Intersection of Patent Infringement and Antitrust Liability in Abbreviated New Drug Application Litigation, The

A battle has been raging, over the past ten years, regarding the competing interests of patent protection and antitrust prohibitions in the specialized area of law concerned with patented drugs regulated by the Food and Drug Administration ( FDA ).\u27 The contestants are the Federal Trade Commission ( FTC ) and parties to Abbreviated New Drug Application (ANDA) litigation, which are a branded drug company and a generic challenger

Two-dimensional aerodynamic characteristics of the OLS/TAAT airfoil

Two flight tests have been conducted that obtained extension pressure data on a modified AH-1G rotor system. These two tests, the Operational Loads Survey (OLS) and the Tip Aerodynamics and Acoustics Test (TAAT) used the same rotor set. In the analysis of these data bases, accurate 2-D airfoil data is invaluable, for not only does it allow comparison studies between 2- and 3-D flow, but also provides accurate tables of the airfoil characteristics for use in comprehensive rotorcraft analysis codes. To provide this 2-D data base, a model of the OLS/TAAT airfoil was tested over a Reynolds number range from 3 x 10 to the 6th to 7 x 10 to the 7th and between Mach numbers of 0.34 to 0.88 in the NASA Langley Research Center's 6- by 28-Inch Transonic Tunnel. The 2-D airfoil data is presented as chordwise pressure coefficient plots, as well as lift, drag, and pitching moment coefficient plots and tables

BIOTECHNOLOGY PATENT LAW TOP TEN OF 2021. EXPERIMENTATION, BLAZE MARKS, AND UNSPECIFIED RANGES

Biotechnology has never demonstrated its benefits to society more than in 2021. The SARS-CoV-2 virus that caused the CoVID-19 pandemic met a formidable opponent in mRNA vaccines developed and supplied by Moderna and Pfizer/BioNTech. These vaccines are claimed in myriad – not Myriad – patents and patent applications, many of which are destined to be litigated over the coming years, not least inspired by the many billions of dollars that have been, and will continue to be, earned by their owners. While the world waits for this storm of patent litigation, federal courts continue to be busy with ownership, licensing, validity, and infringement disputes arising from other biotechnologies, including, perhaps, up-and-coming CAR-T therapies. For the fourth year in a row (of what has become a tradition), we discuss, in this article, the ten most consequential, important, and interesting court decisions involving biotechnology patents. Our top ten decisions may not be the same as top tens compiled by others. However, to quote an expression commonly heard in courts hearing patent cases, à chacun son goût. Patent decisions delivered during 2021 tackled a diverse group of doctrinal issues. As discussed in the article, these ranged from how much experimentation is to be considered undue à la In re Wands, to what level of detail of disclosure is sufficient to satisfy the ever- written description requirement, to which types of behavior may rise to the level of inducement to infringe, not to mention assignor estoppel. Patent litigations filed in federal district court rose to 3,798, a number not seen since 2016. In contrast, the 1,333 patent actions filed with the Patent Trial and Appeal Board (“PTAB“) represented a substantial decline from 2020. In short, despite the challenges of the CoVID- 19 pandemic, patent litigation in 2021 evinced considerable vim and vigor. Described and analyzed in this article are the vimmiest and most vigorous of 2021 patent decisions

Biotechnology Patent Law Top Ten of 2018 Broad Wins, Sovereignty Loses, and Patent Dance

In this article, we discuss what we consider to be the ten important and influential biotechnology patent law judicial decisions of 2018. These hinged on a variety of patent doctrines. An abbreviated new drug application (ANDA) for the multiple sclerosis drug Ampyra set the stage for the Acorda Therapeutics, Inc. v. Roxane Laboratories, Inc. (Fed. Cir. 2018) decision, in which the Court of Appeals for the Federal Circuit (Federal Circuit) provided guidance on how to conduct an obviousness analysis (35 U.S.C. §103). The Berkheimer v. HP Inc. (Fed. Cir. 2018) decision, although addressing a software invention, provided valuable insight into how to determine if inventions fall within patent-eligible subject matter (35 U.S.C. §101). Widely-anticipated by the branded and generic pharmaceutical industries, sovereign Native American nations, and consumers alike, the Saint Regis Mohawk Tribe v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2018) decision held that tribal sovereign immunity could not be used to shield patents covering the drug Restasis in an inter partes review (IPR) proceeding before the Patent Trial and Appeal Board (PTAB). In Regents of the University of California v. Broad Institute, Inc. (Fed. Cir. 2018), the Federal Circuit found there to be no interference-in-fact between patents and patent applications covering CRISPR gene editing owned by the Broad Institute and the University of California. The United States Supreme Court (Supreme Court), in Oil States Energy Services, LLC. v. Greene’s Energy Group, LLC (2018), held that IPR proceedings violate neither Article III nor the Seventh Amendment of the United States Constitution, and, in SAS Institute Inc. v. Iancu (2018), further elaborated the law of IPRs by requiring the United States Patent and Trademark Office (“USPTO”) to produce a final written decision (FWD) on all claims challenged by a petitioner in an IPR petition. How to apply the written description requirement (35 U.S.C. §112) to patent claims covering monoclonal antibodies, as well as the requirements for granting a permanent injunction against infringing medicines or other therapeutic agents, were both the subject of the decision in Amgen Inc. v. Sanofi (Fed. Cir. 2017). The Supreme Court gave its first interpretation of the Biologics Price Competition and Innovation Act (BPCIA) for the approval of biosimilar drugs in Sandoz, Inc. v. Amgen, Inc. (2017), addressing, among other things, the disclosure and information exchange provisions of the statute, commonly known as the “patent dance” over Sandoz’ biosimilar of Amgen’s biologic, Neupogen. In contrast to cases where the Supreme Court deigned to act, the Court decided not to act in Regeneron Pharmaceuticals v. Merus (2018), denying a petition for certiorari to consider the law of inequitable conduct. In a decision of considerable importance, the Supreme Court considered, in Life Techs. Corp. v. Promega Corp. (2017), whether the supply of a single component, Taq polymerase, of a multi-component toolkit for genetic testing by DNA amplification, for combination abroad, violates 35 U.S.C. § 271(f)(1), reversing the Federal Circuit’s decision that it does, and remanding the case for further proceedings. Biotechnology patent law evolved in 2018 across a number of frontiers, and will certainly continue its doctrinal evolution in 2019

Biotechnology Patent Law Top Ten Of 2020: Valeant Victorious, Falling Eagle, and Successful Slayback

This Article discusses the Top 10 BioTechnology Patent Cases of 2020. Suffice it to say that biotechnology patent law will continue to vigorously evolve, and we plan to continue our coverage of its evolution beyond the current trilogy of Biotechnology Patent Law Top Tens. As in previous years, we admit it was difficult to choose precisely ten top biotechnology patent law decisions. There are certainly others we did not include that warrant close attention for their reasonings, rules, and future implications. Nevertheless, both we and our readers can count, so we have done our best to select what we consider to be the top ten biotechnology patent law decisions of 2020. We discuss these decisions below

Biotechnology Patent Law Top Ten of 2022: Inducement, Clear Error, and Interferences Galore

Five-year anniversaries are symbolized by a product of natural biotechnology: wood. This article marks the wood anniversary of the “Top Ten Biotechnology Patent Cases” series that began in 2018. Imagining the world in 2018 is challenging, in part because it was, indeed, a different world. There had not been a major pandemic in one hundred years. Inflation was low. The economy hummed along. No individual war appeared to threaten more than regional stability. O tempora, o mores! The year 2022 was quite different. SARS-CoV-2 continued to stalk the land, having had a monumentally mortiferous effect for several years. High inflation was rampant. The economy was still recovering from one of the deepest declines in history, with imbalances across many sectors. Moreover, eastern Europe had let slip the dogs of war, threatening peace worldwide. Biotechnology also has seen changes of significant magnitude. Venture capital investment in biotechnology was small compared to what it is now. Efficient genome editing was restricted to first-generation CRISPR-Cas9 systems, while now it may be accomplished using more powerful and accurate methods, like base editing and prime editing (the latter offering hope for treatment in almost 90% of genetic diseases). Courts had declared that diagnostic methods did not constitute patentable subject matter, which remains the case today, although clever draftswomen continue their efforts to obtain claims protecting such methods to some extent. Over the course of 2022, courts decided a generous selection of cases covering a wide variety of biotechnology patent law issues. These cases ran the gamut, from patent doctrines concerning satisfaction of the written description requirement for antibody claims to mechanisms for augmenting patent terms using either Patent Term Extension, or Patent Term Adjustment, or both. This article has chosen ten of the most important, though, as is the case every year, our choice of only ten was difficult, and, by necessity, left worthy cases on the cutting room floor

Aerodynamic Characteristics of Two Rotary Wing UAV Designs

This paper presents the results of an experimental investigation of two rotary-wing UAV designs. The primary goal of the investigation was to provide a set of interactional aerodynamic data for an emerging class of rotorcraft. The present paper provides an overview of the test and an introduction to the test articles, and instrumentation. Sample data in the form of a parametric study of fixed system lift and drag coefficient response to changes in configuration and flight condition for both rotor off and on conditions are presented. The presence of the rotor is seen to greatly affect both the character and magnitude of the response. The affect of scaled stores on body drag is observed to be dependent on body shape

Navier-Stokes Simulation of a Heavy Lift Slowed-Rotor Compound Helicopter Configuration

Time accurate numerical simulations were performed using the Reynolds-averaged Navier-Stokes (RANS) flow solver OVERFLOW for a heavy lift, slowed-rotor, compound helicopter configuration, tested at the NASA Langley 14- by 22-Foot Subsonic Tunnel. The primary purpose of these simulations is to provide support for the development of a large field of view Particle Imaging Velocimetry (PIV) flow measurement technique supported by the Subsonic Rotary Wing (SRW) project under the NASA Fundamental Aeronautics program. These simulations provide a better understanding of the rotor and body wake flows and helped to define PIV measurement locations as well as requirements for validation of flow solver codes. The large field PIV system can measure the three-dimensional velocity flow field in a 0.914m by 1.83m plane. PIV measurements were performed upstream and downstream of the vertical tail section and are compared to simulation results. The simulations are also used to better understand the tunnel wall and body/rotor support effects by comparing simulations with and without tunnel floor/ceiling walls and supports. Comparisons are also made to the experimental force and moment data for the body and rotor

INITIAL ASSESSMENT OF SURFACE PRESSURE CHARACTERISTICS OF TWO ROTARY WING UAV DESIGNS

This paper presents results of an experimental investigation of two rotary-wing UAV designs. The primary goal of the investigation was to provide a set of interactional aerodynamic data for an emerging class of rotorcraft. The present paper provides an overview of the test and an introduction to the test articles, and instrumentation. Sample data in the form of fixed system pressure coefficient response to changes in configuration attitude and flight condition for both rotor off and on conditions are presented. The presence of the rotor is seen to greatly affect the magnitude of the response. Pressure coefficients were measured using both conventional pressure taps and via pressure sensitive paint. Comparisons between the two methods are presented and demonstrate that the pressure sensitive paint is a promising method; however, further work on the technique is required