Justia Drugs & Biotech Opinion Summaries

Anjinomoto’s 655 patent claims E. coli bacteria that have been genetically engineered to increase their production of aromatic L-amino acids, such as L-tryptophan, during fermentation, as well as methods of producing aromatic L-amino acids using such bacteria. Ajinomoto filed a complaint against CJ with the International Trade Commission, alleging that CJ was importing certain products that infringed the patent. CJ used several strains of E. coli to produce L-tryptophan products, which it then imported into the United States. The Commission determined that CJ’s earlier strains did not infringe but that CJ’s two later strains did, and that the relevant claim of the 655 patent is not invalid for lack of an adequate written description. The Federal Circuit affirmed, upholding the Commission’s construction of “replacing the native promoter . . . with a more potent promoter.” The court rejected CJ’s claim of prosecution history estoppel and held that the 655 patent expressly provides four examples of “more potent promoters,” so that the Commission supportably found that a skilled artisan could make relatively predictable changes to the native promoter to arrive at a more potent promoter. View "Ajinomoto Co., Inc. v. International Trade Commission" on Justia Law

A teratogen is an agent known to disturb the development of an embryo or fetus. Teratogenic drugs, such as thalidomide, can cause birth defects or other abnormalities following fetal exposure during pregnancy. Celgene’s 501 and 720 patents are generally directed to methods for safely distributing teratogenic or other potentially hazardous drugs while avoiding exposure to a fetus to avoid adverse side effects of the drug. The patents describe the System for Thalidomide Education and Prescription Safety that compiles information about patients and prescribers to prevent the prescription from being filled before appropriate counseling. The Coalition for Affordable Drugs (CFAD) sought inter partes review. The Patent Trial and Appeal Board determined that all of the claims of the 501 patent and multiple claims of the 720 patent were obvious. The Federal Circuit affirmed and held that the retroactive application of IPR proceedings to pre-Leahy-Smith America Invents Act, 125 Stat. 284-341, patents is not an unconstitutional taking under the Fifth Amendment. IPRs do not differ sufficiently from the PTO reconsideration avenues available when the patents here were issued to constitute a taking. View "Celgene Corp. v. Peter" on Justia Law

Recombinant therapeutic proteins are a class of biologic medicines that are manufactured inside living cells. Before a protein can be therapeutically useful, it must first be purified from contaminants. Amgen’s patent claims methods of purifying proteins using hydrophobic interaction chromatography. Amgen sued Coherus for infringing the patent under the doctrine of equivalents because the salt combination used in Coherus’s process did not match any of the three expressly claimed salt combinations in the Amgen patent. The Federal Circuit affirmed the dismissal of the suit, reasoning that prosecution history estoppel bars Amgen from succeeding on its infringement claim under the doctrine of equivalents. During prosecution of the patent, Amgen clearly and unmistakably surrendered salt combinations other than the particular combinations recited in the claims. View "Amgen Inc. v. Coherus Biosciences Inc." on Justia Law

Indivior markets and holds the New Drug Application (NDA) for Suboxone® sublingual film, an opioid addiction treatment that combines two active ingredients: the opioid buprenorphine and the opioid antagonist naloxone. Suboxone Film is applied below a patient’s tongue, where it then rapidly dissolves to release the active ingredients. In 2010, the FDA approved Indivior’s film product, the first such product to gain FDA approval. Previously, Indivior sold buprenorphine/naloxone only in a tablet form. These appeals involve issues of infringement and invalidity of four patents covering pharmaceutical films and methods of making them, particularly two patents that claim pharmaceutical films and are listed in the Orange Book2 as covering Suboxone Film. The district court concluded that the asserted claims of three patents are not invalid as obvious; that one patent is not invalid as indefinite and that Watson infringes that patent; and that DRL and Alvogen do not infringe either of two patents. The court found certain claims in a fourth patent invalid. The Federal Circuit vacated, as moot, the holding that those claims were invalid as obvious but otherwise affirmed. In a parallel inter partes review proceeding, the Patent Trial and Appeal Board had held the claims unpatentable as anticipated and obvious, and the Federal Circuit affirmed. View "Indivior Inc. v. Dr. Reddy's Laboratories, S.A." on Justia Law

UCB’s 434 patent, entitled “Transdermal therapeutic system which contains a d2 agonist and which is provided for treating Parkinsonism, and a method for the production thereof,” claims a polymorph of rotigotine. UCB’s 414 patent is entitled “Polymorphic form of rotigotine and process for production.” UCB has been selling the FDA-approved product, Neupro, since 2007. The district court concluded that Actavis’s generic products infringed the patent under the doctrine of equivalents and upheld the 434 patent's validity over obviousness and anticipation challenges. The court invalidated the 414 patent under 35 U.S.C. 102(a) as known and used by others in the U.S. before the date of invention. The Federal Circuit affirmed. There is not enough evidence to conclude that UCB surrendered polyisobutylene as a possible equivalent; UCB’s claiming of acrylates and silicates does not bar treating polyisobutylenes as an equivalent for infringement purposes and vitiation does not bar application of the doctrine of equivalents here. Actavis offers no examples of prior art that would be ensnared by the addition of polyisobutylene to the claim, in contrast to the claim as is. The court upheld fact findings as to polyisobutylene’s characteristics as compared to silicates and acrylates and as to what a skilled artisan would have known about the interchangeability of polyisobutylene-based adhesives and silicone-based adhesives and the conclusion that the accused products infringe the claims under the doctrine of equivalents. View "UCB, Inc. v. Watson Laboratories Inc." on Justia Law

Mayne’s 745 patent discloses and claims pharmaceutical compositions of azole antifungal drugs that are practically insoluble in aqueous media. The patent explains that insoluble drugs are difficult to formulate into dosage forms because of their low absorption and poor bioavailability and purports to provide a pharmaceutical composition addressing these shortcomings. On MSD’s petition, the Patent Trial and Appeal Board initiated inter partes review and found several claims unpatentable as anticipated or obvious, 35 U.S.C. 103 The Federal Circuit affirmed, upholding the Board’s decision to permit MSD’s amendment, finding no indication of intentional concealment, no bad faith on MSD’s part, no attempt to circumvent the estoppel rules, or any other material benefit to it in its delay in naming MCI as a real party in interest. The Board did not err in its constructions of either “pharmaceutical composition” or the “wherein” clauses; under the Board’s constructions, the claims are obvious or anticipated View "Mayne Pharma International Pty. Ltd. v. Merck Sharp & Dohme Corp." on Justia Law

About 1,300 public entities sued manufacturers, distributors, and retailers of prescription opiate drugs to recover the costs of health problems caused by the opioid crisis. Plaintiffs subpoenaed the U.S. Drug Enforcement Agency’s ARCOS database, a “comprehensive drug reporting system which monitors the flow of DEA controlled substances from their point of manufacture through commercial distribution channels to point of sale or distribution at the dispensing/retail level.” The district court noted that the ARCOS data “are not pure investigatory records compiled for law enforcement purposes, [but] simply business records of defendants; . . . the database does not include any additional DEA analysis or work-product” and concluded that Plaintiffs’ request was reasonable. The court permitted pleadings and other documents to be filed under seal or with redactions, refused a request to disclose the ARCOS data to the media, and entered a protective order.The Sixth Circuit vacated. The district court never made a finding that Defendants or the DEA made “a particular and specific demonstration of fact” justifying the Protective Order. The court expressed concern that the district court may have wanted the threat of public disclosure to motivate settlement discussions. On remand, the court may consider why pieces of ARCOS data related to specific ongoing investigations should not be disclosed but cannot enter a blanket, wholesale ban on disclosure pursuant to state public records requests. No modified protective order may specify that the ARCOS data be destroyed or returned to the DEA at the conclusion of litigation. The court must reconsider each pleading filed under seal or with redactions and make specific determinations as to the necessity of nondisclosure. View "In re National Prescription Opiate Litigation" on Justia Law

T.L. consulted Dr. Jack Goldberg for a blood condition. In October 2010, Dr. Goldberg told T.L. about a new medication, Pegasys. After taking Pegasys, T.L. experienced a number of symptoms, but Dr. Goldberg advised that T.L. should continue taking Pegasys. T.L. began experiencing severe pain in her neck and both arms, requiring hospitalization and rehabilitation. T.L. was diagnosed with inflammation of the spinal cord and experienced partial paralysis on her right side. T.L. brought suit against Dr. Goldberg and his employer, Penn Medicine Cherry Hill. T.L. claimed that Dr. Goldberg deviated from accepted standards of care by prescribing Pegasys to her because she was diagnosed with, and took medication for, chronic depression. During Dr. Goldberg’s deposition, when asked whether he was aware of any studies in the Journal of Clinical Oncology pertaining to the use of Pegasys to treat patients with T.L.’s condition, Dr. Goldberg answered “no.” On T.L.’s motion, the court barred Dr. Goldberg from using any medical literature at trial that was not produced during the course of discovery. At trial, Dr. Goldberg testified that he prescribed Pegasys to T.L. because he relied upon a clinical trial, published in the Journal of Clinical Oncology in 2009, that included patients with a history of depression. T.L.’s counsel did not object. The jury found that Dr. Goldberg did not deviate from the applicable standard of care. T.L. was granted a new trial on grounds that Dr. Goldberg’s discussion of the 2009 publication constituted reversible error. Dr. Goldberg appealed as of right based on a dissenting justice in the Appellate Division's reversal of the trial court. The New Jersey Supreme Court reversed, finding there was no demonstration that the changed testimony caused prejudice to T.L., and the plain error standard did not compel reversal, "especially because counsel’s failure to object was likely strategic." Under the circumstances, T.L. was not entitled to a new trial. View "T.L. v. Goldberg" on Justia Law

Plaintiff filed suit on behalf of his mother's estate against WellDyne and Exactus, asserting claims for negligence, negligence per se and breach of the implied warranty of fitness for a particular purpose against both defendants. Plaintiff also alleged Exactus was vicariously liable for the actions of WellDyne under agency and joint venture theories. In this case, plaintiff's mother died shortly after a hospital stay stemming from her ingestion of prescription medications that were erroneously mailed to her by WellDyne. The district court granted summary judgment in favor of WellDyne and Exactus as to all counts, finding that plaintiff's mother was contributorily negligent as a matter of law which completely barred her recovery in North Carolina.The court reversed the district court's judgment insofar as it granted summary judgment on the basis of contributory negligence and causation, remanding for the district judge to conduct a Daubert analysis of the expert opinions proffered by plaintiff to determine whether taking some of the misdirected medications was the cause of the mother's injuries and death. The court affirmed summary judgment to Exactus; affirmed summary judgment to WellDyne as to the claim for implied warranty of a particular purpose; and remanded. View "Small v. Welldyne, Inc." on Justia Law

Merck’s drug Fosamax treats and prevents osteoporosis in postmenopausal women. When the FDA approved Fosamax in 1995 (21 U.S.C. 355(d)), its label did not warn of the then-speculative risk of atypical femoral fractures associated with the drug. Stronger evidence connecting Fosamax to such fractures developed later. The FDA ordered Merck to add a warning to the Fosamax label in 2011. Individuals who took Fosamax and suffered atypical femoral fractures sued, claiming that state law imposed upon Merck a legal duty to warn. Merck asserted that the FDA would have rejected any attempt to change the label. The district court agreed with Merck’s pre-emption argument and granted Merck summary judgment. The Third Circuit vacated.The Supreme Court remanded. The Third Circuit incorrectly treated the pre-emption question as one of fact. A state-law failure-to-warn claim is pre-empted where there is “clear evidence” that the FDA would not have approved a change to the label. “Clear evidence” shows the court that the manufacturer fully informed the FDA of the justifications for the warning and that the FDA would not approve a label change to include that warning. FDA regulations permit drug manufacturers to change a label to “reflect newly acquired information” if the changes “add or strengthen a . . . warning” for which there is “evidence of a causal association.” The pre-emption question can only be determined by agency actions taken pursuant to the FDA’s congressionally delegated authority. The question of agency disapproval is primarily one of law for a judge to decide. Judges, rather than juries, are better equipped to evaluate an agency’s determination and to understand and interpret agency decisions in the statutory and regulatory context. While contested facts will sometimes prove relevant, they are subsumed within a tightly-circumscribed legal analysis and do not warrant submission to a jury. View "Merck Sharp & Dohme Corp. v. Albrecht" on Justia Law