Symed V. Glenmark: Glenmark Process Does Not Infringe Symed's Process Patent For Linezolid Manufacture

August 3, 2015by Usharani0

The Delhi High Court in its interim order dated 17th July 2015, disposed off the appeal filed by Glenmark against the interim injunction awarded by a single judge of the Delhi High Court on 19th Jan 2015. The 19th Jan 2015 interim injunction restrained Glenmark from making linezolid on the ground that it violated Symed’s patented process. On an appeal by Glenmark, a Division Bench of the Delhi High Court vacated the interim injunction in an interim order dated 5th Feb 2015. As per the recent order dated 17th july 2015, Symed had agreed that the Glenmark process for preparing linezolid is distinct from the patented process and Glenmark is now free to use its process for manufacturing linezolid.

Symed, a Hyderabad based company that manufactures Active Pharmaceutical Ingredients (API) and offers chemistry related services holds two patents, IN213062 (Title: Novel intermediates for linezolid and related compounds; Filed on 20-07-2004) and IN213063 (Title: A novel process for the preparation of linezolid and related compounds; Filed on 19-04-2004) that cover the process of manufacturing linezolid. Linezolid is a synthetic antibiotic that acts as a bacteriostatic agent against Gram-positive bacteria and is used for treating infections caused by these bacteria.

On April 2013, Symed sued Glenmark for infringement of the above mentioned two patents seeking interim injunctions to restrain Glenmark from producing Linezolid. In turn, Glenmark had filed a counterclaim for invalidating Symed’s patents on the ground of lack of novelty. Symed alleged that Glenmark had infringed its patented process for making linezolid since, in a random survey, it found traces of markers/ intermediates that are characteristic of its patented process in the linezolid products produced by Glenmark. CHFA, PHPFMA and Zodiac-4 are the markers/intermediates that were alleged to be found in the linezolid products of Glenmark. CHFA is an intermediate covered by claims 18 and 19 of IN213063, PHPFMA is an intermediate covered by claims 23, 24 and 25 of IN213062 and Zodiac-4 is a carbonylated form of CHFA. Symed claimed that the presence of these markers/intermediates is indicative of the use of the patented process. Subsequently, the Delhi high court awarded interim injunction restraining Glenmark from making linezolid in its 19th January order.

It is worthwhile to note that other than Glenmark, Symed had sued Optimus Pharma, Alkem Laboratories Ltd., Mankind Pharma Ltd. and Sharon Bio-medicine Ltd. for infringement of the above mentioned patents seeking interim injunctions as relief.

Glenmark appealed against the 19th January order and a Division Bench of the Delhi High Court on 5th Feb 2015, vacated the interim injunction order observing that it is mandatory for the Single Judge to discuss applicability of Section 104A of the Patents Act, which was not done. Section 104A shifts the burden of proof in a suit for infringement of a process patent, from the plaintiff to the defendant, provided that the patentee first proves that the product made by the defendant is identical to the product directly made by the patented process. The Division Bench observed that there is no finding rendered prima facie or otherwise that the products made by Glenmark and Symed were identical. The court also directed Glenmark to maintain accounts and file them in the court.

The 17th july 2015 interim order sets down the interim arrangement between Glenmark and Symed that shall continue during the time period of the suit for infringement. The order further refers to an expert report by Prof. Steven W. Baldwin, filed by Glenmark, which states in paragraph 24 that:

“24. The two claimed intermediate compounds discussed above (PHPFMA and CHFA) do not appear in the Glenmark process for making linezolid. Moreover, the reaction conditions involved in the various Glenmark process steps would not produce either of these claimed compounds, even as trace impurities.”

Symed has accepted the report to the extent that the process employed by Glenmark termed as Glenmark process does not violate its patented process of linezolid preparation. Symed has also agreed to Glenmark using the Glenmark process and that the Glenmark process is different from the patented process. The order also states that Glenmark may use any other process that is derived from the Glenmark process so long as it does not violate Symed’s patented processes. Glenmark has affirmed that it will include, in future, in the declaration obtained from the sellers of linezolid API that the sellers do not violate Symed’s patented processes.

Symed V. Glenmark case has evoked considerable interest in terms of it being a process patent case in pharmaceutical field and also in terms of how the courts would interpret Section 104A in the course of the infringement suit.

Usharani

Usharani

Dr. Usharani is a registered Patent agent. She holds a M.Sc., M.Phil. degree in Biochemistry and a Doctoral degree in Biosciences. She also holds a Postdoctoral diploma in Intellectual Property Rights and is trained by the World Intellectual Property Organisation (WIPO) in drafting patent applications

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