Justia Drugs & Biotech Opinion Summaries
Allgenesis Biotherapeutics Inc. v. Cloudbreak Therapeutics, LLC
Cloudbreak’s patent discloses compositions and methods for treating pterygium, an eye condition in which a tumor-like growth extends from the nasal or temporal side of the eye to the cornea, by administering multikinase inhibitors to the eye to inhibit specific growth factors that contribute to tumor growth and hyperemia (i.e., eye redness). The patent discloses that nintedanib in particular “may be one of the most powerful multikinase inhibitors for reducing corneal neovascularization.”In inter partes review, the Patent Trial and Appeal Board held that the petitioner, Allgenesis, failed to prove two claims of the patent are unpatentable. The Federal Circuit dismissed an appeal. Allgenesis failed to establish an injury in fact sufficient to confer standing to appeal. Allgenesis identified no concrete plans to develop and bring to market a nintedanib treatment for pterygium and has not shown its activities will create a substantial risk of infringement or will likely cause Cloudbreak to assert a claim of infringement. The court rejected an argument that Allgenesis suffered an injury in fact based on the Board’s priority determination that will have a preclusive effect on the scope of its pending patent application. Allgenesis has not established that the Board’s decision will have preclusive effect. View "Allgenesis Biotherapeutics Inc. v. Cloudbreak Therapeutics, LLC" on Justia Law
Actelion Pharmaceuticals LTD v. Mylan Pharmaceuticals Inc.,
Epoprostenol, a naturally occurring substance, useful for treating cardiovascular diseases, was discovered in the early 1980s and was first brought to market under the brand name Flolan® in 1995. Epoprostenol is unstable in water, it was prepared as a freeze-dried, or lyophilized, powder for use in the Flolan composition. Actelion owns two patents directed to improved epoprostenol formulations that can be reconstituted with commercially available IV fluids and do not require refrigeration after reconstitution until use.” The inventor “unexpectedly found that epoprostenol solution in the presence of an alkalinizing agent, and high pH (>11) is very stable compared to Flolan.” Mylan sought approval to manufacture and sell a generic epoprostenol sodium for injection by filing an Abbreviated New Drug Application (ANDA) with the FDA, containing a certification that the Actelion patents’ claims were invalid or would not be infringed by the ANDA product.The Federal Circuit vacated the district court’s claim construction order with respect to the term “a pH of 13 or higher” and its judgment of infringement. The issue involves understanding what the significant digits are for “a pH of 13.” The district court must address extrinsic evidence explaining how a person of ordinary skill in the art would view the significant digits for a pH value. View "Actelion Pharmaceuticals LTD v. Mylan Pharmaceuticals Inc.," on Justia Law
Elekta Ltd. v. ZAP Surgical Systems, Inc.
Elekta’s 648 patent, titled “Method and apparatus for treatment by ionizing radiation,” discloses a device for treating a patient with ionizing radiation for certain types of radiosurgery and radiation therapy. The invention uses a radiation source, e.g., a linear accelerator (linac), mounted on a pair of concentric rings to deliver a beam of ionizing radiation to the targeted area of the patient. ZAP Surgical Systems sought inter partes review (IPR). The Patent Trial and Appeal Board addressed Elekta’s arguments that a skilled artisan would not have been motivated to combine, and would not have had a reasonable expectation of success in combining, one prior art device (Grady) with the linac described in the prior art, Ruchala, and whether a skilled artisan would have been dissuaded from combining the devices because one device was an imaging device, rather than a radiation device, and because the linac’s weight would render the Grady device inoperable, imprecise, and unsuitable for treatment.The Board concluded that a skilled artisan would have been motivated to combine Grady and Ruchala. The Federal Circuit affirmed, finding substantial support for the finding that a person of ordinary skill in the art would have been motivated to make the proposed combination. View "Elekta Ltd. v. ZAP Surgical Systems, Inc." on Justia Law
Baxalta Inc. v. Genentech, Inc.
In a “key step” of the "coagulation cascade" that forms blood clots, an enzyme (Factor VIIIa) complexes with another enzyme (Factor IXa) to activate Factor X. Hemophilia A is a disorder where the activity of Factor VIII is functionally absent, impeding the body’s ability to effectively form blood clots. Historically, Hemophilia A has been treated by intravenously administering Factor VIII. Approximately 20–30% of Hemophilia A patients cannot benefit from that treatment because they develop Factor VIII inhibitors. Baxalta’s patent provides alternative means to treat Hemophilia A.Baxalta sued, alleging Genentech’s Hemlibra® (emicizumab) product infringes the patent. Emicizumab is a humanized bispecific antibody that binds to Factor IXa with one arm and Factor X with the other arm, mimicking the function of Factor VIIIa. Following the district court’s construction of the claim terms “antibody” and “antibody fragment” to exclude bispecific antibodies, the Federal Circuit held the proper construction of “antibody” was “an immunoglobulin molecule having a specific amino acid sequence comprising two heavy chains (H chains) and two light chains (L chains),” and the proper construction of “antibody fragment” was “a portion of an antibody” and remanded. On remand, Genentech successfully moved for summary judgment of invalidity of multiple claims for lack of enablement. The Federal Circuit affirmed. The patent fails to teach skilled artisans how to make and use the full scope of claimed antibodies without unreasonable experimentation. View "Baxalta Inc. v. Genentech, Inc." on Justia Law
DiCroce v. McNeil Nutritionals, LLC
The First Circuit affirmed the judgment of the district court dismissing Plaintiff's putative class action against McNeil Nutritionals, LLC and Johnson & Johnson Consumer, Inc. challenging certain statements on the packaging of Lactaid products, holding that the district court correctly dismissed the complaint.Plaintiff brought this action claiming that Lactaid's labels violated federal labeling requirements, leading Plaintiff to have been mislead into purchasing Lactaid products, which she claimed were more expensive than other lactase supplements. The district court granted Defendants' second motion to dismiss. The First Circuit affirmed, holding that Plaintiff's claims were impliedly preempted by the statutory enforcement authority of the Food and Drug Administration. View "DiCroce v. McNeil Nutritionals, LLC" on Justia Law
United States v. Titus
Titus’s solo medical practice, in its last 13 months, earned $1.1 million by distributing more than 20,000 prescriptions for Schedule II drugs. Titus often did only cursory physical examinations before prescribing opioids. He kept prescribing drugs despite signs that his patients were diverting or abusing them. At least two of Titus’s patients overdosed. Other doctors filed professional complaints. Titus closed his practice. Federal agents raided the homes of Titus and two of his employees and found thousands of patient files. Titus was indicted on 14 counts of unlawfully dispensing and distributing controlled substances (based on 14 prescriptions) and maintaining drug-involved premises, 21 U.S.C. 841(a)(1), (b)(1)(C), 856(a)(1).The government's statistician, using the Prescription Monitoring Program, identified 1,142 patients for whom Titus had prescribed controlled drugs, drew a random sample of 300 patients, and extrapolated to conclude that Titus had provided 29,323 controlled substance prescriptions to 948 patients with at least one inconsistent drug test and 1,552 such prescriptions to 352 patients he had already discharged from his practice. The government’s medical expert reviewed 24 of those files and determined that Titus had written illegal prescriptions for 18 of the patients.The district court held Titus responsible for at least 30,000 kilos, citing “general trial evidence” and extrapolating from the 24-file sample. The Third Circuit affirmed Titus’s convictions but vacated his 240-month sentence. The government failed to prove that extrapolating from a small sample satisfied its burden to prove the drug quantity by a preponderance of the evidence. View "United States v. Titus" on Justia Law
Hospital Authority of Wayne County v. AmeriSourceBergen Drug Corp, et al.
The United States District Court for the Northern District of Ohio certified two questions to the Georgia Supreme Court regarding whether a state entity could continue asserting claims against opioid manufacturers and distributors after the State of Georgia entered into a settlement with the pharmaceutical companies, and as part of the settlement, the General Assembly enacted OCGA § 10-13B-1, et seq. (the “Settlement Act”) in 2022, which included a litigation preemption provision that “bar[s] any and all past, present or future claims on behalf of any governmental entity seeking to recover against any business or person that is a released entity under the terms of the relevant settlement.” OCGA § 10-13B-3 (a) (the “preemption provision”). In April 2019, before Georgia entered into the state-wide settlement with the pharmaceutical companies, the Hospital Authority of Wayne County, Georgia (“HAWC”) filed suit against a number of such entities, seeking to recover unreimbursed amounts it claims to have expended in treating opioid-dependent patients. HAWC subsequently chose not to participate in the state-wide settlement and did not individually release any of its claims. At some point, HAWC’s litigation was consolidated, along with over 3,000 other cases, into a federal multidistrict litigation in the District Court. See In re Natl. Prescription Opiate Litigation, (MDL No. 2804). Seven defendants named in HAWC’s complaint filed a motion to dismiss HAWC’s claims against them (the “Motion”), contending that the suit was barred by the preemption provision. The Georgia Supreme Court concluded that the Georgia General Assembly's passage of the preemption provision took away any power HAWC otherwise might have had under OCGA § 31-7-75 to pursue claims that the preemption provision and the Settlement Act were unconstitutional, and the answer to the first question certified by the District Court was no. In light of this answer, the Supreme Court did not need to answer the second certified question. View "Hospital Authority of Wayne County v. AmeriSourceBergen Drug Corp, et al." on Justia Law
Incept LLC v. Palette Life Sciences, Inc.
Incept’s 723 and 913 patents relate to improved methods for treating cancer, particularly prostate cancer, using radiation. The patents describe methods of introducing a filler between a radiation target tissue and other tissue to increase the distance between the two and thereby decrease the amount of radiation received by the non-targeted tissue. Palette sought inter partes review challenging the claims of the patents as unpatentable over prior art, including “Wallace,” describes a method for the “rapid formation of a biocompatible gel . . . at a selected site within a patient’s body.”The Federal Circuit affirmed the Patent Trial and Appeal Board in holding that the claims were anticipated or obvious, 35 U.S.C. 102, 103. Wallace discloses each element of claim 1 of the 723 patent, arranged as in that claim. The Board’s findings of motivation to combine are supported by substantial evidence in the form of the references themselves and Palette’s expert’s detailed testimony, which the Board found “persuasive.” With respect to Incept’s argument that the Board improperly dismissed the market share data that Incept provided, the court deferred to the Board’s findings concerning the credibility of expert witnesses. View "Incept LLC v. Palette Life Sciences, Inc." on Justia Law
Williamson v. Genentech, Inc.
Genentech manufactures and sells Rituxan, a drug used to treat leukemia and lymphoma. Rituxan is sold in single-use vials. Williamson was diagnosed with follicular lymphoma and was treated with Rituxan. Williamson later sued Genentech, on behalf of himself and a putative class of similarly situated individuals. He claims that Genentech violates the unfair competition law by selling Rituxan (and three other medications) in excessively large single-use vials; because the appropriate dosage varies based on a patient’s body size, Genentech’s vial sizes are too large for most patients. He argues Genentech should be required to offer smaller vials to reduce the waste of expensive medicine. In addition to injunctive relief, Williamson seeks to recover the amount the class spent on wasted Rituxan (and three other medications). Williamson took only Rituxan, not the other three medications, and paid a $231.15 deductible– the rest of the payments were made by his health insurer.The court of appeal affirmed the dismissal of the case for lack of standing under California’s unfair competition law (Bus. & Prof. Code 17200). Williamson suffered no economic injury caused by the alleged unfair practices and cannot establish standing by borrowing an economic injury from his insurer. The collateral source rule, under which a tortfeasor must fully compensate a victim and cannot subtract compensation the victim may have received from their insurer or another collateral source, does not apply. View "Williamson v. Genentech, Inc." on Justia Law
Johnson v. C. R. Bard, Inc.
Hoping to minimize her risk of suffering serious complications from future blood clots, Johnson underwent surgery to implant a retrievable intravascular filter–a medical device that is placed in the inferior vena cava to prevent blood clots that develop in the lower body from flowing into the heart and lungs. Johnson’s doctor selected the Meridian filter, which was supposed to be temporary and easily removable. Johnson’s filter migrated and fractured, leaving shards embedded in the wall of her heart and elsewhere. Her surgeon was unable to remove the device safely and fully. As a result, Johnson faces an ongoing risk of infection, pain, and other complications.Johnson sued the manufacturers of the Meridian filter (Bard), claiming that they defectively designed the Meridian filter and failed to warn medical providers about the device’s risks, in violation of Wisconsin law. A jury rejected most of Johnson’s theories but returned a $3.3 million verdict in her favor on her strict liability failure-to-warn count. The Seventh Circuit affirmed, stating that its decision “should not be misinterpreted as our endorsement of some of Johnson’s counsel’s trial tactics.” There was no reversible error in instructing the jury or in permitting certain testimony, in alleged violation of expert witness disclosure requirements. View "Johnson v. C. R. Bard, Inc." on Justia Law