Patent Linkage with Regulatory Approval
26 November 2012
There has been a lot of buzz of late in the Indian pharmaceutical industry due to granting of marketing approvals by the DCGI (Drug Controller General of India) for generic versions of patent drugs.
Last year, the DCGI granted marketing approval to Cipla for the generic version of anti-cancer drug Tarceva, for which Roche held an Indian patent. Subsequent to the receipt of marketing approval, Cipla launched the generic version of the drug in the market in violation of the patent rights of Roche. Subsequently, Cipla applied for marketing approval for generic version of Bayer AG’s cancer drug Nexavar. The DCGI however was directed to reject Cipla’s application in an ex-parte order in December. Cipla has subsequently sought revocation of the order hearing for which has just recently concluded.
In another recent incidence of a similar kind, Hyderabad-based generics company Hetero Pharma has sought regulatory approval from the DCGI for the generic version of Dasatinib, an anti-cancer drug for which Bristol-Myers Squibb (BMS) holds a valid patent. BMS has asked Indian courts for ex parte relief to restrain Hetero from pursuing their application before the DCGI.
At the crux of this fiasco is the Bolar provision (also called the 271(e)(1) exemption or, in the United States, the Hatch-Waxman exemption) which allows the manufacturer of a generic pharmaceutical drug to manufacture, import or use the patented invention for the purpose of submitting information to the government, under any law which regulates manufacture, sale and distribution of drugs. The idea of providing such a provision is to permit a generic company to use the patented product and generate data for regulatory submission before they can sell the product. They cannot sell the product until patent expires. If not for this provision, the generic company could not use the product until the patent expires, meaning it would take additional one or two years after patent expiry before a generic version could be approved and launched, resulting in a defacto extension of the patent term. The Bolar-type provision also attempts to provide linkage between the patent office and the regulatory authority so that marketing approvals are not actually granted during the term of a valid patent. This is the case in the US and in a number of developing countries such as Jordan and Mexico.
The Bolar-type provision is embodied in section 107-A of the Indian Patent Act, which excludes from infringement an act of making, constructing, using, selling or importing a patented invention solely for uses reasonably related to development and submission of information required under any law in India, or in other country, that regulates the manufacture, construction, use, sale or import of any product.
The manufacture, sale and import of drugs in India is regulated by the Drugs and Cosmetics Act, 1940. Unlike the Hatch-Waxman Act, which amended the Federal Food, Drug, and Cosmetic Act, section 505(j) 21 U.S.C. 355(j), to set forth the process by which marketers of generic drugs could file Abbreviated New Drug Applications (ANDAs) to seek FDA approval of the generic versions of patent drugs, the Drugs and Cosmetics Act contains no special provision for the approval of patented drugs.
The argument made by Bayer was that the DCGI cannot grant an approval for any drug which is likely to violate an existing patent right. As mentioned, the courts in the abovementioned case have directed the DCGI to reject Cipla’s application, but an interesting note is, as already mentioned, that in India there is no legal provision in the Patent Act or the Drugs and Cosmetics Act which links the patent office with the offices of health and regulatory authorities. Thus, there is nothing in law which can restrain the DCGI from granting approval for generic versions of patented drugs.
Further, section 107-A of the Indian Patent Act clearly exempts from patent infringement any of acts of making, using or importing a patented invention in so far as such acts are necessary to obtain information for the filing of a drug regulatory application before the DCGI. Mere grant of a marketing approval does not, ipso facto, contravene the patent act or provisions of any other law. Thus, an interesting point of discussion arises that, in the absence of any legal provision, can the courts restrain the DCGI from acting in accordance with the law in granting marketing approval on the mere possibility that such an approval may increase the likelihood of patent infringement?
The aim of section 107 is to ensure that generic drugs are introduced into the market as soon as the patent expires or is invalidated so that consumers may benefit from this early entry of affordably priced drugs. However, the abuse of this provision has increasingly become difficult to keep in check, resulting in litigation in court which could be avoided.
Should regulatory approval be granted for a drug which has more than ten to 15 years of patent term left? Often, it has been the case that the generics company, after receiving marketing approval, has eventually launched the product in market in contravention of patentee’s right.
Though the courts in India have heavily come down on this approach by generic pharma companies in the Hetero and Bayer cases and directed the DCGI against granting of marketing approvals to generic companies for patented drugs, it would be interesting to see how effective courts would be in establishing a credible patent linkage in the absence of any statutory provisions.
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