- Last Thursday, FDA Law Blog reported on the Lupin v. Abbott case scheduled for oral argument at the Federal Circuit on Wednesday. The case concerns a very unusual situation, where Abbott obtained two patent term extensions under 35 U.S.C. § 156 for a single drug product.
- In what is being reported as a setback for the prospects of a biosimilars industry in the United States, the FDA recently denied Genzyme’s request to change the manufacturing site of its drug Myozyme. For more: Boston Globe, Pharmalot, WSJ Health Blog.
- The L.A. Times published an interesting op-ed last week about safety concerns with biotech drugs.
- The New York Times reported last week on a lobbying fight between the brand-name and generic drug industries over inequitable conduct provisions in patent reform legislation.
- FDA Law Blog recently updated their coverage of two interesting cases: Teva vs. FDA, concerning 180-day exclusivity on Risperdal, in which Apotex filed a motion to intervene; Nu-Pharm v. FDA, Nu-Pharm’s ANDA for generic Depakote, in which the D.C. Circuit summarily affirmed the district court’s decision in favor of FDA.
- On April 16, a district court denied Perrigo’s motion for summary judgment that its generic version of Olux (clobetasol propionate foam), a treatment for scalp psoriasis, does not infringe Connetics’ U.S. Patent No. 6,126,920.
- On March 19, a district court denied Ranbaxy’s motion for summary judgment that Roche’s patent on Valcyte (valganciclovir HCl), U.S. Patent No. 6,083,953, is invalid due to incorrect inventorship. Numerous other summary judgment motions are still outstanding in the case.
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
Orange Book Blog 
Leave a comment