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: Paragraph IV Cases
-
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…
-
Pfizer v. Mylan Labs. et al., No. 02-1628 (W.D. Pa. 2007) For the third time, Pfizer’s patent on Norvasc has withstood a validity challenge from a generic rival. Following a week-long trial held last year, Judge Terrence F. McVerry of the U.S. District Court for the Western District of Pennsylvania ruled yesterday that Pfizer’s U.S.…
-
Astellas Pharma et al. v. Ranbaxy et al., No. 05-2563 (D. N.J. 2007) A federal district court last week upheld Astellas Pharma’s patent on Flomax (tamsulosin HCl), preventing Ranbaxy from marketing a generic version of the drug until the patent expires in 2009. Flomax is a treatment for benign prostatic hypertrophy (BPH), with annual sales…
-
We reported last month on a new declaratory judgment action that Apotex filed against GlaxoSmithKline in the Eastern District of Virginia. In its complaint, Apotex alleged that Glaxo’s listing of a patent on Zantac Syrup in the Orange Book gave rise to a justiciable controversy sufficient to support declaratory judgment jurisdiction. The Federal Circuit has…
-
It has always been assumed the answer is "yes." Now the Federal Circuit will answer the question directly in Merck v. Hi-Tech Pharma., which concerns Hi-Tech’s ANDAs for generic versions of Merck’s Trusopt and Cosopt prescription eye drops. The case was argued in December and a decision could come at any time. Merck owns U.S.…
-
The Senate Judiciary Committee passed the "Preserve Access to Affordable Generics Act" (S. 316) today by unanimous consent. If enacted, the bill would prohibit "reverse payment" settlements of Hatch-Waxman litigation, in which an innovator drug company pays a generic drug company to delay marketing its generic drug product. Specifically, the bill would amend the Clayton…
-
Ortho-McNeil Pharma. v. Mylan Labs. et al., No. 04-1689 (D. N.J. 2007) Mylan Laboratories filed an ANDA in 2001 to market a generic version of Topamax (topiramate), Johnson & Johnson’s blockbuster anticonvulsant drug, and asserted that the patent on Topamax was invalid due to obviousness. As we previously reported, last October Judge Stanley R. Chesler…
-
Watson Pharmaceuticals announced today that it has settled a patent infringement suit concerning GlaxoSmithKline’s popular antidepressant Wellbutrin XL (bupropion HCl extended release tablets) for $35 million. The suit was filed in the Southern District of Florida in December 2005 by Andrx Pharmaceuticals, which was acquired by Watson last year. Andrx asserted that Glaxo’s formulation for…
-
Aventis Pharma v. Amphastar Pharms., No. 03-887 (C.D. Cal. 2007) In a ruling issued last Friday, Judge Mariana R. Pfaelzer of the U.S. District Court for the Central District of California held Aventis’s U.S. Patent No. 5,389,618 and its U.S. Reissue Patent No. 38,743 unenforceable due to inequitable conduct. The patents cover Lovenox (enoxaparin), a…
-
Undeterred by the Supreme Court’s denial of its cert petition in Apotex v. Pfizer last year, Apotex has filed yet another lawsuit asserting that listing a patent in the Orange Book establishes a justiciable controversy and therefore declaratory judgment jurisdiction. This argument failed at least twice before, in Teva v. Pfizer (relating to generic Zoloft)…
Orange Book Blog 