No linkage between regulators,patents office
The Supreme Court last week turned down Swiss drugmaker Novartis plea for patent protection for its cancer drug Glivec saying the invention in question did not meet the novelty and therapeutic efficacy criteria,but made it clear that genuine inventions could be rewarded with marketing exclusivity.
Leave aside the debate over patenting criteria,a key issue that patent-holders face in India is that they find it difficult to enforce their patents due to a regulatory lacuna. The countrys drug regulators routinely allow manufacturing-cum-marketing rights for generic versions of patented drugs as there is no linkage between these regulators and the patent authorities.
While a special leave petition (SLP) filed by Germanys Bayer Corporation challenging this lack of harmonisation between the two set-ups is pending with the Supreme Court,the Delhi High Court on Friday refused to grant interim relief on a patent row to US major Merck Sharp and Dohme (MSD),which sought a restraint on Indian firm Glenmark Pharmaceuticals on manufacturing and marketing anti-diabetes drugs Zita and Zita-Met (which are branded generic versions of MSDs patented drugs),sparking the debate yet again.
In the MSD-Glenmark case,the Indian company could launch its branded drugs in the domestic market thanks to the approvals from the drug regulator of Sikkim. (For a new drug one that has been launched globally less than four years earlier approvals from the central drug regulator is necessary for launch in India,while older drugs can be approved by the state authorities the licence being given by them have pan-India relevance.) So Glenmark can continue to market the drugs in India,while Merck holds the patent for it drugs brand-named Januvia and Janumet. The high court dismissed MSDs interim application on the ground that the salt used is not of generic nature,and kept the main petition pending for filing of evidence and other subsequent legal proceedings before its joint registrar on July 16.The local industry is happy with situation while patent-holders are deeply agitated. MSD is extremely disappointed with the decision of denial of injunction by the Delhi High Court against Glenmark for patent violation of our drugs Januvia and Janumet, a company spokesperson said,adding,MSD is considering all options,including an appeal of the decision.
Where is the protection for patented drugs if marketing licences are granted for such drugs, asked Krishna Sarma,patent lawyer and managing partner,Corporate Law Group. She added that there was an immediate need for the Indian government to consider a patent linkage system similar to that being used in other countries like the US.
However,DG Shah of the Indian Pharmaceutical Alliance said: It would obviously be inappropriate to consider any legislative review of the Drugs and Cosmetics Act (under which the drug regulators give approvals/issue licences) while the matter is under consideration by the Supreme Court,particularly when submissions have been made by the Drugs Controller General of India that they cannot be asked to enforce the private rights of a patentee and that they lack the institutional expertise to deal with complex patent issues.
Under the US FDA rules,a marketing approval for a drug can be initiated only after challenging the patent first, said Sarma. Communication between the patent office and the DCGI is necessary to prevent marketing approval of products that infringe existing patents,she added.
The Drugs and Cosmetics Act does not go into the issue of patents and,therefore,the DCGIs mandate does not cover looking into the patent status of any drug before granting a marketing approval, said CM Gulati,editor of the Monthly Index of Medical Specialties (MIMS). Rules allow generic drugmakers to conduct clinical trials on their version of any pioneer drug,and submit studies on toxicity and bioequivalence of the molecule to the DCGI office for approval to market drugs which are already in use. It becomes easier to launch generic versions four years after the launch of the new drug,as documentation requirements get diluted.
There have been a few cases where Indian generic drug companies launched their low-cost versions of patented drugs in India notably,Ciplas launch of generic variants of Roches patented drugs Tarceva and Valcyte. Roche has dragged Cipla to court in both cases and is awaiting the final orders.
Shah,however,pointed out that even the EU authorities dont follow the patent linkage system. (In the Bayer case),the single judge of the Delhi High Court explicitly relied upon findings of the EU Directorate General for Competition that to delay competition,originator companies had intervened before national authorities in a significant number of cases,arguing that marketing authorisations could violate their patent rights,even though marketing authorization bodies may not take this argument into account. Further,the single judge has also noted the finding of the EU Directorate General for Competition that patent-linkage is considered unlawful under EU regulations. Clearly,patent linkage has the danger of abuse and delaying generic entry. Even the EU has not chosen to tread this path and there does not appear to be any reason for India to consider such a measure at this stage.
Patent linkage is the practice of ensuring that if a patent exists and is valid,the marketing approval for its a generic version is not granted. The US follows this system and there is an orange book under which the listing of a patent is required before applying for marketing approval of a drug.