‘Glenmark process’ does not violate Symed’s linezolid patent: DHC

The Delhi High Court vide order dated 17th July, 2015, gave the green light to Glenmark to continue manufacturing and selling ‘linezolid API’ used for drugs treating pneumonia and other bacterial infections. Glenmark is only one of several generics that were hit by patent infringement suits by Symed who won interim injunction orders in three of these cases. The injunction awarded by the Single Judge in the Glenmark case was vacated by the Division Bench vide an order dated 5th February, 2015. The 17th July order further specifies the interim arrangement that will govern the parties in the time period of the suit.

[I’ve edited this post to clarify certain facts. Those edits are represented in square brackets.]

See our detailed posts about the history of this matter here, here and here.

Background

Symed owns two process patents for the manufacture of “novel intermediates for linezolid and related compounds.” On the strength of this patent it sued Glenmark, Optimus Pharma, Alkem Laboratories Limited (Symed has now entered into a settlement with Alkem), Mankind Pharma Limited and Sharon Bio-Medicine Ltd. for infringement, seeking interim injunctions against any manufacture of the drug [by the patented process] in each of these cases. Being a process patent, the crux of the infringement trial lies in Section 104A of the Patents Act which provides for a shift in the burden of proof from the plaintiff to the defendant if it can be demonstrated that:

1. the patented process is for the manufacture of a new product, or
2. if the product is not new that

a) the product in question is identical to the product directly obtained by the patented process and

b) there is a substantial likelihood that the identical product is made by the process and

c) and the patentee has be unable through reasonable efforts to determine the process actually used.

Decision

The two ex parte injunction orders in this series, controversially did not address this enquiry at all. The 19th January order of the Single Judge in the Glenmark case found that the product contained certain unique compounds that indicated that it was made by the patented process. The Division Bench (‘DB’) [in its order dated 5th February, 2015] reversed this finding, noting that

“Linezolid API is not necessarily identical in the case of each of the different companies manufacturing the drug.”

In this [present] order [which supersedes all interim orders passed till date] the DB notes the finding in the expert report produced by Glenmark that the impugned process (‘the Glenmark process’) is, in fact, different from the patented process. The court further notes that both parties accept this finding and more importantly that

“The learned counsel for the respondent accepts 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 as of Symed for production of Linezolid.”

The court, thus, holds that  Glenmark “may use any other process which may be a development of the Glenmark process/ Upjohn process so long as it does not infringe the said patented processes of the respondent.”

In light of the concession on the part of Symed that the Glenmark process is not identical, and that it does not infringe their patent, I fail to see how any cause of action subsists in this suit. More importantly, this raises doubts about the credibility of Symed’s challenge against the other generic companies and certainly necessitates a re-examination of the ex parte injunctions that continue in two of those cases against Optimus Pharma and Sharon Bio-Medicine. Both of these cases have involved a long drawn out litigation on the question of interim relief and are classic illustrations of the futility and unsuitability of the remedy to complex pharmaceutical patents. Even attempts at micromanaging the progress of the case by the DB have been without results with parties seeking adjournments indiscriminately and judges just not having enough time to conduct detailed trials at the interim stage. The fall outs? The time and energy of the courts and counsel, the suspension of business and access to important drugs, and a chipping away of the legitimacy of a system that is repeatedly proving itself unable to deliver.