Posts Tagged: "innovation"

Tillis Renews Request to FDA and USPTO for Independent Assessment of I-MAK Patent Data

On Friday, April 1, Senator Thom Tillis (R-NC) wrote to the Food and Drug Administration (FDA) and the U.S. Patent and Trademark Office (USPTO) to once again voice his concerns about several sources advancing data on the effects of pharmaceutical patents on drug pricing. Tillis is specifically troubled that the data seems to be based on opaque methodologies and to contain inaccurate or incomplete information that may mislead policymakers. In a previous letter to these organizations, he requested the agencies conduct an independent assessment of the accuracy and reliability of those sources. In the present letter, Tillis again highlights his concern about work from the Initiative for Medicines, Access & Knowledge (I-MAK). He had previously written to Tahir Amin, Co-Founder and Co-Executive Director of I-MAK, requesting that I-MAK provide a detailed explanation of its methods to allow others to check the accuracy of I-MAK’s patent data and to assess the credibility of its other assertions.

As Judiciary Committee Votes, Judge Ketanji Brown Jackson Responds to Tillis on IP and Antitrust

As part of the ongoing confirmation process for Judge Ketanji Brown Jackson to the U.S. Supreme Court, Senator Thom Tillis (R-NC) submitted a number of questions for the record, including 35 IP-related questions on topics ranging from patent eligibility to anti-suit injunctions and 15 antitrust questions, to which Judge Jackson recently responded. While Tillis voted against Judge Jackson’s appointment to the U.S. Court of Appeals for the D.C. Circuit Court due to concerns about her judicial philosophy, he recently indicated that she has the appropriate temperament for the Supreme Court. The Senate Judiciary Committee is voting on Jackson’s confirmation today.

Judge Michel Implores Full CAFC to Fix ‘Fuzzy’ Rebuttable Presumption of Nexus Jurisprudence

On March 20, Zaxcom, Inc., the owner of U.S. Patent No. 9,336,307 for Engineering Emmy® and technical OSCAR award-winning wireless microphone technology, petitioned the U.S. Court of Appeals for the Federal Circuit (CAFC) for rehearing en banc after the court found its original patent claims unpatentable as obvious. Zaxcom argued that the CAFC’s precedent in Fox Factory, Inc. v. SRAM LLC, 944 F.3d 1366 (Fed. Cir. 2019), “confused the law” regarding a rebuttable presumption of nexus. Now, former CAFC Chief Judge, Paul Michel, has filed an amicus brief supporting Zaxcom and asking the full CAFC to resolve “unintentional confusion and conflict” in the court’s obviousness jurisprudence.

IP Protects JLTV Despite Sale of Technical Data Package

Oshkosh Corporation has run through a $6.7 billion contract to produce the first 17,000 Joint Light Tactical Vehicles (JLTVs) in a Department of Defense (DOD) program that could produce 55,000 vehicles for the Army and Marines. Oshkosh won the low-rate initial production (LRIP) contract in 2015 to be the sole manufacturer of JLTVs by submitting an original, technologically superior design in a litigated competition with other, arguably, more dominant players in the defense market. Bids for the contract to produce the next tranche of over 15,000 vehicles are due later this year. Competitors for the $7.3 billion recompete contract, including GM Defense, AM General and Navistar, will have access to the proprietary design of the JLTV that Oshkosh used to win the LRIP contract. The U.S. Government has made available to interested bidders a Technical Data Package (TDP) covering the JLTV after purchasing an option in 2016. Oshkosh, however, maintains an intellectual property (IP) portfolio that could counter the sale of the TDP.

NIH’s Fight for Ownership of Moderna’s COVID-19 Patent Highlights Hazards of Business Collaborations

The National Institutes of Health (NIH) is at legal odds with Moderna, claiming that Moderna neglected to add three NIH scientists to Moderna’s patent application on a principal COVID-19 vaccine. If a court ends up siding with NIH, it would co-own any issued patents on the technology, which could prove to be quite valuable; in 2021, Moderna’s vaccine sales were forecasted to be in the range of $15 billion and $18 billion. With an equal undivided interest in the patent, NIH could do whatever it wishes with it, such as licensing it to others and collecting royalties.

USPTO Tasked with Promoting Inclusive Innovation, Improving Prior Art Search Tools Under Commerce Strategic Plan

On March 28, the U.S. Commerce Department issued a strategic plan for fiscal years 2022 through 2026 designed to enhance American competitiveness through the 21st century in several critical areas of the economy, including broadband Internet and supply chain resilience. At several points throughout the Commerce Department’s strategic plan, the importance of intellectual property and the stability provided by certainty in patent rights are acknowledged as key contributors to spurring innovations that benefit American competitiveness against foreign rivals.

Government-Forced Technology Transfer Is Almost Always Wrong

What does the invasion of Ukraine have to do with COVID-19? Would you believe intellectual property is the link? Stay with me on this; it’s an interesting story. Recently, it was confirmed that the Main Intelligence Department of the Ministry of Defense of Ukraine – apparently with some help from volunteer hackers – managed to breach the network of Russia’s most guarded nuclear power facility and make off with extremely valuable trade secrets. The Beloyarsk Nuclear Power Plant contains the world’s only two operational “fast breeder” reactors. More than 20 countries, including the U.S., Japan and France, have been working for decades on this technology, which is supposed to be able to extract close to 100% of the energy from uranium, compared to about 1% for light water reactors. In other words, this is a process that can produce large amounts of energy while completely consuming the fuel and creating virtually no nuclear waste. Whoever is able to commercialize it will make a fortune. So far, no one has come close to the Russians.

Lessons from Junker v. Medical Components, Inc. on Commercial Offers for Sale Invalidating a Patent

Recently, the U.S. Court of Appeals for the Federal Circuit (CAFC) further explained the “on-sale” bar in Junker v. Medical Components, Inc., Case No. 2021-1649 (Feb. 10, 2022). As previously reported here, the case hinged on whether a letter between Larry Junker’s business partner and Boston Scientific Corporation (BSC) was a “commercial offer for sale” before the one-year grace period took effect. The CAFC held that all necessary terms for a commercial offer were present in the letter, and therefore, the letter qualified as a commercial offer for sale invalidating Junker’s patent.

This Week in Washington IP: Using AI for Financial RegTech, New Copyright Challenges in Publishing, and How March-In Rights Can Harm American Universities

This week in Washington IP events, the Senate Committee on the Judiciary kicks off the week by returning to debate over Supreme Court nominee Ketanji Brown Jackson, as well as another nominee selected for the Southern District of New York and its IP-heavy docket. Over in the House of Representatives, the Space Subcommittee discusses ways to work with private commercial firms to develop space situational awareness tools, while the House Task Force on Artificial Intelligence explores the pros and cons of the use of AI systems on RegTech operations within the financial industry. Elsewhere, the Center for the Study of the Presidency & the Congress hosts an event focused on the relationship between IP policy and U.S. innovation leadership; the Hudson Institute takes a look at new challenges to copyright law posed by the digital publishing industry; and the Information Technology & Innovation Foundation looks to correct misconceptions in the advocacy for exercising march-in rights under Bayh-Dole as a price control mechanism for pharmaceuticals.

Senators Tell Raimondo COVID Waiver Compromise Would Be a ‘Gift’ to China and Russia

Senators Thom Tillis (R-NC), Tom Cotton (R-AR) and Marsha Blackburn (R-TN) sent a letter yesterday to Secretary of Commerce Gina Raimondo expressing their “grave concerns” with the compromise language agreed on recently in the ongoing talks to waive intellectual property rights for COVID-related technology under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement. On March 15, the European Union, United States, India and South Africa announced the compromise language. The text is not final and still must get official approval from all 164 World Trade Organization (WTO) member countries.

Data Show USPTO Patent Pro Bono Program is Working for Women and Minorities

Thirty percent of respondents to a survey of applicants using the U.S. Patent and Trademark Office’s (USPTO’s) Patent Pro Bono Program (PPBP) were African American or Black and 41% were female, according to the latest USPTO Director’s Blog. The demographic data were collected voluntarily in 2021from the 21 regional programs that administer the PPBP as part of the broader goal of diversifying the patent system. A 2019 USPTO study found that only 12.8% of all inventors named on U.S. patents are women, while a Harvard study said that white individuals are three times more likely to invent than Black individuals.

VLSI/Fortress IP Patents Likely Invalid Despite OpenSky’s Bad Behavior

You’ve probably heard about all of the VLSI drama: the eye-popping $2.18 billion judgment won by non-practicing entity VLSI (funded by Fortress IP), mysterious post-judgment inter partes reviews (IPRs) filed against the VLSI patents, and finally the now-notorious email from OpenSky offering to disrupt their own IPR in exchange for a fee. Folks have jumped all over the email from OpenSky for its obvious bad behavior, but they are also using it as an indictment of the entire Patent Trial and Appeal Board (PTAB). What is noteworthy here is not the email—this type of behavior is extremely rare. The real story here is what the system got right, and where it failed.

The Hudson Institute Memo Draws the Wrong Conclusions from Discrepancies in I-MAK’s Data

The debate around whether patents are unnecessarily propping up drug prices has been simmering for years. A recent policy memo from the Hudson Institute has thoughtfully raised concerns about the data underlying this debate, and the memo made its way up to the U.S. Senate Judiciary Subcommittee on Intellectual Property. While the memo may have successfully poked holes in some of the data, it draws questionable conclusions regarding what those holes might mean. Unpacking this debate is therefore necessary to guide the correct policy on the intersection of patents and drug prices.

Expert Group Analyzes AI, Copyright and Designs

The European Intellectual Property Office (EUIPO) recently published a deep dive report, titled Study on the Impact of Artificial Intelligence on the Infringement and Enforcement of Copyright and Designs. The report is a product of the Impact of Technology Expert Group, which was established in early 2019. They followed an approach based on Lawrence Lessig’s ‘Code and Other Laws of Cyberspace’ also known as the Code Theory. This describes how human online activity is regulated by law, social norms, and the market, taking into consideration the internet’s technical infrastructure. This approach led to a double-edged sword metaphor, in which a particular technology can be used either to infringe IP rights or to protect/enforce them, presenting to some extent the same features in each case.

Ameranth Attempts to Bump Eligibility Issue Back to Top of SCOTUS’ Inbox

Earlier this month, Ameranth Inc. filed a Petition for a Writ of Certiorari to the U.S. Supreme Court requesting review of the U.S. Court of Appeals for the Federal Circuit’s (CAFC’s) decision affirming a district court ruling that Ameranth’s patent was ineligible under 35 U.S.C. § 101. Ameranth claims that “federal courts have declared thousands of new and useful inventions abstract and patent ineligible” based on SCOTUS’s decision in Alice Corp Pty. v. CLS Bank Int’l (U.S. Supreme Court, 2014). The culmination of the post-Alice upheaval is the CAFC’s paralytic gridlock of denying rehearing en banc in American Axle & Mfg. v. Neapco Holding LLC (CAFC, 2020) according to the petition. Ameranth pled that the court should provide guidance on the standard for patent eligibility, as federal circuits continue to apply the law in a non-uniform and unarticulated manner.