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The Preclinical Research Statutory Infringement Exemption: How Far Back Is 'Reasonably Related'? Image

The Preclinical Research Statutory Infringement Exemption: How Far Back Is 'Reasonably Related'?

K. Shannon Mrksich, Ph.D. & Meredith Martin Addy

On June 13, 2005, the U.S. Supreme Court expanded the safe harbor provision of 35 U.S.C. '271(e)(1) to the "use of patented compounds in preclinical studies ... as long as there is a reasonable basis for believing that the experiments will produce 'the types of information that are relevant to an [Investigational New Drug application ("IND")] or [New Drug Application ("NDA")].'" <i>Merck KGaA v. Integra Lifesciences I, Ltd.</i>, __ U.S. __, 125 S.Ct. 2372, 2383-84 (U.S. 2005) (quoting Brief of U.S. as Amicus Curiae 23) ("<i>Integra II</i>").

Industrywide Patent Enforcement Strategies Image

Industrywide Patent Enforcement Strategies

Alexander I. Poltorak, Ph.D.

Enforcement strategies in an industrywide patent enforcement campaign may differ from strategies advantageous in a single litigation. In a single litigation scenario, the goal is to maximize the recovery in the present case without any consideration given to possible effects the present lawsuit may have on future cases. Although this may be somewhat shortsighted as the same players (plaintiff, defendant, and attorneys) are likely to cross paths again and their previous experience will undoubtedly affect their mutual expectations and behavior in subsequent encounters, in reality it is not taken into consideration as often as it should be. Not so in an industrywide enforcement campaign, where the goal is to maximize the monetary recovery for the patent or patent portfolio with respect to all infringers. In this scenario, each case must be considered not in isolation but in the context of the overall enforcement campaign.

Eminent Domain Law Image

Eminent Domain Law

ALM Staff & Law Journal Newsletters

Expert analysis of major rulings.

Features

Index Image

Index

ALM Staff & Law Journal Newsletters

Everything contained in this issue in an easy-to-follow format.

Real Property Law Image

Real Property Law

ALM Staff & Law Journal Newsletters

Writ Of Assistance Upheld As to Non-Parties in Foreclosure Action Citibank, N.A. v. Plagakis NYLJ 8/15/05, p. 32, col. 1 AppDiv, Second Dept (memorandum…

A Possible Need to Amend CPLR ' 6501 Image

A Possible Need to Amend CPLR ' 6501

Joel David Sharrow

A recent decision of the Supreme Court, N.Y. County, in a landlord-tenant dispute has highlighted the extreme difficulty facing an owner when a notice of pendency is filed against its realty in an action arguably affecting the title to, possession, use or enjoyment of, the owner's real property, CPLR ' 6501.

Landlord & Tenant Image

Landlord & Tenant

ALM Staff & Law Journal Newsletters

Expert analysis of key cases.

Features

Development Image

Development

ALM Staff & Law Journal Newsletters

Recent rulings of importance to your practice.

October issue in PDF format Image

October issue in PDF format

ALM Staff & Law Journal Newsletters

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Practice Tip: New Federal Rules for Electronic Discovery May Become Effective in 2006 Image

Practice Tip: New Federal Rules for Electronic Discovery May Become Effective in 2006

Beth L. Kaufman & David Black

In June 2005, the Committee on Rules of Practice and Procedure of the Judicial Conference of the United States approved comprehensive amendments to the Federal Rules of Civil Procedure regarding discovery of electronically stored information ('ESI'). These amendments were next presented to the Judicial Conference on Sept. 20, 2005 and then to the U.S. Supreme Court and Congress. In their present forms, the amendments would become effective as of Dec. 1, 2006. These e-discovery rule amendments include changes to FRCP Rules 16, 26, 33, 34, 37, and 45, and focus on five areas: 1) early attention to e-discovery issues, 2) discovery of ESI that is not reasonably accessible, 3) procedure for asserting privilege after production, 4) interrogatories and requests for production of ESI, and 5) sanctions and a safe harbor for certain lost ESI.

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