Justia Drugs & Biotech Opinion Summaries

Eilise was born in 1996 and had problems with gross motor skills and language development. After therapy, Eilise showed dramatic improvement. In 2001, Eilise received three vaccinations, including her second dose of the measles, mumps, and rubella vaccine. Five days later, Eilise’s brother witnessed her arching her back, thrusting her head back, rolling her eyes, and jerking. He did not know what was happening. Her parents, who did not witness the seizure, noted that Eilise was feverish and lethargic. Eilise had a grand mal seizure at school. She was taken to a hospital. She had another seizure there. Eilise’s MRI results were generally normal, but her EEG results were “consistent with a clinical diagnosis of epilepsy.” She continued to suffer seizures until she started a ketogenic diet. Her parents filed suit under the National Childhood Vaccine Injury Compensation Program, 42 U.S.C. 300aa, alleging that Eilise suffered from autism as a result of her vaccinations; they later amended to allege, instead, that Eilise suffered from a “seizure disorder and encephalopathy.” The Claims Court affirmed denial of her petition. The Federal Circuit vacated: in certain cases, a petitioner can prove a logical sequence of cause and effect between a vaccination and the injury with a physician’s opinion where the petitioner has proved that the vaccination can cause the injury and that the vaccination and injury have a close temporal proximity. View "Moriarty v. Sec'y of Health & Human Servs." on Justia Law

In consolidated cases, patent-holder plaintiffs market drugs and have patents in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations publication (Orange Book), 21 U.S.C. 355(b)(1). Mylan filed Abbreviated New Drug Applications (ANDA), 21 U.S.C. 355(j), seeking FDA approval to market generic versions of the drugs, certifying that the Orange Book patents are invalid or would not be infringed by the proposed drugs. The plaintiffs sued in Delaware under 35 U.S.C. 271(e)(2)(A). Mylan is incorporated in, and has its principal place of business in, West Virginia and submitted its ANDAs in Maryland; it intends to direct sales into Delaware, among other places, once it has FDA approval. Mylan sent notices to the plaintiffs in New York, Ireland, Delaware and Sweden. One plaintiff is incorporated in Delaware, the U.S. subsidiary of another has its principal place of business in Delaware. Both have sued others for infringement in Delaware. Each district court concluded that Delaware had sufficient contacts related to the subject of these cases to exercise specific personal jurisdiction over Mylan. The judges disagreed about whether Delaware could exercise general personal jurisdiction (independent of suit-related contacts) on the ground that Mylan consented to jurisdiction in registering to do business. Each declined to dismiss. The Federal Circuit affirmed on the issue of specific jurisdiction, declining to address general personal jurisdiction. View "Acorda Therapeutics, Inc. v. Mylan Pharma., Inc." on Justia Law

OWW owns patents directed to cushioning devices that fit over the residual stumps of amputated limbs to make the use of prosthetics more comfortable. OWW has asserted its patents against Alps in several actions, including one filed in 2004 concerning devices consisting of stretchable synthetic fabric, coated with a gel on only the side touching the body, to reduce skin irritation, while the dry side allows free interaction with the prosthesis. After the court issued a claim construction order, Alps filed two successive ex parte reexamination proceedings before the Patent and Trademark Office. The examiner rejected the claims of the patent for obviousness. The Board of Patent Appeals and Interferences reversed, but the court granted Alps summary judgment of invalidity as to all asserted claims. The Federal Circuit remanded. Following remand, the Federal Circuit affirmed findings of inequitable conduct in the second reexamination, but not in the first. OWW executive Colvin was aware that OWW’s reexamination counsel represented to the Board that testimony by Alps’s witness (Comtesse) was uncorroborated; that Colvin was aware of materials that corroborated Comtesse’s testimony; and that Colvin failed to correct counsel’s misrepresentations. Based on that inequitable conduct finding, the patent is unenforceable and the case was exceptional, justifying a fee award against OWW. View "Ohio Willow Wood Co. v. Alps S., LLC" on Justia Law

AngioScore sells angioplasty balloon catheters (AngioSculpt), designed to open arterial blockages. Three AngioScore patents each list three inventors, but none lists Lotan as an inventor. TriReme is a competitor of AngioScore. Apparently concerned that AngioScore might charge TriReme with infringement, TriReme sought to acquire an interest in the AngioScore patents from Dr. Lotan, who performed consulting services for AngioScore. Lotan granted TriReme an exclusive license to “any and all legal and equitable rights” he held in the AngioScore patents. Lotan claimed that his inventive contribution arose from his work in connection with the development of the AngioSculpt catheters in 2003, which is reflected in the AngioScore patents. AngioScore’s defense was based on a 2003 consulting contract between AngioScore and Lotan. AngioScore asserts that it acquired rights to all inventive work completed by Lotan. TriReme brought suit for correction of inventorship, 35 U.S.C. 256. The district court dismissed, finding that TriReme lacked standing. The Federal Circuit reversed and remanded for consideration of whether Lotan’s continued work on AngioSculpt after the contract’s effective date came within the contract’s language. View "TriReme Med., LLC v. Angioscore, Inc." on Justia Law

Samuel’s 575 patent, filed in 1997, claims inventions in the field of intraluminal stent technology. One type of intraluminal stent is a vascular stent. Vascular stents are used to treat medical conditions wherein a vascular wall is unduly constricted, as in the case of vascular stenosis, or unduly enlarged, as in the case of aneurysm. Either of these medical conditions poses an unacceptable risk of insufficient blood flow or vascular rupture. The 575 patent generally claims intraluminal stents that can be affixed to a vascular wall via the use of “an inflatable and deflatable cuff” without penetrating the vessel wall. In a 2013 infringement suit, defendant TriVascular filed a petition for inter partes review. The Patent Trial and Appeal Board found that TriVascular failed to demonstrate that the challenged claims were unpatentable over the applied art; adopted Samuels’ construction of “inflatable protrusions,” as “protrusions that are themselves inflatable, i.e., expandable by being filled with fluid;” and concluded that the 575 patent’s “inflatable protrusions” were not disclosed by the prior art. The Federal Circuit affirmed. View "Trivascular, Inc. v. Samuels" on Justia Law

Oxycodone hydrochloride—the active pharmaceutical ingredient (API) in OxyContin®—is an opioid analgesic used to treat moderate to severe pain. In 2014 the FDA became concerned about 14-hydroxycodeinone, which belongs to a class of potentially dangerous compounds known as alpha, beta unsaturated ketones (ABUKs), and mandated that oxycodone hydrochloride manufacturers either provide evidence that the 14-hydroxy levels in their formulations were safe or reduce the amount of 14-hydroxy to less than 10 ppm. Purdue’s four low-ABUK patents recite an improved formulation of oxycodone hydrochloride, describing an oxycodone salt with extremely low levels of ABUKS. In 2011, Purdue sued Teva for infringement of the low-ABUK patents in response to Teva’s filing of an abbreviated new drug application (ANDA) seeking FDA approval to market generic versions of Reformulated OxyContin®. Purdue later filed similar lawsuits against others. In consolidated cases, the district court found that the asserted claims were infringed by Teva’s proposed generic product, but also held that all of the claims were invalid as anticipated by or obvious over the prior art. The Federal Circuit affirmed, finding claims obvious in light of prior art, 35 U.S.C. 103(a). View "Purdue Pharma L.P. v. Epic Pharma, LLC" on Justia Law

Ethicon’s patent is directed to a surgical device used to staple, secure, and seal tissue that has been incised. As is commonly done during endoscopic procedures, a surgeon will insert the device into the patient and will pull a trigger to latch onto a desired tissue. Once attached, the surgeon will then pull another trigger, which causes a blade to move, cutting the desired tissue. Simultaneously, rows of staples on either side of the cutting blade are actuated against a staple forming surface, both securing and sealing the newly-cut tissue. The Patent Trial and Appeals Board granted inter partes review found all challenged claims invalid as obvious over the prior art. The Federal Circuit rejected an argument that the Board’s final decision is invalid because the same Board panel made both the decision to institute and the final decision and upheld the determination that the claims would have been obvious over prior art. View "Ethicon Endo-Surgery, Inc. v. Covidien, LP" on Justia Law

In 2005, Urbanski filed the 614 application, entitled “Protein and Fiber Hydrolysates” and is directed to a method of enzymatic hydrolysis of soy fiber, such that the product has a reduced water holding capacity suitable for use as food additives. The Patent Trial and Appeal Board affirmed the Examiner’s rejection of certain claims as unpatentable under 35 U.S.C. 103(a). The Federal Circuit affirmed, upholding the determination that the claims would have been obvious over cited references relating to enzymatic hydrolysis of dietary fibers, which are readily combinable. View "In re: Urbanski" on Justia Law

The Patent Trial and Appeal Board granted SAMSF’s motion to cancel certain claims prior to its review of SAMSF’s patents relating to administering the “natural” stereoisomer of 5-methyl-tetrahydrofolic acid (L-5-MTHF) and other vitamins to treat symptoms associated with folate deficiency, which causes health issues, including cardiovascular disease, neurological disorders, birth defects, and skeletal disorders. The Federal Circuit affirmed the Board’s conclusion of obviousness under 35 U.S.C. 103. The court prior rejected SAMSF’s arguments art taught away from its claimed use of a reduced folate to treat folate deficiency, and that objective indicia of non-obviousness further demonstrated the validity of its patents. Although the Board erred in its assessment of the evidence of licensing, its other factual findings were supported by substantial evidence. View "S. Ala. Med. Sci. Found. v. Gnosis, S.P.A." on Justia Law

At the request of Gnosis, the Patent Trial and Appeal Board instituted inter partes review of claims of Merck’s patent, which relates to methods of using folates to lower levels of homocysteine in the human body. Homocysteine is an amino acid that, when present in excessive quantities, can cause severe cardiovascular, ocular, neurological, and skeletal disorders. Merck filed a response and a motion to cancel claims 1–3, 5, 6, and 13, which the Board granted. The Board only reviewed the patentability of dependent claims 8, 9, 11, 12, 14, 15, and 19–22 and found them invalid for obviousness, 35 U.S.C. 103, in light of prior art. The Federal Circuit affirmed, finding that the Board’s factual findings to the contrary were supported by substantial evidence and rejecting Merck’s arguments that the prior art taught away from the claimed method and that objective indicia of non-obviousness further support the patentability of the claims. View "Merck & Cie v. Gnosis, S.P.A." on Justia Law