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USPTO Says Wands Still Controls Post-Amgen in New Enablement Guidelines

The U.S. Patent and Trademark Office (USPTO) published guidelines for examiners today on the topic of enablement in light of the Supreme Court’s May 2023 decision in Amgen v. Sanofi. The Office’s view seems to largely mesh with what our guest authors concluded earlier today—Amgen isn’t getting rid of In re Wands and—at the USPTO at least—the decision has seemingly maintained the status quo.

Amgen v. Sanofi: Seven Months In, Has Anything About Patent Enablement Changed?

Last term, the U.S. Supreme Court did something strange: the Court unanimously affirmed a circuit decision, which had unanimously affirmed a trial court decision. Little about the law seemed ripe for dispute or change, nevertheless, in Amgen v. Sanofi the Supreme Court spoke. Seven months later, innovators and patent practitioners are still scratching their heads. What impact, if any, does Amgen have? Is there a sign lower courts are interpreting Amgen as signaling a change in American patent law or did it merely ratify what already existed?

Federal Circuit Affirms Mixed Rulings for Patent Owner Based on ‘Ordinary Meaning’ of Claim Phrase

The U.S. Court of Appeals for the Federal Circuit (CAFC) in a precedential decision today affirmed two decisions of the Patent Trial and Appeal Board (PTAB) that invalidated some claims and upheld others of a patent owned by Personal Genomics Taiwan, Inc. Based on the PTAB’s claim construction, which the CAFC agreed with, the decision held that Pacific Biosciences had failed to prove the prior art taught the limitation of the preamble phrase of claim 1 in one inter partes review, (IPR) but did prove a different prior art reference taught the limitation in the other proceeding.

The Year Ahead: Where Do We Stand on the USPTO’s ANPRM and the PREVAIL Act?

As we enter 2024, major policy initiatives are pending at the United States Patent and Trademark Office (USPTO) and in Congress aimed at overhauling certain aspects of Patent Trial and Appeal Board (PTAB) practice. These initiatives—the Advance Notice of Proposed Rulemaking (ANPRM) and PREVAIL Act, respectively, are at a critical point, with elections less than a year away. This article discusses the current state of both.

Another 101 Bites the Dust as High Court Denies Realtime Data Petition

The U.S. Supreme Court today denied a petition asking the High Court to clarify patent eligibility jurisprudence under Section 101 since its 2014 ruling in Alice Corp. Pty Ltd. v. CLS Bank Int’l. Realtime Data, LLC asked the Court specifically to address the U.S. Court of Appeals for the Federal Circuit’s (CAFC’s) August 2023 decision holding 211 of its patent claims ineligible as abstract.

Ninth Circuit Denies Review of Decision that IPR Proceedings Do Not Trigger FCA’s Public Disclosure Bar

On January 5, the U.S. Court of Appeals for the Ninth Circuit published an amended opinion and order denying rehearing and rehearing en banc, thus upholding its August reversal of the Northern District of California’s dismissal of a qui tam whistleblower action under the False Claims Act (FCA). The FCA claim was brought by patent attorney Zachary Silbersher against Valeant Pharmaceuticals, predecessor to Canadian drugmaker Bausch Health. The appellate court’s decision turned on the application of the FCA’s public disclosure bar, finding that inter partes review (IPR) proceedings did not trigger the statutory bar to qui tam actions based on evidence previously disclosed during adversarial agency proceedings “in which the Government or its agent is a party.”

SCOTUS Passes on Intel’s Bid to Overturn Fintiv

The U.S. Supreme Court today denied certiorari in Intel v. Vidal, a case that asked the Court to overturn a U.S. Court of Appeals for the Federal Circuit (CAFC) ruling concerning the Patent Trial and Appeal Board’s (PTAB’s) so-called Fintiv framework. The CAFC’s March 2023 decision said appellate review of whether the PTAB’s discretionary denial rules for inter partes review (IPR) are “arbitrary and capricious” was precluded by Section 314(d) of the patent statute.

IP Practice Vlogs: PTAs, PTEs and Terminal Disclaimer Practice under In re Cellect

The Federal Circuit basically confirmed in In re Cellect that terminal disclaimers can knock out patent term adjustment (PTA). If you have patent term extension (PTE) and you filed a terminal disclaimer to overcome an obviousness-type double patenting (ODP) rejection, you can get the PTE term tacked onto the disclaimed date. However, in the case of PTA, the court says that PTA term gets added to the life of the patent first and then the terminal disclaimer goes into effect so that you have disclaimed the PTA term and any extended term such that the two patents now expire on the same date regardless of the PTA. In effect, terminal disclaimers may knock out PTA term.

Other Barks and Bites, January 5, 2024: USPTO Leadership Changes, Electronic Correction Certificates, Design Patent Bar Open for Applicants

In other barks and bites for the first week of 2024, there were several updates from the U.S. Patent and Trademark Office, including recent leadership moves, a U.S. Court of Appeals for the Federal Circuit decision invalidating alternative sweetener patent claims and a precedential designation from the Trademark Trial and Appeal Board.

Examining Upcoming Changes to the Implementing Regulations of the Chinese Patent Law

Recently, amendments to the Implementing Regulations of the Chinese Patent Law were issued and will take effect from January 20, 2024. The Regulations align with the revisions made to the Patent Law in 2020 and provide further guidance. The main changes to the new Regulations, as compared with the 2010 version of the Regulations,  can be summarized as follows.

Seattle Metropolitans Hockey Owner Sues NHL’s Kraken Over Jersey Logos

On December 27, less than one week before the National Hockey League’s (NHL) Seattle Kraken defeated the Vegas Golden Knights in the 2024 Winter Classic, a lawsuit was filed in the Western District of Washington against the Kraken. The lawsuit alleges that Seattle’s NHL franchise wore an infringing jersey during the Winter Classic, and has sold infringing merchandise, after shutting out the legitimate business interests of a passionate Seattle-area fan who revived that city’s championship legacy more than 90 years after the previous franchise folded.

EU Agreement on the Text of a New AI Act

On December 8, 2023, provisional agreement was reached between the European Union (EU) Parliament and the EU Council on the basic content of the new AI Regulation (the “AI Act”) to be implemented as legislation in the EU. The text is still not publicly available as it is subject to certain further refinement over the coming weeks. However, there is information available in the public domain (including press releases issued by the European Union) as to the likely format of the AI Act. Additional background on the legislative process towards the AI Act is available here.

Patent Filings Roundup: New NPE Campaign Dominates December; Calls Against Fintiv Continue

Looking back over the final few weeks of 2023, patent filings were typical at the Patent Trial and Appeal Board (PTAB) and slightly above average in district courts, with the last weeks of the year seeing 68 district court complaints filed and 25 new PTAB petitions [December 11-17]; followed by 57 district court complaints filed and 29 new PTAB petitions [December 18-24]; and wrapped up with 24 district court complaints filed and 13 new PTAB petitions [December 25-31].

CAFC Distinguishes Forum Selection Clause Language from Precedential Cases in Win for Abbott

The U.S. Court of Appeals for the Federal Circuit (CAFC) today issued a precedential ruling that affirmed a district court’s denial of preliminary injunction to DexCom, Inc., holding that the language of the governing contract’s forum selection clause expressly allowed for the filing of inter partes review (IPR) proceedings in certain circumstances. DexCom and Abbott Diabetes Care, Inc. entered into a settlement and license agreement in 2014, following years of patent litigation over their competing glucose monitoring system patents. The governing agreement included a Covenant Period and a forum selection clause that DexCom argued was breached by Abbott’s filing of eight IPR petitions following the expiration of the Covenant Period and 10 months after DexCom filed an infringement suit against Abbott in the Western District of Texas.

HHS Issues RFC on WHO Pandemic Convention’s Provisions Impacting IP Rights

On December 22, the U.S. Department of Health and Human Services (HHS) issued a notice and request for comments (RFC) regarding the United States’ negotiating position on a draft convention on pandemic preparedness being developed at the World Health Organization (WHO). The HHS’ RFC specifically targets certain portions of the draft convention that would impact intellectual property (IP) ownership, research & development, and technology transfer for pandemic-related technologies.