Justia Drugs & Biotech Opinion Summaries

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

Daiichi markets Benicar® for treating hypertension. In seeking FDA approval, Daiichi listed, in the Approved Drug Products with Therapeutic Equivalence Evaluations publication, (Orange Book), the 599 patent covering the drug’s active ingredient, olmesartan medoxomil, which expires in 2016, and the 703 patent covering methods of treatment, which expires in 2021. After Mylan filed an Abbreviated New Drug Application in 2006, Daiichi disclaimed the 703 patent, 35 U.S.C. 253. The district court upheld the validity of the 599 patent. Apotex filed an ANDA for generic olmesartan medoxomil, acknowledging that the 599 patent is valid, barring an effective date of FDA approval earlier than 2016. Daiichi did not sue Apotex for infringing the 703 patent. The FDA has not removed the patent from the Orange Book, despite Daiichi’s request. Apotex sought a declaratory judgment that it will not infringe that patent, to enable it to receive FDA marketing approval. The district court dismissed for lack of a case or controversy. The Federal Circuit reversed. Apotex has a concrete, potentially high-value stake in obtaining a judgment; Daiichi has a concrete, potentially high-value stake in denying Apotex that judgment and delaying Apotex’s market entry, as does Mylan, the first applicant for approval of a generic. View "Apotex, Inc. v. Daiichi Sankyo, Inc." on Justia Law

Cadence’s patents are directed to aqueous phenol formulations— particularly acetaminophen (sometimes referred to as “paracetamol”). The 222 patent, issued in 2000, explains that in aqueous solutions, acetaminophen decomposes into potentially toxic products and is directed at avoiding this decomposition by adding a free-radical capturing agent and a buffer. The 218 patent claims priority to a 2000 French application and discloses a method for obtaining stable acetaminophen formulations by deoxygenating solutions with an inert gas to achieve oxygen concentrations below 2 parts-per-million. Cadence’s FDA-approved injectable acetaminophen product is distributed under the name Ofirmev®. The FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) lists the patents in connection with Ofirmev®. Exela filed an FDA Abbreviated New Drug Application, seeking approval of a generic equivalent of Ofirmev®. The ANDA included a certification under 21 U.S.C. 355(j)(2)(A)(vii)(IV) (Paragraph IV certification) stating that the 222 and 218 patents were invalid and not infringed. Cadence sued Exela for infringement under 35 U.S.C. 271(e)(2)). The district court found the 222 patent not invalid and literally infringed and the 218 patent not invalid and infringed under the doctrine of equivalents. The Federal Circuit affirmed, upholding the constructions of “buffering agent” and “vacuum stoppering step.” View "Cadence Pharma, Inc. v. Exela Pharma Sciences, LLC" on Justia Law

Senju sued defendants for infringement of the reexamined 045 patent, alleging constructive infringement under the Hatch-Waxman Act, 98 Stat. 1585. Defendants counterclaimed seeking a declaratory judgment of noninfringement and invalidity. The patent relates to gatifloxacin, an aqueous liquid pharmaceutical eye drop composition, with added disodium edetate. Seven prior art patents were alleged as the basis for the obviousness determination, each containing some of the same chemistry as the claimed invention. There are several prior patent infringement suits involving the same chemistry and the same 045 patent. The district court adjudged the claims infringed but invalid for obviousness. The Federal Circuit affirmed. The district court properly applied a presumption of validity, considering both the evidence of obviousness and the evidence of unexpected results, to find clear and convincing evidence of invalidity; it was not clear error for the court to conclude that the unexpected results evidence that Senju relied upon during reexamination did not withstand scrutiny by Lupin’s experts and the court. View "Senju Pharma. Co. v. Lupin, Ltd." on Justia Law

Warsaw owns the 973 patent, which claims oversized spinal implants, and the 933 patent, which claims methods and devices for retracting tissue to create a working channel for minimally invasive spinal surgery. NuVasive owns the 236 patent, which relates to neuromonitoring during surgery. Warsaw sued NuVasive, alleging infringement; NuVasive counterclaimed, asserting infringement. A jury found that the asserted claims of the 973 patent were not invalid (infringement was not in dispute), that the asserted claims of the 933 patent were infringed under the doctrine of equivalents (validity was not in dispute), and that the asserted claims of the 236 patent were infringed (validity was not in dispute), and awarded damages for each. The district court denied motions for JMOL or a new trial; denied Warsaw’s requests for supplemental damages and a permanent injunction; and set ongoing royalty rates. The Federal Circuit affirmed with respect to invalidity and infringement of all three patents, but remanded for a new trial on damages with respect to the 973 and 933 patents. On remand, Warsaw will be limited to a reasonable royalty and cannot recover lost profits. View "Warsaw Orthopedic, Inc. v Nuvasiive, Inc." on Justia Law

The application from which the 135 patent issued (28 years later) was filed in 1974. The patent relates to prosthetic vascular grafts made of highly-expanded polytetrafluoroethylene (ePTFE), consisting of solid nodes of PTFE connected by thin PTFE fibrils. The graft formed by ePFTE is homogeneously porous: a structure that allows uniform cell regrowth to establish a firm integration of the graft into the body. The different claims of the patent are directed to grafts made of ePTFE with varying intermodal distances, which are also called fibril lengths. It is sold by Gore under as “Gore-Tex.” In 2003, BPV and Dr. Goldfarb sued Gore for infringement. A jury found the patent valid and that Gore willfully infringed. The Federal Circuit affirmed in 2012, but granted rehearing and vacated for the limited purpose of addressing willfulness, enhanced damages and attorneys’ fees. On remand, the district court again found that Gore, as a “reasonable litigant,” could not have realistically expected its defenses to succeed. The Federal Circuit affirmed, rejecting a claim that neither BPV nor Goldfarb had standing to sue for infringement and holding that Gore’s position was not susceptible to a reasonable conclusion that the patent was invalid on inventorship grounds. View "Bard Peripheral Vascular, Inc. v. W.L. Gore & Assocs., Inc." on Justia Law

Plaintiffs own patents relating to the BRCA1 and BRCA2 genes, mutations of which are linked to hereditary breast and ovarian cancers. In prior litigation, the Supreme Court held that claims of one of the patents were drawn to patent-ineligible subject matter because the isolated DNA strands were natural phenomena. Generic competitors entered the market for kits to test for susceptibility to particular kinds of cancer. Plaintiffs sought a preliminary injunction, alleging infringement of 66 claims across 15 patents. The district court denied a preliminary injunction. The four composition of matter claims on appeal are directed to primers, which are “short, synthetic, single-stranded DNA molecule[s] that bind[] specifically to . . . intended target nucleotide sequence[s].” The court held these were likely patent ineligible because they claim “products of nature.” The method claims on appeal involve comparisons between the wild-type BRCA sequences with the patient’s BRCA sequences. The court reasoned that these were likely ineligible because the only “inventive concepts” are the patent-ineligible naturally occurring BRCA1 and BRCA2 sequences themselves; the other steps are conventional activities, uniformly employed by those working with DNA. The Federal Circuit affirmed, finding that the claims are directed to ineligible subject matter under 35 U.S.C. 101. View "Univ. of Ut. Research Found. v. Ambry Genetics Corp." on Justia Law

Townsend worked as an Arkansas pharmaceutical sales representative for Bayer, selling Mirena, a contraceptive device. Townsend visited physicians, including Dr. Shrum. Townsend learned Shrum was importing from Canada a version of Mirena that was not FDA-approved, at half the cost of the approved version. Shrum had submitted Medicaid claims at the same rate as the approved version and bragged about $50,000 in extra profit. Townsend sought guidance from his superiors. Bayer told Townsend not get involved. Townsend called the Medicaid Fraud Hotline, although he feared losing his job. Shrum was charged with Medicaid fraud. Meanwhile, Bayer changed its method of reimbursing sales expenses. Not understanding the change, Townsend’s wife spent funds intended for those expenses, causing Townsend’s account to be closed temporarily. Although Townsend's account had been reactivated, Bayer fired him, claiming his closed account prevented him doing his job. Townsend sued, citing anti-retaliation provisions of the False Claims Act, 31 U.S.C. 3730(h).). A jury awarded Townsend back pay, doubled to $642,746, and $568,000 in emotional distress damages. The court denied front pay and ordered Bayer to reinstate Townsend. The Eighth Circuit affirmed on all issues except the emotional distress damage award and remanded to allow Townsend the option of accepting a remittitur of $300,000, or a new trial on emotional distress damages. View "Townsend v. Bayer HealthCare Pharm. Inc." on Justia Law

The patents at issue relate DNA testing, specifically to multiplex amplification of short tandem repeat (STR) loci and claim methods or kits for simultaneously determining the alleles present in a set of STR loci from DNA samples, comprising: obtaining a DNA sample; selecting a set of loci of the DNA sample to amplify, including at least the specific loci recited in the claim; co-amplifying the selected loci in a multiplex amplification reaction; and evaluating the amplified alleles to determine the number of STR present at each loci. The district court entered judgment that the asserted claims were not invalid for lack of enablement and obviousness and that certain accused products did not infringe either the Promega patents the Tautz patent, vacating a verdict of damages and willful infringement. The Federal Circuit held that LifeTech was not licensed for all uses of the asserted patents under an agreement with Promega and, therefore, reversed with respect to infringement (under 35 U.S.C. 271(a) and 35 U.S.C. 271(f)(1)), and remanded for determination of damages. The Federal Circuit held that the asserted claims of the Promega patents are invalid for lack of enablement. View "Promega Corp. v. Life Tech. Corp." on Justia Law