Tag Archives: reasonable expectation of success

Pending En Banc Petitions at the Federal Circuit

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by Dennis Crouch

The Federal Circuit recently decided the en banc design patent case of LKQ v. GM, but the court has not issued an en banc decision in a utility patent case since 2018.  There are currently four interesting petitions pending before the court.

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Decoding Patent Ownership beginning with Core Principles

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by Dennis Crouch

In a recent decision, the Federal Circuit vacated a district court's grant of summary judgment that an inventor, Dr. Mark Core, had automatically assigned a patent associated with his PhD thesis to his then-employer and education funder TRW.  Core Optical Techs., LLC v. Nokia Corp., Nos. 23-1001 (Fed. Cir. May 21, 2024). The key issue was whether Dr. Core developed the patented invention "entirely on [his] own time" under his employment agreement. The majority opinion written by Judge Taranto and joined by Judge Dyk held the contract language was ambiguous on this point and remanded for further factual development to determine the parties' intent.  Judge Mayer dissented.

Although not discussed in the court's decision, the appellant brief includes a suggestion that the Federal Circuit should "narrow or overrule" the automatic assignment law seen in FilmTec Corp. v. Allied Signal, Inc., 939 F.2d 1568 (Fed. Cir. 1991), and its progeny

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Supreme Court Declines to Hear Vanda’s Patent Obviousness Appeal

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by Dennis Crouch

The Supreme Court has denied Vanda Pharmaceuticals' petition for certiorari, leaving in place a Federal Circuit decision that invalidated Vanda's patents on methods of using the sleep disorder drug Hetlioz (tasimelteon) as obvious.

Vanda had argued in its cert petition that

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The Use of Mandated Public Disclosures of Clinical Trials as Prior Art Against Study Sponsors

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By Chris Holman

Salix Pharms., Ltd. v. Norwich Pharms. Inc., 2024 WL 1561195 (Fed. Cir. Apr. 11, 2024)

Human clinical trials play an essential role in the discovery, development, and regulatory approval of innovative drugs, and federal law mandates the public disclosure of these trials. Pharmaceutical innovators are voicing concern that these disclosures are increasingly being used as prior art to invalidate patents arising out of, or otherwise relating to, these trials, in a manner that threatens to disincentivize investment in pharmaceutical innovation. A recent Federal Circuit decision, Salix Pharms., Ltd. v. Norwich Pharms. Inc., illustrates the concern.  In Salix, a divided panel upheld a district court decision to invalidate pharmaceutical method of treatment claims for obviousness based on a clinical study protocol published on the ClinicalTrials.gov. website. The case garnered amicus curiae briefs filed by several innovative pharmaceutical companies in support of the patent owner, Salix Pharmaceuticals.

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De Forest Radio v. GE: A Landmark Supreme Court Decision on the Invention Requirement

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By Dennis Crouch

In 1931, the United States Supreme Court decided a landmark case on the patentability of inventions, De Forest Radio Co. v. General Electric Co., 283 U.S. 664 (1931), amended, 284 U.S. 571 (1931). The case involved a patent infringement suit over an improved vacuum tube used in radio communications. While the case predated the codification of the nonobviousness requirement in 35 U.S.C. § 103 as part of the Patent Act of 1952, it nonetheless applied a similar requirement for "invention."

I wanted to review the case because it is one relied upon in the recent Vanda v. Teva petition, with the patentee arguing that the court's standard from 1931 has been relaxed by the Federal Circuit's "reasonable expectation of success" standard. The decision also provides an interesting case study in the way that the court seems to blend considerations of obviousness and

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Munsingwear Mootness in Sumitomo Pharma v. Vidal

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by Dennis Crouch

Although non-precedential, the Federal Circuit's new decision in Sumitomo Pharma v. Vidal offers the important conclusion that a patentee has no standing to appeal an invalidity holding once the patent expires, absent some showing of likely infringement during the prior six years.  Sumitomo Pharma Co. v. Vidal, No. 22-2276 (Fed. Cir. April 5, 2024).  The case is not so bad for the patentee because

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Dow Chemical’s 1945 ‘Perfectly Plain’ Test for Obviousness

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by Dennis Crouch

The pending obviousness petition in Vanda v. Teva has prompted me to look back on some of the key Supreme Court cases cited in the briefs. Last week, I wrote about Atlantic Works v. Brady, 107 U.S. 192 (1883) in a blog post titled The Quest for a Meaningful Threshold of Invention.  Today, I'm looking at Dow Chemical Co. v. Halliburton Oil Well Cementing Co., 324 U.S. 320 (1945), an obviousness case decided just a few years before a rewriting of the 1952 Patent Act.  At the time, the doctrine was identified as "want of invention," but the court's analysis is familiar to anyone practicing patent law today.

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Obviousness and Pharmaceutical Method of Treatment Claims

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by Dennis Crouch

In April 2024, the Federal Circuit issued a significant decision vacating a district court's judgment that Janssen Pharmaceuticals' dosing regimen patent claims were nonobvious. Janssen Pharms., Inc. v. Teva Pharms. USA, Inc., No. 2022-1258 (Fed. Cir. Apr. 1, 2024). The case involved Janson's U.S. Patent No. 9,439,906, which claims methods of treating schizophrenia by administering specific doses of the long-acting injectable antipsychotic paliperidone palmitate.

Teva filed an Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Janssen's Invega Sustenna product, which embodies the claimed methods. In the ensuing Hatch-Waxman litigation, Teva stipulated to infringement but challenged the patent on obviousness and indefiniteness grounds. Following a bench trial Judge Cecchi (D.N.J.) rejected Teva's invalidity defenses, and Teva appealed.

On appeal, Judge Prost authored a unanimous opinion affirming the district court's indefiniteness determination but vacating and remanding on obviousness.  Overall, this is a bad case for pharmaceutical formulary patents.

This post focuses on the court's obviousness holding and its potential implications for pharmaceutical method of treatment claims more broadly. I make three key claims. . .

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Today’s Obviousness Key: Motivation to Combine

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by Dennis Crouch

The Federal Circuit's recent decision in Virtek Vision International ULC v. Assembly Guidance Systems, Inc. focuses on the motivation to combine aspect of the obviousness analysis. The court's ruling emphasizes that the mere existence of prior art elements is not sufficient to render a claimed invention obvious; rather, there must be a clear reason or rationale for a person of ordinary skill in the art to combine those elements in the claimed manner.  In the case, the IPR petitioner failed to articulate that reasoning and thus the PTAB's obviousness finding was improper.

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The Obviousness Hurdle

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by Dennis Crouch

The U.S. Supreme Court is weighing whether to grant certiorari in Vanda Pharmaceuticals v. Teva Pharmaceuticals. I have been closely watching this obviousness case that could have significant implications beyond the pharmaceutical industry.  The following essay provides an overview of the key legal issues at stake and introduces Teva's recent briefing.

The case centers on the proper legal standard for determining when an invention is "obvious" and therefore unpatentable under 35 U.S.C. § 103.  In particular, Vanda argues that the Federal Circuit has unduly raised the non-obviousness hurdle -- barring patents based upon a "mere reasonable expectation of success" or that certain experiments would have been obvious to try, even though the result was not known.

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More on Reasonable Expectation of Success from the Federal Circuit

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by Dennis Crouch

In Sisvel v. TCT Mobile and Honeywell, the Federal Circuit has affirmed the PTAB's IPR findings that the claims are obvious.  The non-precedential decision provides further insight into the Federal Circuit's reasonable expectation of success test.

Sisvel's U.S. Patent 8,971,279 covers a method of sending Semi-Persistent Scheduling (SPS) deactivation signals that essentially "piggyback" on existing messages. SPS is a technique used in LTE networks to more efficiently allocate radio resources to user equipment (UE) for periodic transmissions, such as Voice over IP (VoIP). In SPS, the base station pre-allocates resources to the UE for a set period of time, reducing the need for frequent scheduling requests and grants. SPS deactivation signals are messages sent by the base station to the UE to indicate that the pre-allocated resources are being released and are no longer available for the UE's periodic transmissions. These signals are necessary to free up the resources when they are no longer needed, allowing them to be reassigned to other UEs or used for other purposes.

In the context of Sisvel's '279 patent, the invention was directed to a specific method of sending SPS deactivation signals by filling a preexisting binary field (the resource indication value or "RIV") with all "1"s. This 111111111 technique was intended to provide a more efficient way of signaling SPS deactivation while still ensuring that the deactivation message would not be mistaken for a valid resource allocation message.  In the patented system, the string of ones would always be processed as an invalid value and never mistaken for a valid resource allocation message, providing stability to the network, regardless of size.

TCT Mobile and others petitioned for IPR, asserting that the challenged claims were obvious based on various combinations of prior art, including Samsung and Dahlman. The PTAB found the claims unpatentable as obvious, and Sisvel appealed.

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Pfizer v. Sanofi: Applying the Results-Effective Variable Doctrine in Obviousness Analysis

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by Dennis Crouch

The Federal Circuit has affirmed the PTAB's finding that Pfizer's pneumococcal vaccine patent is obvious, but has vacated and remanded the Board's denial of Pfizer's motion to amend certain claims. Pfizer Inc. v. Sanofi Pasteur Inc., No. 19-1871 (Fed. Cir. Mar. 5, 2024); U.S. Patent No. 9,492,559. Pfizer v. Sanofi Opinion.

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Livestream of LKQ v. GM

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The Federal Circuit is hearing oral arguments today in the design patent case of  LKQ Corporation v. GM Global Technology Operations LLC 21-2348.  Judge Stoll's opinion in the case sides with the patentee GM on the issue of obviousness -- affirming a PTAB decision in favor of the patentee.  LKQ's appellate team led by Prof. Mark Lemley argues that Federal Circuit's obviousness standard (known here as the Rosen-Durling test) makes it too difficult to actual reject or cancel design patent claims.  Lemley argues for a much more flexible and common sense approach as required by KSR.  The USPTO's amicus agrees Federal Circuit law should be expanded, but not as far as suggested by LKQ.  GM argues for the status quo.

According to the listing, the en banc panel today consist of Chief Judge Moore,  and Circuit Court Judges Lourie, Dyk, Prost, Reyna, Taranto, Chen, Hughes, Stoll, and Stark.  Not listed is Judges Cunningham and Newman.  

Livestream below:

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Vanda Seeks Supreme Court Review on Lower Standard for Obviousness

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Vanda Pharmaceuticals recently filed a petition for writ of certiorari, asking the Supreme Court to review a May 2023 decision by the Federal Circuit that invalidated claims from four Vanda patents covering methods of treating Non-24-Hour Sleep-Wake Disorder ("Non-24") using the drug tasimelteon (Hetlioz). Vanda Pharmaceuticals Inc., v. Teva Pharmaceuticals USA, Inc., 23-768 (Supreme Court).  The district court held that all the asserted claims were invalid as obvious, and the Court of Appeals for the Federal Circuit affirmed this decision. Vanda.cert.petition

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Federal Circuit Upholds PTAB’s Obviousness Finding and Joinder Decision in CyWee v. ZTE Smartphone Patent Case

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The Federal Circuit recently affirmed a ruling by the Patent Trial and Appeal Board (PTAB) in an inter partes review (IPR) filed by ZTE and joined by LG, finding claims of CyWee Group’s U.S. Patent No. 8,441,438 unpatentable as obvious. CyWee Group v. ZTE, No. 21-1855 (Fed. Cir. Jan. 18, 2024). The ’438 patent claims 3D motion-tracking technology for handheld devices like smartphones. The appeal included both IPR procedural issues and substantive patent law issues.  In siding with the PTAB, the Federal Circuit rejected CyWee’s argument that the Board should not have allowed LG to oppose CyWee's motion to amend its claims. The court also affirmed the Board’s finding that the proposed amended claims would have been obvious over the prior art.

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Supreme Court on Patent Law: November 2023

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by Dennis Crouch

The Supreme Court is set to consider several significant patent law petitions addressing a range of issues from the application of obviousness standards, challenges to PTAB procedures, interpretation of joinder time limits IPR, to the proper scope patent eligibility doctrine. Here's a brief overview of each case, followed by more details:

  1. MacNeil v. Yita (No. 23-494): This case examines the Federal Circuit's reversal of a PTAB obviousness decision.  Petitioner argues that the appellate court substituted its own findings in the reversal rather than vacating and remanding.  This could be an important case for revitalizing the importance of secondary indicia of non-obviousness.
  2. Intel v. Vidal (No 23-135): This case challenges the "Fintiv rule" that restricts the initiation of inter partes review in cases where parallel district court litigation is pending.  The PTO is changing its approach, but Intel argues that the Agency isn't going far enough.
  3. VirnetX v. Mangrove Partners Master Fund (No. 23-315): This case questions the Federal Circuit's interpretation of time limits for joining IPR partes. Apple joined the petition long after it would have been barred from filing its own.  Although I sympathize with the petition, I believe the Federal Circuit got the statutory interpretation correct.
  4. Realtime Data v. Fortinet (No. 23-491): Here, Realtime Data challenges what it sees as lower court improper expansion of eligibility doctrine.  It asks the court to reiterate that eligibility is generally quite broad, subject to some quite narrow judge-made exceptions.
  5. Tehrani v. Hamilton Technologies (No. 23-575): This case involves a dispute over the PTAB's obviousness finding and the Federal Circuit's affirmation, particularly focusing on the qualifications of an expert witness, the proper interpretation of claim terms, etc.  There is some really interesting parts of the petition and case, but the petition largely re-argues the evidence -- typically a losing approach at the Supreme Court.
  6. Vanda v. Teva (No. 23-___): I expect Vanda to challenge the Federal Circuit's decision on the obviousness of its patents covering methods of using a particular drug. Vanda will argue that the court was too quick to jump to its obviousness conclusion.  If cert is granted, this would be a very important case.
  7. Traxcell Techs. v. AT&T (No. 23-574): This case examines whether attorney fees can be awarded based on pursuing litigation deemed "baseless" after a magistrate judge's non-infringement recommendation but before the district judge finalizes that recommendation.

More detail on each case below:

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Size Matters: Element-by-Element Analysis in Obviousness

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by Dennis Crouch

In re Universal Electronics, Inc., No. 2022-1716 (Fed. Cir. Aug. 15, 2023) (non-precedential)

This was a consolidated appeal from two Patent Trial and Appeal Board (PTAB) decisions affirming the rejection of claims from Universal Electronics, Inc.'s (UEI) U.S. Patent Application Nos. 12/645,037 and 16/279,095 as obvious under 35 U.S.C. § 103.  On appeal, the Federal Circuit has affirmed.

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