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Patent Protection or <i>Per Se</i> Antitrust Violation?
As the winter months approached, a storm was brewing in the antitrust world. The U.S. Courts of Appeals for the Sixth and Eleventh circuits have split over the per se illegality of Hatch-Waxman patent-settlement agreements by which a patent-holding drug maker pays a generic drug company to delay its entry into the market. The Federal Trade Commission (FTC) has harshly criticized these agreements, and now the Supreme Court has an opportunity to calm the fury.
The Issue
At the heart of the storm lies the following question: When does a patent-holding drug company step beyond the bounds of the legal monopoly granted by its patent and into the realm of per se antitrust liability? The Hatch-Waxman Act sets the background for the two circuit court cases. In 1984, Congress passed the Hatch-Waxman Act, formally known as the Drug Price Competition and Patent Term Restoration Act (21 USC ' 355) with the express purpose of “mak[ing] available more low-cost generic drugs.” H.R. Rep. No. 98-857, pt.1, at 14-15 (1984), reprinted in 1984 USCCAN 2647. The Hatch-Waxman Act establishes a special FDA approval procedure for generic drug companies. The generic must file an Abbreviated New Drug Application (ANDA) and certify that its generic drug will not infringe any existing patent (a “paragraph IV certification”). The act also provides a 180-day exclusive marketing period to the first company to file an application with the FDA for a particular generic drug.
Yachts, Jets, Horses & Hooch: Specialized Commercial Leasing Models
Defining commercial real estate asset class is essentially a property explaining how it identifies — not necessarily what its original intention was or what others think it ought to be. This article discusses, from a general issue-spot and contextual analysis perspective, how lawyers ought to think about specialized leasing formats and the regulatory backdrops that may inform what the documentation needs to contain for compliance purposes.
Hyperlinked Documents: The Latest e-Discovery Challenge
As courts and discovery experts debate whether hyperlinked content should be treated the same as traditional attachments, legal practitioners are grappling with the technical and legal complexities of collecting, analyzing and reviewing these documents in real-world cases.
Identifying Your Practice's Differentiator
How to Convey Your Merits In a Way That Earns Trust, Clients and Distinctions Just as no two individuals have the exact same face, no two lawyers practice in their respective fields or serve clients in the exact same way. Think of this as a "Unique Value Proposition." Internal consideration about what you uniquely bring to your clients, colleagues, firm and industry can provide untold benefits for your law practice.
Risks and Ad Fraud Protection In Digital Advertising
The ever-evolving digital marketing landscape, coupled with the industry-wide adoption of programmatic advertising, poses a significant threat to the effectiveness and integrity of digital advertising campaigns. This article explores various risks to digital advertising from pixel stuffing and ad stacking to domain spoofing and bots. It will also explore what should be done to ensure ad fraud protection and improve effectiveness.
Turning Business Development Plans Into Reality
This article offers practical insights and best practices to navigate the path from roadmap to rainmaking, ensuring your business development efforts are not just sporadic bursts of activity, but an integrated part of your daily success.