This landmark judgement is the first “process patent” case in India that actually demonstrates the difficulties and uncertainties that arise in establishing that products are identical. It highlights the significance of Section 104 A of the Patents Act, 1970. In July 2015, Delhi High Court vacated the order of interim injunction granted in Jan, 2015 in favor of Symed Labs Ltd. (hereinafter referred as Symed) for the infringement of their process patent of LINEZOLID against Glenmark Pharmaceuticals (hereinafter referred as Glenmark), a leading Indian pharmaceutical company. Brief facts of the case are as follow:
- On April 12, 2013 Symed, a Hyderabad based company that manufactures Active Pharmaceutical Ingredients (API) filed a suit before the Delhi High Court seeking an interim injunction restraining Glenmark from infringing Symed’s process patents in their manufacture of Linezolid (sold under the brand name LIZOLID).
- Linezolid, a drug used to treat infection caused by gram positive bacteria that are resistant to several other antibiotics.
- Symed alleged Glenmark for infringing of its patents (Patent No. IN213062 & IN 213063). The ‘062’ patent was granted for “Novel Intermediates for Linezolid and related compounds” while the 063 ‘patent’ was granted for “A novel process for the preparation of Linezolid and related compounds”.
- Symed moved an application under Order XXXIX Rules 1 and 2 of the CPC, seeking an interim injunction restraining Glenmark for the manufacture of intermediaries for Linezolid.
- The Single judge of Delhi High Court had granted an ad interim injunction on 19 Jan 2015, restraining the Defendants, through their officers, directors, agents, and distributors from manufacturing, selling, offering for sale, advertising, or directly or indirectly dealing in the production of Linezolid manufactured in a manner so as to result in infringement of the Symed’s registered Patents IN213062 and IN213063 till the disposal of the suit.
- After this, on appeal Glenmark approached the Division Bench of the Delhi High Court.
Issues
The main issues before the Hon’ble Court were:
- Whether the ad interim injunction granted to Symed was valid?
- Whether the Single Judge failed to adhere to Section 104 A (1) (b) of Patents Act, 1970?
Arguments
- By Plaintiff i.e., Glenmark
- They argued that as per Section 104 A (1) (b) of the Patents Act, 1970 the initial burden of proof rests on the patentee to show that the product manufactured by the other party is identical to the product manufactured by the patented process.
- They further contended that the Linezolid API manufactured by them is not identical to the Linezolid API manufactured by Symed.
- Glenmark challenged the validity of the suit on the ground of lack of novelty. They further asserted that the pre-suit lab reports did not indicate the presence of CHFA, whereas, the post-suit reports showed the presence of CHFA (Chloro hydroxprophyl fluro morpholinyl adlaniline).
- Glenmark also stressed that the presence of Zodiac-4 and PHPFMA in the final product does not amount to infringement as these intermediates are produced by processes of manufacture of Linezolid already known in the art.
- They contended that merely because a product is known as Linezolid API, does not mean that the same is identical to the product manufactured by the patentee.
By Defendant i.e., Symed
- The patents are directed towards a more commercially safe and viable process and as disclosed in the prior art was tedious and cumbersome.
- They argued that the presence of CHFA (claimed in ‘062’) and PHPFMA (claimed in ‘063’) makes the patent noel as these products are exclusively formed during the process of production of Linezolid.
- They further contended that the presence of these intermediate compounds in the final product would indicate that it has been manufactured by the patented process.
- They argued that a sample test of Glenmark’s drug was taken, analyzed and the presence of these intermediate compounds i.e., PHPFMA, CHFA and Zodiac-4 were detected.
- Further they stated that presence of these intermediates indicates that Glenmark is infringing Symed’s patents.
Judgement
Court relying on various judgements held that:
“On 17 Jul, 2015, the Hon’ble Delhi High Court reversed the order passed by Single judge and vacated the order of injunction against Glenmark. The Justices have made it clear that Glenmark may use any other process which may be a development of the Glenmark process/ Upjohn process as indicated in the expert report of Prof. S.W. Baldwin so long as it doesn’t infringe Symed’s patented process. It was also made clear that this is an interim arrangement and supersedes all interim orders passed till date and shall continue till the disposal of the suit. This interim arrangement shall be without prejudice to the rights and contentions of the parties in the suit and the counter claim. The court noted that it was incumbent upon the single judge to prima facie come to a finding that the API of both Glenmark and Symed were identical. Furthermore, there is no finding rendered prima facie or otherwise that both the drugs are identical. They directed Glenmark to maintain accounts and file the same in court. The court also observed that the Single Judge didn’t go into the point regarding the applicability of Section 104A of Patents Act, 1970. The Court held that both the processes are not identical, and the Glenmark’s process doesn’t infringe the patent. According to report of Prof. Baldwin the two claimed intermediate compounds discussed above (PHPFMA and CHFA) do not appear in the Glenmark process for making Linezolid. It has been agreed by both the parties that Glenmark shall manufacture Linezolid through its process/ Upjohn process indicated by the expert report and shall not use the patented process of Symed i.e., IN213062 & IN213063.”
This case has evoked considerable interest in terms of it being a process patent case in pharmaceutical field and also in terms of how courts should interpret Section 104A in the course of the infringement suit.
By: Runjhun Sharma, School of Law, Mody University
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