A couple of weeks ago, Rupali carried a piece on the blog titled “‘Glenmark process’ does not violate Symed’s linezolid patent: DHC“. Shortly after, we received an email from Symed stating that the post did not accurately convey the situation at hand. Both the author and I looked over the post and did not see anything amiss, and went on to make some minor clarificatory edits. At this point, I should admit that though I should have, I did not follow up with Symed again to see if those edits clarified what they saw as problematic. In any case, today we received a blog post from Mr Arun C Mohan wherein he puts forth a different viewpoint on the case. Arun, partner at Mohan Associates has written several excellent guest posts for us in the past (search link). Though Arun advises Symed in various litigations, the viewpoints mentioned in the blogpost below are strictly his own personal views. Read on for more:
(At this point, I should mention – despite differences of opinion on the matter, its extremely refreshing to see pleasant, polite and mature communication from all sides, leading towards an active debate on the matter rather than attempts to silence or censor like we’ve had in the past. And on that note, I’d just like to remind our readers that we’re always open to guest posts, and especially open to response pieces to anything we’ve put up on the blog!)
Title: Symed’s Linezolid patent case – A response
Author: Arun C Mohan
The Symed case has been in news for quite some time for its interpretation on what constitutes infringement in a process patent. The piece carried earlier by this blog, I believe is not entirely representative of the factual matrix or findings in the case, and the conclusions are bluntly put glaringly incorrect.
The Symed patents in controversy relate to process patents deployed for the purpose of manufacture of Linezolid, which saw a drastic reduction in the cost of its manufacture by eliminating the usage of various dangerous and expensive reagents, additives and solvents, and also making the process itself immensely more stable and safe. The patents have been recognised in India, Europe and America, and are amongst the drastically small clutch of genuine and workable innovations emanating from the Indian pharmaceutical industry.
The Symed case saw initially an order of interim injunction being granted against Glenmark, the background of which has already been highlighted in this blog. Broadly, the order dated 19.01.2015 of the Learned Single Judge was premised on the lab test reports of Glenmark’s Linezolid products (which were tested not only at Symed’s own laboratory but also at different neutral independent Laboratories all of which showed consistent results) filed by Symed demonstrating that Glenmark’s Linezolid product contains the traces of novel intermediates (called CHFA, PHPFMA and ZODIAC-4) which were novel and route specific markers to Symed’s patented processes. The learned Single Judge’s judgement though does not explore the nuances of Symed’s patents, also acknowledges the fact that the patent though primarily for process purposes also consisted within it intermediaries which were unique ‘markers’ for indicating the process being followed. The impugned patents itself were structured and inseparable from these novel intermediaries, and a reading of the patent would demonstrate that the presence of such intermediaries irrefutably points to the patent process being deployed. This is particularly found at paragraph 29 of this order, which states that the presence of the intermediaries is a strong indicator of the fact that Symed’s patent processes have been adopted by Glenmark.
The subsequent order of the Learned Division Bench saw in my opinion a volte face on Glenmark’s part in claiming that these intermediaries/markers (PHPFMA and CHFA) were never present in its Linezolid product when their alleged ‘Upjohn’ process (being the conventional route) is followed and hence the process was necessarily different. This was not done vide any lab reports or technical findings, but merely on the basis of an expert affidavit filed by Glenmark which restricted itself only to the usage of the conventional route of manufacture by Glenmark, which was never within the sphere of controversy. These are grounds that were entirely independent of the findings of the Learned Single Judge, which were premised on such intermediaries/markers being found in Glenmark’s product. Quite obviously, in the absence of such markers no complainable action could be alleged against Glenmark leading to the interim arrangement decided in the Learned Division Bench. The said arrangement is quite interesting its language as it suggests the following:
- Glenmark is entitled to only use the ‘upjohn’ process i.e. the conventional route or any other process for manufacture of Linezolid which would not give rise to Symed’s novel intermediaries (PHPFMA and CHFA).
- Glenmark’s usage of the above shall be subject to the restriction that such usage or variation thereof does not infringe upon Symed’s suit patents qua IN213062 and IN213063 notably through the absence of novel intermediaries (PHPFMA and CHFA) even as trace elements.
- Any persons selling Linezolid to Glenmark would have to declare in writing that such product is not in violation of Symed’s patents and these declarations may be sought for by Symed in the event of any further allegation of allegation either against Glenmark or its sellers.
The fallout of this arrangement is that Glenmark after several bouts of litigation has for interim purposes conceded the validity of Symed’s patents and in fact, has gone to the extent of ensuring that all persons dealing with it also recognise the same. This is undoubtedly a victory for Symed as the various other cases filed by it would possibly disposed off along the same lines by getting undertakings from defendants that they would disclose the process they intend to use and in ensuring that these do not give rise to Symed’s novel intermediaries.
Such arrangement in general appears to be a very solid common-sense approach to handling process patent matters which are often quite difficult to be tested in the interim stage given the content inherently requiring trial, and I believe in the future would become the standard manner to dispose off such cases unless there are such glaring errors in the process patent that the Courts have no option but to intervene and declare in the interim that the process could not be protected. This case also addresses the increasing importance of intermediates/markers in process patent claims as these finally look beyond what is the sweat and grind of the process and give a readily palatable consensus on whether a process patent has been adopted by a defendant. Finally, I believe the trial in this matter would also be quite interesting also as Glenmark would have to finally clarify whether in fact its product has the novel intermediates claimed by Symed and what are the standards laid down for determining their presence or absence, and most curiously what was in fact the process followed by it for manufacture of Linezolid at the time of filing of the suit. This case could possibly lay down the standards for laboratory testing the Courts can demand for demonstration of what are purely technical claims so atleast in the future such flip-floppery in Courts can be avoided at what has been obviously great effort and cost.