Justia Drugs & Biotech Opinion Summaries

Medtronic sought a declaratory judgment of non-infringement and invalidity of reissue patents covering a cardiac resynchronization therapy device (previously called a biventricular pacer). The district court entered judgment of noniinfringement in favor of Medtronic and judgment of validity and enforceability in favor of the patent holder. The Federal Circuit vacated and remanded, holding that the district court relied on a legally incorrect allocation of the burden of proof to find non-infringement in the limited circumstances of the case and incorrectly construed the claim terms in question. View "Medtronic, Inc. v. Boston Scientific Corp." on Justia Law

Genentech manufactured and sold the psoriasis medication Raptiva, approved by the FDA in 2003. Raptiva works by suppressing T-cells ; because T-cells help fight infections, suppression has the potential to cause potentially life-threatening side effects. Following reports of adverse health effects, including a rare brain infection, Genentech voluntarily removed Raptiva from the market in 2009. Marsh began using Raptiva in 2004 and subsequently suffered viral meningitis and a collapsed lung. She sued in 2011, alleging strict products liability under design-defect and failure-to-warn theories, negligence, breach of warranty, and fraud. She claimed that, before and after FDA approval, Genentech knew of dangerous side effects that it concealed and did not include in the drug’s label. The district court dismissed, holding that Genentech was immune from suit because neither statutory exception to immunity for drug manufacturers applied. Marsh argued that immunity does not apply because failure to submit updated information rendered Raptiva noncompliant with FDA approval when it left Genentech’s control and that her claim was not preempted because it was premised on non-compliance rather than fraud or bribery. The Sixth Circuit affirmed. Allegations underlying Marsh’s argument that immunity does not apply are essentially the type of claim that is preempted.View "Marsh v. Genetech Inc." on Justia Law

Santarus is the exclusive licensee of patents on formulations of benzimidazole proton pump inhibitors, a class of chemical compounds that inhibit gastric acid secretion and help prevent and treat stomach acid-related diseases and disorders. Santarus provides the PPI product omeprazole in formulations covered by the Phillips patents, brand name Zegerid. Par filed an Abbreviated New Drug Application (ANDA) for FDA approval to sell a generic counterpart of the Santarus Zegerid products, invoking the Hatch-Waxman Act (the Drug Price Competition and Patent Term Restoration Act of 1984), which established Paragraph IV certification, 21 U.S.C. 355(j)(2)(A)(vii)(IV), whereby an entity that seeks to market a generic counterpart of a patented drug product or method of use, before the patent has expired, may challenge the patent before actually marketing the drug. The district court found that Par’s ANDA products infringe the patents, but found all asserted claims invalid on the ground of obviousness, 35 U.S.C 103 and found certain claims invalid on the ground of inadequate written description, 35 U.S.C. 112. The district court held that there was not inequitable conduct by the inventor, his assignee, or their counsel in procuring the patents. The Federal Circuit reversed with respect to obviousness, but otherwise affirmed. View "Santarus, Inc. v. Par Pharma., Inc." on Justia Law

Appellants, researchers in the field of adult stem cells who oppose the use of federal funding for the development of embryonic stem cell (ESC) research, filed a complaint seeking declaratory and injunctive relief against the Secretary's implementation of regulations allowing federal funding of such research. The court, applying Chevron analysis, held that the NIH had reasonably interpreted the Dickey-Wicker Amendment's ban on funding "research in which . . . embryos are destroyed" to allow federal funding of ESC research. Further, the preliminary-injunction exception was not applicable to the law-of-the-case preclusion. The court also held that the NIH's interpretation of the Dickey-Wicker Amendment's actual language was reasonable and the NIH's decision to dismiss the comments categorically objecting to ESC was not arbitrary or capricious. Accordingly, the court affirmed summary judgment in favor of the government. View "Sherley, et al. v. Sebelius, et al." on Justia Law

Generic pharmaceutical manufacturers filed abbreviated new drug applications, seeking FDA approval to market generic formulations of the chemotherapy agent pemetrexed, currently marketed as Alimta. Permetrexed won FDA approval in 2004 for use in treating mesothelioma and then in 2008 for treatment of non-small cell lung cancer. A 1989 patent application claimed pemetrexed and a broader group of related antifolates containing pemetrexed’s characteristic core structure. The application, eventually abandoned, founded a family of related applications that yielded the three patents at issue; two have expired, but the 932 patent remains in effect until 2016, due to a patent term extension of over four years to compensate for delays, 35 U.S.C. 156. The ANDAs asserted that the 932 patent was invalid, unenforceable, or would not be infringed by the proposed generic products, 21 U.S.C. 355(j)(2)(A)(vii)(IV). Lily, which markets Alimta, sued alleging infringement, 35 U.S.C. 271(e)(2)(A). The district court rejected arguments that the 932 patent claims were invalid for obviousness-type double patenting over two earlier-issued claims. The Federal Circuit affirmed. View "Eli Lilly & Co. v. Teva Parenteral Med., Inc." on Justia Law

The district court held that medical organizations, researchers, genetic counselors, and patients had standing under the Declaratory Judgment Act to challenge patent claims to "isolated" DNA molecules and granted summary judgment that all of the challenged claims were drawn to non-patentable subject matter under 35 U.S.C. 101. On remand for consideration under Mayo Collaborative Services v. Prometheus, Inc., 132 S. Ct. 1289 (2012), the Federal Circuit affirmed with respect to standing and reversed, in part, on the merits. The court reversed a holding that composition claims to “isolated” DNA molecules cover patent-ineligible products of nature under section 101 because each of the claimed molecules represents a nonnaturally occurring composition of matter. The court also reversed a holding that a method claim to screening potential cancer therapeutics via changes in cell growth rates of transformed cells is directed to a patent-ineligible scientific principle. The court affirmed that method claims directed to “comparing” or “analyzing” DNA sequences are patent ineligible; such claims include no transformative steps and cover only patent-ineligible abstract, mental steps View "Ass'n for Moleculat Pathology v. U.S. Patent & Trademark Office" on Justia Law

DuoProSS and Inviro sell medical syringes designed to prevent accidental needle sticks. A person using an Inviro syringe: rotates the plunger; pulls the plunger back, drawing the needle into the syringe barrel; and snaps off the plunger, sealing the needle inside. Inviro owns the two trademarks at issue: the “SNAP! design mark,” for use with “ medical, hypodermic, aspiration and injection syringes” and the “SNAP SIMPLY SAFER mark,” for use with “cannulae; medical, hypodermic, aspiration and injection needles; medical, hypodermic, aspiration and injection syringes.” Inviro petitioned to cancel a trademark registration owned by DuoProSS for the design mark BAKSNAP, for use with a “safety syringe for medical use.” DuoProSS counterclaimed for cancellation of several Inviro registrations, including the marks at issue. Inviro withdrew its petition and agreed to voluntarily surrender one registration. The Board concluded that other registrations for the SNAP mark in typed format were merely descriptive and ordered cancellation, but declined to cancel the SNAP! design mark and the SNAP SIMPLY SAFER word mark. The Federal Circuit reversed. The Board failed to consider one of the marks as a whole, unduly focusing on one portion (!) and erroneously concluded that puffing could render the marks more than descriptive.View "Duopross Meditech Corp. v. Inviro Med.Devices, Ltd." on Justia Law

Wake Forest is the owner of asserted patents, and KCI are the exclusive licensees of the patents, which claim methods and apparatuses for treating difficult-to-heal wounds by applying suction or negative pressure. In response to S&N’s 2008 announcement that it was launching a new foam-based negative pressure wound treatment product, Wake Forest and KCI asserted that S&N infringes two apparatus claims of the patent and induces infringement of four method claims. Rejecting the jury’s findings of non-obviousness, the district court found obviousness, based on prior art, and rejected infringement claims. The Federal Circuit reversed and remanded. The objective evidence strongly supported the jury’s findings under the first three Graham factors and cut against the view that the claimed inventions were an obvious combination of known elements from the prior art. View "Kinetic Concepts, Inc. v. Smith & Nephew, Inc." on Justia Law

Apotex submitted an Abbreviated New Drug Application (ANDA) to the FDA seeking approval to market a generic version of the anti-allergy eye drop Patanol. Alcon, which markets Patanol, sued Apotex for patent infringement under 35 U.S.C. 271(e)(2)(A). Alcon asserted claims 1-8 of the patent, which is listed in the Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) entry for Patanol. The district court held that claims would not have been obvious over the prior art and were not invalid. The Federal Circuit affirmed in part. Objective evidence indicated that claims 4 and 8 would not have been obvious. Patanol’s achieving nearly 70% market share within two years of its launch, demonstrates that “the commercial success was caused by the merits of the invention as distinct from the prior art.” The remaining claims were, however, obvious. A person of ordinary skill in the art at the time of invention would have been motivated to use olopatadine to treat human eye allergies as claimed for its established antihistaminic efficacy. View "Alcon Research, Ltd. v. Apotex, Inc." on Justia Law

Lovenox (enoxaparin) prevents blood clots. Enoxaparin is a version of heparin. Heparin molecules have considerable diversity in characteristics. Additional diversity is introduced when heparin is broken down, raising a problem with the FDA abbreviated new drug application (ANDA) process. ANDAs are used to obtain approval for a generic version of an existing drug and do not require extensive studies needed to initially prove the drug’s safety and efficacy. Aventis, which marketed Lovenox, asked the FDA to deny ANDA approval for a generic enoxaparin unless the applicant took certain steps. The FDA rejected Aventis’s arguments, stating that ANDA does not describe the information necessary to demonstrate that the active ingredient in the generic product is the same as the active ingredient in the reference drug. The FDA identified its own criteria for determining that generic enoxaparin has the same active ingredient as Lovenox. Amphastar was first to file an ANDA for generic enoxaparin and received FDA approval in2011. Momenta was first to bring generic enoxaparin to market, obtaining FDA approval more than a year earlier. Momenta alleged that Amphastar infringed its patent for analyzing heparin and obtained an injunction. The district court found that Amphastar’s quality control batch testing infringed the patent. The Federal Circuit vacated. The court applied an unduly narrow interpretation of the Hatch-Waxman safe harbor, 35 U.S.C. 271(e)(1).View "Momenta Pharma., Inc. v. Amphastar Pharma, Inc." on Justia Law