scholarly journals Full Federal Circuit Curbs On Sale Bar's Threat to Patents

2018 ◽  
Author(s):  
Zong-Qiang Bill Tian ◽  
Matthew D'Amore
Keyword(s):  
Pharmaceutical Companies ◽  
Commercial Development ◽  
Contracting Out ◽  
Broad Category ◽  
Patented Product ◽  
Federal Circuit

Morrison Foerster Client Alert, July 12, 2016Biotech and pharmaceutical companies received critical guidance from the Federal Circuit yesterday, when the en banc court exempted a broad category of common manufacturing and supply arrangements from the reach of the patent law’s “on sale” bar. In The Medicines Company v. Hospira, Inc., App. No. 14-1469 (Fed. Cir. 2016) (en banc), the Federal Circuit ruled unanimously that “the mere sale of manufacturing services by a contract manufacturer to an inventor to create embodiments of a patented product for the inventor does not constitute a ‘commercial sale’ of the invention” and does not create a potential bar to patentability under 35 U.S.C. § 102(b). The decision reduces the IP risk that smaller pharmaceutical companies faced when contracting out for manufacturing services during commercial development, and provides in-house counsel with signposts to craft agreements that will stay clear of the on sale bar.

Currents in Contemporary Ethics

2003 ◽  
Vol 31 (3) ◽  
pp. 450-454 ◽  
Author(s):  
Mary R. Anderlik ◽  
Mark A. Rothstein
Keyword(s):  
Health Care ◽  
Financial Support ◽  
Large Scale ◽  
University Of California ◽  
Pharmaceutical Companies ◽  
Research Subjects ◽  
Commercial Development ◽  
New Developments ◽  
Financial Gain ◽  
The University

In financial disputes involving research, the parties are traditionally individual researchers and their institutions, biotech and pharmaceutical companies, and other entities engaged in the commercial development of biomedical research. Occasionally, research subjects claim that researchers have misled them or misappropriated their biological materials to derive financial gain. The best known example is the case of Moore v. Regents of the University of California, decided in 1990.With new developments in genomics, large-scale repositories of tissue and other biological specimens are increasingly important. Biobanks have been established by various researchers, commercial entities, health-care institutions, and even entire countries. Individuals who contribute specimens almost always retain no commercial interest in any resulting research and language to that effect is now customarily included in informed consent documents signed at the time the specimen is given. Suppose, however, that the research subjects actually collect the specimens themselves, recruit the researcher, and provide financial support for the research.

scholarly journals Evaluate the adequacy of disclosure as a solution to the problem of conflict of interest in medical research

2020 ◽  
Vol 8 (2) ◽  
pp. 782
Author(s):  
Alanazi Mansour Moklif ◽  
Alanazi Mohammed Ratoubi
Keyword(s):  
Potential Risk ◽  
Conflict Of Interest ◽  
University Research ◽  
Regulatory Mechanisms ◽  
Pharmaceutical Companies ◽  
Undue Influence ◽  
Industry Funding ◽  
Commercial Development ◽  
Financial Relationship ◽  
Research Centres

A potential risk of conflict of interest currently exists in research.  The financial considerations play a greater role in the decisions that are necessary in the process of research. Traditional pharmaceutical companies began to invest, not just in the commercial development of biomedical discoveries for the marketplace, but in the research centres that could deliver the discoveries.  Cooperation and interdependence between industry and research institutions is not inherently wrong, but these unions must be regulated and managed through regulatory mechanisms. When a financial relationship is been disclosed, it would be closely evaluated in order to determine the risk of an undue influence leading to bias, or loss of scientific objectivity. To sum up, a conflict of interest is a potential, but not a certain occurrence. Banning funding for university research by industry is unrealistic.  The only effective way to proceed is to implement oversight and regulation that makes both industry funding entities and researchers aware that their activities will be monitored for the benefit of public safety as the more valued concern.

Use of EDS mapping to characterize thermochemical stability of fibers in intermetallic matrix composites

1992 ◽  
Vol 50 (1) ◽  
pp. 160-161
Author(s):  
John R. Porter
Keyword(s):  
Spatial Information ◽  
Beam Current ◽  
Fiber Types ◽  
Ceramic Fibers ◽  
Dye Transfer ◽  
Science Center ◽  
Commercial Development ◽  
Nih Image ◽  
Intermetallic Matrix Composites ◽  
Thermochemical Stability

New ceramic fibers, currently in various stages of commercial development, have been consolidated in intermetallic matrices such as γ-TiAl and FeAl. Fiber types include SiC, TiB2 and polycrystalline and single crystal Al2O3. This work required the development of techniques to characterize the thermochemical stability of these fibers in different matrices.SEM/EDS elemental mapping was used for this work. To obtain qualitative compositional/spatial information, the best realistically achievable counting statistics were required. We established that 128 × 128 maps, acquired with a 20 KeV accelerating voltage, 3 sec. live time per pixel (total mapping time, 18 h) and with beam current adjusted to give 30% dead time, provided adequate image quality at a magnification of 800X. The maps were acquired, with backgrounds subtracted, using a Noran TN 5500 EDS system. The images and maps were transferred to a Macintosh and converted into TIFF files using either TIFF Maker, or TNtolMAGE, a Microsoft QuickBASIC program developed at the Science Center. From TIFF files, images and maps were opened in either NIH Image or Adobe Photoshop for processing and analysis and printed from Microsoft Powerpoint on a Kodak XL7700 dye transfer image printer.

Morphology of High-Performance Rigid-Rod Polymer Fibers and Molecular Composites

1989 ◽  
Vol 47 ◽  
pp. 338-339
Author(s):  
W.W. Adams ◽  
S. J. Krause
Keyword(s):  
Tensile Strength ◽  
High Performance ◽  
Liquid Crystalline ◽  
Molecular Level ◽  
Synergistic Effects ◽  
Tensile Modulus ◽  
Commercial Development ◽  
The Matrix ◽  
Molecular Composites ◽  
Rigid Rod

Rigid-rod polymers such as PBO, poly(paraphenylene benzobisoxazole), Figure 1a, are now in commercial development for use as high-performance fibers and for reinforcement at the molecular level in molecular composites. Spinning of liquid crystalline polyphosphoric acid solutions of PBO, followed by washing, drying, and tension heat treatment produces fibers which have the following properties: density of 1.59 g/cm3; tensile strength of 820 kpsi; tensile modulus of 52 Mpsi; compressive strength of 50 kpsi; they are electrically insulating; they do not absorb moisture; and they are insensitive to radiation, including ultraviolet. Since the chain modulus of PBO is estimated to be 730 GPa, the high stiffness also affords the opportunity to reinforce a flexible coil polymer at the molecular level, in analogy to a chopped fiber reinforced composite. The objectives of the molecular composite concept are to eliminate the thermal expansion coefficient mismatch between the fiber and the matrix, as occurs in conventional composites, to eliminate the interface between the fiber and the matrix, and, hopefully, to obtain synergistic effects from the exceptional stiffness of the rigid-rod molecule. These expectations have been confirmed in the case of blending rigid-rod PBZT, poly(paraphenylene benzobisthiazole), Figure 1b, with stiff-chain ABPBI, poly 2,5(6) benzimidazole, Fig. 1c A film with 30% PBZT/70% ABPBI had tensile strength 190 kpsi and tensile modulus of 13 Mpsi when solution spun from a 3% methane sulfonic acid solution into a film. The modulus, as predicted by rule of mixtures, for a film with this composition and with planar isotropic orientation, should be 16 Mpsi. The experimental value is 80% of the theoretical value indicating that the concept of a molecular composite is valid.

The Eleventh Circuit Holds that Agreements in which Pharmaceutical Companies Pay Generic Companies Not to Compete May be Valid

2004 ◽  
Vol 32 (1) ◽  
pp. 181-184
Author(s):  
Amy Garrigues
Keyword(s):  
Pharmaceutical Companies ◽  
Court Decisions ◽  
Patent Holder ◽  
Trial Court ◽  
Court Of Appeals ◽  
The Us ◽  
Antitrust Laws ◽  
Per Se ◽  
Appeals Court ◽  
Two Sides

On September 15, 2003, the US. Court of Appeals for the Eleventh Circuit held that agreements between pharmaceutical and generic companies not to compete are not per se unlawful if these agreements do not expand the existing exclusionary right of a patent. The Valley DrugCo.v.Geneva Pharmaceuticals decision emphasizes that the nature of a patent gives the patent holder exclusive rights, and if an agreement merely confirms that exclusivity, then it is not per se unlawful. With this holding, the appeals court reversed the decision of the trial court, which held that agreements under which competitors are paid to stay out of the market are per se violations of the antitrust laws. An examination of the Valley Drugtrial and appeals court decisions sheds light on the two sides of an emerging legal debate concerning the validity of pay-not-to-compete agreements, and more broadly, on the appropriate balance between the seemingly competing interests of patent and antitrust laws.

Offer of methods for minimizing key investment risks of “R-Pharm” JSC

2020 ◽  
Vol 17 (1) ◽  
pp. 58-67
Author(s):  
N. A. Kabanova ◽  
I. K. Alekseeva
Keyword(s):  
Strategic Planning ◽  
Pharmaceutical Company ◽  
Simulation Modeling ◽  
Return On Investment ◽  
System Analysis ◽  
Social Orientation ◽  
Pharmaceutical Companies ◽  
The Subject ◽  
High Degree

The article is devoted to the assessment of potential investment risks of the pharmaceutical company “R-Pharm” JSC with the aim of identifying the highest priority risks and developing methods for minimizing them. The relevance of the study is determined by the fact that the pharmaceutical business is characterized by a high degree of social orientation and annually invests $ 140 billion in the development of production and research, which determines the need for a risk-based approach to ensure the return on investment. The subject of this article is the investment risks of pharmaceutical companies, and the subject of research is the domestic pharmaceutical company “R-Pharm”. In order to assess the potential investment risks of “R-Pharm” JSC, the authors used elements of simulation modeling and system analysis. The proposed methods to minimize key investment risks are aimed at improving the efficiency of investment activities and is recommended as an element of the strategic planning of the company.

Relationship between Cross-Border Mergers and Acquisitions and International Trade: The Case of Russian Pharmaceutical Industry

2020 ◽  
pp. 81-94
Author(s):  
Alexandra V. Chugunova ◽  
Olga A. Klochko
Keyword(s):  
International Trade ◽  
Mergers And Acquisitions ◽  
Volume Growth ◽  
Pharmaceutical Products ◽  
Pharmaceutical Companies ◽  
Cross Border ◽  
Export Volume ◽  
Relationship Of ◽  
Geographical Diversification ◽  
The Relationship

This research studies the relationship of cross-border mergers and acquisitions to international trade through the lens of Russian pharmaceutical market. To this aim, the study analyses the woks of foreign economists dedicated to evaluating the link between foreign direct investment and international trade, and the influence of mergers and acquisitions on countries’ export and import flows. The research also presents a correlation analysis between the volume of Russian pharmaceutical exports and imports and cross-border deals performed by foreign pharmaceutical companies in Russia. We characterize these deals and conduct a comparative analysis of the regional structure of Russian pharmaceutical exports and imports as well as of the countries of origin of buyers in cross-border mergers and acquisitions. The results of the analysis indicate a positive relationship between cross-border mergers and acquisitions and Russian pharmaceutical exports, which is reflected in the export volume growth and its geographical diversification. However, it is outlined that particular problems of the industry hinder the amelioration of Russian positions in international exports. Similarly, the relationship between cross-border deals and Russian imports is positive: the major pharmaceutical products supply flow occurs from the countries of origin of buyers in cross-border mergers and acquisitions conducted in the Russian pharmaceutical sector.

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