Spurred by President Biden's call for action to increase drug competition and a 2021 letter addressed to the U.S. Patent and Trademark Office (USPTO) by Senators Leahy and Tillis requesting the USPTO "to take action to...more
On November 30, 2021, a jury in the patent infringement suits between Illumina, Inc. and BGI Genomics Co. in the U.S. District Court for the Northern District of California returned a verdict invalidating certain patent...more
Introduction: Alpha-Gal Syndrome -
Alpha-gal syndrome (AGS) is an allergy to red meat and other products made from mammals. In addition to red meat allergy, AGS can also manifest as frequent and deadly-if-untreated...more
Introduction: Meat Alternatives and Cultured Meat -
Conventional meat production has been implicated in environmental damage, the rise of antibiotic resistant bacteria, and increasing emission of greenhouse gasses....more
The Federal Circuit recently issued a split panel decision on induced infringement. The court's decision is important in that it may, if upheld upon further appeal and not distinguished by subsequent courts, limit the ability...more
In this issue, we discuss how real-world evidence can be an important component of satisfying drug approval and post-approval study requirements and also, can provide other tangible advantages to drug sponsors. We also look...more
10/22/2020
/ Bayh-Dole Act ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Drug Approvals ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medical Devices ,
Pharmaceutical Industry ,
Prescription Drugs ,
Real World Evidence ,
Telehealth
Yesterday, the President issued an executive order (EO) on drug pricing for pharmaceuticals covered under Medicare parts B and D. The EO, in essence, proposes a form of price controls for drugs covered under Medicare parts B...more
Laboratory Developed Tests and Their Regulation -
Laboratory developed tests (LDTs) are in vitro diagnostic tests (IVDs) that are designed, developed, manufactured, and performed within a single laboratory. Although the...more
Recently, the Federal Circuit issued its holding in a case dealing with asserting claims of an extended patent covering administration of dimethyl fumarate formulations to treat multiple sclerosis (MS). Dimethyl fumarate...more
8/25/2020
/ Appeals ,
FDA Approval ,
Life Sciences ,
Marketing Exclusivity Periods ,
Noninfringement ,
Patent Infringement ,
Patent Litigation ,
Patent Term Extensions ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Reaffirmation ,
Treatment Method Patents
COVID-19, the disease caused by the SARS-CoV-19 virus, is complex, and the number, type, and severity of symptoms often vary from patient-to-patient. COVID-19 complications and outcomes can vary by age, the presence of...more
The number of cases of SARS-CoV-2 corona virus infection, and COVID-19, the disease caused by virus, continues to increase in the United States—both in number and in location (real-time map). At the same time, the number and...more
Drugs can be divided into two categories: 1) Prescription (Rx) drugs, which require a physician's or other authorized healthcare provider's prescription to obtain; and 2) over-the-counter (OTC) drugs, which can be purchased...more
The Federal Circuit, in Illumina, Inc., v. Ariosia, reversed the summary judgment decision of a lower trial court and upheld—as patent subject matter eligible—claims in two patents (U.S. 9,580,751; U.S. 9,738,931). The...more
The number of cases of SARS-CoV-2 coronavirus infection, and COVID-19, the disease caused by the virus, continue to increase in the United States—both in number and in location (real-time map). At the same time, the number...more
The number of cases of SARS-CoV-2 coronavirus infection, and COVID-19, the disease caused by the virus, continue to increase in the United States—both in number and in location (real-time map). At the same time, the number...more
U.S. prescription drugs can broadly be divided into two categories: 1) small molecule drugs and 2) biologics. Small molecule drugs tend to be chemically synthesized and often have molecular weights under 1,000 Daltons....more
3/9/2020
/ Abbreviated New Drug Application (ANDA) ,
Biologics ,
Biologics Price Competition and Innovation Act of 2009 ,
Biosimilars ,
BPCIA ,
FDA Approval ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Pharmaceutical Industry ,
Prescription Drugs
Recently, a New York-based dietary supplement manufacturer (and its subsidiaries) issued a nationwide recall of all lots of dietary supplement products manufactured and sold between January 2013-November 2019. Because the...more
2/12/2020
/ CGMP ,
Consent Decrees ,
Department of Justice (DOJ) ,
Dietary Supplements ,
Drug Compounding ,
Due Diligence ,
Enforcement Actions ,
FDA Warning Letters ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Inspections ,
Manufacturers ,
Patent Infringement ,
Product Recalls
Guidance Relevant for Purposes of Determining Orphan Drug Designation and Exclusivity. Finalizes Six Other Gene Therapies.
Two "hot" areas in drug development are i) gene therapies, and ii) therapies for orphan diseases....more
The legal definitions of a drug and a medical device set forth in the Food, Drug, and Cosmetic Act have some important overlapping provisions. Because of the overlapping provisions, theoretically the U.S. Food and Drug...more
12/20/2019
/ 510(k) RTA ,
FDA Approval ,
FDA Warning Letters ,
Food and Drug Administration (FDA) ,
Manufacturers ,
Medical Devices ,
Pre-Market Notification ,
Premarket Approval Applications ,
Prescription Drugs ,
Regulatory Burden ,
Statutory Interpretation ,
Venture Capital
The 21st Century Cures Act created the Regenerative Medicine Advanced Therapy (RMAT) designation in recognition of the growing importance of regenerative medical therapies. An RMAT designation conveys significant regulatory...more
Recently, Stat+ reported that a group of prominent venture capitalists (VCs) issued a strong warning to Congress. The warning: H.R. 3, the newly introduced Lower Drug Costs Now Act, if enacted, will "severely constrain" the...more
Introduction: Citizen Petitions in the News -
Citizen petitions and stay of action petitions (collectively, citizen petitions or petitions) are in the news. Formally, citizen petitions are a mechanism for "interested...more
11/7/2019
/ Abbreviated New Drug Application (ANDA) ,
Administrative Proceedings ,
Anti-Competitive ,
Biosimilars ,
Citizen Petitions ,
Dietary Supplements ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Noerr-Pennington Doctrine ,
Public Health ,
Sham Citizen Petitions
Navigating the U.S. Healthcare Regulatory Landscape for Wearable Devices -
Complex Environment Includes Key Federal Agencies FDA, FTC, OCR, CPSC, CMS, and OIG -
The wearable device market is emerging as a key player...more
6/19/2019
/ Biotechnology ,
California Consumer Privacy Act (CCPA) ,
Centers for Medicare & Medicaid Services (CMS) ,
Consumer Product Safety Commission (CPSC) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
FTC Act ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Life Sciences ,
Medical Devices ,
OIG ,
Pharmaceutical Industry ,
Technology-Assisted Review ,
Telemedicine ,
Value-Added Services
Recently, the United States Food and Drug Administration (FDA) Commissioner Scott Gottlieb issued a statement (the statement) outlining a new policy to improve access and foster price competition for branded drugs that are...more
Recently, the U.S Court of Appeals for the Federal Circuit issued a split panel decision in Athena.Athena, which examined the patent subject matter eligibility of four claims in one issued patent, upheld a district court's...more