Justia Patents Opinion Summaries

Antares’s 015 patent, entitled “needle assisted jet injector,” discloses a system in which a needle punctures the skin before forcefully expelling a medication. With typical injectors the medication itself ruptures the outer layers of skin. During prosecution, the applicants distinguished prior art by emphasizing the “jet injector” limitation. The originally issued claims all contained the “jet injection” limitation. Antares later sought reissue under 35 U.S.C. 251, stating that the patentee claimed “more or less than he had a right to claim.” The 846 reissue patent was granted. Specification and claims 1–22 were unaltered; claims 23–37 were added. The original claims recite embodiments of a jet injection device and specify, for example, the exact plunge depth of the needle assist. The reissue claims are not restricted to jet-injection devices, but concern safety features; they recite a different invention than originally claimed. Defendants submitted an FDA new drug application for pre-filled methotrexate syringes. Antares sought a preliminary injunction. Defendants counterclaimed for invalidity, arguing that the reissue claims were invalid for violating the recapture rule and failing the original patent requirement. The district court denied a preliminary injunction. The Federal Circuit affirmed; the reissue claims are invalid under section 251’s “original patent” requirement. View "Antares Pharma, Inc. v. Medac Pharma, Inc." on Justia Law

AntiCancer, Inc. owns patents for technology related to the imaging of gene expression using a green fluorescent protein linked to a gene promoter. The fluorescent protein is derived from a species of green-glowing jellyfish, Aequorea victoria. The patented inventions are described as useful for drug discovery and evaluation in cancer control and treatment. The district court entered summary judgment of noninfringement, not on the substantive merits of any issue, but on a procedural aspect at the threshold of the litigation arising from application of the Patent Local Rules of the Southern District of California. The court imposed a fee-shifting sanction as a condition of permitting AntiCancer to supplement the Preliminary Infringement Contentions that found to be defective under Patent Local Rule 3.1. The Federal Circuit vacated the condition and remanded. Considering the language and purposes of the Local Rule, and the record of what Anti-Cancer disclosed in its Contentions and the limited, specific criticisms of the Contentions’ sufficiency, there was no reasonable basis for making the finding of bad faith that would be required to sustain the fees sanction. View "Anticancer Inc. v. Pfizer, Inc." on Justia Law

In 1996, Campbell and Ian successfully produced the first mammal ever cloned from an adult somatic cell: Dolly the Sheep. Known as somatic cell nuclear transfer, the process involves removing the nucleus of a somatic cell and implanting that nucleus into an enucleated (i.e., without a nucleus) oocyte. A somatic cell is any body cell other than gametes (egg or sperm). An oocyte is an egg cell prior to maturation and a nucleus is the organelle that holds a cell’s genetic material (DNA). Often called “adult” cells, somatic cells are differentiated, i.e., they are specialized to perform specific functions. Liver, heart, and muscle cells are differentiated, somatic cells. To create Dolly, Campbell and Wilmut fused the nucleus of an adult, somatic mammary cell with an enucleated oocyte. The obtained the 258 patent for the process. The Patent and Trademark Office rejected their claims to the cloned animals, set forth in the 233 application, “Quiescent Cell Populations for Nuclear Transfer.’ In 2013, the Patent Trial and Appeal Board affirmed the rejection, finding that the claimed subject matter was ineligible for patent protection under 35 U.S.C. 101 because it constituted a natural phenomenon that did not possess “markedly different characteristics than any found in nature” and that the subject matter was anticipated by and obvious in light of prior art (35 U.S.C. 102 and 103) because the clones were indistinguishable from clones produced through prior cloning methods, i.e., embryotic nuclear transfer and in vitro fertilization. The Federal Circuit affirmed, citing Section 101.View "In re: Roslin Inst. (Edinburgh)" on Justia Law

Braintree manufactures the SUPREP® Bowel Prep Kit, which helps to prepare patients for colonoscopies. In the late 1990s, two colon cleansing options existed; the safest required patients to drink large volumes of unappetizing isotonic prep formulas, resulting in low patient compliance, and a low-volume, hypertonic prep that could cause severe electrolyte shifts, leading to heart failure, kidney failure, neurological impairment, and even death. Braintree’s patent discloses a combination of magnesium sulfate, potassium sulfate, and sodium sulfate, which can be digested in small volumes to safely and effectively induce colonic purging without causing clinically significant electrolyte shifts. Novel filed an abbreviated new drug application (ANDA) and Braintree responded with a patent infringement case (Hatch- Waxman Act, 35 U.S.C. 271(e)(2)(A). The district court granted summary judgment of infringement based on its construction of four disputed claim terms. The Federal Circuit affirmed a finding Braintree’s patent not invalid, but reversed with respect to construction of the claim term “clinically significant electrolyte shifts” and vacated with respect to infringement.View "Braintree Labs, Inc. v. Novel Labs, Inc." on Justia Law

Gilead owns patents directed to antiviral compounds and methods for their use. The 375 and 483 patents list the same inventors and their written descriptions disclose similar content, but they do not claim priority to a common application and have different expiration dates. Gilead sued Natco for infringement of the 483 patent after Natco filed an FDA request for approval to market a generic version of one of Gilead’s drugs that is allegedly covered by the 483 patent. Natco asserted that the 483 patent was invalid for obviousness-type double patenting over the 375 patent. Gilead argued that the 375 patent cannot serve as a double patenting reference against the 483 patent because, even though the 483 patent’s expiration date is 22 months after the 375 patent’s expiration date, the 375 patent issued after the 483 patent. The district court, pursuant to a stipulation, granted Gilead final judgment on infringement. The Federal Circuit vacated and remanded. Because the obviousness-type double patenting doctrine prohibits an inventor from extending his right to exclude through claims in a later-expiring patent that are not patentably distinct from the claims of the inventor’s earlier-expiring patent, the 375 patent qualifies as an obviousness-type double patenting reference for the 483 patent. View "Gilead Sciences, Inc. v. Natco Pharma. Ltd." on Justia Law

Plaintiffs’ patent concerns the anti-hypertension drug with the brand name Tarka,® a combination of the angiotensin converting enzyme (ACE) inhibitor trandolapril, and the calcium channel blocker (also called “calcium antagonist”) verapamil hydrochloride. The FDA approved a New Drug Application (NDA) for a Tarka® product in 1996. In 2007 Glenmark filed an abbreviated new drug application (ANDA) for a generic counterpart Tarka. Since the patent had not expired, Glenmark filed a Hatch-Waxman “Paragraph IV Certification.” Plaintiffs filed an infringement suit. Launch of Glenmark’s generic product was stayed for 30 months under 21 U.S.C. 355(j)(5(B)(iii). After the stay expired in 2010, Plaintiffs sought a preliminary injunction, which the district court denied. In June 2010 Glenmark launched its generic product “at-risk,” while litigation proceeded. Glenmark admitted infringement and the jury held that the patent had not been proved invalid. The jury awarded $15,200,000 in lost profits and $803,514 in price erosion damages. The Federal Circuit affirmed, rejecting claims that the patent was invalid, that Glenmark was entitled to a new trial based on a prejudicial jury instruction on evidence spoliation, and that no damages should be awarded due to lack of standing of certain Plaintiffs.View "Sanofi-Aventis Deutschland GMBH v. Glenmark Pharm., Inc." on Justia Law

Generic drug manufacturers submitted Abbreviated New Drug Applications for FDA approval to manufacture and sell of generic versions of Boniva® before expiration of Roche’s patents, which are directed to methods of treating osteoporosis by monthly administration of ibandronate, one of a class of compounds known as bisphosphonates. Bisphosphonates generally have a low bioavailability when administered and oral administration of bisphosphonates can result in adverse esophageal and gastrointestinal side effects. Patients taking bisphosphonates previously had to take the bisphosphonate tablet in a fasting state at least 30 minutes before eating or drinking, which created compliance problems. Roche sued, alleging infringement under 35 U.S.C. 271(e)(2) based on the ANDA filings. The Federal Circuit affirmed the district court’s denial of the preliminary injunction. The district court entered summary judgment of invalidity of certain claims due to obviousness under 35 U.S.C. 103(a), finding that once monthly oral dosing of ibandronate was established in prior art and that the combination of prior art references suggested a dosage f about 150 mg per month, or at least indicated that a monthly dose of 150 mg was obvious to try. The Federal Circuit affirmed. View "Hoffmann-La Roche Inc. v. Apotex Inc." on Justia Law

Endo sells Opana® ER extended-release tablets containing a painkiller, oxymorphone. In earlier litigation, Endo sued Roxane and Actavis for patent infringement, 35 U.S.C. 271(e)(2)(A), based on their Abbreviated New Drug Applications to market generic versions of Opana® ER. The lawsuits settled; Endo granted defendants a license and a covenant not to sue. After making the agreements the 122 and 216 patents issued to Endo. They are continuations of the same parent application and directed to extended-release oxymorphone compositions and methods of treating pain using those compositions. Endo also acquired the unrelated 482 patent, concerning purified oxymorphone compositions and methods of making those compositions. The asserted patents are listed in the Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) entry for Opana® ER. Endo again sued for infringement and sought a preliminary injunction to prevent marketing or sales of generic oxymorphone formulations. The district court held that Endo was estopped from claiming that the activity of defendants, “which has gone on for a substantial period of time, is now suddenly barred because of these new patents.” The Federal Circuit vacated, finding that the defendants did not have an express or implied license to practice the patents at issue.View "Endo Pharm. Inc. v. Actavis, Inc." on Justia Law

Senju’s patent covers an ophthalmic solution for eye drops containing Gatifloxacin, an antimicrobial agent, to kill bacteria. Tear dilution and the outer layer of the eye can prevent Gatifloxacin from passing into and treating the aqueous humor. The patent discloses a solution combining Gatifloxacin with disodium edetate, to expand the intercellular spaces of the cornea, accelerating passage of Gatifloxacin solution into the eye. In 2007, Apotex filed an Abbreviated New Drug Application with the FDA (Hatch-Waxman Act, 98 Stat. 1585), requesting approval to manufacture and sell a generic version of the solution. Senju filed an infringement action. The district court held that, though the ANDA product infringed claims 1–3, 6, 7, and 9, claim 7 was invalid as obvious. The Federal Circuit affirmed. In the gap between the court’s 2010 issuance of findings and its December 2011 entry of final judgment, Senju requested reexamination of claims 1–3, 6, 8, and 9; amended claim 6 to include additional limitations; and added new independent claim. In October 2011, the PTO issued a reexamination certificate cancelling claims 1–3 and 8–11, and certifying amended claim 6, new independent claim 12, and new dependent claims as patentable. Before entry of final judgment in the first action, Senju sought a declaratory judgment that Apotex’s manufacture, use, or sale of Gatifloxacin ophthalmic solution infringed claims set forth in the reexamination certificate. The district court dismissed. The Federal Circuit affirmed, finding the suit barred by claim preclusion.View "Senju Pharm. Co., Ltd. v. Apotex, Inc." on Justia Law

Shire markets oral pharmaceuticals under the brand name LIALDA®. Its patent, entitled “Mesalazine Controlled Release Oral Pharmaceutical Composition,” concerns controlled-release compositions for treating inflammatory bowel diseases, such as Crohn’s and ulcerative colitis. The active ingredient is 5-aminosalicylic acid, also called mesalazine or mesalamine, which treats inflamed areas in the bowel by direct contact with the intestinal mucosal tissue. It must pass through the stomach and small intestine without being absorbed into the bloodstream and must be administered throughout the entire length of the colon so that the mesalamine contacts all affected tissues. The oral composition must, therefore, contain a high percentage of mesalamine. The patent teaches an inner lipophilic matrix and an outer hydrophilic matrix to address the limitations of the prior art systems. According to the patent, the combination of a lipophilic and hydrophilic matrix in an inner-outer matrix system, respectively, is advantageous because the inner-outer matrix properties cause the mesalamine to be released in a sustained and uniform manner. Watson submitted an Abbreviated New Drug Application seeking approval to sell generic LIALDA®. Shire sued. After construing claim language, the district court found infringement. The Federal Circuit reversed. The district court’s constructions of “inner lipophilic matrix” and “outer hydrophilic matrix” impermissibly broadened the ordinary meaning of the terms.View "Shire Dev., LLC v. Watson Pharm., Inc." on Justia Law