Brief for Amicus Curiae, Pharmaceutical Research and Manufacturers of America, in Opposition to Overruling the Present Standard of Review of Patent and Trademark Office Decisions

Brief for Amicus Curiae, Pharmaceutical Research and Manufacturers of America, in Opposition to Overruling the Present Standard of Review of Patent and Trademark Office Decisions PDF Author: Pharmaceutical Research and Manufacturers of America
Publisher:
ISBN:
Category : Patent practice
Languages : en
Pages : 14

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Brief for Amicus Curiae, Pharmaceutical Research and Manufacturers of America, in Opposition to Overruling the Present Standard of Review of Patent and Trademark Office Decisions

Brief for Amicus Curiae, Pharmaceutical Research and Manufacturers of America, in Opposition to Overruling the Present Standard of Review of Patent and Trademark Office Decisions PDF Author: Pharmaceutical Research and Manufacturers of America
Publisher:
ISBN:
Category : Patent practice
Languages : en
Pages : 14

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Brief for Amicus Curiae New York Intellectual Property Law Association in Support of Reviewing Patent and Trademark Office Fact-finding Under the Clearly Erroneous Standard of Review

Brief for Amicus Curiae New York Intellectual Property Law Association in Support of Reviewing Patent and Trademark Office Fact-finding Under the Clearly Erroneous Standard of Review PDF Author: New York Intellectual Property Law Association
Publisher:
ISBN:
Category : Patent practice
Languages : en
Pages : 34

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Generic drug entry prior to patent expiration an FTC study

Generic drug entry prior to patent expiration an FTC study PDF Author:
Publisher: DIANE Publishing
ISBN: 1428951938
Category :
Languages : en
Pages : 129

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The Law of Patents for Useful Inventions

The Law of Patents for Useful Inventions PDF Author: William Callyhan Robinson
Publisher:
ISBN:
Category : Patent laws and legislation
Languages : en
Pages : 754

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Appellate Mediation Program

Appellate Mediation Program PDF Author: United States. Court of Appeals (District of Columbia Circuit)
Publisher:
ISBN:
Category : Appellate procedure
Languages : en
Pages : 12

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Keeping Faith with the Constitution

Keeping Faith with the Constitution PDF Author: Goodwin Liu
Publisher: Oxford University Press
ISBN: 0199752834
Category : Law
Languages : en
Pages : 274

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Book Description
Chief Justice John Marshall argued that a constitution "requires that only its great outlines should be marked [and] its important objects designated." Ours is "intended to endure for ages to come, and consequently, to be adapted to the various crises of human affairs." In recent years, Marshall's great truths have been challenged by proponents of originalism and strict construction. Such legal thinkers as Supreme Court Justice Antonin Scalia argue that the Constitution must be construed and applied as it was when the Framers wrote it. In Keeping Faith with the Constitution, three legal authorities make the case for Marshall's vision. They describe their approach as "constitutional fidelity"--not to how the Framers would have applied the Constitution, but to the text and principles of the Constitution itself. The original understanding of the text is one source of interpretation, but not the only one; to preserve the meaning and authority of the document, to keep it vital, applications of the Constitution must be shaped by precedent, historical experience, practical consequence, and societal change. The authors range across the history of constitutional interpretation to show how this approach has been the source of our greatest advances, from Brown v. Board of Education to the New Deal, from the Miranda decision to the expansion of women's rights. They delve into the complexities of voting rights, the malapportionment of legislative districts, speech freedoms, civil liberties and the War on Terror, and the evolution of checks and balances. The Constitution's framers could never have imagined DNA, global warming, or even women's equality. Yet these and many more realities shape our lives and outlook. Our Constitution will remain vital into our changing future, the authors write, if judges remain true to this rich tradition of adaptation and fidelity.

The Public Domain

The Public Domain PDF Author: James Boyle
Publisher: Createspace Independent Publishing Platform
ISBN: 9781979963077
Category :
Languages : en
Pages : 292

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Book Description
In this insightful book you will discover the range wars of the new information age, which is today's battles dealing with intellectual property. Intellectual property rights marks the ground rules for information in today's society, including today's policies that are unbalanced and unspupported by any evidence. The public domain is vital to innovation as well as culture in the realm of material that is protected by property rights.

The Law and Economics of Generic Drug Regulation

The Law and Economics of Generic Drug Regulation PDF Author: Christopher Scott Hemphill
Publisher: Stanford University
ISBN:
Category :
Languages : en
Pages : 249

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Book Description
This dissertation examines the law and economics of generic drug entry, and the problems that arise from specific U.S. regulatory arrangements that govern innovation and competition in the market for patented pharmaceuticals. As Chapter 1 explains, competitive entry by generic drug makers is limited by both patents and industry-specific regulation, which together provide the means for brand-name drug makers to avoid competition and thereby recoup large investments in research, development, and testing. At the same time, the complex rules of the Hatch-Waxman Act furnish a pathway by which generic drug makers may challenge the validity or scope of brand-name patents, with a view to entering the market with a competing product prior to patent expiration. The subsequent chapters examine several aspects of the competitive interaction between brand-name and generic drug makers. Chapter 2 analyzes settlements of patent litigation between brand-name and generic drug makers, in which the brand-name firm pays the generic firm in exchange for delayed market entry. Such pay-for-delay settlements are an important, unresolved question in U.S. antitrust policy. The analysis reveals that the pay-for-delay settlement problem is more severe than has been commonly understood. Several specific features of the Act—in particular, a 180-day bounty granted to certain generic drug makers as an incentive to pursue pre-expiration entry—widen the potential for anticompetitive harm from pay-for-delay settlements, compared to the usual understanding. In addition, I show that settlements are "innovation inefficient" as a means of providing profits and hence ex ante innovation incentives to brand-name drug makers. To the extent that Congress established a preferred tradeoff between innovation and competition when it passed the Act, settlements that implement a different, less competition-protective tradeoff are particularly problematic from an antitrust standpoint. Chapter 3 synthesizes available public information about pay-for-delay settlements in order to offer a new account of the extent and evolution of settlement practice. The analysis draws upon a novel dataset of 143 such settlements. The analysis uncovers an evolution in the means by which a brand-name firm can pay a generic firm to delay entry, including a variety of complex "side deals" by which a brand-name firm can compensate a generic firm in a disguised fashion. It also reveals several novel forms of regulatory avoidance. The analysis in the chapter suggests that, as a matter of institutional choice, an expert agency is in a relatively good position to conduct the aggregate analysis needed to identify an optimal antitrust rule. Chapter 4 examines the co-evolution of increased brand-name patenting and increased generic pre-expiration challenges. It draws upon a second novel dataset of drug approvals, applications, patents, and other drug characteristics. Its first contribution is to chart the growth of patent portfolios and pre-expiration challenges. Over time, patenting has increased, measured by the number of patents per drug and the length of the nominal patent term. During the same period, challenges have increased as well, and drugs are challenged sooner, relative to brand-name approval. The analysis shows that brand-name sales, a proxy for the profitability of the drug, have a positive effect on the likelihood of generic challenge, consistent with the view that patents that later prove to be valuable receive greater ex post scrutiny. The likelihood of challenge also varies by patent type and timing of expiration. Conditional on sales and other drug characteristics, drugs with weaker patents, particularly those that expire later than a drug's basic compound patent, face a significantly higher likelihood of challenge. Though the welfare implications of Hatch-Waxman patent challenge provisions are complicated, these results suggest these challenges serve a useful purpose, in promoting scrutiny of low quality and late-expiring patents.

Investing in Patents

Investing in Patents PDF Author: Russell Krajec
Publisher: Blueiron Press
ISBN: 9780997410105
Category :
Languages : en
Pages : 215

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Book Description
Most patents are worthless. By some estimations, this could be true of 95% of patents. Startup companies don't help themselves by making fatal mistakes, from filing provisional patents (almost always a bad idea) to treating their first patent as the most important one in their portfolio (it almost never is). How can an investor help their portfolio companies navigate the system? "Investing In Patents" discusses the patent process from an investor's view, but with insider knowledge.Investment-grade patents do not just happen by chance, they are curated through due diligence prior to filing the patent, then careful and consistent management through the process. Good patents are clear, straightforward, and easy to read. Understandable patent applications are easier to examine, meaning the issued patent is legitimate and defensible. Good patents have real, solid commercial value. The value of a patent only comes when it captures commercial value - not when it captures some cool technology. BlueIron IP's business is investing in patents, and this book discusses BlueIron's techniques and tools for evaluating inventions and managing portfolios specifically for startup companies. Startup companies have specific characteristics and needs that dictate strategies that often do not apply to larger companies with established products and systems. "Investing In Patents" discusses how startups need to manage their patent process, and how investors and guide them.

In Re Lyons

In Re Lyons PDF Author:
Publisher:
ISBN:
Category :
Languages : en
Pages : 210

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Book Description