Justia Drugs & Biotech Opinion Summaries

The patent, issued in 1995, entitled “Valve Prosthesis for Implantation in the Body and a Catheter for Implanting Such Valve Prosthesis,” describes a prosthetic heart valve, mounted on a stent and implanted by catheter to avoid open heart surgery. The district court found the patent valid and infringed by and that the infringement was willful. The jury awarded damages of $72,645,555 in lost profits and $1,284,861 as a reasonable royalty. The district court entered judgment on the verdict, but declined to enhance damages for the willful infringement. The court also declined to issue an injunction against future infringement, apparently on defendant’s representation that, if enjoined, it would move its manufacturing operations to Mexico. The court also denied a request to modify the litigation-agreed protective order and to permit patent counsel and technical expert to participate in ongoing reexamination proceedings of the patent in suit and related patents. The Federal Circuit affirmed, but remanded reconsideration of the denial of an injunction in view of the representation of changed circumstances, and for reconsideration of the ruling on the protective order as applied to patents not in suit, to the extent that this issue has not become moot. View "Edwards Lifesciences AG v. Corevalve, Inc." on Justia Law

A chiropractor pleaded guilty to defrauding health insurers and to money laundering and was sentenced to 70 months (the bottom of the guidelines range) and to pay restitution of almost $2 million. At the guilty-plea hearing the judge asked the defendant whether he was “currently under the influence of any drugs, medicine, or alcohol,” and the defendant answered: “prescription medications.” He told the judge that he was taking medicines for “high anxiety, depression, adult attention hyperactivity disorder, and depression,” but stated that he was “thinking clearly.” He waived his right to appeal, but six weeks later moved to retract the plea, claiming that he had been taking psychotropic drugs, rendering his plea involuntary. The judge denied the motion because the defendant had presented no evidence that switching from Prozac to Lexapro could have the dramatic effects he claimed it had, and because at the plea hearing he had been alert and responsive and exhibited no signs of confusion. The Seventh Circuit affirmed.View "Unted States v. Hardimon" on Justia Law

Hibbard, then 41 years old and working as a teacher, received a flu vaccination in 2003. She claims that the flu vaccine caused her to develop a neurological disorder known as dysautonomia, a dysfunction of the autonomic nervous system and sought compensation under the National Childhood Vaccine Injury Act of 1986, 42 U.S.C.300aa-1 to 300aa-34. Following a two-day hearing, a special master found that Hibbard had failed to show that her dysautonomia resulted from autonomic neuropathy caused by the vaccine she received in 2003. The Court of Federal Claims upheld the decision. The Federal Circuit affirmed, finding substantial evidence to support the denial. View "Hibbard v. Sec'y Health & Human Servs." on Justia Law

In 2010-2011 several hundred plaintiffs filed 10 lawsuits in Illinois state courts against Abbott, for personal injuries they allege were caused by Depakote, a prescription. Plaintiffs moved the Supreme Court of Illinois to consolidate and transfer their cases to St. Clair County, pursuant to Illinois Supreme Court Rule 384; the Supreme Court has not ruled. Abbott removed each of the cases to federal court, asserting that the motion to consolidate brought the cases under the “mass action” provision of the Class Action Fairness Act, 28 U.S.C. 1332(d)(11)(B)(i), which allows the removal of any case where 100 or more people propose to try their claims jointly. Cases filed in St. Clair and Madison counties were removed to the Southern District of Illinois and cases filed in Cook County were removed to the Northern District; plaintiffs moved to remand in both courts. The Northern District denied plaintiffs’ motion to remand. The Seventh Circuit held that removal was proper, rejecting plaintiffs’ argument that they did not propose a joint trial because their motion to consolidate did not address how the trials of the various claims in the cases would be conducted, other than proposing that they all take place in St. Clair County.View "Abbott Labs., Inc. v. Alexander" on Justia Law

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