Insights

On March 13, 2025, the United States Court of Appeals for the Federal Circuit issued a decision about Patent Term Extensions (PTEs) under the Hatch-Waxman Act for reissue patents. In Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc. (No. 2023-2254), the Court confirmed that the PTE provision under 35 U.S.C. § 156 refers to the original patent’s issue date, not the reissue patent’s issue date. Thus, the issue date of the original patent should be used when calculating the extension period.

On Wednesday, March 5, 2025, the United States Patent Trial and Appeal Board (“PTAB”) handed down the latest decision in the COVID vaccine proceedings between Pfizer Inc. (“Pfizer”) and BioNTech SE (“BioNTech”) and ModernaTX, Inc. (“Moderna”). The PTAB found all challenged claims unpatentable in two patents held by Moderna related to Moderna’s COVID-19 vaccine technology: U.S. Patent Nos. 10,702,600 (the “’600 patent”) and 10,933,127 (the “’127 patent”), both entitled “Betacoronavirus mRNA Vaccine.”

Before leaving for an extended recess period ahead of the November general election, Congress left unfinished several proposals with ramifications for generic and biosimilar drug competition. This client alert summarizes some of that legislation and possible next steps in the “lame duck” period before the end of the year.

Traditionally, a response to a Final Office Action (“FOA”) issued by the United States Patent and Trademark Office (“USPTO”) often involves filing a Request for Continued Examination (“RCE”) in order for the Examiner to consider further claim amendments.  In 2013, the USPTO launched the After Final Consideration Pilot program 2.0 (“AFCP 2.0”) as an alternative.  The AFCP 2.0 program allows patent applicants to request consideration of an amendment after a FOA without additional fees and grants examiners extra time to review the after-final amendment.  This provides applicants the chance to file after-final amendments without incurring the significant fees associated with an RCE.  The AFCP 2.0 program also provides an opportunity for applicants to have an interview with the Examiner and this increased communication often led to efficient resolution of prosecution. 

The USPTO has just issued an update to its guidance on subject matter eligibility, discussing the application of these guidelines to emerging technologies such as AI-related and AI-assisted inventions.  These guidelines are currently open to public comment until September 16.   

On January 10, 2024, the United States Patent and Trademark Office (USPTO) published Guidelines for assessing enablement after the Supreme Court’s recent decision in Amgen Inc. et al. v. Sanofi et al.  The Guidelines inform Examiners and the public on the Office’s implementation of the Amgen opinion. In sum, the Guidelines maintain the status quo.   

In the April 12, 2023 decision in Sequoia Technology, LLC v. Dell, Inc., No. 21-2263, a case involving infringement and validity of a patent related to digital storage of data in a server, the Federal Circuit reversed the district court, in part, and held that a “computer-readable recording medium storing instructions” does not encompass transitory media. 

Although the Patent Trial & Appeal Board’s (PTAB) reliance on Fintiv to deny petitions for Inter Partes Review (IPR) has waned since Kathi Vidal was named Director of the USPTO and the advent of Sotera stipulations, these so-called Fintiv denials remain the subject of intense scrutiny by the patent bar. On March 13, 2023, the Federal Circuit Court of Appeals revived a challenge to the PTAB’s practice of discretionary denials under Fintiv, allowing it to proceed before the district court.[1] This revival will no doubt be welcomed by patent challengers who dislike the PTAB’s current practice under Fintiv.

The United States Patent and Trademark Office Patent Trial and Appeal Board (PTAB) will now be accepting petitions for expedited resolution of ex parte appeals. The “Fast-Track Appeals Pilot Program” launched July 2, 2020. Like the popular Track One prioritized examination program, this new program is intended to provide applicants with another opportunity to expedite prosecution.

Across the globe, countries scramble to enforce social distancing and other emergency safety measures in attempts to reduce the spread of COVID-19. During this uncertain time, it is important for those who hold worldwide intellectual property portfolios to be aware that the impact of the pandemic on the operations of patent and trademark offices worldwide has varied substantially. While some offices have offered relief to those impacted by the outbreak by automatically extending deadlines, other offices have closed and postponed all operations indefinitely for the duration of the outbreak. Below is a summary of how intellectual property offices around the world will operate amidst the pandemic. This information will be updated to reflect any updates from the intellectual property offices and can be found at Crowell & Moring’s Coronavirus Resource Center.

In Supernus Pharmaceuticals, Inc. v. Iancu, the Federal Circuit held that the USPTO improperly imposed a Patent Term Adjustment (PTA) deduction for “applicant delay” during a period when the applicant “could have done nothing to advance prosecution.”  The PTA deduction at issue in Supernus was charged under 37 CFR §1.703(c)(8) for an Information Disclosure Statement (IDS) filed after a Request for Continued Examination (RCE) had been filed, but the decision could have broader implications.  This decision could substantially increase PTA in situations where applicant delay was subtracted due to filing a “supplemental paper” under 37 CFR §1.704(c)(8). 

Since the early days of the America Invents Act (AIA), the U.S. Patent and Trademark Office has required patent owners seeking to amend claims in post-grant proceedings, such as inter partes reviews (IPRs), to demonstrate patentability of the amended claims, not only over a petitioner’s instituted grounds of unpatentability, but in light of all prior art known to the patent owner. As a result of this heightened standard, the Patent Trial and Appeal Board has thus far denied 95 percent of all patent owners’ motions to amend. This practice was upended on Wednesday, October 4, 2017, by a sharply divided en banc panel of the Federal Circuit in Aqua Prod., Inc. v. Matal, No. 2015-1177 (Fed. Cir. Oct. 4, 2017).

In a recent decision by the Patent and Trial Review Board (PTAB) in Covidien LP v University of Florida Research Foundation Inc. IPR2016-01274, Paper 21 (PTAB Jan. 25, 2017), the PTAB granted a motion to dismiss three inter partes reviews (IPRs) challenging U.S. Patent No. 7,062,251 owned by University of Florida Research Foundation (UFRF), holding that UFRF was entitled to sovereign immunity under the Eleventh Amendment of the U.S. Constitution. This decision is significant for those state universities and their research foundations with patent portfolios who may find themselves on the receiving end of an IPR petition.

Shakespeare wrote, "What's in a name? That which we call a rose by any other name would smell as sweet." But Shakespeare certainly was not referring to the pharmaceutical marketplace, where drug product names play a critical role in healthcare delivery. Drug product names affect everything from how clinicians perceive the drug to how pharmacists dispense it, and how insurance plans pay for it. The ongoing debate is whether biosimilars, should have the same non-proprietary name as the original biologic, the "reference product," or whether they should have their own unique name. Arguments are made by the brand-name drug makers that a unique name for each biosimilar that distinguishes it from the reference product should be required as it would facilitate tracking adverse events and side effects in patient records. But the generic-drug makers argue that unique names for each biosimilar would confuse physicians and pharmacists wishing to make substitutions. Not only may a name impact the biologic's market share, the name may significantly impact prescribing, dispensing, and adverse event reporting and therefore patient safety as well as. Finally, after much lobbying by both brand and generic manufacturers, on Aug. 27, 2015 the U.S. Food and Drug Administration (FDA) released a long-awaited draft guidance document on the naming of biosimilars.

The United States Supreme Court yesterday issued its long-awaited decision in Bilski v. Kappos, 561 U.S. ___ (2010). Although this case was expected to be a vehicle for a definitive pronouncement on the patentability of so-called "business methods," the Supreme Court decided the case on much narrower grounds, leaving the broader question unanswered. Specifically, the Supreme Court agreed with the United States Court of Appeals for the Federal Circuit that the particular invention at issue, directed to a method for managing risk in commodities markets, was unpatentable. However, rather than relying on the "machine-or-transformation" test that the Federal Circuit erroneously determined was the exclusive test for deciding whether a claimed "process" qualified as patentable subject matter, the Supreme Court found the invention at issue unpatentable under its own precedent rejecting the patentability of abstract ideas.

In The Johns Hopkins University et al. v. Datascope Corp. (2007-1530; October 2, 2008), Johns Hopkins sued Datascope for infringing three U.S. patents directed to methods for mechanically fragmenting blood clots. At trial, a jury found, inter alia, that Datascope infringed all of the asserted claims of the three patents. In response, Datascope filed a motion for judgment as a matter of law (JMOL) or for a new trial, which was denied by the district court. Datascope then appealed. A divided panel of the Federal Circuit holds that the jury's conclusion was not supported by substantial evidence and that Datascope's motion for JMOL should have been granted.

In Janssen Pharmaceutica, N.V. et al. v. Apotex, Inc. (No. 2008-1062; September 4, 2008), the Federal Circuit affirms a district court's dismissal of a generic drug manufacturer's (Apotex's) declaratory judgment counterclaims of non-infringement based on the filing of Apotex's Abbreviated New Drug Application ("ANDA"). At issue are patents for the anti-psychotic drug risperidone (Janssen's U.S. Patent Nos. 4,804,663; 5,453,425; and 5,616,587).