In a groundbreaking development, Israeli behemoth Teva Pharmaceutical Industries Ltd. (Teva) has suffered a third consecutive blow after the US Patent Office (USPTO) invalidated its third patent [U.S. Patent No. 8,969,302] for COPAXONE (Glatiramer Acetate) on September 1, 2016. According to The Financial Express, the USPTO upheld a Mylan’s challenge in an Inter-partes Review (IPR) and found that all claims in the said COPAXONE patent were un-patentable.
The 40mg version of COPAXONE is a $4 billion blockbuster injectable drug used for treating multiple sclerosis. It is important to differentiate the 40mg version from the 20-mg variant of COPAXONE; most of the patents for which have expired in 2014.
Shortly before this decision, the USPTO also invalidated Teva’s two other patents [U.S. Patent Nos. 8,232,250 and 8,399,413] in COPAXONE. Interestingly, Mylan had also filed a petition against a fourth COPAXONE patent. However, the USPTO’s Patent Trial and Appellate Board rejected this application for procedural reasons.
According to market analyst Zacks.com, Mylan believes itself to be the first to have filed a complete Abbreviated New Drug Application (ANDA) under Paragraph IV of the Hatch-Waxman Act in the US. [Kamakhya has summarised the ANDA process here]. Mylan’s ANDA contains a paragraph IV certification for COPAXONE, which entitles Mylan to get 180 days of marketing exclusivity for selling a generic version of COPAXONE; subject to approval from the US Food and Drug Administration.
Generic entry delayed?
Despite this development, FiercePharma (FP) has reported that Teva’s branded drug isn’t out of the exclusivity game yet. FP notes that Teva still has a chance to defend itself in court on the fourth patent covering COPAXONE; a decision in which is expected in 2017. FP has also reported a statement by Leerink Partners analyst Jason Gerberry, where he claims that “[W]e expect Teva to exhaust all legal appeals, assuming all its Copaxone IP is invalidated, which would keep generic challengers off the market until 2018,”. Nevertheless, these factors can only delay generic entry at best; as the USPTO’s invalidation of three COPAXONE patents is likely to lead Teva to another loss in this battle.
In an update post last year, Aparajita succinctly traced the developments in the Teva’s litigation against NATCO for restraining the latter from manufacturing a generic version of COPAXONE for sale in India and for export to the US for sale by Mylan. NATCO and Mylan reportedly turned market partners for the purpose of manufacturing and selling a generic version of COPAXONE in the USA. On 21st August 2016, one of our readers Ms. Garima Kaur posted a comment asking if Teva had truly withdrawn its Patent Application No. 2234/DELNP/2007 for an improved process in COPAXONE owing to Mylan’ pre-grant opposition. The Application is described as a patent for a “PROCESS FOR PREPARATION OF MIXTURE OF POLYPEPTIDES USING PURIFIED HYDROBROMIC ACID“.
It is highly pertinent to note that the news of such a withdrawal is, (…drumroll…) most certainly true! In response to Prof. Basheer stated emphatically, “Yes indeed. I just confirmed from one of the parties to this dispute that the patent application for an allegedly improved process was indeed withdrawn.” This is a phenomenal victory for Mylan; who has been trying to introduce generic versions of COPAXONE in the US and in India for nearly a decade.
An End to the Battle in India?
As stated earlier, Teva initiated two infringement proceedings before the Delhi HC against NATCO for its Patent No. 190759: one in 2007 to restrain the latter from manufacturing a generic version of Copaxone in India (“the 2007 Litigation”); and another in 2012 to restrain the NATCO from manufacturing another generic version of Copaxone by using a different process for the purpose of exporting it to the US (“the 2012 Litigation”). The 2007 litigation came to an abrupt end in August 2014 after the Delhi HC disposed it off for lack of evidence led by both parties. On the other hand, whereas the Delhi HC returned the plaint filed under 2012 Litigation for on grounds of lack of jurisdiction, mainly because it was a quia timet action where no part of the alleged infringing activity was taking place in Delhi. [Read more about quia timet actions here].
Mathews had noted that the 2012 Litigation had not entirely ended. This is because the Delhi HC had only returned the plaint and as, opposed to having rejected it. He rightly apprehended that Teva was still free to pursue the action before a more appropriate forum in India. However, this is highly unlikely after relentless efforts by Mylan and NATCO towards successfully invalidating Teva’s US patents in COPAXONE; so much so that Teva seems to have given up and withdrawn one of its applications in India as well!