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IP News

Compiled by Kathlyn Card-Beckles

Recent rulings of importance to your practice.

Features

In the Spotlight

William Crowe

Tenants that seek the future ability to sublease a portion of their space frequently settle for language to the effect that the landlord will not unreasonably withhold, delay, or condition its consent to a proposed sublease by the tenant. Unfortunately, this typical language only provides a tenant with minimal protection.

The Leasing Hotline

ALM Staff & Law Journal Newsletters

Recent rulings of importance to you and your practice.

Features

Vigilance and Planning Are Necessary in Bankruptcy Matters

Raymond J. Werner

Two recent decisions by the U.S. Court of Appeals for the Seventh Circuit have attracted the attention of leasing lawyers. Both of those cases demonstrate that landlords and tenants alike may be taken by surprise by the operation of the Bankruptcy Code.

The Evolution of a Lease Provision: Sublease and Assignment

Myles Hannan & Gina A. Leib

In the absence of a lease provision restricting subleasing and assignment, common law permits a tenant to freely sublease its leased premises or assign its leasehold interest in the leased premises. In order to provide for maximum landlord control over a tenant's ability to sublease or assign its leasehold interest, while at the same time balancing the need of tenants for an exit strategy, modern forms of leases contain extensive assignment and sublease provisions. This article traces the manner in which those provisions have evolved over the years.

Features

New Pharmaceutical Agreement Notification Filing Requirements

ALM Staff & Law Journal Newsletters

As of Jan. 7, 2004, pursuant to Section 1112 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, agreements between brand-name and generic pharmaceutical companies regarding the manufacture, marketing, and sale of generic versions of brand-name drug products are required to be filed with the Federal Trade Commission and the U.S. Department of Justice.

Features

Case Briefing

ALM Staff & Law Journal Newsletters

Recent rulings of importance to your practice.

Features

Risk Assessment and Post-Market Programs

Roseann B. Termini

How do the medical device industry and the FDA prevent risks to the end user once the product is marketed? There is no simple answer to this question. Post-market vigilance in terms of risk assessment involves complex issues. These issues involve a cost/benefit analysis in terms of a "best approach" to post-market co-vigilence.

Features

FDA Cannot Force an Over-the-Counter Drug Switch

Andrew S. Krulwich

Does the Food and Drug Administration have authority to force manufacturers of prescription drug products to switch those products to over-the-counter (OTC) distribution against their will? The FDA is currently grappling with this issue, a dispute that has generated substantial controversy, including statements by FDA officials and coverage in leading newspapers.

Pennsylvania Remains a <i>Frye</i> State

ALM Staff & Law Journal Newsletters

Chief Justice Ralph J. Cappy of Pennsylvania's Supreme Court issued an opinion on Dec. 31, 2003, declaring that the State of Pennsylvania would remain a "<i>Frye</i> state" and would not follow suit with much of the rest of the nation in using the <i>Daubert</i> test to qualify expert witnesses.

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MOST POPULAR STORIES

  • Surveys in Patent Infringement Litigation: The Next Frontier
    Most experienced intellectual property attorneys understand the significant role surveys play in trademark infringement and other Lanham Act cases, but relatively few are likely to have considered the use of such research in patent infringement matters. That could soon change in light of the recent admission of a survey into evidence in <i>Applera Corporation, et al. v. MJ Research, Inc., et al.</i>, No. 3:98cv1201 (D. Conn. Aug. 26, 2005). The survey evidence, which showed that 96% of the defendant's customers used its products to perform a patented process, was admitted as evidence in support of a claim of inducement to infringe. The court admitted the survey into evidence over various objections by the defendant, who had argued that the inducement claim could not be proven without the survey.
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  • In the Spotlight
    On May 9, 2003, the U.S. Attorney's Office for the District of Massachusetts announced that Bayer Corporation, the pharmaceutical manufacturer, had been sentenced and ordered to pay a criminal fine of $5,590,800 stemming from its earlier plea of guilty to violating the Federal Prescription Drug Marketing Act by failing to list with the FDA its drug product, Cipro, that was privately labeled for an HMO. Such listing is required under the federal Food, Drug &amp; Cosmetic Act. The Federal Prescription Drug Marketing Act, Pub. L. 100-293, enacted on April 22, 1988, as modified on August 26, 1992 by the Prescription Drug Amendments (PDA) Pub. L. 102-353, 106 Stat. 941, amended sections 301, 303, 503, and 801 of the Federal Food, Drug, and Cosmetic Act, codified at 21 U.S.C. '' 331, 333, 353, 381, to establish requirements for distributing prescription drug samples.
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