Symed Labs invented a new process for preparation of Linezolid as compared to the earlier existing processes which were tedious and cumbersome. Symed Labs came to know that Glenmark Pharmaceuticals has also come out with an identical process for preparation of Linezolid which included the key intermediaries in the linezolid manufacturing process. Aggrieved with violation of its Patent, Symed Labs filed a suit for Patent infringement seeking an injunction against Glenmark before the Delhi High Court.
Symed Labs contended in the suit -
- The processes for preparation of Linezolid as disclosed in the prior art were tedious and cumbersome.
- In an effort to develop a more economical, safe and commercially viable process for preparation of Linezolid, Symed lab developed novel processes involving novel intermediates i.e. "N - [3 - Chloro - 2 - (R) - hydroxprophy1] - 3 - fluoro - 4 - morpholinyl - anlaniline" (CHFA) (claimed in Claims 18 and 19 of IN213063); "N - 3 [Phthalimido - 2 - (R) - hydroxprophyl] - 3 - fluoro - 4 (morpholinyl) aniline" (PHPFMA) (claimed in Claims 23, 24 and 25 of IN213062) and Zodiac-4 (resulting from Carbonylating the CHFA with carbonylating agent N, N-carbonyldiimidazole), as the key intermediates which are exclusively formed/generated and used in the processes for the production of Linezolid as claimed in the suit patents IN'062 and IN'063.
- Symed Labs in December 2012 came to know that Glenmark was manufacturing Linezolid in finished dosage form and samples of the same disclosed the presence of PHPFMA and Zodiac-4 which were the key ingredients in the linezolid manufacturing processes as claimed in the suit patent by Symed Labs.
Glenmark in response made the following assertions -
- Symed lab and Glenmark had long standing business relationship since the year 2003 and Glenmark was granted the drug license to manufacture and sell Linezolid API in 2002 and it has been selling 'Linezolid' tablets in open market to the knowledge of Symed Labs since then. The veracity of the Symed lab's claim is questioned on the ground that in the pre-suit lab reports, presence of CHFA, being considered as one more indicator of the plaintiff's process, was not found whereas in post-suit analysis, suddenly CHFA was also deducted in the product of Glenmark.
- The processes as well as the intermediates claimed in the suit by Symed Labs were not novel and did not fall within the ambit of an invention.
Discussing the novelty of the process patent of Symed Labs the court ruled that monopoly over the patent is the reward of the inventor as the inventor spends a lot of time and money in inventing a product or a process.
The protection to the patent processes ought to be granted to the Plaintiff as damages will not be an efficacious remedy. Thus, there will be irreparable loss and injury because of the long uninterrupted use of patents, the balance of convenience also lies in favour of the Plaintiff.
The Court upholding the validity of the process patent of Symed Labs which was subsisting since the year 2007 observed that Symed Labs has been able to establish a prima facie case in their favour. The fact that Glenmark did not lay any challenge or applied for revocation of Symed Lab's patents before filing of the instant suit was taken against them by the court. As Glenmark were not able to explain the process which they have been using to obtain Linezolid API, the court took such non disclosure as a ground to pass an order of injunction against Glenmark.