Posts in Patents

Updated WHO Pandemic Accord Retains Commitments for Non-Exclusive Licensing and Royalty Waivers

On April 19, the World Health Organization (WHO) released an updated draft proposal of an international agreement on the global response to future pandemics. While the WHO pandemic agreement has been met with widespread support from many of the international agency’s member nations, including the United States, it retains provisions limiting intellectual property (IP) rights that have encouraged opposition from lawmakers and pharmaceutical innovators alike.

Unveiling The Untapped Potential of Brazil’s Solar Energy Market

Brazil, a country known for its abundant natural resources, is emerging as a significant player in the global renewable energy sector. Brazil has one of the highest levels of insolation in the world (ranging from 4.25 to 6.5 sun hours per day according to the Solar and Wind Energy Resource Assessment Project – (SWERA) and is therefore uniquely positioned to harness the power of the sun.

Chamber Appeals Decision to Deny Expedited FOIA Request on March-In Proposal

The U.S. Chamber of Commerce’s Global Innovation Policy Center (GIPC) has filed an appeal with the U.S. Department of Commerce, which denied the GIPC’s January 2024 Freedom of Information Act (FOIA) request seeking more detail about the working group behind the Biden Administration’s draft framework for considering the exercise of march-in rights. The proposed framework was published in the Federal Register in December 2023 by the Department of Commerce and the National Institutes for Standards and Technology (NIST) and included suggestions on whether and when to exercise “march-in rights” under the Bayh-Dole Act that would arguably significantly broaden the criteria for compulsory licensing of patented technology developed with federal funding.

SCOTUS Scraps Vanda’s Bid for Guidance on Obviousness Standard

The U.S. Supreme Court today denied a petition for certiorari seeking clarification from the Court on the proper standard for a showing of obviousness. Vanda Pharmaceuticals filed the petition following the U.S. Court of Appeals for the Federal Circuit’s (CAFC’s) May 2023 decision invalidating Vanda’s patent on a method of using the drug tasimelteon to treat Non-24-Hour Sleep-Wake Disorder. The CAFC came to its decision in part because the court said the disclosure of clinical trials was evidence that a person of ordinary skill in the art “would have had a reasonable expectation of success.” Vanda argued in its Supreme Court petition that a “predictable results” standard should be applied instead and maintained that the High Court said as much in KSR v. Teleflex.

AI Tools for Patent Drafting: LLMs Will Likely Never Write Claims as Well as Humans

Like most patent attorneys, I get multiple emails each month for artificial intelligence tools purporting to help patent attorneys draft patent applications. I have done demos, and I have no doubt that in five years almost all patent drafting practitioners will be using these generative AI tools in some capacity. But I am also convinced that these tools will not be especially helpful in drafting claims.

Young Sheldon’s Inventorship Woes: Important Lessons for All Young Inventors

As the hit sitcom Young Sheldon comes to an end next month, a look back at the series offers an opportunity for young inventors to learn about inventorship. The coming-of-age show centers around a boy genius, Sheldon, who has run the gamut of growing up in expedited fashion—experiencing high school, college dorm life, and even a first (failed) kiss (attempt), all before being eligible to drive. Another milestone in Sheldon’s life—his first inventorship dispute—shows that it doesn’t take a boy genius to become a young inventor.

Thoughts on the USPTO’s NPRM: Not Bad But the Big Challenges Remain

Times are changing at the Patent Trial and Appeal Board (PTAB)! Not only are there rumors that the Senate IP Subcommittee may be a matter of several weeks away from marking up the PREVAIL Act and voting it out of committee, but the United States Patent and Trademark Office (USPTO) has finally issued a Notice of Proposed Rulemaking (NPRM) relating to several changes to the Code of Federal Regulations as they pertain to patent challenges at the PTAB.

USPTO Publishes Long-Awaited Proposed Rule on PTAB Changes

The U.S. Patent and Trademark Office (USPTO) today announced a Notice of Proposed Rulemaking (NPRM) that will be officially published in the Federal Register tomorrow and that addresses a subset of issues from the controversial April 2023 Advance Notice of Proposed Rulemaking (ANPRM). USPTO Director Kathi Vidal received criticism following the ANPRM, most notably from Congress. In a House IP Subcommittee meeting held last year, members of the Subcommittee expressed confusion about the ANPRM and suggested Vidal may have been exceeding her authority with some of the proposals.

Stay on Top of Hot Topics in Patent Damages Litigation

In patent litigation, damages issues are sometimes treated as an afterthought when compared to the issues of infringement and invalidity. However, achieving a client’s goals requires an attorney to place damages at the center of the litigation strategy from the very beginning. Damages, quite simply, can make or break a case. And it is a quickly evolving field, rife with inconsistent judicial decisions, vague standards, and new techniques for measuring damages. Below are some of the current hot topics in patent litigation—and tips for practitioners on both sides of the “v” on how to handle them.

Patent Filings Roundup: Slow Week in PTAB and District Court, Ideahub Subsidiary Challenges Instituted; Patent Armory Continues the Offensive

It was a slow week for new patent filings at the Patent Trial and Appeal Board (PTAB) and in the district courts. This week saw only 18 new filings at the PTAB—one of which was a Post Grant Review, while the remaining were inter partes reviews (IPRs). Texas Instruments, Inc. continued challenging Greenthread LLC patents, filing four IPRs against  four patents (bringing the total number of IPRs Texas Instruments has filed up to seven). Amazon filed two IPRs against one Nokia Technologies Oy [associated with Nokia Corporation] patents; Apple filed five IPRs against three Resonant Systems Inc. (d/b/a RevelHMI) patents; and Micron filed two IPRs against two Yangtze memory Technologies Company Ltd.

From Foundation to Fortress: Developing an IP Strategy for Success

While many see intellectual property merely as a shield, its greater power rests in its strategic use to spark innovation and propel business growth. In this article I describe a systematic approach for developing IP strategies that are tailored to the technology and objectives of each business, so that the resulting IP can be used to drive the achievement of those goals.

USPTO Proposes Making Director Review Process Official

The U.S. Patent and Trademark Office (USPTO) announced today that it will be publishing a Notice of Proposed Rulemaking (NPRM) tomorrow aimed at formalizing the rules governing Director Review of Patent Trial and Appeal Board (PTAB) decisions under the America Invents Act (AIA). In July 2021, the USPTO announced that it would be implementing an interim rule at the agency in response to the U.S. Supreme Court’s late June 2021 decision in Arthrex v. Smith & Nephew. In the Arthrex ruling, the Court found that the constitutional Appointments Clause violation created by the process for appointing administrative patent judges (APJs) to the PTAB was best cured by review of APJ decisions by the USPTO Director. The interim rule began the process of determining how that review process would play out during the day-to-day operations of the PTAB.

Federal Circuit Says District Court Erred in Assessing Inequitable Conduct in Toddler Dining Mat Patent Case

In a precedential decision issued Friday by Judge Leonard Stark, the U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed a district court’s judgment that Luv n’ care, Ltd. and Nouri E. Hakim (LNC) succeeded in proving Lindsey Laurain and Eazy-PZ, LLC (EZPZ) were barred from relief due to unclean hands but vacated the court’s judgment for EZPZ of no inequitable conduct. The CAFC also vacated a grant of partial summary judgment of invalidity and vacated orders denying LNC attorney fees and costs.

CAFC Panel Splits on Reasonable Expectation of Success Analysis

In a precedential decision authored by Judge Lourie, the U.S. Court of Appeals for the Federal Circuit affirmed a district court’s final judgment that certain claims of several patents owned by Salix Pharmaceuticals for a drug used to treat irritable bowel syndrome (IBS) and other ailments were invalid as obvious. The CAFC also affirmed an order of the district court that instructed the Food and Drug Administration (FDA) that the effective approval date of generic company Norwich’s Abbreviated New Drug Application (ANDA) may not precede the expiration dates of the claims of three other Salix patents that were found to be valid and infringed by Norwich. Norwich cross-appealed from that order and also from the denial of its motion to modify the district court’s final judgment.

Bayh-Dole Coalition: Activist Groups’ Bid for Medicare to Make Generic Xtandi is a ‘Desperate Ploy’

On April 9, Knowledge Ecology International (KEI), the Union for Affordable Cancer Treatment (UACT) and Universities Allied for Essential Medicines (UAEM) sent a letter to Chiquita Brooks-LaSure, Administrator for the Centers for Medicare and Medicaid Services, requesting that CMS use alleged statutory authority to allow companies to make and sell generic versions of the blockbuster prostate cancer drug, Xtandi®. The letter comes two months after the Department of Health and Human Services (HHS) denied an appeal of a decision not to march in on the drug under 35 USC §203.