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ANDA Litigation Discovery
Patent infringement litigation based on an Abbreviated New Drug Application ('ANDA') presents certain unique challenges to the discovery process. Unlike ordinary patent litigation, little if any information helpful to the patent owner is publicly available. Instead, the patent owner must rely on a well thought out discovery plan to obtain certain information from the ANDA applicant. Suggestions for designing such a plan are presented below.
Background
The Drug Price Competition and Patent Term Restoration Act of 1984, more commonly known as the Hatch-Waxman Act ('the Act'), was established to balance the entry of generics into the marketplace while maintaining research and development incentives for innovator companies. A generic drug manufacturer may challenge the market exclusivity enjoyed by the manufacturer of a patented drug by filing an ANDA. In conjunction with the ANDA, the generic manufacturer is required to file one of four Certifications, namely, a Paragraph I, II, III, or IV Certification. The most common certification is the Paragraph IV Certification, in which the ANDA applicant certifies that the manufacture, use, or sale of the proposed generic drug product (the 'ANDA product') does not infringe the patent covering the drug and/or that the patent is invalid or unenforceable. (Certification under paragraphs I-III generally does not result in litigation as they certify that: (I) no patent information has been filed with the FDA, (II) the patent has expired, or (III) the patent will expire on a date certain.) Once the application and the Certification have been filed, the ANDA applicant is required to give notice of its filing to the New Drug Application ('NDA') holder and the patent owner within 20 days.
Major Differences In UK, U.S. Copyright Laws
This article highlights how copyright law in the United Kingdom differs from U.S. copyright law, and points out differences that may be crucial to entertainment and media businesses familiar with U.S law that are interested in operating in the United Kingdom or under UK law. The article also briefly addresses contrasts in UK and U.S. trademark law.
The Article 8 Opt In
The Article 8 opt-in election adds an additional layer of complexity to the already labyrinthine rules governing perfection of security interests under the UCC. A lender that is unaware of the nuances created by the opt in (may find its security interest vulnerable to being primed by another party that has taken steps to perfect in a superior manner under the circumstances.
Strategy vs. Tactics: Two Sides of a Difficult Coin
With each successive large-scale cyber attack, it is slowly becoming clear that ransomware attacks are targeting the critical infrastructure of the most powerful country on the planet. Understanding the strategy, and tactics of our opponents, as well as the strategy and the tactics we implement as a response are vital to victory.
Legal Possession: What Does It Mean?
Possession of real property is a matter of physical fact. Having the right or legal entitlement to possession is not "possession," possession is "the fact of having or holding property in one's power." That power means having physical dominion and control over the property.
The Stranger to the Deed Rule
In 1987, a unanimous Court of Appeals reaffirmed the vitality of the "stranger to the deed" rule, which holds that if a grantor executes a deed to a grantee purporting to create an easement in a third party, the easement is invalid. Daniello v. Wagner, decided by the Second Department on November 29th, makes it clear that not all grantors (or their lawyers) have received the Court of Appeals' message, suggesting that the rule needs re-examination.