By Kevin Outterson Call for Abstracts: 2015 bioIP Faculty Workshop The American Society for Law, Medicine & Ethics (ASLME) is pleased to announce the first annual bioIP Faculty Workshop on May 7, 2015 at Boston University School of Law. The Workshop will offer a unique opportunity for three junior scholars (in their first decade of…
By Rachel Sachs Last month, as it wrapped up the 2014 Term, the Supreme Court decided a patent law case that could have a major impact on method patents in the medical arena. No, I’m not talking about Alice Corp. v. CLS Bank, the most Rorschach-like of the Term’s many patent opinions. I’m talking about…
By I. Glenn Cohen Update: The Moore Foundation has generously paid to make my article available as open access on their website here. Today I am speaking at Health Affairs’ “Using Big Data to Transform Health Care” in DC, that will also launch its new issue devoted to the topic. I have a co-authored paper…
By The Petrie-Flom Center Post-Trial Responsibilities: Ethics and Implementation Thursday, September 18, 2014 Harvard Law School, Wasserstein Hall, Milstein East AB, 1585 Massachusetts Ave. This event is free and open to the public, but due to limited seating registration is required. Please register online. Law, policy, and guidance are vague, sometimes conflicting, and generally lacking in…
By Bob Bohrer Cross-post from Pharmaceutical Policy There were two stories in The New York Times that, although not directly related, are the basis for today’s post. The first, by Andrew Ross Sorkin, Do Drug Companies Make Drugs, or Money?,appeared in the Business Section on page B1 on June 3, 2014. The second, by Andrew Pollock, New System for…
By Diana R.H. Winters While today’s unanimous (sans Justice Breyer, who recused himself) decision by the Supreme Court in POM Wonderful LLC v. Coca-Cola Co. was certainly not a surprise, especially after the clear tenor of the oral argument, the case may have some implications for FDA law going forward. In this case, POM Wonderful…
By Timo Minssen In a recent blog I discussed the benefits and potential draw-backs of a new “EU Regulation on clinical trials on medicinal products for human use,” which had been adopted by the European Parliament and Council in April 2014. Parallel to these legislative developments, the drug industry has responded with its own initiatives providing for varying degrees…
Please join us for a day-long conference at Harvard Law School on September 18, 2014, which will include presentations by leading experts and varied stakeholders as well as small group discussion and break out sessions that will work toward developing consensus in this difficult area. Key questions include: How should post-trial access be defined? What type of interventions…
Stay abreast with recent developments and trends determining the legal and regulatory framework of the European pharmaceutical industry. What are the most significant current issues shaking and shaping the pharmaceutical industry today? The business environment and legal framework relevant to the pharmaceutical industry continues to change rapidly in the face of constant challenges posed by…
By Timo Minssen Following the approval of the European Parliament (EP) earlier last month, the Council of the European Union (the Council) adopted on 14 April 2014 a “Regulation on clinical trials on medicinal products for human use” repealing Directive 2001/20/EC. As described in a press-release, the new law: “aims to remedy the shortcomings of…
