Search Results for: "sas institute"

Biologics Patent Enforcement: Regeneron Patents Block Biosimilar Entry for EYLEA

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by Dennis Crouch

In a pair of significant decisions issued today, the Federal Circuit upheld preliminary injunctions blocking the launch of biosimilar versions of Regeneron's blockbuster drug EYLEA® (aflibercept). Regeneron Pharms., Inc. v. Mylan Pharms. Inc., No. 2024-1965 (Fed. Cir. Jan. 29, 2025) (precedential); and Regeneron Pharms., Inc. v. Mylan Pharms. Inc., No. 2024-2009 (Fed. Cir. Jan. 29, 2025) (nonprecedential). The cases pit Regeneron against foreign manufacturers, including Samsung Bioepis (SB) and Formycon AG, who had obtained FDA approval for their biosimilar products under the Biologics Price Competition and Innovation Act (BPCIA). Writing for a unanimous panel, Judge Taranto focused on three key issues: (1) personal jurisdiction over foreign biosimilar manufacturers; (2) obviousness-type double patenting in the biologics context; and  (3) standards for preliminary injunctive relief.  The decisions effectively maintain Regeneron's market exclusivity for EYLEA®, which generates approximately $6 billion in annual sales and serves as a primary treatment for several serious eye conditions including wet age-related macular degeneration. U.S. Patent No. 11,084,865.

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Recent Patent Cases at the Supreme Court

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by Dennis Crouch

The Supreme Court has not granted certiorari in any patent cases this term. But the 2024 docket includes a number of important petitions -- some focusing on procedural issues and others on fundamental patent law questions. Here is a quick review of those currently pending before the high court:

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Expert Witness Ethics and Economics: Unpacking the Federal Circuit’s En Banc Review of Damages Testimony in EcoFactor v. Google

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by Dennis Crouch

This is a post about damages expert testimony and the pending en banc case of EcoFactor v. Google. But, before delving into those details I wanted to first provide a personal anecdote -- my experience with expert witnessing.

My personal experience with expert witnessing has been quite limited but instructive.  While expert witnesses are charged with providing truthful and complete testimony, they are inevitably selected and compensated based upon their predicted ability to support a particular party's position. Although my compensation wasn't directly contingent on favorable testimony, I recognized that future engagements would depend on my perceived effectiveness as an advocate.  I started getting an icky feeling - a strong tug on my conscience. I particularly recall the internal pull to shade the truth in the client's favor and even began to think of the client as "my client."  That is an ethical problem.  The expert witness is expected to serve as an independent advisor to the court, providing objective analysis based solely on the facts and their expertise. This fundamental tension between duty to the court and financial incentives ultimately led me to step away from expert witnessing entirely.  If I'm going to be a "hired gun," I want to do so as the attorney where my ethical duty is to side with my client rather than as a quasi-objective expert witness.

While most expert witnesses are not attorneys, the modern American expert witness system essentially places compensated advocates on the stand.  The folks who are hired to testify are great at testifying.  I like the quote I found in a Unified Patents brief from a century ago where P.G. Wodehouse captured this reality in Mike and Psmith: "He was rigidly truthful, where the issue concerned only himself. Where it was a case of saving a friend, he was prepared to act in a manner reminiscent of an American expert witness." In the quote, Wodehouse suggests that an expert witness's testimony, while technically under oath, may be shaped more by allegiance to the retaining party than by rigid adherence to objectivity.

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Supreme Court Patent Cases – November 2024

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by Dennis Crouch

Patent law cases continue to be brought to the Supreme Court's attention, even though the court has not granted certiorari in any patent case for some time.  Twelve potential cases have documents on file with the court. Currently, eight certiorari petitions are briefed and pending before the Court, while four additional petitions are anticipated in the coming months based on recently-filed extension requests.

As has been true in recent years, patent eligibility petitions occupy a substantial portion of the docket, mostly focusing on software patents. Two Hatch-Waxman cases are pending as is a case focusing on the on sale bar post-AIA and post-Helsinn.  In addition, two cases focus on the Federal Circuit's ongoing and unjustified use of summary affirmances for a large portion of its docket.

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The Federal Circuit’s Antisuit Injunction Decision in Ericsson v. Lenovo has Broader Implications for Global SEP Litigation

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I previously wrote about the Federal Circuit’s FRAND international injunction decision in Ericsson v. Lenovo, but also invited Prof. Jorge Contreras to provide his insight.  Contreras is one of the world’s leading experts on FRAND litigation and standards-essential patent licensing.  His analysis of the Federal Circuit’s decision in Ericsson particularly highlights the court’s new limits on injunctive relief for FRAND violators and suggests renewed U.S. court engagement in global rate-setting disputes. — Dennis Crouch

= = =

Guest Post by Professor Jorge L. Contreras

On October 24, 2024, the Court of Appeals for the Federal Circuit (No. 24-1515, 2024 U.S. App. LEXIS 26863) cleared the way for Lenovo to seek an antisuit injunction against Ericsson in the parties’ global FRAND litigation. In doing so, it established important precedent for cases involving standards-essential patents.

Background

The case stems from the dispute between Ericsson and Lenovo over licenses to their respective portfolios of patents essential to the 5G wireless telecommunications standards (standards-essential patents or SEPs). Under the applicable rules of the European Telecommunications Standards Institute (ETSI), each of the parties committed to grant licenses under its SEPs to manufacturers of standardized products on terms that are fair, reasonable and nondiscriminatory (FRAND). As the parties, after years of negotiation, were unable to agree on the FRAND royalties for a cross-license of these SEPs, they each initiated litigation in various jurisdictions including the United Kingdom, Brazil, Colombia, the US International Trade Commission and the U.S. District Court for the Eastern District of North Carolina (EDNC). In the EDNC, each party accused the other of infringing its 5G SEPs and breaching its contractual FRAND obligations to ETSI.

In late 2023, Ericsson obtained injunctions against Lenovo’s sale of 5G-enabled phones in Brazil and Colombia. In response, Lenovo petitioned the EDNC for an antisuit injunction (ASI) (technically, a temporary restraining order), which would have barred Ericsson from enforcing its Brazilian and Colombian injunctions against Lenovo until the resolution of the FRAND dispute in the U.S. court. In February 2024, the EDNC denied Lenovo’s motion for an ASI (No. 5:23-CV-00569-BO, 2024 U.S. Dist. LEXIS 26060, 2024 WL 645319).  Lenovo appealed to the Federal Circuit, which reversed and remanded. (more…)

AI’s Role in U.S. Elections: Republican vs. Democratic Views

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Our guest author today is a very bright high school student, Kavya Gundlapalli, who is considering a career in law. – DC

Guest Post by Kavya Gundlapalli*

As America heads toward the 2024 presidential election, artificial intelligence (AI) has emerged as a surprising campaign flashpoint. From voter targeting to political advertising, AI is reshaping how candidates connect with voters – and exposing a divide over how this powerful technology should be governed.  A partisan split in this area mirrors broader ideological differences about government regulation, with Republicans championing market freedom and innovation, while Democrats tend to advocate for the same, but with stronger federal oversight and ethical guardrails.  (more…)

Free Post: En Banc Review in Allergan: Rehearing Petition Tackles ODP Safe Harbor and WD Essential Elements

Patent

by Dennis Crouch

This post focuses on the issues raised in the patent challenger Sun Pharma’s recent en banc petition in Allergan USA, Inc. v. MSN Laboratories Private Ltd and Sun Pharmaceutical Indus. Ltd., No. 2024-1061 (Fed. Cir. 2024).  The original panel majority opinion is controversial on two separate fronts. First, it created an obviousness-type double patenting (ODP) safe harbor for certain patents whose term had been extended via patent term adjustment (PTA); Second, the court OK’d the omission of what appeared to be an essential element (a glidant) from the claims, finding sufficient written description support despite the specification only describing formulations that included a glidant. This omission was particularly notable as it occurred after the patentee learned during litigation that the accused products did not include a glidant.

I’ve divided this post into two parts: Part I – ODP Safe Harbor and Part II – Written Description Essential Element. (more…)

Supreme Court denies Cert

Patent

by Dennis Crouch

The Supreme Court has denied certiorari in all of the patent cases it considered in its  first conference of the October 2024 term:

  • Denied: 23-1349 Provisur Technologies, Inc. v. Weber, Inc..  Does an on sale product constitute a printed publication that can be asserted in an IPR.
  • Denied: 23-1298 United Therapeutics Corporation v. Liquidia Technologies, Inc. Whether the IPR statute and SAS require the Federal Circuit to review de novo, or only for an abuse of discretion, the PTO's reliance on new grounds and new printed publications—not raised in the initial petition?
  • Denied: 23-1231 Cellect, LLC v. Vidal.  Whether a patent procured in good faith can be invalidated on the ground that statutory Patent Term Adjustment created an improper term extension under the judge-made doctrine of obviousness type double patenting.
  • Denied: 23-1217 Chestek PLLC v. Vidal. Whether the PTO is exempt from notice-and-comment requirements when exercising its rulemaking power under 35 U.S.C. § 2(b)(2).
  • Denied: 23-1184 Eolas Technologies v. Amazon.com, Inc. Whether the claims recite patent-eligible subject matter under 35 U.S.C. § 101 and Alice Corp.
  • Denied: 23-1142 Surti v. Fleet Engineers, Inc. Whether the Court erred in denying proper compensation.

Only a handful of cases are still pending before the court:

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Secret Springing Prior Art and Inter Partes Review

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by Dennis Crouch

The Federal Circuit is set to decide an important issue regarding the scope of prior art that can be considered during inter partes review (IPR) proceedings in the pending appeal of Lynk Labs, Inc. v. Samsung Electronics Co., Ltd.  At issue is whether section 102(a)(2) prior art qualifies for use in an IPR proceeding because those applications were not yet publicly accessible until after the priority date of the challenged patent.  This case has very significant implications because 102(a)(2) prior art is extensively used - especially in crowded and rapidly moving areas of technology.  The question, is whether this type of 102(a)(2) prior art qualifies as a "patent or printed-publication" under the IPR limits of section 311(b).   Note that the same issue is raised in  another pending CAFC case VLSI Tech. LLC v. Patent Quality Assurance LLC, No. 23-2298 (Fed. Cir.).

The dispute stems from an IPR petition filed by Samsung challenging claims of Lynk Labs' U.S. Patent No. 10,687,400 ("the '400 patent") related to LED lighting systems. Samsung's petition relied upon a prior-filed patent application ("Martin") as a key prior art reference. (Application No. 10/417,735 subsequently published as U.S. Patent App. Pub. No. 2004/0206970).  This prior application is not prior art under 102(a)(1) - because it was not patented or published until after Lynk's effective filing date. However, the prior application is prior art under the "secret springing prior art" provision of 102(a)(2), since it was on file prior to Lynk and then subsequently published.  I refer to this as "secret springing prior art" because Martin was only secretly on file at the time Lynk filed its application - later, once Martin published it suddenly became prior art --back dated to the application filing date.

The PTAB instituted review and ultimately found the challenged claims unpatentable based in part on the Martin reference.

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Eligibility, IPRs, and Diversity: The Faces of 2024 Patent Reform

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by Dennis Crouch

Senator Coons and Tillis are pushing three primary patent bills through the Judiciary Committee,

  • S. 2220, the PREVAIL Act (tightening IPR procedure)
  • S. 2140, the Patent Eligibility Restoration Act (PERA) (limiting eligibility law)
  • S. 4713, the IDEA Act (measuring demographics of inventors).

Although the committee markup was set for September 19, it has now been postponed until the 26th.  It appears that a number of Senate committee members have taken issue with the proposals and an extra week is needed to negotiate through those.  Sen. Whitehouse mentioned that he, along with a number of colleagues, have been hearing from constituents opposed to the legislation.  I expect lobbying will be high.

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Announcing FRAND: German Case Law and Global Perspectives

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Guest Post by Thomas F. Cotter, Taft, Stettinius & Hollister Professor of Law, University of Minnesota Law School

Cover of FRAND

As readers of this blog are aware, organizations such as the European Telecommunications Standards Institute (ETSI), IEEE, and others promulgate standards that enable products such as smartphones and other complex technological devices to interoperate.  These standard-setting organizations (SSOs) encourage their members to commit to licensing patents that may be essential to the practice of the relevant standards on fair, reasonable, and nondiscriminatory (FRAND) terms.  Because SSOs do not define the meaning of FRAND, however, when the owners of these standard-essential patents (SEPs) and the companies that implement them fail to reach terms, litigation is often the result.  And because patents are territorial rights, FRAND litigation often spans the globe—though because of its importance to the European market, Germany has been home to many of the most important FRAND cases over the past decade.  The German FRAND case law, in turn, is based in part on the German courts’ interpretation of European Union competition (antitrust) law, and differs in important respects from the approaches taken in FRAND cases in other leading jurisdictions, including the United Kingdom, the United States, and China. (more…)

The Art of Losing Gracefully or How Koki’s appellate loss is truly a win.

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by Dennis Crouch

We have seen lots of ITC action recently. In the new Koki v. ITC decision, the Federal Circuit found that the accused infringer Koki lacked Constitutional standing to bring the appeal  based upon a binding promise not to sue submitted by the patentee Kyocera.

As I discuss at the end of this post, although Koki is the nominal loser, the company substantially advanced its position on appeal because Kyocera was forced to declare (and then clarify) its promise in order to obtain dismissal.

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A few initial thoughts on Loper Bright and the end of Chevron Deference

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by Dennis Crouch

This is just a first look at how overturning Chevron may impact patent practice. 

In the past, both the USPTO and patent attorneys have largely ignored the larger scope of administrative law, but in recent years USPTO operations have been under tighter control from the White House, and courts have increasingly asked whether the agency is following the rules.  Administrative patent law was truly launched with  the American Invents Act of 2011 and the resulting administrative patent trials by the PTAB -- resulting in hundreds of appeals arguing that the USPTO's procedural approach is an abuse of administrative power.  Importantly, the Supreme Court in Cuozzo Speed Techs. v. Com. for Intell. Prop., 579 U.S. 261 (2016) provided the patent office with Chevron deference for its determinations regarding AIA trials, including issues such as its approach to claim construction.  But Chevron has now been overruled, and many are wanting the Federal Circuit to revisit the USPTO approach.

Although I expect that the outcome

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USPTO Granted Remand in Important Antibody Written Description Case

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by Dennis Crouch

The Federal Circuit has remanded the Xencor appeal -- allowing USPTO  leadership an opportunity to re-focus on the written description requirement for both Jepson claims and means-plus-function claims in the antibody art.  I have several prior posts about the case:

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Improving Efficiency to Increase Competition Act: Burdens of Bayh-Dole

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by Dennis Crouch

The Leading pro-IP Senators, Thom Tillis (R-NC) and Chris Coons (D-DE) recently introduced a bill focusing on patents stemming from research paid-for by federal grants. The proposed legislation, titled the “Improving Efficiency to Increase Competition Act,” would require a government study on reporting requirements related to the landmark Bayh-Dole Act of 1980.

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