Post-Biosimilars? Lawsuits!!
June 11, 2009 at 12:43 pm EST | Tags: Biosimilars, Legal, Patents
Presented by PharmaVendor
According to legal website Law360, any biologics legislation that gets passed will bring with it a flurry of lawsuits.
Ahhh, good for patent lawyers – bad for everyone else (unless of course you sell your biologics manufacturing plant to Pfizer, Merck, etc. for $500M).
Weil Gotshal’s Nicholas Groombridge, co-chair of the firm’s patent litigation practice, says that as it stands, generic companies have no incentive to forgo a challenge to a patent’s validity.
Groombridge also said that the current ANDA style of litigation needs reform and that once there is an established regulatory path (which will most likely be during the Obama Administration), the lawsuits will start hitting:
“In the pharma space, the basic structure of ANDA litigation needs legislative revision. Legislative policy should work for innovation, not against it…It seems that biologics will also be subject to some form of ANDA-style regulation, and when that happens there will be a wave of ANDA-style litigation in the bio space.”
Here’s the article (subscription required).
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Agreed, the current legislation is all screwed up. I hate generics and people who think drugs just fall out of the sky for free. Nothing is free, people.
I hear Weil has hired some really kick-ass patent lawyers lately. There is even this one lawyer who did medical research at an elite medical school before becoming a lawyer. That sounds like someone I would want to have working on my patents.