IP News
Recent rulings of importance to your practice.
Vigilance and Planning Are Necessary in Bankruptcy Matters
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
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.
In the Spotlight
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.
Risk Assessment and Post-Market Programs
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.
New Pharmaceutical Agreement Notification Filing Requirements
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.
FDA Cannot Force an Over-the-Counter Drug Switch
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
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.
