Justia Drugs & Biotech Opinion Summaries

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

Plaintiff sought to develop a rapid, self-administered test to determine a person’s HIV status. The development process included collection of human blood and saliva samples. Plaintiff sued the United States under the Federal Tort Claims Act for the destruction of its blood and saliva specimens by the Food and Drug Administration. The specimens had been seized during a criminal investigation and the freezer in which they were stored broke down. The district court entered summary judgment that the suit arose from a law enforcement officer’s detention of property, excepting the claims from the FTCA waiver of sovereign immunity, 28 U.S.C. 2680(c). The Seventh Circuit affirmed. The government presented uncontroverted evidence that the officer detained the specimens as a law enforcement officer View "On-Site Screening, Inc. v. United States" on Justia Law

Borrome, a citizen of the Dominican Republic, and, since 1996 a lawful permanent resident of the U.S. pled guilty in 2002 to violations of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301-399d, prohibitions on unlicensed wholesale distribution of prescription “drugs” in interstate commerce. He was sentenced him to four months’ imprisonment followed by four months’ home confinement. In 2010 he was served with a notice of removal and the IJ reasoned that because Borrome’s offense involved unauthorized distribution of a Schedule II controlled substance (Oxycontin ), it is an aggravated felony under 8 U.S.C. 1101(a)(43)(B) pursuant to the “hypothetical federal felony test,” so that Borrome was removable under 8 U.S.C. 1227(a)(2)(B)(i) as an alien convicted of violating any law “relating to a controlled substance.” The Board of Immigration Appeals affirmed. Borrome has been removed from the United States. The Seventh Circuit reversed, concluding that violation of the FDCA wholesale distribution provisions does not constitute an aggravated felony and that those laws are not laws relating to a controlled substance. View "Borrome v. Att'y Gen. of the U.S." on Justia Law

Schering held a patent on the controlled release coating applied to potassium chloride crystals for treatment of potassium deficiencies. Potential generic manufacturers filed an abbreviated application for approval (ANDA),Hatch-Waxman Act, 21 U.S.C. 301-399, asserting that the Schering patent was invalid or would not be infringed by their new generic drugs. Schering’s subsequent infringement suits were resolved through agreements in which it paid the generic manufacturers to drop patent challenges and refrain from producing a generic drug for a specified period. Congress amended Hatch-Waxman to require pharmaceutical companies who enter into such settlements to file for antitrust review. The FTC filed an antitrust action with respect to Schering’s settlements. Plaintiffs sued on behalf of a class of purchasers of the drug. The Third Circuit affirmed the district court’s certification of the class, but reversed its presumption that Schering’s patent was valid and gave Schering the right to exclude infringing products until the end of its term, including through reverse payment settlements. The court directed use of a “quick look rule of reason analysis” based on economic realities of the settlement rather than labels. The court must treat any payment from a patent holder to a patent challenger who agrees to delay entry into the market as prima facie evidence of unreasonable restraint of trade, rebuttable by showing that the payment was for a purpose other than delayed entry or offers some pro-competitive benefit. View "In Re: K-Dur Antitrust Litigation" on Justia Law

Lupin submitted an Abbreviated New Drug Application (ANDA) to the Food and Drug Administration seeking approval to market a generic version of Fortamet, an extended-release tablet of metaformin hydrochloride. Shionogi, which markets Fortamet, sued Lupin for patent infringement under 35 U.S.C. 271(e)(2)(A) asserting, among others, the 866 patent), which is listed in the Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) entry for Fortamet. Lupin attempted to launch its generic Fortamet “at risk,”( without a final judgment on the merits in the litigation). Shionogi obtained a preliminary injunction. The Federal Circuit vacated and remanded. The district court incorrectly concluded that Lupin failed to raise a substantial question of validity regarding the asserted claims of the 866 patent, an abused its discretion by issuing a preliminary injunction. View "Sciele Pharma Inc. v. Lupin, Ltd." on Justia Law