By Kurt R. Karst – Earlier this week, the U.S. Senate passed, by a 69-30 vote, H.R. 2112, the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2012, as part of an omnibus package of three spending measures. The House and Senate …
By Kurt R. Karst – In a 53-page decision handed down earlier this week by the California Court of Appeal, Fourth Appellate District (Division I), the Court ruled that patent settlement agreements between Bayer AG and several generic drug manufacturers did not violate the Cartwright Act …
By Kurt R. Karst – The U.S. Patent and Trademark Office (“PTO”) recently indicated in a letter to FDA that U.S. Patent No. RE 41,571 (“the ‘571 patent”), a method-of-use patent listed in the Orange Book covering BUTRANS (buprenorphine) Transdermal System is not eligible for a …
By Ricardo Carvajal – NIH and USDA announced a joint workshop on Using Nanotechnology To Improve Nutrition Through Enhanced Bioavailability and Efficacy. Among the goals of the workshop are to “identify knowledge gaps in the use of nutrients (and bioactive food components) for disease prevention,” and to …
By Ricardo Carvajal – FDA updated its guidance on administrative detention of food to reflect the expansion of the agency’s authority under the Food Safety Modernization Act ("FSMA"). As we noted in a prior blog posting, the FSMA made it easier for FDA to administratively …
By Kurt R. Karst – Like the character Michael Keaton plays in the 1988 film “Beetlejuice,” in which spirit (a “bio-exorcist”) comes back from the afterlife (after having his name said three times) to wreak havoc and to try and scare away the new inhabitants of …
By Kurt R. Karst – On October 25, 2011, the Federal Trade Commission (“FTC”) announced the release of its annual summary of agreements filed with the Commission during the last fiscal year (Fiscal Year 2011) – “Agreements Filed with the Federal Trade Commission under the Medicare …
By Carmelina G. Allis – A billhas been introduced in the U.S. Senate, the “Medical Device Regulatory Improvement Act” (S. 1700) to amend the least burdensome and conflicts of interest provisions in Sections 513 and 712 of the Federal Food, Drug, and Cosmetic Act (the Act), respectively, …
By Ricardo Carvajal – The 7th Circuit Court of Appeals affirmed a district court’s dismissal of an action alleging consumer fraud in food labeling claims for fiber. As we noted in a prior posting, Plaintiff alleged that Defendants violated state consumer fraud laws by failing to …
By Kurt R. Karst – A recent decision out of the U.S. District Court for the Eastern District of Virginia that Teva Pharmaceuticals USA, Inc.’s (“Teva’s”) generic version of Pfizer Inc.’s (“Pfizer’s”) VIAGRA (sildenafil citrate) Tablets would infringe Orange Book-listed U.S. Patent No. 6,469,012 (“the ‘012” …
By Anne K. Walsh – In what may be a game-changer for drug companies, a court in the District of Columbia has been asked to set forth parameters for a pharmaceutical company that markets its products in a way that the government may consider to be …
By Kurt R. Karst – Like any good thriller movie that coaxes you into a feeling of finality – right before the surprise twist makes you jump out of your seat – the saga over a Patent Term Extension (“PTE”) for U.S. Patent No. 5,196,404 (“the ‘404 …
By Kurt R. Karst – On October 19, 2011, FDA issued a proposed rule to amend the Agency’s December 29, 1992 (57 Fed. Reg. 62,076) orphan drug regulations. The proposal is not a whole-scale overhaul of FDA’s orphan drug regulations, but rather a group of amendments …
By Jennifer D. Newberger – On October 14, 2011, Representative Brian Bilbray (R-CA) introduced H.R. 3203, the “Novel Device Regulatory Relief Act of 2011.” This bill intends to amend section 513(f) of the Federal Food, Drug, and Cosmetic Act (“FDC Act”) to expedite the process for …
By Cassandra A. Soltis – Earlier this year, we reported on the Interagency Working Group’s (“IWG’s”) proposed voluntary principles for marketing food to children. The IWG includes representatives from the Federal Trade Commission (“FTC”), the Centers for Disease Control and Prevention, the Food and Drug Administration, …
