The High Court of Delhi has restrained Mumbai-based generic drug maker Glenmark Pharmaceuticals Ltd from manufacturing and selling, directly or indirectly, Linezolid, manufactured through the process patented by the Hyderabad-based pharma company Symed Laboratories Ltd. The Justices have made it clear that the appellant (Glenmark) may use any other process which may be a development of Glenmark process / Upjohn process so long as it does not infringe the patented processes of the respondent (Symed).
Symed Laboratories Ltd. is an Indian bulk drug manufacturer based in Hyderabad. Among other drug products, it manufactures Linezolid, an antibacterial used to treat skin and blood infection including pneumonia. Symed owns two process patents (IN213062 and IN213063) for the manufacture of intermediates for linezolid. The product patent for the drug is owned by Pfizer. Symed has sued a number of Indian manufacturers of Linezolid for patent infringement including Glenmark, Optimus Pharma, Alkem Laboratories Limited (Symed has now entered into a settlement with Alkem), Mankind Pharma Limited and Sharon Bio-Medicine Ltd.
The Delhi High Court had granted an ad interim injunction on 19 January 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.
The grant of interim injunction had been predicated on four criteria:
- That there is a prima facie case in favour of the plaintiff;
- That the plaintiff is likely to suffer an irreparable injury if the defendant is not restrained;
- That the balance of convenience lies in favour of the plaintiff; and
- That public interest would not be dis-serviced by the grant of the injunction.
However, the injunction against Glenmark was vacated by the Delhi High Court consisting of Justice Badar Durrez Ahmed and Justice Sanjeev Sachdeva within 2 weeks of the Single Judge’s decision. The other defendants in this case have not been as lucky and continue to suffer the injunction.
While setting aside the January 19 order, the court noted: “It was incumbent upon the single judge to prima facie come to a finding that the active pharmaceutical ingredient (API) of both Glenmark and Symed were identical.”
“This (prima facie finding) does not appear to have been done. In these circumstances, we are vacating the interim order and modifying the same by directing appellant (Glenmark) to maintain accounts and file same in court..,” the Bench said and listed the matter for further hearing on 16 March 2015.
It was also noted by the Court that the single judge did not go into the point regarding applicability of section 104A of the Patents Act 1970 as per which in suits alleging infringement of process patents, the defendant (Glenmark) has to prove that its process is different from that of the plaintiff.
Symed Labs Ltd. vs Glenmark Pharmaceuticals Ltd. on 17 July 2015
In the very recent decision, the Delhi High Court has ordered that Glenmark shall use its process which is virtually identical to the Ujohn process as indicated in the expert report of Prof. Steven W. Baldwin (filed by Glenmark). The Court noted that the expert report indicates that the appellant (Glenmark) process and the Uphohn process are different from the process of preparation of Linezolid, which is employed by the respondent (Symed).
It has been agreed by both the parties that the appellant (Glenmark) shall manufacture Lineolid through its process indicated in the expert report which does not infringe upon the patented process of Symed as indicated in the report. The learned counsel for the respondent (Symed) has accepted the report to the extent that the process shown as the Glenmark process which is virtually identical to the Upjohn process does not infringe the patented process of Symed for production of Linezolid. The learned counsel for the appellant has also stated that they have not and shall not use the patented process of Symed numbered as IN213062 and IN213063.
Paragraph 24 of the report of Prof. Stephen W. Baldwin reads as under:
“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 comounds, even as trace inpurities“
[CHFA (N-[3-Chloro-2-(R)-hydroxprophy1]-3-fluoro-4-morpholinyl-anlaniline) : PHPFMA (N-3 [Phthalimido-2-(R)-hydroxprophyl]-3-fluoro-4 (morpholinyl) aniline]
While both the parties have accepted the above extracted paragraph No.24 of the report, the Justices have made it clear that the appellant (Glenmark) may use any other process which may be a development of Glenmark process / Upjohn process so long as it does not infringe the said patented processes of the respondent.
Dr. Singhvi, the learned senior Advocate stated on behalf of appellant (Glenmark) that the appellant has already been and will continue to take declarations from sellers of Linezolid to the effect that the seller does not violate anybody’s registered patent and will also in future specify in the declaration b the seller that he does not violate Symed’s aforesaid two patented processed, adding that in the event the respondent initiates legal proceedings against a seller for infringement of the aforesaid two patents, the appellant, on a request being made, would supply the aforementioned declaration.
About the Author: Antony David, Senior Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at: email@example.com