Bayh-Dole Opponents Slam-Dunked Once Again

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.

USPTO Flexes it’s AIA Powers To Make Retroactive Substantive MPEP Policy Changes

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.

Patent Prosecution Tip: File Your Continuation and Divisional Applications Prior to or With Payment of the Issue Fee

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.

SCOTUS Skeptical that Bad Spaniels is Parody, But Questions Need to Overturn Rogers

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.

The Final Word: Who Weighed in After the Second Extension of USPTO’s Robust and Reliable Patents RFC

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.

Establishing the Impact of Standard-Documentation on SEP Validity

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.

Justices Seek Abitron Parties’ Help in Articulating Bounds of Extraterritorial Application of Lanham Act

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.

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