Who Watches the Watchmen? Supreme Court to Decide Fate of Administrative Patent Judge Appointments

The Supreme Court of the United States is to decide the fate of administrative patent judges of the Patent Trial and Appeal Board, namely whether the current appointment scheme violates the Appointments Clause of the U.S. Constitution. This case, which may have broad implications on post-grant proceeding process before the USPTO, is being watched by companies around the world.

To read the full text of this Duane Morris Alert, please visit the firm website.

Inconsistency Among Courts Regarding Pleading Standards for Parallel Claims Involving Medical Devices

The Massachusetts Supreme Judicial Court recently addressed the question of what pleading standard is required in Massachusetts to allege parallel state law claims involving medical devices to avoid preemption under the federal law regulating medical devices.  The Court’s decision sheds light on the lack of consensus among state and federal courts on this issue, which may impact the time and resources that litigants and the courts expend on claims that may later prove to be meritless.

To read the full text of this post by Duane Morris attorney Sharon O’Reilly, please visit the Duane Morris Products Liability Blog.

Forum Selection Clause Held Inapplicable for Precluding Inter Partes Review Before the Patent and Trial Appeal Board

Confidentiality agreements or nondisclosure agreements (NDAs) are generally one of the first documents that in-house counsel require teams to execute when exploring licensing and/or research opportunities with third parties. NDAs are meant to protect the confidential information of one or both parties while each party determines whether the collaboration is worth pursuing. However, in a recent case in the Southern District of New York, one party tried to invoke a forum selection clause of an NDA to prevent the other party from challenging patents using inter partes review at the USPTO’s Patent Trial and Appeal Board.

To read the full text of this Duane Morris Alert, please visit the firm website.

FTC Announces Crackdown on Deceptive Marketing of CBD Products

In connection with a crackdown on CBD manufacturers pursuant to its “Operation CBDeceit,” the FTC announced today settlements with six CBD-infused product manufacturers who, according to the FTC, allegedly made a “wide range of scientifically unsupported claims about their ability to treat serious health conditions, including cancer, heart disease, hypertension, Alzheimer’s disease, and others.” Under the settlements of the respective complaints against them, each of the manufacturers will be required to pay a fine, and cease making “unsupported health claims” in connection with the marketing of their products.

To read the full text of this post by Duane Morris partner Seth Goldberg, please  visit the Duane Morris Cannabis Industry Blog.

FDA’s Additional Draft Guidance on Biosimilarity and Interchangeability to Seek Comments and Suggestions by January 19, 2021

The U.S. Food and Drug Administration (FDA) recently published the draft guidance, Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act, Guidance for Industry. Comments can be submitted to FDA by January 19, 2021.

To read the full text of this Duane Morris Alert, please visit the firm website.

Patent-Eligible Subject Matter in Biotech Should Recite More Than a “Telescope”

In Abbott Laboratories v. Grifols Diagnostic Solutions Inc., the U.S. District Court for the Northern District of Illinois opined as to patent-eligible subject matter in the context of a biological invention. The case presents another situation in which the law of nature and natural phenomenon judicial exceptions have come to the forefront in the analysis of patent-eligible subject matter.

To read the full text of this Duane Morris Alert, please visit the firm website.

 

PBMs Must Say Goodbye to Manufacturer Rebates

Pharmacy benefit managers (PBMs) play a significant role in U.S. drug pricing, yet their existence is little known to those outside of the pharmaceutical and insurance arenas. In an effort to modify one of the largest drivers in increasing drug costs―rebates paid to PBMs by drug manufacturers―the U.S. Department of Health and Human Services on November 20, 2020, published three final rules that, most notably, declared that these rebates are no longer protected by the safe harbors to the anti-kickback statute.

To read the full text of this Duane Morris Alert, please visit the firm website.

HHS OIG’s Special Fraud Alert on Speaker Programs by Pharma and Device Companies

On November 16, 2020, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a Special Fraud Alert addressing speaker programs presented by pharmaceutical and medical device companies. Such programs, at which companies may pay physicians or other health care professionals (HCPs) for speeches or presentations about drugs and devices in addition to providing remuneration to attendees, are frequently sponsored by pharmaceutical and device companies seeking to provide education regarding their products. Highlighting what it called “inherent fraud and abuse risks,” OIG’s Special Fraud Alert expressed concerns surrounding the offer or payment of remuneration from pharmaceutical and device companies to physicians or other HCPs associated with such programs.

To read the full text of this Duane Morris Alert, please visit the firm website.

Could COVID-19 Data Help Medical Device Manufacturers Accelerate the FDA Approval Process?

Medical device shortages and shortcomings during the COVID-19 pandemic have led the Food and Drug Administration (FDA) to grant Emergency Use Authorization (EUA) to many medical devices manufacturers. Were it not for these EUAs, these manufacturers would be unable to market their devices, as their FDA applications would still be pending. Once the present “emergency” ends, these EUAs will expire, and manufacturers will again be unable to market their devices for the indications cleared under the EUA.

Still, the real-world evidence (RWE) gained about these devices while marketed under the EUA need not be lost with the passing of the pandemic. Once the pandemic ends, manufacturers should be able to use the data collected to support their pending applications for market clearance and for new indications for already-cleared devices.

To read the full text of this article by Duane Morris partners Frederick R. Ball and Erin M. Duffy, please visit the Wharton Health Care Management Alumni Association website.

3D Printing in the Life Sciences: Mitigating the Risks

With each passing year, the long-predicted aspirational advantages of 3D printing in the life sciences industry become a reality.  Forecasts of large scale printing operations at or near major hospitals are fulfilled. Visions of bioprinted organs have become a reality. 3D printing is reaching the lofty potential projected by the life sciences industry years ago. However, the topic of litigation risks with 3D printing in the life science industry is often overlooked. […]

Yet, the widespread use of additive manufacturing by companies and individuals outside of the life sciences industry also underscores the potential litigation risks with 3D printing.

To read the full text of this article by Duane Morris partner Sean Burke, please visit the 3DHeals website.