Trends in Early-Stage Boston Med-Tech Investment

By Stephen M. Honig

Duane Morris supports a proprietary platform in Boston that permits emerging life science and med device companies to pitch to a varied group of investors, from qualified angels to major pharmas. We also represent companies seeking financing and independent investors in this space. In assisting in due diligence during the first eight months of 2021, certain matters have been emphasized in diligence review.

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Attorney General’s Memorandum Allows Prosecution for Noncompliance with Agency Guidance Documents

On July 1, 2021, U.S. Attorney General Merrick Garland published a memorandum that rescinds two previous memoranda―the Sessions Memorandum and Brand Memorandum―that prohibited Department of Justice attorneys from using noncompliance with federal agency guidance documents as a basis for civil and criminal enforcement cases. Garland’s memorandum states these previous policies were “overly restrictive,” “discouraged the development of valuable guidance” and hindered DOJ’s litigation of cases when relevant agency guidance was available.

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

Federal Circuit’s Rehearing Decision Confirms Induced Infringement Even When Skinny Label Was Used

In a recent 2-1 decision after a rehearing, GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., the Federal Circuit confirmed that substantial evidence supported the jury’s findings of induced infringement throughout the term of GSK’s patent, including the “partial label period” when Teva used a skinny label to carve out a patented method.

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

FDA Issues Final Guidance on Form and Content of Unique Device Identifier Labeling System

On July 7, 2021, the U.S. Food and Drug Administration (FDA) issued a final guidance regarding the form and content of unique device identifier (UDI) labeling. The guidance will assist labelers of medical devices and FDA-accredited issuing agencies (who operate systems for issuing UDIs used by labelers) in meeting the requirements under 21 CFR Part 801, Subpart B, and the Unique Device Identification System Final Rule, 78 FR 58786 (September 24, 2013) (UDI Rule).

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

Duane Morris Life Sciences & Medical Technologies Industry Group Ranked in The Legal 500

Duane Morris’ Life Sciences and Medical Technologies Industry Group has been ranked in The Legal 500 US 2021 guide.

An excerpt from the publication:

Duane Morris LLP is recommended for its expertise in M&A, patents, and commercial licensing and collaboration agreements, acting for domestic companies in addition to a strong roster of clients in the Asia-Pacific region.

Testimonials

        • “They understand client’s needs and work very closely to address those. Team has subject knowledge and applies it effectively in strategizing pre-litigation and litigation matters.”
        • “They suggest different strategies and ideas for defenses. Also, innovative ways for settlement terms. Billing is also great and adjusts according to client’s needs.”
        • Rick Ball is the individual who stands out. He gels with client’s team very well, understands their needs, flexible, innovative, strategizes properly.”

For more information, please visit the firm website.

Parent Companies Can Be Liable for a Subsidiary’s Alleged Infringement Under Rule 12(b)(7)

What liability does a parent company have when a subsidiary’s actions allegedly constitute patent infringement?

That is the question answered in a recent patent infringement case, Akoloutheo, L.L.C. v. System Soft Technologies, Inc., No. 4:20-cv-985, 2021 WL 1947343 (E.D. Tx. May 14, 2021). In particular, Akoloutheo sheds light on the application of Rule 12(b)(7) in a situation where a subsidiary of the defendant parent company is the primary participant in the acts giving rise to the infringement action and could not be joined to the present infringement action. Based on the court’s determination, parent companies should not expect to escape infringement liability by pinning the blame on a subsidiary and seeking a dismissal via a 12(b)(7) motion when the subsidiary cannot be joined due to it being viewed as a joint tortfeasor and thus does not need to be joined to the present action under Rule 19. Further, the infringement statute may impute infringement liability on the parent through an inducement or contributory theory. Thus, despite the protection offered through the creation of separate corporate entities, parties should be aware that infringement liability may extend to both the parent and subsidiary under the theories of induced infringement or contributory infringement, even if the subsidiary is the primary participant in the alleged infringing acts.

View the full Alert on the Duane Morris LLP website.

Proposed Temporary Waiver of COVID-19 Vaccine-Related Intellectual Property Rights: Considerations and Implications

The World Trade Organization is considering a proposal, advanced by India and South Africa in October 2020, to waive intellectual property rights related to the development of the vaccines against COVID-19 for the duration of the pandemic. The Biden administration has indicated its support.

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

SCOTUS Curbs FTC’s Enthusiasm by Limiting Relief Available Under Section 13(b) of the FTC Act

On April 22, 2021, the Supreme Court of the United States unanimously held that Section 13(b) of the Federal Trade Commission Act does not authorize the FTC to seek, or a court to award, equitable monetary relief. The decision is likely to have a significant impact on the FTC’s decision-making process in bringing future cases directly to federal district court, as opposed to going through the administrative process, and it will likely spur congressional debate and possibly lead to new legislation.

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

ASTM International Approves New National Standard for Barrier Face Coverings

On February 15, 2021, ASTM International, a voluntary standards-setting organization, approved a new national standard for barrier face coverings that establishes minimum design, performance, labeling and care requirements for disposable and reusable face masks. Manufacturers should take full advantage of this new guidance as it implements a universal standard for the evaluation of barrier face coverings utilized by a majority of Americans every day.

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

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.