Posts in IPWatchdog Articles

This week in Other Barks & Bites: the U.S. Supreme Court heard oral arguments in two cases related to trademark law; the USPTO has delayed the planned Non-DOCX filing surcharge fee again; Moderna CEO faces Senate HELP Committee; the Indian Patent Office denies Johnson & Johnson a patent extension for a tuberculosis drug; and one of The Isley Brothers files a trademark lawsuit against his brother.

On March 22, the U.S. Chamber of Commerce’s Global Innovation Policy Center (GIPC) sent a letter addressed to Senators Bernie Sanders (I-VT) and Bill Cassidy (R-LA), respectively the Chair and Ranking Member of the U.S. Senate Committee on Health, Education, Labor, and Pensions, regarding a Health Committee hearing held that same day on the pricing of Moderna’s COVID-19 vaccine. The GIPC’s letter sought to push back on false narratives regarding the role of public funding in private pharmaceutical research & development (R&D,) and also doubled down on the Center’s criticisms of drug pricing controls in the recently enacted Inflation Reduction Act.

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.

The United States Patent and Trademark Office (USPTO) sent out an email alert on March 16, 2023 about its transition to eGrants for patents. This change to electronic patent grants as opposed to paper patents is in accord with the USPTO’s continued changes to an all-electronic and no paper system. Prior changes have included all-electronic office actions, and of course the USPTO’s EFS-Web system, in which filings are made electronically with the USPTO. One important thing to realize is that a patent may grant very soon after payment of the issue fee, so if the Applicant desires to have a continuation, continuation-in-part (CIP), and/or divisional application filed (all such applications are referred to as “continuing applications”), they should really do so before or at the same time the issue fee is paid, in order to maintain the pendency with the to-be-issued patent.

At today’s hearing in Jack Daniel’s v. VIP Products, the U.S. Supreme Court Justices suggested to both sides that there might be an easier way out on the facts of this particular case than either party is proposing, but weighed the need to overturn the Second Circuit’s test in Rogers v. Grimaldi, 875 F.2d 994 (2d Cir. 1989), which some of the Justices characterized as injecting unnecessary confusion. Though the Court seemed equally concerned about retaining a way for defendants making clearly parodic use of a mark to get out of litigation quickly, which Rogers is intended to do, they questioned both sides about why in this case they couldn’t either find for Jack Daniel’s by just saying that VIP is clearly using a source identifier on a commercial product, or remand to the district court to say they failed to properly weigh the parody or proximity factors of the product, for instance. Overall, the Justices seemed skeptical that the product in question represents a non-commercial use.

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.

The U.S. Supreme Court today heard oral arguments in Abitron Austria GmbH v. Hetronic International, Inc., which asks the Court to consider whether the U.S. Court of Appeals for the Tenth Circuit erred in applying the Lanham Act extraterritorially to Abitron’s foreign sales, “including purely foreign sales that never reached the United States or confused U.S. consumers.” The Justices struggled with the appropriate reach of the Lanham Act and whether reversing the Tenth Circuit would require overruling Steele v. Bulova Watch Co., 344 U.S. 280, 282-285 (1952), but overall seemed to be considering the need for a new or narrowed test to account for the realities of modern commerce.

Today, the U.S. Chamber of Commerce’s Global Innovation Policy Center (GIPC) published a Patient Access Report profiling the many ways in which drug pricing controls, often enacted in the name of ensuring widespread access to low-cost medicines, actually result in less access to innovative medicines that are more widely available in free markets. The GIPC’s report comes at a time during which the Biden Administration has taken recent action on drug pricing provisions included in the Inflation Reduction Act passed into law last August, which could have deleterious effects on patient access in the United States.

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.    

Faegre Drinker’s Patent Prosecution team is actively recruiting for a full-time Patent Associate to join the Intellectual Property group in our Chicago, IL, Denver, CO, Fort Wayne, IN, Indianapolis, IN, Minneapolis, MN, Philadelphia, PA, Washington, DC, or Wilmington, NC, offices. Successful candidates should have 1-3 years of experience drafting patent applications. A background and degree(s) in Mechanical, Biomedical, Chemical, or Electrical Engineering is preferred. Backgrounds in chemistry, physics, optics, material science, or other applicable technical experience will be considered. Candidates must be collaborative and motivated to succeed in a client-focused, team-oriented environment. Candidates must also have excellent academic credentials and have strong written and oral communications skills.

For well over a year, Senator Elizabeth Warren (D-MA) and some members of Congress have engaged in a campaign to urge the Health and Human Services Secretary Xavier Becerra to break patents on pharmaceuticals to lower drug prices by invoking a century-old statute, Title 28 of the U.S. Code 1498. This is their “game plan”: HHS should contract with generic drug companies willfully to infringe pharmaceutical patents, thereby requiring any damages to be paid from public funds. This strategy took a new tack in early March 2023, when the Biden Administration’s Justice Department filed a surprise “Statement of Interest” in a private lawsuit on behalf  “the Government and its Department of Health and Human Services and the Department of Defense.” The case, filed in Delaware federal court, was initiated by Arbutus Biopharma and Genevant Sciences, which allege that that patents they own were infringed by Moderna in producing its version of the COVID-19 vaccine.

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.