Proveris v. Innovasystems: Redefining a Patented Invention Under § 271(E)(1): An Examination of the Federal Circuit’s Narrowing of the § 271(e)(1) “Safe Harbor” Exemption
Duane C. Marks By reducing the scope of “patented inventions” within § 271(e)(1) to only inventions comporting with the “perfect product fit” analysis, Proveris has drastically altered the function of § 271(e)(1) and potentially impairs the ability of generic manufactures to fully utilize the ANDA process created in Title I of the Act. Adherence to Proveris’ “perfect product fit” rule risks establishing loopholes that potentially allows patent holders of pioneer drugs and medical devices to delay generic manufacturers from bringing less expensive generics to the market. This Note critiques the Federal Circuit’s recent narrowing of § 271(e)(1) in Proveris. Part...
The Biologics Price Competition and Innovation Act: Innovation Must Come Before Price Competition
Robert N. Sahr In an effort to reduce the costs of medicine for patients, Congress must be especially careful not to impair the ability of the biotechnology industry to thrive by substantially diminishing profitability. Currently, the biotechnology industry is “still relatively nascent” and is largely fueled by venture capital investment. Of the approximately 1400 biotechnology companies operating in the United States today, only twenty are profitable. Many of these companies are small, with revenues of under a million dollars per year, and do not even have a product on the market yet. Leaders in the biotechnology industry have expressed concern...