How will amendments to Patents Bill help pharma?

The amendments address the demands for making the law more friendly to the domestic pharmaceutical industry, while meeting international obligations. It makes it legal to sell cheaper existing copies of those drugs filed for patent protection between 1995 and â€™05, even after they are granted patents on merit in the coming days. This automatic licensing under reasonable royalty, makes Indian firms immune to infringement proceedings in the case of drugs filed during the 10 year transitional period. It also gives an opportunity to local firms to bust a likely patent through opposition proceedings before and after its grant. Together with the other amendments, the Bill passed in both Houses of the Parliament, addresses all vital demands of the domestic industry and the left parties that lobbied for them. What does the conditional exclusion of new forms of older drugs from patenting, mean for Indian and multinational drug firms? The amendments does not allow patenting of a new form of a known substances unless they significantly differ in properties with regard to efficacy. This will help domestic companies, since a patent applicant will not be able to extend market monopoly of older drugs with minor modifications in its form. At the same time, this would help a genuine innovation of a multinational to get market protection when it substantially differs in efficacy. This tough barrier for patenting incremental developments will drastically reduce the number of patents likely to be granted compared to the previous provision. The Bill specifically mentions forms such as salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substances under this conditional exclusion. Drug makers have been accused of getting patents for new forms and using them as cover to extend the market monopoly of an older drug nearing its patent expiry. Patent applications are drafted in a broad way that the claims regarding a particular form could be used to force relatively similar products out of the market. The new provision will put a lid on this and will also reduce litigation. What do the amendments mean for the IT industry? The Bill has dropped the provision allowing patents for a computer programmeâ€™s technical applications to the industry or its combination with hardware as those used in mobile phones. How will the new pre-grant opposition norm help a patent challenger? The amendments have restored the 11 grounds in the existing law for opposing the grant of a patent, which were removed in the Ordinance. Now, besides the other substantive grounds, one can oppose a patent application if he feels the applicant has obtained the invention wrongfully. The one opposing the application, can be party to the proceedings and can avail a hearing by the patents controller to convince him of the grounds for rejecting the application. Also, the time for filing a pre-grant opposition has been extended to six months. How does the relaxed compulsory licensing provision help generic drug industry? In times of a national emergency, the government has the power to violate a patent it has issued and ask a generic drug maker to produce it for domestic needs. The company can export that drug to countries without local manufacturing capacity. A notification by that country will suffice, making the entire process easier. Also, the time available to a patent holder to respond to a firm seeking a license on reasonable terms, has been fixed at six months, after which the government could consider a compulsory license.

How will amendments to Patents Bill help pharma?

The amendments address the demands for making the law more friendly to the domestic pharmaceutical industry, while meeting international obligations.

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