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Search Results (2430) Documents on biotech life sciences Show: results per page Sort by:  | FDA Sends Letter to Mobile App Developer for Failure to Obtain 510(k) Clearance
Carmelina G. Allis; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article May 24, 2013, previously published on May 22, 2013 FDA has issued an “It Has Come to Our Attention Letter” to Biosense Technologies Private Limited for failure to have a 510(k) clearance for its mobile app, the uChek Urine Analyzer. The app can be downloaded for 99 cents through the iTunes Apps Store, and uses the phone’s camera...
| | USPTO Launches New After Final Consideration Pilot Program to Reduce Requests for Continued Examination (RCEs)
Courtenay C. Brinckerhoff; Foley & Lardner LLP;
Legal Alert/Article May 24, 2013, previously published on May 20, 2013 In a Federal Register Notice published on May 17, 2013, the USPTO announced After Final Consideration Pilot Program 2.0 (AFCP 2.0) as part of its ongoing efforts to “reduce pendency by reducing the number of Requests for Continued Examination (RCE) and encouraging increased collaboration...
| | CDRH Issues Final Appeals Guidance, Q&A About FDASIA Appeals Process
Jennifer D. Newberger, Jeffrey K. Shapiro; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article May 23, 2013, previously published on May 20, 2013 As discussed in our prior posts, the Center for Devices and Radiological Health (“CDRH”) has taken much needed steps to improve the most commonly used appeal process, request for supervisory review, available under 21 C.F.R. § 10.75.
|  | Monsanto Ruling Protects Innovators of Self-Replicating Biotechnology
William L. Warren, David E. Wigley; Sutherland Asbill & Brennan LLP;
Legal Alert/Article May 17, 2013, previously published on May 14, 2013 On May 13, 2013, a unanimous U.S. Supreme Court held in Monsanto v. Bowman that the doctrine of patent exhaustion does not permit a farmer to reproduce patented seeds for planting and harvesting without the patent holder's permission, thus affirming the U.S. Court of Appeals for the Federal...
| | FDA Announces Public Meeting Regarding Device Modifications
Jennifer D. Newberger; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article May 16, 2013, previously published on May 14, 2013 In the Federal Register of May 8, 2013, FDA announced a public meeting titled “510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device.” The notice states that the focus of the meeting will be “FDA's interpretation of its regulations...
| | Patent Exhaustion and Self-Replicating Technologies
Antoinette F. Konski; Foley & Lardner LLP;
Legal Alert/Article May 16, 2013, previously published on May 13, 2013 Today in Bowman v. Monstanto Co., 569 U.S. -- (2013), a unanimous Supreme Court held that under the doctrine of patent exhaustion,the authorized sale of a patented article only gives the purchaser or any subsequent owner of the patented article the right to use or resell that article. It does not...
| | Federal Circuit Upholds One Claim Covering Combigan
Courtenay C. Brinckerhoff; Foley & Lardner LLP;
Legal Alert/Article May 8, 2013, previously published on May 7, 2013 In Allergan, Inc. v. Sandoz, Inc., the Federal Circuit reversed the district court in part, finding that Allergan’s composition claims and most of its method claims are invalid as obvious, but upholding one method claim because it recites a non-obvious result. Some of the court’s...
| | Generic and Innovator Drugs: The Next Generation
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article May 8, 2013, previously published on May 7, 2013 Growing up in the late 1970s and 1980s I was a fan of several science fiction television series and movies: Dr. Who, Star Wars, and, of course, Star Trek. I remember well the voyages of the starship Enterprise under the command of Captain James T. Kirk (in rerun). I also remember the September 1987...
| | Supreme Debate: Are Human Genes Patentable
Therese M. Finan; Venable LLP;
Legal Alert/Article May 6, 2013, previously published on April 30, 2013 On April 15, 2013, tackling an issue of significant importance to the biotechnology and health care industries, the U.S. Supreme Court heard oral arguments over whether human genes are patentable and more specifically, whether isolated DNA is patentable.
| | Congress Drafts Compounding Legislation -- Defines Compounded Drugs as "New Drugs" Under the FFDCA and Creates Bright Line Between "Traditional Compounders" and "Compounding Manufacturers"
Duane Morris LLP;
Legal Alert/Article May 2, 2013, previously published on April 29, 2013 In the wake of the New England Compounding Center meningitis outbreak, the federal government has actively pushed for greater legislative oversight over compounding pharmacies. On April 26, 2013, the U.S. Senate Committee on Health, Education, Labor & Pensions ("HELP") released...
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