A federal judge has ordered the U.S. Food and Drug Administration to decide after a long delay whether Novartis AG can market a version of human growth hormone as a bioequivalent to the one already sold by Pfizer Inc. The order by Judge Ricardo Urbina of the U.S. District Court for the District of Columbia […]

Prof. James Edward Maule, at MauledAgain, plays host to a special Tax Day Edition of Blawg Review #53. But, as Prof. Maule points out, every day is Tax Day given the plethora of ways in which governmental agencies extract their pound of flesh. Sales taxes. Real estate transfer taxes. Use taxes. Telephone taxes. Tire excise […]

Rep. Jenkins introduced a bill, H.R. 5120, to amend title 35, United States Code, to change the provisions for patent term extensions for drup patents. Specifically, the bill would amend 35 USC 156, which extends the term for a patent where the product has been subject to a regulatory review period before its commercial marketing […]

The NewStandard ran an article outlining that Drug Firms ‘gouge’ consumers by taking taxpayer handouts. The article points to the government grants offered to Big Pharma companies, which then make huge profits off the drugs they sell. Hence, the argument goes, we are paying twice for drugs. If only it were that simple. American consumers […]

The U.S. Court of Appeals for the Federal Circuit, in Aventis Pharma S.A. v. Amphastar Pharmaceuticals, Inc., and Teva Pharmaceuticals Usa, Inc., (No. 05-1513; April 10, 2006), held that if there is another reasonable inference for not disclosing information during prosecution, the failure to disclose may have been due purely to inadvertence. In the case, […]

I just returned from the BIO 2006 conference in Chicago. It was a fantastic meeting with lots of excitement in the biotech arena. Almost every U.S. state had a booth and lots of governors and state officials were in attendance. With sponsorships going for over $200K, there were big bucks being splashed around – including […]

Jon Dudas, Commissioner of the U.S. Patent and Trademark Office, urged Congress to move ahead with legislation to improve the patent system. He told a U.S. House of Representatives Judiciary subcommittee that it should adopt provisions that would prevent questionable patents from being approved and give companies more leeway to challenge patents after they’re issued. […]

The Midwest will be showing its strengths, especially in the areas of agricultural biotech and in the convergence of the medical device, diagnostic and therapeutic companies, at the upcoming BIO 2006 in Chicago next week. I will be among the predicted record attendance of over 25,000 registrants. If you’d like to take time to meet […]