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
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Category: 180-Day Exclusivity
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In Re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litigation, No. 2011–1399 (Fed. Cir. 2011) This case has an unusual history. Here is a brief summary of recent events: April 8: U.S. District Court for the District of Delaware enjoins Mylan from launching its generic AMRIX until the court issues its opinion on the patent infringement and validity issues in…
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In Re: Cyclobenzaprine Hyldrochloride Extended-Release Capsule Patent Litigation, No. 09-md-2118-SLR (D. Del. 2011) In a strange turn of events, the district court that just eight days earlier found the asserted claims of the patents on Amrix invalid, granted a motion for a temporary restraining order against Mylan. As we previously reported, on May 12, following…
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Mylan Pharms. v. FDA and Ranbaxy Labs., No. 11-566-JEB (D.D.C. 2011) In an Opinion released earlier today, the U.S. District Court for the District of Columbia dismissed Mylan's lawsuit that sought to force FDA to act on Ranbaxy's ANDA for generic Lipitor (atorvastatin) and determine whether Ranbaxy forfeited its 180-day exclusivity for the product. The…
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Mylan Pharms. and Matrix Labs. v. FDA, No. 11-566 (D.D.C.) Last month, Mylan filed suit against the FDA in the U.S. District Court for the District of Columbia, seeking a declaration that there is no applicable period of 180-day exclusivity for generic Lipitor (atorvastatin) that would block approval of Mylan's atorvastatin ANDA; and an injunction…
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Pfizer Inc. et al. v. Apotex Inc. et al., No. 08-7231 (N.D. Ill. 2010) The litigation between Pfizer and Apotex over Apotex's ANDA for a generic version of Lipitor (atorvastatin calcium) presents the fairly typical scenario of a later ANDA filer (Apotex) trying to trigger the 180-day exclusivity of the first filer (in this case,…
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Millenium Pharms. and Schering Corp. v. Teva, No. 09–105 (D. Del. 2010) Under the “failure to market” forfeiture provision, the first ANDA filer forfeits its exclusivity is it fails to market its ANDA product within 75 days of a Federal Circuit decision of patent invalidity or noninfringement. See 21 U.S.C. 355(j)(5)(D)(i)(I)(bb)(AA). This presents a dilemma…
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Last week, I gave a talk about non-patent exclusivity at ACI's FDA Boot Camp conference in Boston. The talk covered new chemical entity (5-year) exclusivity; new clinical trial (3-year) exclusivity; orphan drug exclusivity; pediatric exclusivity; and generic drug (180-day) exclusivity. You can download a copy of my slides here. In June, I gave a talk about…
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Boehringer Ingelheim v. Barr and Mylan, No. 05-700-JJF (D. Del. 2008) Last week, following a bench trial held in March, the U.S. District Court for the District of Delaware held that Boehringer Ingelheim’s patent on Mirapex (pramipexole dihydrochloride) is invalid for obviousness-type double patenting. Mirapex, indicated for the treatment of Parkinson’s disease and Restless Leg…
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Teva announced yesterday that the FDA granted final approval to its ANDA for generic Risperdal (risperidone) tablets, that it was awarded 180-day exclusivity as the first paragraph IV filer for risperidone, and that it immediately commenced a commercial launch. FDA confirmed the final approval in a press release. Risperdal is a schizophrenia drug marketed by…
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King Pharmaceuticals markets Altace (ramipril), which is indicated for the treatment of high blood pressure. Until last year, when the Federal Circuit invalidated King's compound patent on ramipril, King earned about $700 million annually from U.S. sales of Altace. Although Lupin was the ANDA filer who prevailed against King in the patent litigation, Cobalt Labs,…
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