Justia U.S. Federal Circuit Court of Appeals Opinion Summaries

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

Leucovorin is a compound used to ameliorate the toxic effects of methotrexate, a chemotherapy treatment; to treat folate deficiency; and to enhance the efficacy of a 5-fluorouracil cancer treatment. Spectrum, the exclusive licensee of the 829 patent, holds the approved New Drug Application for a levoleucovorin formulation, and listed the patent as claiming the drug product in the Food and Drug Administration publication, Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book), and markets Fusilev®. Sandoz submitted an Abbreviated New Drug Application (ANDA) in 2011, seeking FDA approval for a drug product that will be imported in the form of single-use vials with 175 mg or 250 mg of levoleucovorin, indicated for methotrexate rescue at doses of 7.5–75 mg per dose. Its ANDA contained a certification that the 829 patent was invalid or would not be infringed by the ANDA product, 21 U.S.C. 355(j)(2)(A)(vii)(IV). After receiving notice of that certification, Spectrum filed suit. The district court found certain claims invalid as obvious and others not infringed. The Federal Circuit affirmed, rejecting Spectrum’s argument that an aggregation of Sandoz’s approved product—that is, the total amount of levoleucovorin drug product to be imported—would infringe the claims. View "Spectrum Pharma., Inc. v. Sandoz Inc." on Justia Law

Shire’s patents are directed to derivatives of amphetamines, used to treat various disorders, including attention deficit hyperactivity disorder. A drawback to the use of amphetamines is their potential for abuse. The patents describe modifying amphetamine to decrease its activity when administered in high doses—as when the drug is being abused—but to maintain activity similar to that of unmodified amphetamine when delivered at lower doses. Shire’s FDA-approved capsules are distributed under the brand name Vyvanse®. The FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) lists all the Vyvanse® patents. Defendants filed Abbreviated New Drug Applications (ANDAs) for generic versions of Vyvanse® before expiration of the patents The ANDAs included Paragraph IV certifications, 21 U.S.C. 355(j)(2)(A)(vii)(IV), stating that the patent claims are invalid or not infringed. Shire sued under 35 U.S.C. 271(e). The court found certain claims not invalid, denied defendants’ motion to amend their invalidity contentions to include an on-sale bar claim, and found that Johnson induced infringement by providing the active pharmaceutical ingredient to the ANDA defendants. The Federal Circuit affirmed in part, finding that defendants failed to raise a genuine issue of material fact that the asserted claims are obvious and that court did not abuse its discretion in denying the motion to amend. In the circumstances of this case Johnson cannot be liable for induced infringement before FDA approval of the ANDA application. View "Shire LLC v. Amneal Pharma., LLC" on Justia Law

The three patents at issue share the same written description and explain that medical implements, such as catheters and luer ports, are common sites for transmissions of pathogens into patients. To prevent such transmissions, medical staff traditionally swabbed a site before making connections to medical implements. Swabs came in a small pad of cotton gauze soaked in a cleaning agent (e.g., isopropyl alcohol) and packed in a foil package to prevent evaporation. After swabbing, the site is allowed to dry, killing any pathogens. In practice, these swabbing procedures were often “overlooked” or “poorly executed.” The inventors provided a cleaning device that includes a cap that twist on to the medical implements and, when used, reliably disinfects a medical implement. In an infringement suit, the district court granted summary judgment of invalidity, finding the asserted claims obvious under 35 U.S.C. 103. The Federal Circuit reversed. The patent holder established a genuine dispute over whether one of ordinary skill in the art would have been motivated to add a vent to the disinfecting cap described in prior art. View "Ivera Med. Corp. v. Hospira, Inc." on Justia Law

Dome owns a patent for making contact-lens materials that are rigid and gas permeable. On reexamination, the U.S. Patent and Trademark Office found that the claimed method at issue was obvious and therefore unpatentable. The district court found that a person of ordinary skill would have been motivated to combine the prior art and that the prior art did not teach away from the claimed invention, so that the claims were unpatentable under 35 U.S.C. 103. The court found that Dome’s proffered evidence of objective indicia did not indicate nonobviousness. The Federal Circuit affirmed. View "Dome Patent L.P. v. Lee" on Justia Law

Glaucoma is an eye disease associated with elevated intraocular pressure (IOP). Treatments that effectively reduce IOP can slow the progression of the disease. In 2001, the FDA approved Lumigan 0.03%®, a topical solution developed by Allergan, for treating open angle glaucoma and ocular hypertension. Although Lumigan 0.03% was effective at lowering IOP, it also caused frequent, severe hyperemia. Many patients stopped using it without consulting their physicians, causing gradual vision loss. Allergan explored alternative formulations and developed Lumigan® 0.01%, which has a three-fold lower bimatoprost concentration than Lumigan 0.03%, and a four-fold higher concentration of a preservative for inhibiting bacterial growth. In 2010, the FDA approved Allergan’s New Drug Application for Lumigan 0.01% for the same approved uses as Lumigan 0.03%. Allergan’s patents are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) as claiming Lumigan 0.01% and its approved uses. Generic manufacturers submitted Abbreviated New Drug Applications to the FDA, for generic versions of Lumigan 0.01% before expiration of the patents. Allergan sued, asserting infringement. The district court held, and the Federal Circuit affirmed that, the patents were not shown to be invalid for obviousness under 35 U.S.C. 103, and that claims of two patents were not shown to be invalid for lack of an adequate written description under 35 U.S.C. 112. View "Allergan, Inc. v. Sandoz, Inc." on Justia Law

Under the Biologics Price Competition and Innovation Act (BPCIA), 124 Stat. 119, an abbreviated biologics license application (aBLA) requires proof that a product is “biosimilar” to an approved reference product, plus information regarding the FDA’s determination that the reference product is safe. ABLA approval may not take effect until 12 years after licensing of the reference product. BPCIA allows patent infringement suits before approval: the applicant provides confidential access to its aBLA within 20 days after the FDA accepts its application. The parties negotiate a list of patents that would be subject to an immediate infringement action. Under subsection 262(l), the applicant gives notice at least 180 days before commercial marketing, to allow a suit for preliminary injunction. If the applicant discloses information, neither may bring suit based on non-listed patents before notice of commercial marketing. Amgen has marketed Neupogen® since 1991. Sandoz filed an aBLA, for a Neupogen biosimilar. Sandoz notified Amgen that intended to launch its biosimilar upon approval and that it “opted not to provide” its aBLA, so that Amgen was entitled to sue under section 262(l). In 2015, the FDA approved Sandoz’s aBLA. Sandoz gave a “further notice” of commercial marketing. Amgen sued, asserting state law claims of unfair competition based on BPCIA violations; conversion for wrongful use of Amgen’s approved license; and patent infringement. The court held that BPCIA permits an applicant not to disclose its aBLA; that such a decision alone does not permit the reference product owner to obtain relief; and that the applicant may give notice of commercial marketing before FDA approval. The Federal Circuit affirmed dismissal of Amgen’s state law claims, but otherwise vacated and directed the court to consider the patent infringement claims. View "Amgen, Inc. v. Sandoz, Inc." on Justia Law

TMC owns patents relating to the drug bivalirudin, a synthetic peptide anti-coagulant. TMC sells the drug for injection under the Angiomax® brand and, from 1997 to 2006, purchased pharmaceutical batches from BV Laboratories. In 2005, BV created batches of bivalirudin with levels of impurity that exceeded the FDA approved maximum. TMC hired a consultant, who discovered that certain methods of adding a pH-adjusting solution during the compounding process minimize the impurity. In 2008, TMC filed two patent applications, describing this discovery. A year before filing these applications, TMC hired BV to prepare batches of bivalirudin using the patented method. Each was released to TMC for commercial packaging. In 2010, TMC sued Hospira, alleging infringement by Hospira’s ANDA filings. The district court found the patents not infringed and not invalid as obvious, indefinite, or under the on-sale bar under 35 U.S.C. 102(b), which applies when, before the critical date, the claimed invention was the subject of a commercial offer for sale and was ready for patenting. The court found that the claimed invention was ready for patenting but not commercially offered for sale. The Federal Circuit reversed, finding that the batches prepared by BV were sold to TMC and not prepared primarily for experimental purposes. View "The Medicines Co v. Hospira, Inc." on Justia Law

On the day the RE 048 patent issued, Pfizer filed suit against five generic drug manufacturers, alleging infringement. The district court granted the defendants summary judgment in part in part, finding that the RE 048 patent was not a valid reissue patent, because Pfizer’s asserted error of prosecuting a prior patent application as a continuation-in-part, rather than as a divisional, was not correctable by reissue under section 251. The court further found that the safe harbor provision of 35 U.S.C. 121 did not apply to the RE 048 patent, and that the relevant claims of the RE 048 patent were invalid for obviousness-type double patenting in light of an earlier patent. A final judgment of invalidity was entered against Pfizer. The Federal Circuit affirmed. The applications from which the two patents issued do not share “common lineage in the divisional chain,” they are not derived from the same restriction requirement. Restriction requirements (1994 and 1997) were not imposed on the same compound, composition, and method-of-use claims. View "G.D. Searle LLC v. Lupin Pharma., Inc." on Justia Law