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To receive disability compensation based on service, a veteran must demonstrate that the disability was incurred or aggravated in the line of duty, 38 U.S.C. 101(16). Congress has enacted presumptive service connection laws to protect certain veterans who faced exposure to chemical toxins but would find it difficult to prove a “nexus” between their exposure and their disease. Under the Agent Orange Act, 38 U.S.C. 1116, any veteran who served in Vietnam during the Vietnam era and who suffers from any designated disease “shall be presumed to have been exposed during such service” to herbicides. The VA determines which diseases qualify for presumptive service connection and defines service in Vietnam. Absent on-land service, the VA concluded that the statute did not authorize presumptive service connection for veterans serving in the open waters surrounding Vietnam. The Federal Circuit upheld that position in 2007. In 2016, the VA amended its M21-1 procedures manual to also exclude veterans who served in bays, harbors, and ports of Vietnam. The VA did not implement this additional restriction by way of notice and comment regulation as it did its open waters restriction and has not published its view on this issue in the Federal Register. The Federal Circuit rejected a challenge for lack of jurisdiction. The VA’s revisions are not agency actions reviewable under 38 U.S.C. 502. The M21-1 Manual provisions are only binding on Veterans Benefits Administration employees. View "Gray v. Secretary of Veterans Affairs" on Justia Law

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In 2016, Harvard filed a patent-infringement case against Micron, which is incorporated in Delaware and has its principal place of business in Idaho, alleging that venue in the District of Massachusetts was proper under 28 U.S.C. 1391(b); 1400. Micron moved to dismiss for failure to state a claim, but did not object to venue under Rule 12(b)(3). Months later, the Supreme Court interpreted 28 U.S.C. 1400(b) (TC Heartland decision): “a domestic corporation ‘resides’ only in its State of incorporation for purposes of the patent venue statute.” Micron then moved to dismiss or to transfer the case. The district court denied the motion, reasoning that, under Rule 12(g)(2) and (h)(1)(A), Micron had waived its venue defense by not objecting to venue in its first motion to dismiss. The Federal Circuit vacated and remanded. TC Heartland changed the controlling law: at the time of the initial motion to dismiss, the venue defense now raised by Micron was not “available,” making the waiver rule of Rule 12(g)(2) and (h)(1)(A) inapplicable. That waiver rule, however, is not the only basis on which a district court might reject a venue defense for non-merits reasons, such as by determining that the defense was not timely presented. A less bright-line, more discretionary framework applies even when Rule 12(g)(2) and hence Rule 12(h)(1)(A) does not. View "In re: Micron Technology, Inc." on Justia Law

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LifeTech sold genetic testing kits to detect the presence of “short tandem repeat” (STR) sequences of DNA. Its “STR kits,” were assembled in the United Kingdom and consisted of five components. At least one component was supplied from the U.S. Promega, the exclusive licensee of the U.S. “Tautz patent,” which expired in 2015 and claimed methods and kits for analyzing DNA to determine the identity and kinship of organisms, sued LifeTech for infringement. In 2014, the Federal Circuit held that a multi-component product assembled overseas could infringe a U.S. patent under 35 U.S.C. 271(f)(1)1 when only a single component is supplied from the U.S. The Supreme Court reversed, holding that section 271(f)(1) does not cover the supply of a single component of a multicomponent invention. On remand, the Federal Circuit first reaffirmed: that the asserted claims of four Promega patents were invalid for failure to comply with the enablement requirement, 35 U.S.C. 112; that certain of LifeTech’s alleged acts of infringement were not licensed under a license agreement between LifeTech and Promega; and that LifeTech was not required to “actively induce” a third party to combine the components of the accused products to be liable under section 271(f)(1)--that requirement could be met if LifeTech had the specific intent to combine the components itself. The court then reinstated the district court’s grant of judgment as a matter of law that Promega failed to prove infringement under 35 U.S.C. 271(a)3; 271(f)(1). View "Promega Corp v. Life Technologies, Inc." on Justia Law

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Sanofi’s patents describe and claim compositions and uses of the cardiovascular (antiarrhythmic) drug dronedarone. The 800 patent, which expires in 2019, claims pharmaceutical compositions containing dronedarone. The 167 patent, which expires in 2029, claims methods of reducing hospitalization by administering dronedarone to patients having specified characteristics. In 2009, Sanofii received New Drug Application approval for 400 mg tablets of dronedarone, sold as Multaq®. Both patents are listed in the FDA publication Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) as patents claiming either Multaq® or a method of using Multaq®. Defendants, hoping to market generic versions of Multaq®, filed abbreviated new drug applications with the FDA, certifying under 21 U.S.C. 355(j)(2)(A)(vii)(IV), their beliefs that both patents were invalid and/or that the manufacture, use, and sale of the proposed generic drugs would not infringe either patent. Sanofi sued for infringement under 35 U.S.C. 271(e)(2)(A). The district court ruled, and the Federal Circuit affirmed, that as to the 167 patent, Sanofi proved that sale of the proposed generic drugs, with the proposed labels, would induce physicians to infringe, and defendants did not prove that any asserted claims were invalid for obviousness. As to the 800 patent, the courts rejected the non-infringement argument. View "Sanofi v. Watson Laboratories Inc." on Justia Law

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Simmons contacted counsel in 2011, claiming that he developed Guillain-Barre Syndrome as a result of his 2010 flu vaccination. He provided his vaccination record. Counsel agreed to represent him. Counsel was subsequently unable to contact Simmons and sent a letter in 2013, stating that their attorney-client relationship had terminated. That letter was returned as undeliverable. Nearly two years later, shortly before the limitations period on his Vaccine Act claim would expire, Simmons contacted counsel’ and expressed that he would like to proceed. Counsel spoke with Simmons one additional time. The next day, on October 22, 2013, counsel filed Simmons’s petition, without any medical records or other supporting evidence. In January 2014, the special master ordered counsel to produce medical records. Counsel stated that counsel had again lost contact with Simmons and was unable to acquire those records. The master dismissed the case for failure to prosecute. Counsel then filed petitions seeking $8,267.89 in fees and costs. The master noted that because there was no direct evidence of bad faith and counsel had a vaccination receipt, counsel had satisfied the good faith and reasonable basis requirements and awarded fees. The Claims Court and Federal Circuit disagreed. The master erred in finding that counsel had a reasonable basis for Simmons’s claim. The fact that the statute of limitations was about to expire did not excuse counsel’s obligation to show some basis for the claim that Simmons suffered Guillain-Barre beyond their conversations. View "Simmons v. Secretary of Health and Human Services" on Justia Law

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TRICARE provides current and former members of the military and their dependents' medical and dental care. Hospitals that provide TRICARE services are reimbursed under Department of Defense (DoD) guidelines. TRICARE previously did not require, DoD to use Medicare reimbursement rules. A 2001 amendment, 10 U.S.C. 1079(j)(2), required TRICARE to use those rules to the extent practicable. DoD regulations noted the complexities of the transition process and the lack of comparable cost report data and stated “it is not practicable” to “adopt Medicare OPPS for hospital outpatient services at this time.” A study, conducted after hospitals complained, determined that DoD underpaid for outpatient radiology but correctly reimbursed other outpatient services. TRICARE created a process for review of radiology payments. Each plaintiff-hospital requested a discretionary payment, which required them to release “all claims . . . known or unknown” related to TRICARE payments. Several refused to sign the release and did not receive any payments. Although it discovered calculation errors with respect to hospitals represented by counsel, TRICARE did not recalculate payments for any hospitals that did not contest their discretionary payment offer. The Claims Court dismissed the hospitals’ suit. The Federal Circuit reversed in part, finding that they may bring a claim for breach of contract but may not bring money-mandating claims under 10 U.S.C. 1079(j)(2) and 32 C.F.R. 199.7(h)(2) because the government’s interpretation of the statute was reasonable. View "Ingham Regional Medical Center v. United States" on Justia Law

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Freeman's company, RNR located eight mining claims on public lands of the Rogue River Siskiyou National Forest. In 2011, RNR filed a plan of operations with the U.S. Forest Service for commercial mining of ore that “contains commercially recoverable amounts of nickel, chromium[,] and iron” from two deposits over the course of 30 years. RNR proposed the construction of nearly eight miles of new roads, excavation of a pit for water storage, construction of two crossings over a creek, and creation of a processing facility on a 20-acre site, to be located on lands managed by the U.S. Department of the Interior’s Bureau of Land Management (BLM). Officials concluded that the BLM office had not received a complete plan of operation and requested a proposal for bulk sampling and construction of a pilot-prototype plant. Officials repeatedly asserted they would not process the pending plan without more specific information and a pilot-prototype. RNR did not respond to those requests, but sued, alleging a regulatory taking. The Federal Circuit affirmed the dismissal, of the suit finding the claim not ripe. The Forest Service has not reached a final decision and it is not clear compliance with its requests would be futile. View "Freeman v. United States" on Justia Law

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Two-Way’s patents, entitled “Multicasting Method and Apparatus,” generally relate to a system for streaming audio/visual data over a communications system like the internet. The patents explain that internet systems typically operate on a point-to-point, unicast, basis. In unicast systems, a message is converted into a series of addressed packets which are routed from a source node to a destination node. Unicast systems cannot broadcast a message from a source node to all the other recipients in a network, as this type of operation could easily overload the network. IP Multicasting provides a way to transmit one packet of information to multiple recipients; packets destined for several recipients are encapsulated in a unicast packet and forwarded from a source to a point in a network where the packets are replicated and forwarded on to all desired recipients. The patents explain that this technology had previously been used to provide internet-based audio/visual conferencing servicing and radio-like broadcasts and describe the invention as an improved scalable architecture for delivering real-time information. The Federal Circuit affirmed a holding that certain claims are directed to patent-ineligible subject matter under 35 U.S.C. 101. The claims are directed to abstract ideas and contain no additional elements that transform them into an application of the abstract ideas. View "Two-Way Media Ltd. v. Comcast Cable Communications, LLC" on Justia Law

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In 2003, the FDA granted Bayer approval to market vardenafil hydrochloride trihydrate to treat erectile dysfunction (ED) under the name Levitra. Vardenafil belongs to a class of ED drugs called phosphodiesterase inhibitors. When the FDA approved Levitra, two other phosphodiesterase inhibitors were already on the market: Pfizer launched Viagra in 1998, and Eli Lilly launched Cialis in 2003. Each is formulated as immediate-release tablets that are swallowed whole. Bayer’s 950 patent issued in 2013, claiming priority to 2005; it is directed to a formulation of vardenafil as “an uncoated tablet which disintegrates rapidly in the mouth,” vardenafil ODT, which Bayer markets as Staxyn. Watson filed an FDA Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Staxyn. Bayer alleged infringement. The Federal Circuit reversed the district court’s holding Watson failed to prove by clear and convincing evidence that two claims would have been obvious, 35 U.S.C. 103. The district court clearly erred in finding a skilled artisan would not have been motivated to use the claim elements to formulate an ED drug as a fast-dissolving tablet; the claims would have been obvious. View "Bayer Pharma AG v. Watson Laboratories, Inc." on Justia Law

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Mastermine’s patents disclose methods and systems “that allow[] a user to easily mine and report data maintained by a customer relationship management (CRM) application” and describe a process by which an electronic worksheet is automatically created. Within this electronic worksheet, a multi-dimensional analysis table, known as a pivot table, “allows the user to quickly and easily summarize[] or view large amounts of CRM data.” The patents further describe that a user is able to “analyze the captured CRM data and ‘mine’ the data for important insights” upon generation of the pivot table. In Mastermine’s infringement suit against Microsoft, the district court construed the term “pivot table” to mean “an interactive set of data displayed in rows and columns that can be rotated and filtered to summarize or view the data in different ways” and entered a stipulated judgment of noninfringement and invalidity for indefiniteness. The Federal Circuit reversed and remanded as to indefiniteness. The claims do not improperly claim both an apparatus and a method of using the apparatus. The court found the district court’s claim construction supported by the intrinsic evidence. View "Mastermine Software, Inc. v. Microsoft Corp." on Justia Law