Justia Drugs & Biotech Opinion Summaries

Abbott owns the 752 patent and the 509 patent, which share a common specification that describes methods and devices “for the in vivo monitoring of an analyte using an electrochemical sensor to provide information to a patient about the level of the analyte” in the bloodstream. The specification describes methods and devices for monitoring glucose levels for diabetics. And notes that a variety of devices exist for monitoring glucose levels in the blood stream, but some of these devices include sensor guides that are “typically bulky and do not allow for freedom of movement.” In response to a third-party request for reexamination, the Board of Patent Appeals and Interferences rejected several claims in the patents as indefinite, anticipated, or obvious over several combinations of prior art references. The Federal Circuit vacated in part, noting that the U.S. PTO conceded that the examiner’s official notice rejections should be withdrawn. The rejections were based on unreasonable claim constructions; under the broadest reasonable construction, “electrochemical sensor” is properly interpreted to mean a discrete electrochemical sensor devoid of external connection cables or wires to connect to a sensor control unit. View "In re Abbott Diabetes Care, Inc." on Justia Law

Pozen developed a method for treating migraines by combining two drugs, sumatriptan and naproxen, in a single tablet, which it markets with GlaxoSmithKline as Treximet. Sumatriptan, a 5-HT receptor agonist, was developed in the late 1980s and is widely accepted as an effective medicine for migraines, but it does not prevent the reoccurrence of migraine symptoms. Naproxen is anonsteriodal anti-inflammatory drug. Pozen filed a New Drug Application (NDA) for Treximet and obtained approval from the FDA in 2008; the relevant patents are included in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book), 21 U.S.C. 355(b)(1). Generic pharmaceutical manufacturers filed ANDAs (abbreviated new drug applications) to market generic forms of Treximet before the expiration of Pozen’s patents, certifying that the patents listed in the Orange Book are “invalid or will not be infringed” by the generic products. Thereafter, Pozen filed complaints for infringement, 35 U.S.C. 271(e)(2)(A). The district court held that Pozen’s patents are not invalid as obvious under 35 U.S.C. 103 and were infringed by the ANDA filings and enjoined the generic manufacturers from making, using, importing, selling or offering to sell their generic products in the United States. The Federal Circuit affirmed. View "Pozen, Inc. v. Par Pharma., Inc." on Justia Law

The 772 application is directed to methods and compositions for recombining DNA in a eukaryotic cell (a cell with a nucleus), such as a human cell. The Board of Patent Appeals and Interferences affirmed rejection of independent claim 29 of the 772 application, as obvious over the combination of a patent and an article. Claim 29 covers a method of recombining DNA in a eukaryotic cell using modified versions of wild-type Int. The Federal Circuit affirmed. The disclosures provide substantial evidence that a person of ordinary skill in the art would have had a reasonable expectation of success for using the modified integrases disclosed in the article in place of wild-type Int in the method taught in the patent. View "In re Droge" on Justia Law

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

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

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

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