Generic exclusivity extended? – Teva sues 16th generic over Carvedilol

I have just found out from the Generic Pharmaceuticals and IP blog that Teva has now sued 16 companies in relation to its Carvedilol process patents.

The 16 defendants are: Zentiva; Mylan; Taro Pharmaceuticals; Lupin; Moehs Iberica; Urquima; Orchid; Wanbury;Z hejiang  Huahai; USV Ltd.; Cadila; Ranbaxy; Dr. Reddy’s Laboratories; Watson; Zambon andApotex.

As I mentioned in my earlier post – this is an interesting way for Teva to seek a shared monopoly with the innovator. The trite response is that, if they have filed patents, then they are entitled to enforce them. Of course.

What’s really interesting, though, is that the scale of the attack on other generic companies is, to my knowledge unprecedented. Here we have a relatively new, aggressive approach to the generic side of the game. Traditionally, most generic pharmaceutical companies seem to have filed patents in order to ensure publication and freedom to operate, rather than setting out to obtain their own, separate monopoly alongside that of the innovator.

The strategy won’t work in every situation, but here are some thoughts on what may be required – what would you add?

1. The innovator’s process patents must have a lengthy monopoly period left to run (otherwise competitor generic companies will simpl follow the innovator’s process);

2. The process described in the original Composition of Matter patent must be uneconomical at commercial scale (other wise the competitor companies will follow it once it has expired);

3. The company setting out to use this strategy must commence development very early to ensure earlier priority date than the inevitable swarm of competitors who will file patents according to the more usual timelines.

4. The patents must be such that together with the innovator’s patent portfolio, they effectively block all readilly identifiable and commercially viable alternatives.

5. etc

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