The FDA is following through on plans to issue a proposed rule to revise regulations to allow generic drugmakers to update labeling. The rule would update current regulations that prevent generic drugmakers from doing so, even if they become aware of a potential risk not mentioned in labeling. By contrast, brand-name drugamkers can update warnings and precautions on labeling before obtaining FDA approval. Additionally, Merck won an important court ruling for the entire pharmaceutical industry. A federal court decided that, under certain circumstances, drugmakers may defend themselves against product liability lawsuits by citing preemption.
Merck and AstraZeneca Agree to Amend Partnership – Theradiag Acquires Innovative MicroRNA Technology Platform – 8×8 Sells Patent Family – MPEG LA Announces Call for Patents Essential HEVC – International Rectifier Enters Into Patent License Agreement – Acacia Subsidiary Acquires 156 U.S. and International Patents – Acacia Subsidiary Acquires Patents for X-Ray Powder Diffraction.
Last week, on Friday, June 15, 2012, Merck (NYSE: MRK) announced the U.S. District Court for the District of New Jersey (Judge Peter G. Sheridan) ruled against the company on the issue of patent infringement in its suit against Apotex Inc. According to Merck, global sales of Nasonex® in 2010 topped $1.2 billion. See Merck News. A variety of Internet sources place the Nasonex® market share of the inhaled steroid market at 47%. Therefore, this patent loss some 6 years before the Nasonex® patent expires is a big deal.
The victories selected represent a diverse array of wins, which a press release announcing the Top 10 list says is due to “the differing objectives of IP litigation today.” These victories range from multimillion-dollar jury verdicts, including the biggest patent award ever, which was won by Johnson & Johnson’s Centocor Ortho Biotech unit against Abbott Laboratories, to the i4i injunction win blocking the distribution of Microsoft Word editions having a popular XML feature.
Earlier today, Judge Garrett Brown of the United States Federal District Court for the District of New Jersey, issued an Order and Findings of Fact and Conclusions of Law in the dispute between between Merck and Teva Pharmaceuticals. Judge Brown found that the patent in question, US Patent No. 5,565,473, was valid and enforceable, and that the Teva’s Abbreviated New…