Justia Drugs & Biotech Opinion Summaries

IL-13 is a regulatory molecule called a cytokine. Cytokines interact with cytokine receptors located on target cells. Sanofi and Pfizer were conducting research, for therapeutic and diagnostic purposes, and each discovered and filed patent applications directed to the polynucleotide encoding the IL-13 protein binding chain. The patent is awarded to the first applicant to conceive and reduce to practice the invention represented by an interference count, in accordance with Patent and Trademark Office (PTO) rules. Sanofi had a December 6, 1995 priority date. Pfizer’s filing date was March 1, 1996; Pfizer bore the burden of proving a date of conception earlier than Sanofi’s date. Pfizer presented evidence that it had isolated and identified the desired cDNA before that date, but, due to sequencing errors, did not then have a completely accurate analysis of the entire nucleotide sequence. The PTO Board found that Pfizer had “the claimed polynucleotide in hand with some additional identifying information including at least a partial sequence,” and ruled that Pfizer “established conception and actual reduction to practice of a polynucleotide within the scope of count 3” before the Sanofi date. The Federal Circuit affirmed; possession and appreciation of the actual isolated DNA is dispositive for priority of conception for an interference count directed to isolated DNA.View "Sanofi-Aventis v. Pfizer, Inc." on Justia Law

The patent concerns blood glucose monitoring systems, used by individuals with diabetes. Such systems typically consist of an electrochemical meter and disposable test strips onto which the user places a drop of blood. The strip contains “working electrodes” or “reference electrodes,” that connect to the meter during operation. Each working electrode is coated with an enzyme and a mediator. The enzyme reacts with glucose in the blood sample, releasing electrons. The mediator then transfers those electrons to the working electrode, which is connected to the meter, which measures the resulting electric current to determine blood glucose level. Meters and test strips of this general design became available in the 1980s. LifeScan’s patent claims to improve earlier systems with a method of comparing measurements from separate working electrodes. Significant differences in the readings of the working electrodes indicate problems such as inadequate sample volume or manufacturing defects, and the readings are to be discarded. A reference electrode on the strip serves as a common reference for both working electrodes. LifeScan manufactures such a system, the “OneTouch Ultra” and claimed infringement by defendant. The district court found likely infringement and entered an injunction. The Federal Circuit reversed, finding that defendant established a patent exhaustion defense. View "Lifescan Scotland, Ltd. v. Shasta Tech., LLC" on Justia Law

Synthes filed suit, alleging that SK’s M6-C and M6-L intervertebral implants infringed claims of a Synthes patent that is directed to an “Intervertebral Implant,” a prosthetic device designed to replace a diseased or degenerated disc located between adjacent vertebrae of the human spine. The Synthes patent originated from a German language Patent Cooperation Treaty application filed in 2003. The asserted claims were added by amendment in 2008. A jury found that SK’s implants did not infringe the asserted claims and that the claims were invalid for lack of written description. The Federal Circuit affirmed both the finding of invalidity and the district court’s denial of SK’s request for attorneys’ fees.View "Synthes USA LLV v. Spinal Kintetics, Inc." on Justia Law

At age four months, Elias received a Diptheria-Tetanus-acellular-Pertussis (DTaP) vaccine. Elias developed a seizure disorder shortly afterwards. While a petition for compensation under the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. 300aa-1, was pending, Elias died as a result of his seizure disorder at the age of seven. A special master determined that the DTaP vaccine caused Elias’ epilepsy and resulting death. The Secretary of Health and Human Services and the estate agreed to a $250,000 death benefit plus $175,000 for actual pain and suffering and past unreimbursable expenses. The estate also sought future lost earnings under section 300aa-15(a)(3)(B). The special master determined that the estate was entitled to future lost earnings. Subject to the right to seek review, the Secretary proffered, and the estate accepted the sum of $659,955.61 as a measure of the lost earnings. The Claims Court affirmed the special master’s future lost earnings award. The Federal Circuit reversed, holding that an estate cannot recover lost future earnings under section 300aa-15(a)(3)(B) when the person injured by a vaccine dies before entry of a compensation judgment. View "Tembenis v. Sec'y of Health & Humans Servs." on Justia Law

The patent examiner rejected claims in an application directed to a bone screw with a shank that is easy to produce and eliminates the need for an additional element to avoid splaying. The Patent Trial and Appeals Board affirmed. The Federal Circuit vacated on the basis that the examiner and the Board stated different grounds for rejection. View "In re Biedermann" on Justia Law

Plaintiff alleged that Bayer defrauded the United States government through its marketing and sale of the cholesterol-lowering drug Baycol. On appeal, plaintiff challenged the dismissal of the qui tam action she brought against Bayer Healthcare under the False Claims Act (FCA), 31 U.S.C. 3729-3733. Based upon the court's review of plaintiff's allegations regarding the Department of Defense (DoD) contracts, the court concluded that her complaint satisfied Rule 9(b)'s requirements and survived a motion to dismiss under Rule 12(b)(6). Accordingly, the court reversed the district court's judgment with regard to her allegations regarding the DoD contracts and remanded for further proceedings. However, the court affirmed the district court's judgment with respect to the allegations involving federal health insurance reimbursement claims under United States v. ex rel. Roop v. Hypoguard USA, Inc. View "Simpson v. Bayer Healthcare, et al." on Justia Law

Sunovion owns the rights to the patent, which is directed to pharmaceutical compositions of the single-enantiomer drug eszopiclone, the active ingredient in the chiral drug marketed as a sleep medication with the brand name Lunesta®. The district court held, on summary judgment, that Dr. Reddy’s Laboratories did not infringe certain claims in that patent. The Federal Circuit reversed. Although the district court did not err in construing the claim term “essentially free” as containing less than 0.25 percent levorotatory isomer, Sunovion was entitled to a judgment of infringement as a matter of law under 35 U.S.C. 271(e)(2)(A). A generic manufacturer’s “certification” pledging not to infringe cannot override the conclusion that when a drug manufacturer seeks FDA approval to market a generic compound within the scope of a valid patent, it is an infringement as a matter of law. View "Sunovion Pharm., Inc. v. Teva Pharm. USA, Inc." on Justia Law

The patents at issue relate to methods and devices for sealing a vascular puncture, which occurs when a medical procedure requires a puncture through the skin and into a vein or artery to insert a medical device, such as a catheter, into a patient’s vasculature. After such a procedure, the medical professional typically removes the medical device from the vasculature. Prior to development of the technology at issue, the medical professional was then required to apply external pressure to the puncture site until clotting occurred, sometimes for an extended period of time. This caused discomfort and increased the recovery time. The Janzen and Fowler patents disclose methods and devices for sealing a vascular puncture to improve patient recovery. The district court held that the safe-harbor provision of 35 U.S.C. 121 protects the Janzen patent from invalidity due to double-patenting; construed key terms in the Janzen patent; and found that the Fowler patents were not invalid for obviousness. The Federal Circuit reversed the safe harbor ruling, which rendered the rulings regarding the claim constructions moot, and affirmed that the Fowler patents are nonobvious and not shown to be invalid. View "St. Jude Med., Inc. v. Access Closure, Inc." on Justia Law

Bayer’s patent concerns genetically modifying plants to confer resistance to a common herbicide (2,4-D) by inserting a particular DNA segment into plant cells, which reproduce to create new cells that contain that gene. Those cells produce an enzyme that catalyzes a biochemical reaction with 2,4-D in which the herbicide is broken down into something harmless to the plant. A plant with the gene survives 2,4-D application while surrounding weeds do not. At the time of the patent application, the inventors had sequenced one gene coding for one enzyme, using a test supposedly capable of finding other, similar genes. In writing the application, they claimed a broad category based on the function of the particular enzyme, defining the category by using a term with established scientific meaning. Years before the patent issued, experiments showed that the term did not apply to the particular enzyme whose gene was sequenced, but Bayer did not change its claim language. When Bayer sued Dow for infringement, Bayer recognized that the term’s established scientific meaning, did not cover the accused product, which was, itself, different from the enzyme whose gene Bayer’s inventors had sequenced. Bayer argued for broad functional claim construction. The district court entered summary judgment of noninfringement, citing particularly the great breadth of the asserted functional construction. The Federal Circuit affirmed. View "Bayer CropScience AG v. Dow AgroSciences, LLC" on Justia Law

Zizic is the former CEO of BioniCare, which sold the BIO-1000, a medical device designed to treat osteoarthritis of the knee. BioniCare attempted to bill Medicare for the BIO-1000, but many claims were denied as not medically necessary. Q2A contracted with the government to review such claim denials across the nation. Q2A’s denials were reached without physician review, which is required by the Medicare Act, 42 U.S.C. 1395, HHS regulations, and its contract. A former Q2A employee testified that it implemented an internal policy to deny all BIO-1000 claims, which were reviewed by a single nurse rather than a panel of physicians; later allowed non-physician subcontractors to prepare BIO-1000 appeals for review by a single physician; and finally developed a mail merge letter that automatically denied BIO-1000 claims without any review. BioniCare’s trustee in bankruptcy became aware of and disclosed these practices. Zizic filed a qui tam suit under the False Claims Act, 31 U.S.C. 3729-33. The district court dismissed, concluding that it lacked jurisdiction because the allegations against Q2A and RTS were based on prior public disclosures and because Zizic was not an original source of that information. The Third Circuit affirmed. View "Zizic v. Q2Adm'rs LLC" on Justia Law