Novartis Sues Macleods Over Famciclovir Patent

Novartis has lately filed a civil lawsuit against the Mumbai-based generic manufacturer Macleods Pharmaceuticals Limited for infringement of US Patent No. 5,866,581 listed with the Orange Book for Famvir tablets, generically Famciclovir. The lawsuit is filed in the US District Court for the District of Columbia in response of Macleods submission to the FDA an abbreviated new drug application (ANDA) seeking approval to market generic Famciclovir 125mg, 250mg and 500mg tablets before the expiration of the ‘581 patent. With this development, Macleods is another Indian company that joined the league of Paragraph IV challengers from India.

Piramal acquired i-pill from Cipla

Lately Cipla sold its money-spinning contraceptive brand product “i-pill” to Piramal Healthcare for INR. 95 crores. I-pill is an emergency contraceptive pill containing 1.5mg of Levonorgestrel which was launched by Cipla in the Indian market, followed by another Indian pharma company Mankind under the brand name Unwanted 72. In past, the Government of India criticized and banned airing of i-pill advertisements on television due to irresponsible advertising.

In Europe, 1.5mg Levonorgestrel is marketed as Postinor-1 by Hungarian company Gedeon Richter which holds patent protection for 1.5mg dose of Levonorgestrel as claimed by EP-B1-1.448.207. Bayer and HRA Pharma are two other companies marketing 1.5mg Levonorgestrel in the Europe as Levonelle One Step and NorLevo under license from Richter. In the United States, Gedeon Richter developed and manufactured 1.5mg Levonorgestrel tablet in partnership with Teva Pharmaceutical Industries Ltd. and currently marketed by Duramed Pharmaceuticals under the brand name Plan B One-Step. Gedeon currently has two pending US Application Nos. 20050032755 and 20050288264 for 1.5mg Levonorgestrel.

In India, Gedeon Richter holds two Indian Patent Nos. 206098 and 202297 covering 1.5mg dose of Levonorgestrel. Interestingly, Gedeon that aggressively licensed 1.5mg Levonorgestrel in various developed and developing markets including Canada and the US never initiated any legal proceedings against Cipla and Mankind for launching 1.5mg dose of Levonorgestrel in India. May be Gedeon had no faith in Indian patent system particularly after witnessing big pharma giants like Bristol-Myers, Bayer and Roche miserably failing to stop Cipla from launching generic copies of their patented drugs and enforcing their patent rights in India. Already it is slowly becoming well-known fact that Indian patent has no value, not even worth a paper on which it is issued – thanks to Indian judiciary which went on creating one after one biased and flawed precedents with respect to pharma patents.

As far as my understanding of patent law is concerned, a patent right excludes third party including the Government from the act using, manufacturing or selling the patented product without the permission of patentee. However, the Government may still manufacture or use the patented product under the Government-use exemption. Ironically in India, the Government’s own agency is involved in issuing licenses to third party to manufacture and sell the patented drugs that clearly contravenes the spirit of patent right (obviously allowing third party to manufacture and sell patented drugs from commercial use do not fall within the Government-use exemption) but still Indian judiciary is finding hard to understand that such act of granting licenses to manufacture and sell patented drug constitute violation of patent right under section 47 of the Patents Act, 1970.