Posts in Guest Contributors

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.

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.    

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.

Recently, ChatGPT (Generative Pre-trained Transformer), an artificial intelligence (AI) chatbot program developed by OpenAI, has become a popular topic, attracting much attention and discussion. Its applications in the fields of natural language processing and text analysis have been well documented and have aroused great interest. It can be used to generate various language models, such as natural language texts, dialogues, and question-answering. It is currently one of the most advanced and efficient technologies in the language field. ChatGPT has a wide range of applications. In fields like medical, financial, legal, and media, ChatGPT can also be used to generate and analyze text data, thereby improving work efficiency and accuracy. Recently, the technology has even been used in the realm of intellectual property, with some having used it to draft patent applications.

Wi-Fi 6 shares new technologies with LTE and 5G that are subject to heavy patenting. The firms and institutions that currently monetize their standard essential patents (SEPs) against LTE and 5G will likely be looking to increase their royalty income from Wi-Fi 6 and 6e. This could mean that the recent disputes over LTE and 5G standardization participants’ fair, reasonable, and non-discriminatory (FRAND) SEP licensing commitments will spill over into Wi-Fi. Current Wi-Fi litigation trends suggest that this is already afoot, and the recent licensor-friendly changes in the IEEE IPR rules are feared to only fuel this trend.

Whether or not the law recognizes a machine as the inventor-at-law, the facts are indispensable to determination of the true inventor-in-fact. In the case of Stephen Thaler’s attempt to obtain patent protection for a food container and light stick he says were independently invented by his AI machine, DABUS, the inventor-in-fact will be either Thaler or his machine. The procedural posture of Thaler v. Vidal caused the discourse to jump over the facts of how the food container and the light stick were invented by DABUS. These overlooked facts may reveal the true inventor, regardless of whether or not the type of inventor is recognized by the current law. 

Artificial Intelligence (AI) is providing enormous productivity and increased value in many applications. But AI is no panacea and is not yet sufficiently well developed to be precise or dependable everywhere. For example, much better AI training data is required to reliably estimate patent essentiality to standards such as 4G and 5G, where AI is being advocated by various experts and has already been adopted by one patent pool. There is also a lot of room for improvement in inferencing.

Several carefully watched copyright developments are combining to have a significant impact on the invention as well as the content landscape. A judgment from the Supreme Court of the United States is expected any day that will address the potentially shape-shifting Warhol Foundation “fair-use” suit against rock photographer, Lynn Goldsmith. This decision is also of concern to inventors and patent holders, few of whom see the writing on the IP wall: weaker intellectual property rights are gaining momentum, and lawmakers and the public don’t know enough to care.

There was a slight uptick in district court filings last week after a slow January and February, with 43 new patent filings, including a design patent battle involving tumblers and multiple filings indicating an association with high-volume plaintiffs such as Jeffrey Gross and Leigh Rothschild. It was a busy week at the Patent Trial and Appeal Board (PTAB), with over 32 new challenges last week, with only one procedural denial on an institution decision—but that was not based on discretionary denial, which remains often briefed but rarely successful for the time being. Of course, the big news this week was that the Federal Circuit has revived an Administrative Procedure Act (APA) challenge to the Fintiv decision on discretionary denial itself as arbitrary agency action that skirted proper procedure and had an outsized impact on a broad swath of cases.

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”.

Israel is known as the land of milk and honey, the Holy Land, and the Startup Nation. And it consistently ranks in the top five countries for number of Patent Cooperation Treaty (PCT) patent applications filed per capita. But due to its relatively small size, it’s understandably not known as a hotbed of major patent deals. Yet, surprisingly, the person responsible for making many of the biggest patent deals in the world happen is an unassuming lawyer based in Tel Aviv, Lillian Shaked.