This comment highlights the importance of context, the appropriate test, and balance for the IP/competition intersection. First, it emphasizes the importance of context, in particular the regulatory regime in the pharmaceutical industry, highlighting the role the FTC can play through litigation,...

Innovation is crucial to the U.S. economy. But many of our laws and policies are not promoting innovation. This Essay addresses this problem. The first set of proposals focuses on copyright law. The recommendations avoid vague copyright law and suggest the elimination of statutory damages and...

One of the areas of copyright law in most desperate need of reform is statutory damages. And while damages awards against direct infringers have received most of the attention, the effect on secondary infringers threatens to be far more detrimental for innovation. This submission to the...

In my testimony to the Senate Judiciary Committee, I explained the benefits of legislation addressing anticompetitive conduct that brand-name drug companies have employed: sample denials, pay-for-delay settlements, citizen petitions, product hopping, and patent thickets. By increasing generic...

My testimony to the Health Subcommittee of the House Energy & Commerce Committee supports legislation being considered to lower high drug prices.First, I support the CREATES Act and FAST Generics Act, which would ensure that generic companies receive the samples they need to enter the...

The antitrust analysis of product hopping is nuanced. The conduct, which consists of a drug company's reformulation of its product and encouragement of doctors to switch prescriptions to the reformulated product, sits at the intersection of antitrust law, patent law, the Hatch-Waxman Act, and...

This short comment offers five proposals that could encourage a more robust market for biosimilars, targeting REMS denials, non-REMS denials, citizen petitions, and disparagement, and discussing coordination with the FTC

This short comment applauds the FDA's proposed Guidances on shared REMS (Risk Evaluation and Mitigation Strategies). The FDA requires REMS when a drug's risks (such as death or injury) outweigh its rewards. Brands have used REMS, intended to bring drugs to the market, to block generic...

As CEO of Turing Pharmaceuticals, Martin Shkreli made worldwide headlines by obtaining marketing rights to pyrimethamine (Daraprim) and quickly increasing the price 5000 percent, from $13.50 to $750 per pill. In addition to increasing price, Turing initiated another less widely appreciated move...

Drug prices are in the news. “Pharma Bro” Martin Shkreli increased the price of Daraprim, a treatment for fatal parasitic infections, by 5000%. Mylan found itself on the hot seat for raising the price of the anaphylaxis-treating EpiPen 15 times in 7 years, resulting in a 400% increase to...