different from the original product. This will avoid endless litigation and prevent "evergreening" by unscrupulous patent applicants. The IDMA also suggested that the Right of Pre-Grant Opposition as contained in the Patents' Act 1970 (before the Ordinance) should be retained.
IDMA's other suggestion to the government is that to allow continued generic production of crucial drugs which are expected to be affected by the Mail Box Patents, in the interest of patients by allowing statutory royalty payment to the Patent Holder.
On compulsory licensing provision, IDMA suggests that the procedures of issuance of Compulsory Licences under Sections 87 and 88 should be simplified and time lines fixed, so that Compulsory Licences required for urgently required medicines are issued expeditiously to other parties in public interest subjected to payment of reasonable compensation to the Patent-holder.
However, the IPA stand on Section 92A, which deals with compulsory licence for export of patented pharmaceutical products in certain exceptional circumstances, requires even LDCs under the extended transition period upto 2016 to grant the Compulsory Licence. This is contrary to the TRIPS Council decision and will expose LDCs to undue pressures.
Similarly, the IPA noted about Section 11A (Publication of applications) that the option for early publication of the application and conferring like privileges and rights as if a patent for the invention has been granted on the date of publication has potential for abusive practices wherein the applicant for a weak patent may delay examination of patent, thereby placing generic producer at a disadvantage, which is not a TRIPS requirement.
It adds that the Section 39 (Prohibition to apply, under certain circumstances, for patents relevant for defence purposes, etc.), which was provided for inventions, is relevant for defence and atomic energy only. This is now being expanded to cover any application outside India. This will be prejudicial to the interest of domestic pharmaceutical companies filing patents for incremental inventions outside India, given the complexity of the filing, speed and the need for confidentiality.