Posts Tagged: "patents"

On Monday, March 27, the Supreme Court will hear oral argument in Amgen v. Sanofi, a case with the parties and 27 Amici, including the United States, weighing in on whether and how the Court should address the enablement requirement of Section 112 in the context of genus claims, and in particular, genus claims to antibodies in the pharmaceutical sciences. Depending on how the court focuses its analysis, the opinion could be as narrow as how the jury instruction should read for pharmaceutical antibody claims written in the form of “a binding site plus a function.” But some of the briefs invite the court to loosen the constraints of Section 112 by eliminating the requirement of enablement of the “full scope” of the claimed embodiments in favor of a test focused on the “make and use the invention” language in the statute without the “full scope of the claimed embodiments” language the courts have used for years, with implications not just for pharma but for any art that uses functional or genus claiming.

Perhaps after their favorite theory was blown apart again, as it has been every time it’s been trotted out over the past 20 years, the critics of the Bayh-Dole Act learned a painful lesson. Their carefully constructed thesis that the law contains a hidden provision allowing the government to set prices on successfully commercialized products has been summarily rejected by every Democratic or Republican Administration which has considered it. They say the definition of insanity is doing the same thing repeatedly while expecting a different result. But that didn’t keep the proponents from refiling the same petition which was rejected three times in the Obama-Biden Administration. So once again, the National Institutes of Health (NIH) denied the request that it should “march-in” under the law against the prostate cancer drug, Xtandi, because critics felt it is not “reasonably priced.” Apparently, the petitioners thought that the fourth time would be the charm. Now they know better. And this time, NIH included a subtle, but fatal blow to attempts to go down this path again.

The United States Patent and Trademark Office (USPTO) publishes the Manual of Patent Examining Procedure (MPEP) (currently electronically, but spanning thousands of pages in printed form) to provide examiners and patent practitioners with guidance on the patent statute, USPTO regulations, and patent prosecution practices and procedures. USPTO regulations are promulgated pursuant to the Administrative Procedure Act (APA), which requires a process that includes publication of proposed rules and a public comment period and are binding on the public. The 2011 Leahy-Smith America Invents Act (AIA) strengthened the USPTO’s already-considerable policymaking powers. In a recent law review article addressing the USPTO’s post-AIA policymaking powers, William Neer recognized the USPTO’s AIA-empowered potential to engage in retroactive substantive rulemaking and determined that the USPTO promulgated more rules post-AIA than it did pre-AIA. This article discusses substantive MPEP procedural changes implemented retroactively by the USPTO.

In early March, the U.S. Patent and Trademark Office (USPTO) published the final batch of comments for its “Request for Comments on USPTO Initiatives to Ensure the Robustness and Reliability of Patent Rights.” In total, the USPTO received 227 comments, after extending the deadlines for submissions twice. There were some concerns that the repeated extensions of the submission deadline created uncertainty. When IPWatchdog reached out to the USPTO, the organization had no official comment other than to note that a number of stakeholders had asked for more time to finalize and submit comments, and the Office wanted to hear from as many parties as possible.

Standard-documentation from online sources maintained by standard setting organizations (SSOs) is usually an important source of relevant prior art. Such prior art can include technical specifications, technical reports, change requests, liasioning statements, work item descriptions, study documents, recommendations and RFCs. However, accessing this documentation available in SSO websites is often not easy.

In Part I of this two-part article, we provided an analysis of the Wi-Fi 6 litigation and technology landscape. This Part II discusses important changes to the IEEE rules governing the reasonable and non-discriminatory (RAND) licensing encumbrances on SEPs held by participants in IEEE standardization work. Unfortunately, these rule changes fall short of clarifying what RAND means for Wi-Fi licensors and implementers. Instead, fueled by Wi-Fi 6’s growing valuation and adoption of heavily patented core technologies from LTE and 5G, the rule changes arguably will only heat up the current litigation trend.    

This week in Washington IP news, the Senate Committee on Health, Education, Labor, and Pensions will question the CEO of Moderna about the company’s potential price hike of the COVID vaccine. In the House, the Committee on Foreign Affairs will hear from Secretary of State Antony Blinken on competition with China. Elsewhere, the Hudson Institute is holding an event one day before the Supreme Court hears oral arguments in a case that could have big implications for trademark law.

Lenovo has been ordered to pay InterDigital a lump sum of $138.7 million for a global FRAND (fair, reasonable and non-discriminatory) license covering sales of cellular devices from 2007 to December 31, 2023, in the second full FRAND trial to be decided by the UK courts, following the landmark Unwired Planet case. (Interdigital Technology Corporation & Ors v Lenovo Group Ltd (FRAND Judgment – Public Version) [2023] EWHC 539 (Pat).) In his redacted judgment published on March 15, Mr. Justice Mellor found that neither InterDigital’s August 2021 license offer (which amounted to $337 million) nor Lenovo’s counter offer (which comprised a lump sum of $80 million +/-15% for all sales in the six-year term to the end of 2023 with a full release for all past sales for no additional consideration) were FRAND or within the FRAND range.

On March 13, the U.S. Court of Appeals for the Federal Circuit (CAFC) issued a precedential decision in Intel Corp. v. PACT XPP Schweiz AG reversing a final written decision of the Patent Trial and Appeal Board (PTAB) that found Intel had failed to show that PACT’s patent claims were invalid for obviousness. In reversing, the Federal Circuit ruled that the PTAB improperly rejected Intel’s “known technique” rationale supporting a motivation to combine prior art references under the flexible analysis set out by the U.S. Supreme Court’s landmark 2007 obviousness ruling in KSR v. Teleflex.

The USPTO was actively working behind the scenes to revise sections of the Manual of Patent Examining Procedure pertaining to the subject of its recent Request for Comments, including policies and procedures relating to restriction, continuation, divisional, double patenting and terminal disclaimer practice. Three days after the RFC response period ended, the USPTO announced publication of a revised version of the MPEP in the Federal Register. The revised MPEP (Ninth edition, revision 07.2022) was made retroactive to July 2022…. An analysis of the revised MPEP reveals that it contains multiple changes that not only fail to address the President’s and Senators’ concerns [patent thickets], but instead actively facilitate more “restriction thickets”.

The U.S. Court of Appeals for the Federal Circuit (CAFC) on Monday said that Apple has standing to pursue its claim that the U.S. Patent and Trademark Office (USPTO) Director’s instructions to the Patent Trial and Appeal Board (PTAB) regarding discretionary denial practice under Apple Inc. v. Fintiv, Inc. were made without proper notice-and-comment rulemaking. The CAFC affirmed the district court’s ruling on two other challenges brought by Apple, Cisco, Intel and Edwards Lifesciences, but said that at least Apple had standing to present the challenge that the discretionary denial instructions were improperly issued and reversed on that ground. The appeal relates to Apple’s and the other companies’ challenge of the Fintiv instructions governing the PTAB’s discretion to deny institution of inter partes review (IPR) proceedings based on their contention that they will result in too many denials.

Innovation is the foundation of America’s ability to compete in a global economy, and the cornerstone of America’s foundation is our patent system. This is especially true when it comes to American leadership in life sciences. Yet, Washington is debating proposals, driven by political narratives, that will limit the availability of patents and that fail to consider the impact on innovation and American competitiveness. Our founding fathers inherently understood that entrepreneurship ran deep within the fabric of our country and that a system was needed to unlock its genius. Developed by our founding fathers, the patent system has evolved with the times and continues to set the global standard on supporting inventors of all stripes. Decisions made by George Washington, Thomas Jefferson, and others continue to provide the legal certainty necessary for investors to support research and development.  

The U.S. Court of Appeals for the Federal Circuit (CAFC) on Monday granted Patent Quality Assurance’s (PQA’s) motion to dismiss its January 24 petition for a writ of mandamus asking the CAFC to restore it as a party to its high-profile inter partes review (IPR) proceeding against VLSI Technology. U.S. Patent and Trademark Office (USPTO) Director Kathi Vidal in December 2022 ruled that PQA abused the IPR process by filing an IPR and threatening to join a separate IPR against VLSI in order to receive a payout from the technology firm. She also found that PQA misrepresented an “exclusive engagement” with a witness, Dr. Adit Singh, who was involved in another IPR petition against VLSI brought by OpenSky. She sanctioned PQA by dismissing it from the proceeding and said that, “though the behavior here may not be as egregious as that of OpenSky… I find that PQA’s behavior, nonetheless, amounts to an abuse of process.”

The United States Court of Appeals for the Federal Circuit (CAFC) ruled on March 1 that the Patent Trial and Appeal Board (PTAB) erred in its analysis of an inter partes review (IPR) filed by streaming giants Netflix and Hulu. The CAFC vacated and remanded the case, ordering the PTAB to once again review the patent dispute filed against DivX. “Because the Board legally erred in its obviousness analysis, and the error cannot be regarded as harmless, we vacate and remand,” wrote the CAFC judges in their ruling. Netflix and Hulu petitioned the PTAB to carry out an IPR in February 2020 of DivX’s U.S. Patent No. 10,225,588. The petition claimed the ‘588 patent was unpatentable due to obviousness.

U.S. Patent and Trademark Office (USPTO) Director Kathi Vidal today issued a second Director Review decision correcting the Patent Trial and Appeal Board (PTAB) on its approach to the “compelling merits” analysis outlined in her June 2022 Guidance Memo. In AviaGames, Inc. v. Skillz Platform, Inc., IPR2022-00530, Vidal vacated the PTAB’s denial of AviaGames’ petition to institute IPR of certain claims of Skillz’s U.S. Patent 9,479,602 B1. She explained that the Board’s determination to deny the petition following a Fintiv analysis was improperly based on the district court’s judgment of invalidity under 35 U.S.C. § 101, since that is “a statutory ground that could not have been raised before the Board” and “does not raise concerns of inefficient duplication of efforts or potentially inconsistent results between the Board and the district court.”