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Wednesday, May 16, 2007

Shame Shame Drug Game Part 2

The Hatch-Waxman Act (ie. the Drug Price Competition & Patent Term Restoration Act) was designed to give generic drug manufacturers strong incentives to develop lower-cost generics to save you, the consumer, mucho dinero. The main perk for GenCo is 180 days of exclusive generic marketing if the generic can be produced in a way that is non-infringing to BrandCo's magical production process or if GenCo has a valid challenge to the patent upon which BrandCo's drug relied.

Big money, no whammies, stop! Stopped on a whammie. BrandCo filed a patent infringement action within 45 days of my GenCo patent application for a sweet sweet patented generic deal that would give me exclucive rights for up to 3 years (Patented generics are the new black, or is it the new pink that was the new black, can I get a wah wah-Budeprion/Buproban).

Now, watch them pull a rabbit out of their hat! The Uruguay Round Agreements Act of 1994 (URAA) changed the length of patent for ALL inventions from 17 years post patent grant date to 20 years from the date of patent application. I smell a lobbyist, I mean a rat because this includes ALL BrandCo drug patents that did not expire prior to 1994. So now BrandCo not only gets a 3+ year patent extension they also still qualify for an additional letigious patent extension via Hatch-Waxman.

I strike back at BrandCo with the Medicare Prescription Drug Improvement and Modernization Act that limits their letigious choke-hold on my ANDA to ONE 30-month stay against marketing the generic. I will be sitting pretty if my generic comes to market, but wait, somewhere a "concerned" citizen has filed a petition to prevent my generic from being approved. I smell a rat, I mean a lobbyist or other BrandCo supporter because ALL issues in this "concern for public safety" petition must be resolved before I can market my generic. Shenanigans!

After all of these thorns in my side, I produce my generic. Only one problem.....there was a declaratory judgement which resulted in NO assurance that my generic is not in violation of the brand-name patent. This means that I can produce and sell my generic but BrandCo may sue for patent infringement at any moment.

You sank my battleship!


Anonymous said...

Great research! I will have my students review this for their pop quiz. Keep up the good work bloggers

Mc RPh said...

Research? That's a new one on me. Hey Big N Tasty, I always thought the Hatch-Waxman Act was just something you personally did (along with a manicure and pedicure) before going out on the town. You know how we gotta run a tidy bakery. =)