Recent Posts
- Hikma v. Vanda: Oral Argument Recap
- Teva v. Lilly should not be read as creating a new 112 rule for method of use claims
- Should ANDA filers be using the PTAB to mount early challenges to OB patents?
- Switching to WordPress
- Judge Hughes concurrence highlights post grant review appeal standing issue for pharma cases
Category: Pharma Business News
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Bloomberg reports that the topic of reverse payment settlements of Hatch-Waxman litigation came up in a recent Senate hearing. Bloomberg TV interviewed me yesterday about reverse payment settlements. On Pharma has the video. DUSA Pharmaceuticals announced that a federal court recently lifted the preliminary injunction that prevented River’s Edge Pharmaceuticals from selling generic Nicomide, a…
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The Generic Pharmaceutical Association (GPhA), the trade association representing generic drug makers in the United States, is holding its annual meeting this weekend in Phoenix. Unfortunately, I couldn’t attend. A number of interesting news reports are coming out of the meeting: Generic Biotech Bill Will Pass This Year, Hatch Says (Bloomberg) U.S Regulators Aim to Add Resources for Generic Drug…
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The new Thai government has been experimenting with the compulsory licensing provisions of Article 31 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). To date, Thailand has unilaterally declared compulsory licenses for three patented drugs: (i) Stocrin, a first-line anti-retroviral used in treating HIV/AIDS; (ii) Kaletra, a second-line anti-retroviral also used to…
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A recent report published in the Journal of the American Medical Association found that the FDA’s Pediatric Exclusivity Provision (PEP) does not necessarily yield lucrative returns for innovator drug companies. The PEP authorizes the FDA to grant innovator drug companies a six-month extension of marketing exclusivity (beyond patent expiration) in exchange for conducting studies of…
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The Antitrust & Competition Policy Blog reports on a new paper by Prof. Christopher Leslie of Chicago-Kent College of Law advocating the use of antitrust law to challenge the licensing of invalid patents. Richard Epstein, my law school Property professor, has a new book out entitled Overdose: How Excessive Government Regulation Stifles Pharmaceutical Innovation. Judy…
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This week's issue of Chemical and Engineering News features a year-end summary of what many believe has been a dismal year for the pharmaceutical industry (click here for article). Despite Wall Street's gloom, the report predicts a solid future for pharma. Sales in 2006 continued to grow at a 6% clip in the United States. …
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In advance of Merck’s patent on Zocor expiring tomorrow (Friday), and the expected launch of generic versions of Zocor by Ivax (a Teva unit) and Ranbaxy, Merck has made deals with some insurance companies to sell branded Zocor for less than Ivax and Ranbaxy planned to charge for their generics. Teva’s stock price dropped about…
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Vermont Senator Patrick Leahy, co-chairman of the Intellectual Property Subcommittee of the Senate Judiciary Committee, introduced a bill last week entitled "Life-Saving Medicines Export Act of 2006." If enacted, the bill would provide for compulsory licensing of patented medicines (including vaccines and diagnostic tests) in the United States. According to a statement from Sen. Leahy's…
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