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News from the FDA Image

News from the FDA

ALM Staff & Law Journal Newsletters

The latest from the FDA.

U.S. Seeking Share of Payout on Implants Image

U.S. Seeking Share of Payout on Implants

Jonathan Ringel

Nine years and at least $1 billion ago, class-action plaintiffs settled their claims with makers of silicone breast implants. But one rather weighty party remains unhappy with the deal ' the United States government.

Supremes Mull Maine Discount Prescription Program Image

Supremes Mull Maine Discount Prescription Program

Tony Mauro

The Supreme Court appears torn over what to do with Maine's discount prescription drug program, which has been challenged by the pharmaceutical industry and the Bush Administration as a violation of the federal Medicaid law.

Federal Circuit Negative on Best-mode Defense Image

Federal Circuit Negative on Best-mode Defense

John J. Molenda, Brian D. Coggio & Joseph Evall

The U.S. Court of Appeals for the Federal Circuit has taken an increasingly dim view of an accused infringer's attempt to invalidate the claims of a patent-in-suit by alleging that the patentee failed to satisfy the best-mode requirement.

Features

A China Checklist Image

A China Checklist

Jon F. Tuttle & Min (Amy) Xu

Any company considering an expansion into China should be aware of the specific challenges of Chinese intellectual property law. As the country takes its place in the global economy, many aspects of IP law are evolving quickly. Often, the company with the best IP strategy gains a critical advantage over its competitors.

Features

Patent Reissue Strategies and Pitfalls Image

Patent Reissue Strategies and Pitfalls

Kirk A. Gottlieb & Robert R. Sachs

A properly drafted set of patent claims captures any foreseeable competitor activity without being so broad as to read on the prior art. In the real world, such perfect claims are difficult to craft. Oftentimes, patent claims are drafted too narrowly and competitive products avoid infringement. Likewise, later discovered prior art may render broad claims invalid. But all is not lost, as the United States Patent Code provides patentees with procedures for correcting imperfect claims.

Patents As a Defense in the Customs Office Image

Patents As a Defense in the Customs Office

Howard M. Gitten

The shortage of key personnel in cutting-edge technology industries has been a bane to technology companies that for the last decade have found themselves relying more and more on imported brainpower. This problem has particularly affected smaller companies that are less able to pay the highest salaries in order to attract employees. U.S. companies often find themselves turning to Europe, India and the Far East to import key technical staff. To hire a foreign national, appropriate government approval, in the form of an H-1B visa, is required. However, H-1B visas last only 3 years and can be renewed for only one additional three-year term. Thus, these employees often return to their home countries once their visas expire.

Features

New Financial Concepts in Patents Image

New Financial Concepts in Patents

Nir Kossovsky

The bear market, the uncertain economy and pre-war jitters caused companies to seek to increase their cash reserves and to look aggressively for opportunities to increase their revenue. Certain advanced financial strategies recently used in financial markets may offer companies the opportunity to do just that. In particular, in-house patent attorneys and consultants should seriously consider recommending patent monetization as an alternative to standard patent licensing. The emerging monetization strategies that provide alternatives to licensing are founded on the growing appreciation that patents are actually an asset class in a financial sense as compared to a mere asset from an accounting sense. An asset class, as distinct from an asset, comprises a collection of assets that have in common systematic or macroeconomic drivers of price and risk.

Features

Testimony Of Expert Under Daubert And FRE 702 Upheld Image

Testimony Of Expert Under Daubert And FRE 702 Upheld

Andrew J. Olek

The Federal Circuit ruled that a district court properly performed the 'gatekeeping' role required of it by the U.S. Supreme Court in <i>Daubert v. Merrell Dow Pharmaceuticals, Inc.</i> and by Rule 702 of the Federal Rules of Evidence when it allowed the testimony of plaintiff's damages expert. <i>Micro Chemical, Inc. v. Lextron, Inc.</i> (Fed. Cir., Jan. 24, 2003). The plaintiff, Micro Chemical, alleged that defendants Lextron and Turnkey Computer Systems, Inc. infringed Micro Chemical's U.S. Patent No. 5,315,505 for a computerized medical records system for tracking health histories and medical treatments of livestock.

Features

ITC Proves Useful Resource for Life Science Firms Image

ITC Proves Useful Resource for Life Science Firms

Ralph A. Mittelberger

The U.S. International Trade Commission (ITC)'s power to seal the country's borders against importation of products covered by U.S. patents makes this federal agency a powerful resource for patent holders. Still, many life sciences companies doing business in this country fail to utilize this quasi-judicial body to protect their pharmaceuticals, medical devices and other patented products.

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