This article appeared in the August 2008 edition of INNsight

Star wars – The generic empire strikes back

In a newsletter devoted to patent issues, it is nothing new to read about a generic company being sued for by another company for possible infringement of the patent on one of the litigant’s leading brands. What is new, though, is when the party that has instigated the litigation is itself a generic company.

As so often happens in this column, the spotlight turns on Teva who is suing its generic competitors Momenta and Sandoz in the US. What has happened here is that Momenta and Sandoz have filed a Paragraph IV declaration together with their ANDA submission to the FDA for a generic version of Copaxone, Teva’s Multiple Sclerosis treatment. For those who are unfamiliar with the US system, let me explain that a Paragraph IV declaration requires that ,” ...the applicant shall provide the patent number and certify, in its opinion and to the best of its knowledge, ...that the patent is invalid, unenforceable, or will not be infringed…”

They are called “Paragraph IV” filings because the alternative is to call them “applications filed under regulation CFR 314.94 (a)(12)(i)(A)(4)”. Whatever it is called, making such a declartion is tantamount to throwing down the gauntlet before the patent owner and saying “sue me if you dare, your patents are worthless”. The same legislation offers the patent owner the opportunity to do just that and sue within 45 days of being notified and that is what Teva has done. The product accounts for around US$1.1 billion of Teva’s turnover so that it is not going to let the challenge pass as too much is at stake.

What is fascinating here is the role reversal with Teva on the receiving end of just the sort of attack that it has launched against dozens of other products. It will be even more fascinating to watch and see how much the company has leaned from its own experience of finding and exploiting loopholes in the generic defences of other companies. When drafting the various patents protecting the active substance Glatiramer, did Teva analyse them minutely to seek out the potential loopholes and then plug them? Or will it turn out to have been out-manoeuvred by its main competitor.

One must suspect that out there in the world of Big Pharma, senior executives are rubbing their hands with glee at the prospect of their chief tormentor being put through the same tortures as they have suffered in the past. Perhaps, too, the joy is made greater by the sight of two generic giants fighting it out with each other in the courts for once instead of fighting it out with another Big Pharma victim.

This is not the first time, though, that Teva has taken generic competitors to court over alleged patent infringements. In October 2007, the company sued several companies in the US over process patents for the manufacture of Carvedilol (=Coreg, GSK) when they tried to launch a generic. The list is impressive; Teva took action against the following companies: Apotex; Cadila; Dr. Reddy's Laboratories; Lupin; Moehs Iberica; Mylan; Orchid; Ranbaxy; Taro Pharmaceuticals; Urquima; USV Ltd.; Wanbury; Watson; Z Hegelian Huahai; Zambon and Zentiva – 17 companies in total!

Earlier in 2007, Teva also sued over infringements of its Sertraline polymorph process patents. This time its targets were :- Andrx, Apotex, Cipla; Genpharm, Hetero Drugs, Invagen, Lupin, Sandoz; Zydus-Cadila.

In both cases, as with Gabapentin (Pfizer’s Neurontin), Teva had built up a protective wall of patents around an API without in the process infringing the originator’s patents but cleverly shutting off alternatives to the originator’s product to block its competitors. As a result, Teva won for itself a long period of exclusivity with generic Gabapentin while its generic competitors sat by in frustration.

So. back to the issue of Copaxone /Glatiramer. Will Teva replicate its previous experience and show that it has protected its API with a cast-iron and impregnable wall of patents? Or have its opponents spotted something that it missed? Sandoz and Momenta must be pretty confident that they have got some advantage over Teva because they can be in no doubt that its patent team and legal team constitute formidable opponents with an impressive record of success. This should be just as exciting as any episode of the original Star Wars!

If you have any questions or comments,

Please feel free to contact me

peter@interpharm-consultancy.co.uk

www.interpharm-consultancy.co.uk