German firm seeking the introduction of patent linkage in India.
In a victory for patients, a division bench of the Delhi High Court on Tuesday dismissed an appeal by German pharma multinational Bayer seeking introduction of patent linkage in India, which can delay entry of low-cost generic drugs.
The appeal was filed against an earlier judgment by a single bench of the Delhi High Court in August 2009, which rejected Bayer’s attempt to bring patent linkage, a system wherein the Drug Controller General of India (DCGI) refuses to grant marketing approval to a generic drug if the innovator holds its patent.
Bayer had appealed against a marketing approval given by DCGI to Cipla Ltd’s Soranib, a copycat of Bayer’s innovation Sorafenib Tosylate, which is used to treat cancer of renal cells.
Bayer had claimed it was the Indian patentee of Sorafenib also and had initially asked the DCGI to restrain Cipla from making, selling or distributing the substitute for its drug.
Bayer further claimed that the proprietary rights to the molecule Sorafenib Tosylate vested with Bayer Healthcare LLC, which, in turn, had given the rights in India to Bayer Corp.
The court held that Bayer was asking DCGI to enforce its rights as a patent holder in terms of Section 48 of the Patents Act, which did not come under its jurisdiction.
Section 48 of the Patents Act deals with the rights of the patentee. The high court maintained that “the scheme of both, the Patents Act and Drugs and Cosmetics Act, are distinct and separate and the attempt by Bayer to establish a linkage cannot be countenanced. Whether patent linkage should be introduced is an issue that requires a policy decision to be taken by the government. It is not for the court to determine if the government should bring in a system of patent linkage.
According to a Bayer spokesperson, the company is disappointed and disagrees with the court’s decision and will consider its legal options pertaining to the issue.
Anand Grover, counsel for Cancer Patients Aid Association, which had intervened in this case, said Bayer and other pharma companies should respect the fact that patent and drug regulatory systems are independent mechanisms.
According to Anuradha Salhotra, managing partner at law firm Lall Lahiri & Salhotra, which specialises in intellectual property, DCGI should not be asked to look into the patent status of drugs.
According to patent law experts, patent linkage undermines public health safeguards in the Indian patent legislation such as Bolar exception, and compulsory licence.
Bolar exception allows marketing approval of generics when a patent is in place, so that generic can be introduced as soon as the patent expires, says a patent expert from New Delhi. “A compulsory license is issued if patented drugs are unavailable or unaffordable. Patent linkage could block marketing approval of generics, thereby rendering compulsory licenses useless.”
Bayer, a German firm, has been pressing hard to bring in patent linkage even though the European Union doesn’t have such a system. In fact, going by the European Generic Medicines Association, patent linkage is contrary to EU regulatory law and is one of the key entry barriers for generics. (With NW18)
Source: DNA India