Justia Patents Opinion Summaries

Institut Pasteur owns three U.S. patents, which claim methods and tools for the site-directed insertion of genes into eukaryotic chromosomes. Precision requested inter partes reexamination of each. A Patent and Trademark Office examiner rejected a number of Pasteur’s claims for obviousness, under 35 U.S.C. 103.The Patent Trial and Appeal Board affirmed the rejections, concluding that the claimed inventions were obvious extensions of two prior-art references disclosing similar methods of targeting non-chromosomal DNA in prokaryotic cells. With respect to one patent, the Federal Circuit dismissed Pasteur’s appeal as moot, because Pasteur presented only substantively amended claims and amended claims cannot be entered after the patent has expired. With respect to another patent, the court reversed the Board’s conclusion as unsupported by substantial evidence and containing an erroneous obviousness analysis, including improper discounting of Pasteur’s objective indicia of non-obviousness. The court vacated the Board’s decision on the third patent and remanded for consideration of what motivation, if any, a skilled artisan at the relevant time would have had to pursue the claimed invention. View "Institut Pasteur & Universite v. Focarino" on Justia Law

Tolmar’s filed an Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Differin® Gel, 0.3%, a topical medication containing 0.3% by weight adapalene approved for the treatment of acne. Galderma sued Tolmar, alleging that Tolmar’s ANDA product infringed its patents. The district court ruled against Tolmar, finding the Galderma patents not invalidity for obviousness under 35 U.S.C.103. The Federal Circuit reversed, after examining prior art. While the comparable tolerability of 0.1% and 0.3% adapalene was unexpected in view of the prior art, a skilled artisan would have expected that tripling the concentration of adapalene would have resulted in a clinically significant increase in side effects, so the result does not constitute an unexpected result that is probative of nonobviousness. The commercial success of Differin® is of “minimal probative value.” View "Galderma Labs, L.P. v. Tolmar, Inc." on Justia Law

OWW owns related patents directed to cushioning devices that fit over the residual stumps of amputated limbs to make the use of prosthetics more comfortable. Some of the patents have been asserted in patent infringement suits and many have been involved in reexamination proceedings before the Patent and Trademark Office. OWW sued Alps for infringement of the 237 patent, entitled “Gel and Cushioning Devices,” lists Kania as the sole inventor and has an application date of 1996. The district court issued its claim construction order. Alps subsequently initiated the first of two consecutive ex parte reexaminations of the 237 patent. After a stay was lifted, the district court granted summary judgment to Alps, finding certain claims invalid due to the collateral estoppel effect of parallel litigation and other claims invalid for obviousness. The district court also granted OWW summary judgment of no inequitable conduct. The Federal Circuit affirmed on the issues of collateral estoppel and obviousness, but reversed and remanded on the issue of inequitable conduct. Issues of material fact regarding whether OWW committed inequitable conduct during the reexamination proceedings by withholding information preclude summary judgment.View "Ohio Willow Wood Co. v. ALPS South, LLC" on Justia Law

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

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

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