Posts Tagged: "innovation"

Just when you think you have enough things to worry about, you stumble  upon  one more. In its wisdom, Congress enacted a “Medicare Drug Price Negotiation Plan” as part of the Inflation Reduction Act. The program kicks in by imposing “maximum fair prices” for drugs as determined by the Centers for Medicare & Medicaid Services (CMS). In setting these prices, Congress included such factors as the R&D costs for each drug and whether they have been recovered and the current cost of producing and distributing the drug in question. But it was the third criteria which caught my eye—“Prior Federal financial support for novel therapeutic discovery and development with respect to the drug.”

This week in Washington IP news, the Senate and House are back in session and holding a variety of hearings on departments’ 2024 budget requests, including for the Department of Commerce and the National Science Foundation (NSF). Elsewhere, the Council for Innovation Promotion (C4IP) is holding a webinar on proper use of Section 1498(a) of the U.S. Code; and the United States Patent and Trademark Office (USPTO) is hosting regional events in Central Virginia and Silicon Valley to promote resources available to prospective innovators and entrepreneurs.

U.S. Patent and Trademark Office (USPTO) Director Kathi Vidal held a virtual conversation with the intellectual property (IP) press on Wednesday to coincide with a one-year anniversary Director’s blog post published today. “If last year was about listening…this is really the year where we’re trying to bring that to impact,” said Vidal. Vidal said the work she did in her first year in office was about providing clarity and sometimes learning from “unintended consequences,” but this year is going to be about implementation based on the feedback they’ve been provided via the various requests for comments, listening sessions and other initiatives the Office has undertaken. “We now have more knowledge to shape real policy,” Vidal said.

By now, unless you live in a total IP blackout zone, you’ve heard about the Unitary Patent and Unified Patent Court (UPC). Your friends in Europe, particularly, have been insistent on informing you, whether you want to know or not, with daily (if not hourly) email blasts, since January of this year. But most of what they tell you misses the forest for the trees. Here’s why. Let’s begin at the beginning. Aside from your client telling you to, why do you file a patent application? The only answer is: it is a hedge as to the future. The reason for that is that you and they have no way of knowing at the time of filing whether this will be the “next big thing” or just another “thing”. You might say or even believe that filing an application is about “protection” or potential “revenue”. But it isn’t.

The European Union is considering a new regulatory regime for the licensing and litigation of standard essential patents (SEPs) that will destabilize the global telecommunications market. This proposed regulatory regime is unbalanced in favoring implementers over innovators, and thus it threatens to hamstring the explosive technological and economic growth in this vital sector of the modern innovation economy. Although the EU has finally awoken to the competitive and geopolitical threat posed by China, this regulatory proposal undermines efforts by the EU and the United States to sustain their global technological leadership.

The U.S. Court of Appeals for the Federal Circuit (CAFC) today affirmed in a precedential decision the Patent Trial and Appeal Board’s (PTAB’s) finding that Moderna Therapeutics proved certain claims of Arbutus Biopharma Corporation’s mRNA delivery patent invalid as anticipated. U.S. Patent No. 9,404,127 is titled “Non-liposomal Systems for Nucleic Acid Delivery” and is directed to “an invention that provides stable nucleic acid-lipid particles (‘SNALP’) that have a non-lamellar structure and ‘comprise a nucleic acid . . . methods of making the SNALP, and methods of delivering and/or administering the SNALP.’” SNALP has a three-dimensional structure that is either a lamellar morphology or non-lamellar (pictured).

This week in Washington IP news, Congress is still on a state work period, but events continue in the Washington area as the United States Patent and Trademark Office (USPTO) holds a STEM educational event for K-12 students and their families. Elsewhere, the Brookings Institution will hear from U.S. Treasury Undersecretary Jay Shambaugh about the state of the global economy.

Current artificial intelligence (AI) systems can generate an astonishing variety of content, including text-based works, audio, video, images, programming code, product designs, technical papers, etc. In many cases, the output from an AI system is virtually indistinguishable from that of a human. This trend is expected to continue at an ever-increasing rate in the coming years. Since content solely generated by an AI system is not available for protection under existing intellectual property laws, the following are practical guidelines for human creators who wish to protect content that was created with the assistance of an AI system.

On Wednesday, April 4, the Patent Trial and Appeal Board (PTAB) denied VLSI’s motion to terminate Intel’s involvement in an inter partes review (IPR) of VLSI’s U.S. Patent No. 7,725,759. In addition to Intel, OpenSky is also a petitioner in the IPR, which pertains to claims 1, 14, 17, 18, 21, 22, and 24 of the ‘759 patent. VLSI argued that a previous March 2021 district court ruling that found Intel had not proven invalidity of claims 14, 17, 18, and 24 of the patent precluded the tech firm from continuing to pursue this IPR. However, Intel successfully made the case that claim preclusion does not apply thanks to the America Invents Act (AIA). Additionally, it argued that the IPR and district court proceedings do not involve the same accused product and have different standards of proof.

On March 30, U.S. Patent and Trademark Office (USPTO) Director Kathi Vidal issued a decision on sua sponte Director review that vacated a decision of the Patent Trial and Appeal Board (PTAB), which had previously denied institution of inter partes review (IPR) proceedings brought by semiconductor company Wolfspeed. In her latest in a series of sua sponte decisions, Director Vidal ruled that the PTAB erred in determining that prior art asserted by Wolfspeed was essentially the same as other prior art asserted against the same Purdue University patent claims in previous IPR proceedings that were also denied institution by the PTAB.

On March 31, the U.S. Court of Appeals for the Federal Circuit issued a precedential decision in Philip Morris Products S.A. v. International Trade Commission affirming a Section 337 ruling by the U.S. International Trade Commission (ITC) that blocked the importation and sale of electronic vape tobacco products infringing patents owned by R.J. Reynolds Vapor Company. While much of the precedential decision deals with Philip Morris’ procedural and agency challenges to the ITC’s ruling, the Federal Circuit also rejected arguments that several patentability findings entered by the ITC were not supported by substantial evidence. The present appeal stems back to an ITC complaint filed by R.J. Reynolds in April 2020 seeking a Section 337 investigation into Philip Morris’ IQOS line of heat-not-burn tobacco vaping products. The two patents asserted by R.J. Reynolds are U.S. Patent No. 9901123, Tobacco-Containing Smoking Article, and U.S. Patent No. 9930915, Smoking Articles and Use Thereof for Yielding Inhalation Materials. After a yearlong investigation, the administrative law judge (ALJ) concluded that the accused IQOS products infringed claims of both patents, that R.J. Reynolds established the existence of a domestic industry with respect to both patents, and that the public interest did not weigh against entry of a limited exclusion order (LEO).

The U.S. Solicitor General on Wednesday filed an amicus brief with the United States Supreme Court advising it to grant Teva Pharmaceuticals’ petition for writ of certiorari relating to generic manufacturers’ liability for infringement through the use of “skinny labels” on generic drugs. The SG’s brief said that the U.S. Court of Appeals for the Federal Circuit (CAFC) got it wrong, and that the decision could upend the careful balance contemplated by the Hatch-Waxman Amendments between incentivizing new brand name drugs and allowing cheaper generics into the market.

A bipartisan group of congress members sent a letter to U.S. Patent and Trademark Office Director Kathi Vidal late last week urging her to implement some of the proposals outlined in her October 2022 Request for Comments on Robust and Reliable Patents in order to address problems around drug pricing. The letter was sent by Representatives Jodey Arrington (R-TX), Lloyd Doggett (D-TX), Michael Burgess (R-TX), Ann McLane Kuster (D-NH), and Darrell Issa (R-CA). They specifically expressed concerns about the practice of “patent thicketing” and gave the example of two separate patents granted for a rheumatoid arthritis biological drug by the same company, where the difference in the claims was seemingly minor. The letter cites to a video titled “The Case for Patent Reform,” featuring Senior Vice President and Head of Legal & Intellectual Property Biosimilars at Fresenius Kabi, for this reference.

The International Trade Commission (ITC) conducted an all-day hearing today featuring a range of stakeholders with interests in the World Trade Organization’s (WTO) pending decision on extending what has come to be known as the TRIPS [Agreement on Trade-Related Aspects of Intellectual Property Rights] waiver from strictly COVID-19 vaccine technologies to COVID-19 related therapeutics and diagnostics. The initial agreement on waiver came in June of last year and left most of those at the table unhappy. The decision presently applies only to “ingredients and processes necessary for the manufacture of the COVID-19 vaccine” and contemplates extending that to therapeutics and diagnostics no later than six months after the date of the decision, which would have been December 17, 2022. However, that was delayed in December amid concerns there wasn’t enough information to make an informed decision on extension.