The FDA Exemption from Patent Infringement, what is it?

The Food and Drug Administration’s (FDA) exemption (35 USC 271 (e) (1)) from Patent Infringement is a limited exemption enacted by Congress to permit the use of a patented drug for the purpose of determining the bio-equivalency of a generic drug.  This form of pre-clinical and clinical trial research is necessary to obtain the FDA’s approval for competing products.

The FDA exemption is also referred to as the Hatch-Waxman Act.   It has also been interpreted broadly by the US Supreme Court to cover medical devices, as well, as upstream and downstream phases of research in product development.   See. Eli Lilly and Company v. Medtronic Inc., 496 U.S. 661, 670-1, 110 S.Ct. 2683, 2689-90, (1990) and Merck KGAA v. Integra Life Sciences Inc., 125 S.Ct. 2372, 2380-1, (2005).

The continued growth of the FDA exemption has led to concerns over a bio-tech research tool patent owner’s ability to assert a patent infringement claim.  For an in-depth discussion of the pharmaceutical industry, concerns of bio-tech research tool patent owners and the impact of the FDA Exemption see our Patent Publications section.

The DMCA’s Safe Harbor, what is it?

The DMCA’s Safe Harbor provision was enacted by Congress to shield Internet Service Providers (ISPs) from liability for another’s copyright infringement. The US policy to continue to facilitate the growth of the Internet and interactive media to preserve the competitive market, often conflicts with protecting a Copyright Owner’s incentive to create when determining whether or not an ISP will be liable to a Copyright Owner for contributory, inducing or vicarious infringement based on anothers direct infringement.  

The Safe Harbor (17 USC 512 (a)-(d)) shields a qualifying ISP that has reasonably implemented a policy to shut down a repeat copyright infringer’s account.  The Safe Harbor also requires a Copyirght Owner to provide statutory notice of the infringement to an ISP.  17 USC 512 (c) (3).  The Copyright Owner must substantially comply with the notice requirement in order to impute actual knowledge of infringement to the ISP. 17 USC 512 (c) (3) (B) (ii). 

On the other hand, if an ISP interferes with standard technical measures used by Copyright Owners to protect their Copyrights, then the Safe Harbor may not protect its actions.  17 USC 512 (i) (2).  It is unclear how the ‘”notice and take down procedures”, the ”reasonable implementation” and the “standard technical measures” doctrines will be interpreted and applied to properly protect a Coyright Owner’s incentive to create original works of authorship, while continuing to permit the expansion and growth of the Internet. 

For a recent case attempting to put some flesh on these doctrines see Perfect 10 Inc., v. CC Bill LLC, 488 F.3d 1102 (9th Cir. 2007).