The main legal principle established in the judgment is that the exception provided under Section 107A of the Patents Act, 1970 is wide enough to permit the export of patented products for use by an overseas importer to conduct studies and generate data for seeking regulatory approvals in that country.

Vibhu Bakhru, J.

1. This is an application filed on behalf of respondent no.5 (hereafter referred to as ‘NPL’) inter alia praying for permission to export 1 kg. of Active Pharmaceutical Ingredient (hereafter ‘API’) Sorafenib for the purposes of conducting development/clinical studies and trials. The said application was necessitated because of an interim order dated 26.03.2014 passed by this Court whereby respondent nos. 1 to 4 were directed to ensure that no consignment from India containing ‘Sorafenat’ covered by compulsory license be exported.

2. The controversy to be addressed is whether, the export of API by the applicant would fall within the affirmative defense to infringement of the non-applicant’s patent as available by virtue of section 107A of the Patents Act, 1970 (hereafter the ‘Act’).

3. Briefly stated the relevant facts for considering the controversy are that the petitioner (hereafter referred to as ‘Bayer’) was granted a patent for a pharmaceutical product titled “Carboxyaryl Substituted Diphenyl Ureas” under the Indian Patent No.215758, for a period of 20 years from 12.01.2000. ‘Sorafenib tosylate’ is a compound, which is sold by Bayer under the brand name ‘Nexavar’. The said product is used for treatment of patients with advanced stages of kidney and liver cancer. The said drug is stated to be a life extending drug, which extends the life of a patient by four to five years in case of kidney cancer and six to eight months in case of liver cancer.

4. Bayer alleged that NPL was manufacturing and dealing with a product which was covered under the said patent and accordingly filed a civil suit [i.e. CS(OS) No.1090/2011] for restraining NPL from launching, making, using, offering for sale, selling and importing Sorafenib/Sorafenib tosylate or any product comprising of the said ingredient or any generic version of Sorafenib/Sorafenib tosylate or any other product covered by the patent granted to Bayer.

5. NPL applied for and was granted a compulsory license on 09.03.2012 to manufacture pharmaceutical products, which were covered under the Bayer’s Patent No. 215758. The Controller of Patents, Mumbai found that reasonable requirement of public with respect to the product in question had not been satisfied and that the drug in question was not made available to public at reasonable affordable price. Accordingly, the Drug Controller granted the compulsory license to NPL for manufacturing the pharmaceutical product covered under the Patent No. 215758 held by Bayer on certain terms and conditions including that the license be used “solely for the purpose of making, using, offering for sale and selling the drug covered by the patent for the purpose of treating HCC and RCC in humans within the territory of India”.

6. NPL has been manufacturing a product under the brand name ‘Sorafenat’ by virtue of the said compulsory license. However, as indicated above, NPL is not permitted to export the same.

7. After the grant of compulsory license as aforesaid, Bayer moved applications before the Patent Office, Mumbai seeking termination/revocation/cancellation of the compulsory license granted to NPL. Bayer also, allegedly, received information that ‘Sorafenat’ which was manufactured by NPL was being exported outside India by NPL in violation of the terms of the compulsory license. This prompted Bayer to approach this Court, by way of the present writ petition, seeking directions to respondent nos.1 to 4 to confiscate and seize consignment for export containing the product covered under the compulsory license granted to NPL. The above captioned writ petition was listed on 26.03.2014 and this Court passed an interim order directing respondent nos.1 to 4 to ensure that no consignment containing Sorafenat covered by the compulsory license is exported.

8. By the present application, NPL is seeking permission for exporting 1 kg. of the Active Pharmaceutical Ingredient (API) Sorafenib for the purposes of conducting development/clin