India: Patent Linkage with Regulatory Approval

Off lately there has been a lot of buzz created in the Indian Pharmaceutical industry due to granting of marketing approvals by DCGI (Drug Controller General of India) for generic versions of patent drugs. Last year, DCGI granted marketing approval to Cipla for the generic version of an anticancer 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. Cipla also applied for marketing approval of 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 sought revocation of the order, hearing for which has just recently concluded. In another recent incidence of a similar kind, Hyderabad based generic company Hetero Pharma has sought regulatory approval from DCGI for the generic version of Dasatinib an anticancer drug for which Bristol-Myer Squibb (BMS) holds a valid patent. BMS has moved to courts in India seeking 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 as 271(e)(1) exemption or Hatch-Waxman exemption in USA) 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. If not for this provision, the generic company could not use the product until the patent expires meaning it would take additional 1 to 2 years after patent expiry before generic version could be approved and launched resulting in a defacto extension of the patent term. The Bolar type provision in one way 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 US and a number of developing countries like Jordan, Mexico, etc.

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 Drugs & 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 & Cosmetics Act 1940 however, contains no special provision for the approval of patented drugs.

The argument made by Bayer in the Bayer V/s UOI and Cipla case was that DCGI cannot grant an approval for any drug which is likely to violate an existing patent right. As mentioned, the Courts in the above mentioned case have directed the DCGI to reject Cipla’s application but an interesting point to take note of is, as already mentioned, in India there is no legal provision in The Patent Act or the Drugs & Cosmetic’s Act which links the patent office with the offices of health and regulatory authorities. Thus, there is nothing in law which can restrain 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. The point of discussion arises here is that, in the absence of any legal provision, can the courts restrain DCGI from acting in accordance with law in granting marketing approval on the mere possibility that such an approval may increase the likely hood 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 monitor resulting in court litigations. The term ‘uses reasonably related to the development’ is a subjective term not defined by any statue. An argument can be put forward as to what constitutes reasonable use? How much quantity of drug may be required for ‘uses reasonably related to development’ and submission of information? Can manufacture or import of excessive quantity of drugs and subsequent stock piling be allowed under the pretext of ‘uses reasonably related to development’ in the Indian scenario? “Stockpiling” of drugs in anticipation of patent expiration are NOT considered as valid practices under a 2000 WTO ruling involving the Canadian Bolar provision. Canadian laws in question allowed a “stockpiling exception” 6 months prior to the expiration of the patent. This was ruled by WTO as contrary to TRIPS. India does not make any such exception in any of it laws. Another valid question arises, should a regulatory approval be granted for a drug which has more than 10 to 15 years of patent term left? Often it has been the case that the generic company after receiving the 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 as well as Bayer case and directed 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.


One thought on “India: Patent Linkage with Regulatory Approval

  1. informative thanks

    just an observation:.. in the second paragraph…
    “The Bolar type provision in one way 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.”..

    is not quite right in india….the closest section identified .. 107-A(a) in no way attempts to provide this linkage.. rather it serves a very niche need of letting the development continue.. ( one of the means to enable what is generally said in sec. 83)..,.. this (107A(a)) subsection just provides an exceptoin to the negative right granted by the patent…so any restriction of the kind that will arise from patent linkage..needs to be embedded in the regulatory laws..drugs and cosmetic act.. case of such products…and some other regulatory law in case of other….cause 107A(a) does not make any distinction for only pharma products…

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