Justia Patents Opinion Summaries

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

VSi’s patents are directed to features of an online analytical processing (OLAP) cube capable of collecting and processing “live” data from multiple incompatible databases. According to the patents, before the invention, data from different databases had to be converted into a compatible format and stored in a data warehouse before it could be analyzed. Prior art systems were thus analyzing “stale” data. The inventions sought to overcome that problem by creating an OLAP cube capable of collecting and processing information from incompatible databases at run-time without going through an intermediate warehouse repository of “stale” data. VSi sued MicroStrategy and TIBCO in separate infringement suits. The district court did not consolidate the suits, but considered the claim construction issues relating to the expression “disparate databases.” The district court construed that term in favor of defendants, granted summary judgment that all claims asserted against MicroStrategy were invalid for lack of enablement, and granted summary judgment that all claims asserted against TIBCO were invalid for lack of enablement and written description. The Federal Circuit affirmed the claim construction, but remanded, finding that there are genuine issues of material fact regarding whether the asserted claims are enabled and have sufficient written description support. View "Vasudevan Software, Inc. v. Tibco Software, Inc." on Justia Law

IV alleged infringement of five patents. A year later, JPMC moved to stay the case pending the result of four covered business method reviews (CBMR) JPMC planned to file with respect to the patents. JPMC filed CBMR petitions for two patents, but never filed the other two promised petitions. Before the Patent Trial and Appeal Board acted on the petitions, the district court denied JPMC’s motion to stay, applying the four-factor test from the America Invents Act, 125 Stat. 284, 329–31. The court stated that, because there are multiple patents and claims in suit, it would be inappropriate to stay the entire litigation while waiting to see if the PTAB would initiate review of only two; that the litigation would likely be resolved more quickly than any extended CBM review; that it was largely speculative to argue that the PTAB’s resolutions of the CBMR petitions would reduce the court’s workload; and that any reduction was offset by IV’s right to a speedy trial. The Federal Circuit dismissed for lack of jurisdiction to consider an interlocutory appeal from a decision on a motion to stay until the PTAB institutes a CBMR proceeding. View "Intellectual Ventures II LLC v. JPMorgan Chase & Co." 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

Exela petitioned the Patent and Trademark Office to “reconsider and withdraw” its revival of the national stage application and to cancel the 218 patent, assigned to SCR Pharmatop. The PTO declined to consider Exela’s petition, stating that no law or regulation authorizes non-party challenge to a PTO ruling to accept a tardy filing. Exela then brought suit under the Administrative Procedure Act, arguing that the PTO’s action was ultra vires and that Exela’s petition should have been considered and favorably decided. The district court, on reconsideration and in view of new Fourth Circuit precedent, dismissed Exela’s complaint for failing to meet the statute of limitations for claims filed against the United States, including APA claims. The Federal Circuit affirmed the dismissal, on the ground that PTO revival rulings are not subject to third party collateral challenge, thereby precluding review regardless of whether Exela’s claims were time-barred. View "Exela Pharma Sciences, LLC v. Lee" on Justia Law

Kennametal’s 519 patent was filed in 2004 and issued in 2007. It relates to cutting tools containing ruthenium as a binder that are coated using physical vapor deposition. After being sued for infringement, Ingersoll successfully petitioned the Patent and Trademark Office for inter partes reexamination of the 519 patent. The district court stayed the litigation. The Patent Trial and Appeal Board entered a new anticipation ground of rejection against certain of claims and affirmed the Examiner’s obviousness rejection of certain remaining claims. The Federal Circuit affirmed. Substantial evidence supported the determinations of anticipation and obviousness. View "Kennametal, Inc. v. Ingersoll Cutting Tool Co." 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