Justia Drugs & Biotech Opinion Summaries

Verinata and Ariosa compete in the field of noninvasive prenatal diagnostics, including testing for fetal chromosomal abnormalities. Verinata owns the 430 patent, which describes methods of noninvasive prenatal testing for the presence of fetal chromosomal abnormalities, particularly “aneuploidy,” i.e., the presence of an abnormal number of copies of a chromosome. Ariosa petitioned the Patent Trial and Appeal Board for inter partes review and challenged the claims for obviousness under 35 U.S.C. 103. The Board concluded that Ariosa had not met its burden of proving that claims 1–18 and 19–30 would have been obvious.The Federal Circuit vacated and remanded because the Board’s language suggests it did not sufficiently consider a 2008 patent that discloses a method of determining fetal aneuploidy by isolating fetal cells, not cell-free DNA. View "Ariosa Diagnostics v. Verinata Health, Inc." on Justia Law

Cubist Pharmaceuticals owns five follow-on patents that relate to the antibiotic daptomycin, which it sells under the name Cubicin. Hospira sought authorization to sell a generic version of Cubist’s daptomycin product, which led Cubist to file suit charging Hospira with patent infringement (Hatch-Waxman Act, 21 U.S.C. 355 and 35 U.S.C. 156 and 271(e)(2). The district court held, and the Federal Circuit affirmed, that some of the asserted claims of four of Cubist’s patents were invalid for anticipation and all the asserted claims of those patents sdfd invalid for obviousness. As for the fifth patent, the court held the two asserted claims not invalid and ruled that Hospira’s proposed products infringed those claims. View "Cubist Pharma., Inc. v. Hospira, Inc." on Justia Law

Enoxaparin, an anticoagulant that helps prevent blood clots, was approved for U.S. marketing in 1993 under the name Lovenox. In 2010, Momentaed market a generic version of enoxaparin. Momenta is also the assignee of the 886 patent, directed to a process used to ensure each batch of generic enoxaparin meets quality standards. Teva, another generic manufacturer, sought to enter the enoxaparin market. It does not manufacture enoxaparin, but sources it from an Italian company that manufactures, analyzes, tests, packages, and labels Teva’s generic version of enoxaparin. Momenta sued Teva for infringement, asserting that it intended to market in the U.S. an enoxaparin product that was manufactured using a process covered by the 886 patent. The court found Teva’s conduct did not infringe because it fell within the safe harbor in 35 U.S.C. 271(e)(1); it is not infringement for a party to use a patented invention “solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs.” The court also rejected Momenta’s contention that Teva’s U.S. sales constitute infringement under section 271(g), which prohibits selling within the U.S. a product which is made by a process patented in the U.S. The Federal Circuit affirmed as to noninfringement under 271(g), but vacated the “safe harbor” determination. View "Momenta Pharma, Inc. v. Teva Pharma. USA, Inc." on Justia Law

Irritable bowel syndrome (IBS) is a condition defined and diagnosed by its constellation of symptoms. A patient’s symptoms define the type of IBS with which a patient is diagnosed. Prometheus sued, alleging infringement of the 770 patent, which claims a method of treatment for IBS-D utilizing alosetron (brand name Lotronex), and has a priority date of 1997. The The district court found the claims invalid as obvious over the prior art or, in the alternative, invalid on grounds of obviousness-type double patenting over the now-expired 800 patent (issued in 1994). The Federal Circuit affirmed, finding the claims of the 770 patent invalid as obvious over the 800 patent and other prior art. View "Prometheus Labs, Inc. v. Roxane Labs., Inc." on Justia Law