Justia Patents Opinion Summaries

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

In earlier litigation, Teva challenged the validity and enforceability of GSK’s patents on lamotrigine, Lamictal’s active ingredient. Teva was first to file an FDA application, alleging invalidity or nonenforceability, and seeking approval to produce generic lamotrigine tablets and chewable tablets for markets alleged to be annually worth $2 billion and $50 million,. If the patent suit resulted in a determination of invalidity or nonenforceability—or a settlement incorporating such terms—Teva would be statutorily entitled to a 180- day period of market exclusivity, during which time only it and GSK could produce generic lamotrigine tablets. After the judge ruled the patent’s main claim invalid, the companies settled; Teva would end its patent challenge in exchange for early entry into the chewables market and GSK’s commitment not to produce its own, “authorized generic” Lamictal tablets. Plaintiffs, direct purchasers of Lamictal, sued under the Sherman Act, 15 U.S.C. 1 & 2, claiming that the agreement was a “reverse payment” intended to induce Teva to abandon the patent fight and eliminate the risk of competition in the lamotrigine tablet market for longer than the patent would otherwise permit. The district court dismissed. The Third Circuit vacated, citing Supreme Court precedent, holding that unexplained large payments from the holder of a drug patent to an alleged infringer to settle litigation of the patent’s validity or infringement (reverse payment) can violate antitrust laws. View "King Drug Co of Florence Inc, v. Smithkline Beecham Corp." 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

In 1996, Drs. Lo and Wainscoat discovered cell-free fetal DNA (cffDNA) in maternal plasma and serum, the portion of maternal blood samples that other researchers had previously discarded as medical waste. cffDNA is non-cellular fetal DNA that circulates freely in the blood stream of a pregnant woman. Applying a combination of known laboratory techniques to their discovery,they implemented a method for detecting the small fraction of paternally inherited cffDNA in maternal plasma or serum to determine fetal characteristics, such as gender. The invention, commercialized by Sequenom as its MaterniT21 test, created an alternative for prenatal diagnosis of fetal DNA that avoids the risks of widely-used techniques that took samples from the fetus or placenta. In 2001, they obtained the 540 patent, which does not claim cffDNA or paternally inherited cffDNA, but claims methods of using cffDNA to diagnose certain fetal characteristics based on the detection of paternally inherited cffDNA. The district court found that the asserted claims of the 540 patent are not directed to patent eligible subject matter and were invalid under 35 U.S.C. 101. The Federal Circuit affirmed. While the discovery regarding cffDNA was a significant contribution to the medical field, that alone does not make it patentable. View "Ariosa Diagnostics, Inc.v. Sequenom, Inc." on Justia Law

Elan marketed metaxalone, a muscle relaxant, under the brand-name Skelaxin. Years after Skelaxin’s approval, Elan learned that another company conducted in vivo bioequivalence fasting studies and in vitro dissolution tests on metaxalone and that, based on the results, the FDA proposed to change the designation of metaxalone from “non bioproblem” to “bioproblem.” Elan initiated a study and observed a significant effect of food on bioavailability. Elan petitioned the FDA to require both fed and fasting data for any abbreviated new drug application for a generic version of Skelaxin and to revise its product label. The FDA granted both. Elan obtained patents based on its bioavailability data, which were later invalidated in light of prior art. Classen’s 472 patent is directed to a method for accessing and analyzing data on a commercially available drug to identify a new use of that drug, and commercializing that new use. Classen alleged that Elan infringed that patent when it studied the effect of food on Skelaxin’s bioavailability, used the data to identify a new use, and commercialized that use. The court entered summary judgment of noninfringement, finding Elan protected by the safe harbor provision of 35 U.S.C. 271(e)(1), for activities “reasonably related to the submission of information” under the Federal Food, Drug, and Cosmetic Act. During ex parte reexamination of the 472 patent, the PTO cancelled 107 of the 137 originally issued claims. The Federal Circuit affirmed with respect to the 271(e)(1) exemption, but remanded an allegation that activities that occurred after the FDA submissions infringed the 472 patent and were not exempt. View "Classen Immunotherapies, Inc. v. Elan Pharma., Inc." on Justia Law

Takeda owns several asserted patents that cover several methods of administering colchicine products to treat gout. Colchicine itself, which has been used for centuries, is not covered by Takeda’s patents. Takeda has patents directed to treating acute gout flares and others directed to methods for administering colchicine for prophylaxis of gout in patients who are concomitantly taking certain drug inhibitors known as “CYP3A4” and “P-gp” inhibitors. In 2010, Hikma sought FDA approval of a colchicine product for prophylaxis of gout flares. It submitted an New Drug Application under the Hatch Waxman Act, 21 U.S.C. 355(b)(2). In 2014, the FDA granted Hikma approval to market its Mitigare colchicine capsule. Hikma launched Mitigare, and Takeda filed suit, asserting induced infringement under 35 U.S.C. 271(b) based on Hikma’s labeling of the Mitigare product. Hikma planned on launching an authorized generic version of Mitigare in October 2014. The district court granted Takeda’s request for a temporary restraining order, but later denied a preliminary injunction. The Federal Circuit affirmed. Takeda acknowledged that evidence of mere knowledge of infringing uses is not sufficient and did not establish a probability of success on the issue of infringement. View "Takeda Pharma., U.S.A. v. Hikma Am., Inc." on Justia Law

Pfizer’s patent discloses methods of treating eye infections by topical administration of azithromycin to the eye and states that before the invention, azithromycin was commonly administered orally for the treatment of antibacterial infections, but was not known to be effective when topically administered to the eye. Insite owns three patents. Inspire is the licensee of all four patents and markets the FDA-approved topical azithromycin solution, “Azasite®.” The FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations lists the four patents. Sandoz filed an Abbreviated New Drug Application for its generic version of Azasite® with a certification under 21 U.S.C. 355(j)(2)(A)(vii)(IV) that the patents were invalid or not infringed. The patent holders sued under 35 U.S.C. 271(e). After claim construction, Sandoz stipulated to infringement. The district court ruled that Sandoz failed to show that the asserted claims would have been obvious to a person of ordinary skill in the art and upheld the validity of the patents under 35 U.S.C. 103(a). The Federal Circuit affirmed, rejecting an argument that the court “misframed” the inquiry relating to development of “improved topical treatments for ocular infections,” rather than the narrower problem of topically administering azithromycin to treat conjunctivitis. View "Insite Vision, Inc. v. Sandoz, Inc." on Justia Law

The patents relate to pharmaceutical formulations containing omeprazole, the active ingredient in Astra’s prescription drug, Prilosec, which is effective in treating acid-related gastrointestinal disorders. The omeprazole molecule can be unstable. To protect it from stomach acid, formulators have used an enteric coating. Enteric coatings contain acidic compounds, which can cause the omeprazole to decompose. To enhance storage stability, alkaline reacting compounds must be added, which can compromise a conventional enteric coating. The inventors of the patents at issue added a water-soluble, inert subcoating, separating the alkaline material from the enteric coating. The resulting formulation provides a dosage form of omeprazole with good storage stability, sufficient gastric acid resistance, and rapid release. After a finding of infringement, the district court awarded $76,021,994.50 plus prejudgment interest on a reasonable royalty theory of recovery. The Federal Circuit rejected challenges to the evidentiary analysis and conclusion that a 50 percent royalty rate constituted fair compensation under the reasonable royalty theory; upheld a finding that there was no reason to exclude the value of the active ingredient when calculating damages and refusal to discount the value of Astra’s patents based on the existence of alternatives to the infringing formulation that Apotex actually used; and reversed the award relating to the pediatric exclusivity period. View "Astrazeneca AB v. Apotex Corp." on Justia Law

Enzo’s 767 patent involves the use of nucleotide probes that allow a scientist to detect, monitor, localize, or isolate nucleic acids when present in extremely small quantities, as is necessary for the sequencing of deoxyribonucleic acid (DNA). A jury found that Applera directly infringed all of the asserted claims, that Applera induced its customers to infringe all of the asserted claims, and that the claims at issue were not proven by clear and convincing evidence to lack enablement or written description. The Federal Circuit vacated the judgment of infringement and remanded, finding error in the district court’s claim construction, which construed the claims at issue to cover both direct and indirect detection of a signalling moiety. View "Enzo Biochem, Inc. v. Applera Corp." on Justia Law