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FDA Proudly Announces Its First Approval of an Interchangeable Biosimilar

On July 28, 2021, the Food and Drug Administration (FDA) announced the approval of the first “interchangeable biosimilar”—in this case Mylan Pharmaceticals Inc.’s Semglee® (insulin glargine-yfgn), which is both biosimilar to, and interchangeable with, its reference product Lantus® (insulin glargine), a long-acting insulin analog. Acting FDA Commissioner Janet Woodcock, M.D. called it a “momentous day.”… Continue Reading

Patents for Humanity: The USPTO Recognizes Innovation Relating to COVID-19

The United States Patent and Trademark Office (USPTO) has announced the final deadline for submission of applications for its Patents for Humanity COVID-19 award: The submission deadline is 5 p.m. ET, September 30, 2021. Patents for Humanity is the United States Patent and Trademark Office’s (USPTO) awards competition recognizing innovators who use game-changing technology to … Continue Reading

Litigators Take Note – Yu v. Apple is Not Just About Subject Matter Eligibility of Patents

Much of the discussion about the Federal Circuit’s precedential opinion in Yu et al. v. Apple, Inc. et al. has focused on the perceived confusion and dysfunction of U.S. patent law that invalidates a claim directed to an “improved digital camera” as a patent-ineligible “abstract idea.” After delving into the underlying record, this author posits … Continue Reading

Taking Another Page from the ABA: The USPTO Enacts New Rules of Professional Responsibility for Patent Attorneys and Agents

To mitigate potential conflicts of interest and to improve the public’s understanding of the United States Patent and Trademark Office (USPTO) procedures, the agency has recently made various amendments to its rules relating to the conduct of registered patent attorneys and agents. The resulting changes mirror some well-recognized provisions of the American Bar Association’s (ABA) … Continue Reading

Caution! Technical Documents Concerning Efforts to Design Around a Patent Are Discoverable — Even When Done at the Direction of Counsel

A recent order from a patent infringement lawsuit in the Northern District of Illinois serves as a good reminder that factual information about attempts to design around a patent are generally discoverable. This case also distinguishes discoverable factual information from privileged opinion and mental impressions of design-around efforts. In addition, the order suggests “exceptional circumstances” … Continue Reading

When Cease-and-Desist Letters Create a Risk of a Declaratory Judgment Backlash: Observations from Trimble Inc. v. PerDiemCo LLC

With its recent decision in Trimble Inc. v. PerDiemCo LLC, the Federal Circuit has opened the door for declaratory judgment actions a bit wider. The Court reversed the Northern District of California’s dismissal of a patent declaratory relief action based on lack of personal jurisdiction, and limited the scope previously articulated by its 1998 decision … Continue Reading

When Compulsory Licenses Apparently Just Won’t Do: The US Backs Waiver of Rights to IP Relating to COVID-19

On Tuesday, May 5, 2021, the U.S. Trade Representative Katherine Tai released an unprecedented statement supporting a “Covid-19 TRIPS Waiver.” Specifically, Ambassador Tai stated “[t]he Administration believes strongly in intellectual property protections, but in service of ending this pandemic, supports the waiver of those protections for COVID-19 vaccines. We will actively participate in text-based negotiations … Continue Reading

Beware! Reliance on Aspirational and Futuristic Statements in a Prior Art Reference May Require Supporting Evidence

In patent disputes involving complex technologies, especially when the disputed patent was developed in an early stage of the technical field, research papers and similar publications are oftentimes relied on to make obviousness-based invalidity challenges. It is common for such research papers to include predictions or aspirations with regards to potential future developments in the … Continue Reading

Delaware Reminds Litigants Not to Wait to Disclose Infringement Theories Under the Doctrine of Equivalents

Back in July and December 2020, we wrote about the seeming rise in allegations of infringement allegations under the doctrine of equivalents (DOE) in life sciences cases. We noted that in those recent cases the Federal Circuit provided in-depth analyses of the application of DOE, prosecution history estoppel, and the various other limits on the … Continue Reading

Understanding IP in China: Design Patents

In the last of his recent series of blogs on IP in China, Dr. Paolo Beconcini discusses amendments expanding the scope of design protection in China and predicts a new flood of “junk” design applications. He discusses the basis and requirements for Chinese design patents, including issues relating to functionality. He also discusses some structural issues that … Continue Reading

Understanding IP in China: A Brief Retrospective

In the first of a new blog series, Dr. Paolo Beconcini examines the past and present of the Chinese IP regime and the various factors that influenced its development over the past several decades. Included are a short history of the US-China relationship, how it has impacted China’s reform of its IP regime, and what … Continue Reading

New Provisions for EU-UK Pharmaceuticals

The UK Parliament and EU Commission have now agreed on a wide-ranging EU-UK Trade and Cooperation Agreement, focused on the supply of goods. Pharmaceuticals are highlighted in a number of areas. For example, Annex TBT-2 of the Agreement provides for recognition of Good Manufacturing Practice (GMP) inspections for medicinal products carried out in the other … Continue Reading

Federal Circuit Endorses the Doctrine of Equivalents Again for Lilly’s ALIMTA®:  Different Amendment, Same Result

Back in July we wrote about the doctrine of equivalents (DOE) in bio/pharma cases in general, and the on-going saga of DOE in Lilly’s ALIMTA® litigation specifically. Last week, the Federal Circuit penned a new chapter, issuing a non-precedential decision in Eli Lilly and Company v. Apotex, Inc. Didn’t this all end last June? Not … Continue Reading

Brexit Impacts on Trade: Relief for Pharmaceuticals and Advice for Contracting

Brexit threatens to have a significant impact on import to and export from the UK of both goods and services. Recent legislative measures have provided more time for  implementing medicines regulation in Northern Ireland, so that business can prepare in relation to batch testing, importation and Falsified Medicines Directive requirements, as reported by Adrian Spooner … Continue Reading

UK Begins Review of National Gambling Legislation

The UK government has started its review of national gambling legislation, likely to result in the introduction of a new Gambling Act. New measures could include tighter restrictions on gambling sponsorship and advertising, such as gambling operators no longer being allowed to advertise on the shirts of sports teams or any other visible part of … Continue Reading

USPTO and DOJ Promoting Innovation and Collaboration in Life Sciences

Beginning September 23, a free two-day workshop will address issues relating to innovation by life sciences companies, including IP and antitrust issues arising from collaborations and partnerships. The US Patent and Trademark Office (USPTO) is co-sponsoring the event with the Department of Justice. The program will address the role of patents in the research and … Continue Reading

At 40 Years Old, the Orange Book Gets a Fresh Look as FDA Seeks Comments on Patent Listability

Back in June, the United States Food and Drug Administration (FDA), “as part of an Agency-wide effort to modernize the Orange Book,” published a request for comments relating to patent listing. Apparently prompting this request was FDA’s recognition that New Drug Application Sponsors have “submitted patents for listing in the Orange Book, including certain types … Continue Reading

Guidance for UK Life Sciences Offered During End of Brexit Transition

With the Brexit transition period ending on December 31st, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is issuing guidance for the UK Life Science industry – including guidance on clinical trials, market authorizations, and manufacture and supply, among other areas. The guidance will apply from the start of 2021. Squire Patton Boggs’ Triage … Continue Reading

Tech Sprint for Innovations in Electronically-Delivered Adverse Action Notices

The Consumer Financial Protection Bureau is providing a new forum for innovation – designated as Tech Sprints – to generate “actionable ideas” for reducing regulatory burdens and improving consumer understanding of financial services. Tech Sprints will be held virtually, and competing teams will work to realize identified goals. The first Tech Sprint, to be held … Continue Reading

The Federal Circuit Expressly Declares that Juries Determine the Standard-Essentiality of Patent Claims

In Godo Kaisha IP Bridge 1 v. TCL Commun. Tech. Holdings Ltd.,[1] the Federal Circuit definitively answered the question: “Who determines the standard-essentiality of the patent claims at issue—the court, as part of claim construction, or the jury, as part of its infringement analysis?” According to this precedential decision authored by Judge Kathleen O’Malley: “Where … Continue Reading
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