Searching Content indexed under Healthcare by Finnegan, Henderson, Farabow, Garrett & Dunner, LLP ordered by Published Date Descending.
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The Amazing Story Of The Unsinkable Claim 8: How Many Lives Does A Patent Claim Have?
Decision: Mylan Pharmaceuticals Inc. v. Research Corporation Technologies, Inc., 914 F.3d 1366 (Fed. Cir. 2019) (LOURIE, Bryson, Wallach)
United States
19 Jul 2019
FDA Issues An Update To Working Model For Software Precertification
In January 2019, FDA issued an update to the Working Model for its Software as a Medical Device ("SaMD") Precertification Program.
United States
14 May 2019
FDA Final Guidance On Application Of Statutory Factors In Determining When A REMS Is Necessary
On April 4, 2019, FDA issued final guidance on FDA's application of the statutory factors in determining when a risk evaluation and mitigation strategy (REMS) is necessary.
United States
30 Apr 2019
FDA Final Guidance On Immunogenicity Testing Of Therapeutic Protein Products
On January 23, 2019, FDA issued final guidance on immunogenicity testing of therapeutic protein products.
United States
4 Feb 2019
FDA Draft Guidance On Common Issues In Drug Development For Rare Diseases
On January 16, 2019, FDA issued draft guidance on Rare Diseases: Common Issues in Drug Development. The FDA intends the guidance to help sponsors conduct more efficient ...
United States
29 Jan 2019
FDA Issues Guidance On Logical Observation Identifiers Names And Codes For In Vitro Diagnostic Tests
On June 15, 2018, FDA issued Guidance on Logical Observation Identifiers Names and Codes (LOINC) for in vitro diagnostic (IVD) tests.
United States
22 Jan 2019
FDA Issues Draft Guidance On Management Of Cybersecurity In Medical Devices
On October 18, 2018, FDA issued draft Guidance on Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.
United States
23 Nov 2018
FDA Draft Guidance On Early Drug Development And The Role Of Pre-IND Meetings For Rare Diseases
On October 15, 2018, FDA issued draft guidance on Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings.
United States
8 Nov 2018
CAFC Affirms PTAB's Priority Determination In Natural Alternatives v. Iancu
In Natural Alternatives International, Inc. v. Iancu., No. 2017-1962 (Fed. Cir. Oct. 1, 2018), the CAFC affirmed the PTAB's priority determination invalidating Natural Alternative's patent directed to a human dietary supplement that increases the anaerobic working capacity of muscle and other tissues.
United States
15 Oct 2018
Patenting The Future Of Medicine: The Intersection Of Patent Law And Artificial Intelligence In Medicine
Artificial intelligence (AI) is rapidly transforming the world of medicine, and the intellectual property directed to these inventions must keep pace.
United States
16 Feb 2018
Cancer Immunotherapy Pilot Program Set To Expire In June Unless Extended
Last year, President Obama announced the National Cancer Moonshot, an initiative with the goal of making ten years' worth of advances in cancer research and treatment over the following five years.
United States
4 Jul 2017
Could The 'Dance' Already Be Over? ACA Repeal And Biosimilars
As President Donald Trump completes his first several weeks in office, he has made clear that one of his top priorities is repealing the Patient Protection and Affordable Care Act.
United States
10 Apr 2017
How Digital Health Startups Can Leverage Intellectual Property
One of the fastest growing segments of startups is digital health startups, creating cutting-edge innovations that improve the management and operations of hospitals and clinical practices, and the effectiveness of patient care.
United States
24 Jan 2016
Physicians' Direction Or Control Over Patients' Drug Administration Results In Finding Of Induced Infringement Against Generic Drug Manufacturers
Thus, there would be no defense of divided infringement because through this attribution, physicians would directly infringe the patent claims, and the generic drug manufacturer defendants would induce such infringement because their drug labeling instructs physicians to follow the patented regimen.
United States
22 Oct 2015
Healthcare Patents Not Immune From Covered Business Method Review
When Congress debated and enacted Section 18 of the AIA, creating "covered business method (CBM) review," healthcare industry patent holders took comfort in the statute's seemingly narrow reach.
United States
14 Oct 2015
Federal Circuit Affirms Preliminary Injunction Barring Defendant from Launching FDA-Approved Generic Drug
In AstraZeneca LP v. Apotex, Inc., Nos. 09-1381, -1424 (Fed. Cir. Nov. 1, 2010), the Federal Circuit upheld the district courtís finding of no anticipation of AstraZeneca LP and AstraZeneca ABís (collectively "AstraZeneca") method claims and affirmed the district courtís grant of a preliminary injunction against Apotex, Inc. and Apotex Corp. (collectively "Apotex").
United States
5 Jan 2011
Trade Dress Protection: Eye Candy
The sweeping competition injected into the industry by generic-drug manufacturers has increased the need for brand-name drugmakers to boost consumer recognition of, and desire for, their branded products.
United States
5 Jun 2009
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