There are a number of hot issues in Hatch Waxman Act litigation, but the following is a summary noting some considerations for the pioneering patent holder, first and subsequent companies producing generics:
1) The FDA exemption provides an exemption from infringement for using a patented drug or class III medical device obtain FDA approval to bring a competitor to the market;
2) the generic or competing company can provide an ANDA with an appropriate paragraph IV cert to the patent holder and the patent holder gets a 45 day window to sue for patent infringement;
3) the pioneer and the first filing generic can enter into a settlement agreement to provide the first filing generic a 180 day exclusivity period to market the generic (this can impact a second generic’s ability to file a declaratory judgment complaint, but may raise anti-trust concerns for the pioneer or patent holder);
4) the pioneer or patent holder can acquire a thirty month stay by challenging the generic’s paragraph IV certification (only one under the 2003 Medicare Amendments);
5) “Skinny labeling” may protect against infringement claims avoid infringement claims, but may not protect against inducing patent infringement (particularly in cases involving A-rated generics);
6) research tools may be swallowed up by the expansion of the definition of reasonably related to obtaining FDA approval of generic or competing product (demonstrating substantial equivalence in a clinical sense to the patented product); and
7) Patent owners can seek an extension of the patent term to account for regulatory delays in bringing the drug to the market.
This is a summary of some of the hot issues in Hatch Waxman Act Litigation. In relating, the FTC may often investigate a variety of the settlements between the patent owner and the First filing generic. There are a variety of issues relating to the Food and Drug Cosmetics Act and the Orange Book that should be considered in any Hatch Waxman Act litigation matter. Moreover, there may be a variety of concerns relating to Antitrust matters, second coming generics, the efficacy rates of the generic, and nuisances for method claims to drugs and medical devices regulated by the FDCA.
If you have any concerns or questions about Hatch Waxman Act litigation, in particular, 35 USC section 271 (e), then please feel free to contact us.