Justia Drugs & Biotech Opinion Summaries

A jury found that Demant and Widex infringed the 749 and 850 patents. The court entered judgment finding noninfringement of the 749 patent, finding that prosecution history estoppel barred the finding of infringement under the doctrine of equivalents. The patents relate to technology for reducing acoustic feedback in a programmable digital hearing aid. All hearing aids have: a microphone that picks up sound and converts it to an electrical signal, a speaker (receiver) that converts the signal back into sound waves, and sound processing circuitry that adjusts received sound to compensate for any hearing impairment. Some of the amplified sound from the speaker may also travel back to the microphone via an “acoustic feedback path” and is amplified along with all other sound arriving at the input microphone. The resulting cycle of amplification causes the whistling sound known as “feedback.” The common specification. with a 1986 priority date, describes a method of reducing feedback by creating an electrical feedback path and inserting a programmable filter in that path to mimic the effects of acoustic feedback on the phase and amplitude of a sound signal in the transmission channel. This electrical feedback signal then cancels the acoustic feedback signal. The Federal Circuit affirmed. View "Energy Transp. Group, Inc. v. Wm. Demant Holding A/S WDH, Inc." on Justia Law

Abbott owns the 752 patent and the 509 patent, which share a common specification that describes methods and devices “for the in vivo monitoring of an analyte using an electrochemical sensor to provide information to a patient about the level of the analyte” in the bloodstream. The specification describes methods and devices for monitoring glucose levels for diabetics. And notes that a variety of devices exist for monitoring glucose levels in the blood stream, but some of these devices include sensor guides that are “typically bulky and do not allow for freedom of movement.” In response to a third-party request for reexamination, the Board of Patent Appeals and Interferences rejected several claims in the patents as indefinite, anticipated, or obvious over several combinations of prior art references. The Federal Circuit vacated in part, noting that the U.S. PTO conceded that the examiner’s official notice rejections should be withdrawn. The rejections were based on unreasonable claim constructions; under the broadest reasonable construction, “electrochemical sensor” is properly interpreted to mean a discrete electrochemical sensor devoid of external connection cables or wires to connect to a sensor control unit. View "In re Abbott Diabetes Care, Inc." on Justia Law

Pozen developed a method for treating migraines by combining two drugs, sumatriptan and naproxen, in a single tablet, which it markets with GlaxoSmithKline as Treximet. Sumatriptan, a 5-HT receptor agonist, was developed in the late 1980s and is widely accepted as an effective medicine for migraines, but it does not prevent the reoccurrence of migraine symptoms. Naproxen is anonsteriodal anti-inflammatory drug. Pozen filed a New Drug Application (NDA) for Treximet and obtained approval from the FDA in 2008; the relevant patents are included in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book), 21 U.S.C. 355(b)(1). Generic pharmaceutical manufacturers filed ANDAs (abbreviated new drug applications) to market generic forms of Treximet before the expiration of Pozen’s patents, certifying that the patents listed in the Orange Book are “invalid or will not be infringed” by the generic products. Thereafter, Pozen filed complaints for infringement, 35 U.S.C. 271(e)(2)(A). The district court held that Pozen’s patents are not invalid as obvious under 35 U.S.C. 103 and were infringed by the ANDA filings and enjoined the generic manufacturers from making, using, importing, selling or offering to sell their generic products in the United States. The Federal Circuit affirmed. View "Pozen, Inc. v. Par Pharma., Inc." on Justia Law

Plaintiffs appealed the district court's grant of summary judgment in favor of Merck in their diversity action alleging wrongful death. Plaintiffs' son died after being administered a Measles, Mumps, and Rubella vaccine manufactured by Merck. On appeal, plaintiffs contended that the district court erred in applying the standards of the National Childhood Vaccine Injury Act, 42 U.S.C. 300aa-22, to their individual claims for damages. Having concluded that Section 22 of the Act generally applied to limit tort liability in a parent's claim for individual injuries, the court determined that plaintiffs' suit was a "civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine" and thus limited by the Act. Accordingly, the court affirmed the judgment. View "Holmes, et al. v. Merck & Co., Inc." on Justia Law

The 772 application is directed to methods and compositions for recombining DNA in a eukaryotic cell (a cell with a nucleus), such as a human cell. The Board of Patent Appeals and Interferences affirmed rejection of independent claim 29 of the 772 application, as obvious over the combination of a patent and an article. Claim 29 covers a method of recombining DNA in a eukaryotic cell using modified versions of wild-type Int. The Federal Circuit affirmed. The disclosures provide substantial evidence that a person of ordinary skill in the art would have had a reasonable expectation of success for using the modified integrases disclosed in the article in place of wild-type Int in the method taught in the patent. View "In re Droge" on Justia Law

In 2008, Michigan passed the MMMA, Comp. Laws 333.26421, to protect medical marijuana. Any “qualifying patient” who possesses a registry identification card is not “subject to arrest, prosecution, or penalty of any manner, or denied any right or privilege, including but not limited to civil penalty or disciplinary action by a business.” Plaintiff was employed by Wal-Mart for five years before he was terminated after testing positive for marijuana, in violation of the company’s drug use policy. The test was administered on the day after Plaintiff injured his knee at work. Plaintiff was diagnosed with sinus cancer and an inoperable brain tumor at age 17; he experiences constant pain and side effects of medications. In 2008, Plaintiff’s oncologist recommended marijuana; Plaintiff obtained a registry card and maintains that he followed state laws, never used marijuana at work, nor did he work under the influence. Plaintiff sued in state court for wrongful discharge and MMMA violation; defendants removed to federal court based on diversity. The district court denied remand and dismissed. The court held that the store manager, a Michigan resident, was fraudulently joined and that the MMMA does not regulate private employment. The Sixth Circuit affirmed, noting that the manager had no potential liability. View "Casias v. Wal-Mart Stores, Inc." on Justia Law

Medtronic sought a declaratory judgment of non-infringement and invalidity of reissue patents covering a cardiac resynchronization therapy device (previously called a biventricular pacer). The district court entered judgment of noniinfringement in favor of Medtronic and judgment of validity and enforceability in favor of the patent holder. The Federal Circuit vacated and remanded, holding that the district court relied on a legally incorrect allocation of the burden of proof to find non-infringement in the limited circumstances of the case and incorrectly construed the claim terms in question. View "Medtronic, Inc. v. Boston Scientific Corp." on Justia Law

Genentech manufactured and sold the psoriasis medication Raptiva, approved by the FDA in 2003. Raptiva works by suppressing T-cells ; because T-cells help fight infections, suppression has the potential to cause potentially life-threatening side effects. Following reports of adverse health effects, including a rare brain infection, Genentech voluntarily removed Raptiva from the market in 2009. Marsh began using Raptiva in 2004 and subsequently suffered viral meningitis and a collapsed lung. She sued in 2011, alleging strict products liability under design-defect and failure-to-warn theories, negligence, breach of warranty, and fraud. She claimed that, before and after FDA approval, Genentech knew of dangerous side effects that it concealed and did not include in the drug’s label. The district court dismissed, holding that Genentech was immune from suit because neither statutory exception to immunity for drug manufacturers applied. Marsh argued that immunity does not apply because failure to submit updated information rendered Raptiva noncompliant with FDA approval when it left Genentech’s control and that her claim was not preempted because it was premised on non-compliance rather than fraud or bribery. The Sixth Circuit affirmed. Allegations underlying Marsh’s argument that immunity does not apply are essentially the type of claim that is preempted.View "Marsh v. Genetech Inc." on Justia Law

Santarus is the exclusive licensee of patents on formulations of benzimidazole proton pump inhibitors, a class of chemical compounds that inhibit gastric acid secretion and help prevent and treat stomach acid-related diseases and disorders. Santarus provides the PPI product omeprazole in formulations covered by the Phillips patents, brand name Zegerid. Par filed an Abbreviated New Drug Application (ANDA) for FDA approval to sell a generic counterpart of the Santarus Zegerid products, invoking the Hatch-Waxman Act (the Drug Price Competition and Patent Term Restoration Act of 1984), which established Paragraph IV certification, 21 U.S.C. 355(j)(2)(A)(vii)(IV), whereby an entity that seeks to market a generic counterpart of a patented drug product or method of use, before the patent has expired, may challenge the patent before actually marketing the drug. The district court found that Par’s ANDA products infringe the patents, but found all asserted claims invalid on the ground of obviousness, 35 U.S.C 103 and found certain claims invalid on the ground of inadequate written description, 35 U.S.C. 112. The district court held that there was not inequitable conduct by the inventor, his assignee, or their counsel in procuring the patents. The Federal Circuit reversed with respect to obviousness, but otherwise affirmed. View "Santarus, Inc. v. Par Pharma., Inc." on Justia Law

Appellants, researchers in the field of adult stem cells who oppose the use of federal funding for the development of embryonic stem cell (ESC) research, filed a complaint seeking declaratory and injunctive relief against the Secretary's implementation of regulations allowing federal funding of such research. The court, applying Chevron analysis, held that the NIH had reasonably interpreted the Dickey-Wicker Amendment's ban on funding "research in which . . . embryos are destroyed" to allow federal funding of ESC research. Further, the preliminary-injunction exception was not applicable to the law-of-the-case preclusion. The court also held that the NIH's interpretation of the Dickey-Wicker Amendment's actual language was reasonable and the NIH's decision to dismiss the comments categorically objecting to ESC was not arbitrary or capricious. Accordingly, the court affirmed summary judgment in favor of the government. View "Sherley, et al. v. Sebelius, et al." on Justia Law