The patent world is full of trap doors that lie waiting for unsuspecting inventors. Without a good map and an intentional path, mistakes and missteps can be plentiful and costly. Some of these mistakes are reversible with limitations. Others have no undo button. When is it safe to talk about your idea or sell your invention? How do you hedge against invalidation and rejection from blind spots with competitor IP and prior art? How do you ensure you actually own your invention when working with employees and contractors? The answers to these questions – and even knowing to ask them in the first place – goes a long way toward keeping inventors on solid ground. Long term success will depend on the steps taken – or not – very early in the journey. This timing is unfortunate for many inventors, however, since it’s also when they know the least about the process.
The patent world is trained on the upcoming Supreme Court Amgen v. Sanofi case. That case is the first time in over 75 years that the Supreme Court is evaluating the meaning and scope of the enablement requirement of 35 U.S.C. § 112. The case offers the Court an opportunity to correct a negative trend in enablement law that has made it more difficult to protect groundbreaking, pioneering inventions. Waiting in the wings, however, is an equally important Section 112 case: . There, the petitioner sought review on whether “the ‘written description of the invention’ [is] to be measured by the statutory standard of ‘in such full, clear, concise, and exact terms as to enable any person skilled in the art to make and use the same.’” As is apparent, Juno’s written description issue is highly intertwined with the Section 112 enablement issue in Amgen v. Sanofi.
Paul Morinville, Founder of US Inventor, recently published a response to my column criticizing RALIA, a bill in Congress that would abolish the Patent Trial and Appeal Board (PTAB). I offer a few observations in reply. I argued in “The Made in China Act,” November 16, 2022, that juries are not an effective or reliable check on patent validity and that eliminating contested validity reviews at the United States Patent and Trademark Office (USPTO) would be a disaster for U.S. manufacturing. As if determined to prove my point, the VLSI patent-assertion group recently obtained yet another monster infringement verdict against Intel based on a patent that probably shouldn’t have issued.
The United States Patent and Trademark Office (USPTO) issued a Notice on the “Duties of Disclosure and Reasonable Inquiry During Examination, Reexamination, and Reissue, and for Proceedings Before the Patent Trial and Appeal Board” on July 29, 2022 (87 FR 45764-67), without a big reaction from the IP community. Patent attorneys mostly scratched their heads wondering what it means, especially as it was created in the backdrop of an attack on drug companies and drug pricing. The attack was motivated by a now largely discredited disinformation campaign by the advocacy group I-MAK (Initiative for Medicines, Access and Knowledge; an oxymoron), based on non-peer reviewed erroneous patent data analysis (see supporting false analyses by Univ. of Calif. Hastings Law School “Evergreen Drug Patent Search” and R. Feldman, “May your drug price be evergreen” J. Law and Biosciences Vol 5(3) Dec 2018, 590-647). Notwithstanding, the White House and certain members of Congress picked up I-MAK’s “Overpatented, Overpriced” faulty advocacy piece (2018; updated Sept 2022), and without checking the integrity of the data, quoted to it, and got to work.
In Plastipak Packaging Inc. v. Premium Waters Inc., Appeal No. 2021-2244, decided December 19, 2022, the U.S. Court of Appeals for the Federal Circuit’s (CAFC’s) newest judge threw a curveball on the topic of inventorship. Judge Leonard Stark wrote the precedential opinion, joined by Judges Newman and Stoll, and ultimately reversed and remanded the U.S. District Court for the Western District of Wisconsin’s grant of summary judgment in favor of Premium Waters, Inc. Plastipak’s 12 patents in suit generally had to deal with unfinished plastic bottles as used during manufacturing.
This year was a busy one for the International Trade Commission (ITC) compared to the last few years. As of December 15, 2022, there were 56 complaints filed, compared to 50 in all of 2021. The Commission also instituted more investigations in 2022 than 2021 and has a higher number of active cases compared to last year, according to Docket Navigator as of December 7, 2022. With in-person hearings resuming, it is an exciting time at the ITC. And with the evolving landscape of venue jurisprudence in the district courts, we expect the growth to continue into 2023. This article highlights a few new developments at the ITC over the past year, as well as several important decisions.
Substantial patent litigation activity occurred in the mRNA space in 2022, involving nearly all of the major mRNA and lipid nanoparticle (LNP) pioneers. Since this is the most significant happening in this space with respect to IP in 2022, this post will provide an overview of that activity as well as a summary exposure analysis.
Another year down, and another year of interesting developments as the Patent Trial and Appeal Board (PTAB) continued its reign as the most significant patent court in the country. Last year ended with a growing sense that change was on the horizon with President Biden’s nomination of Director Kathi Vidal. And that change did arrive as Director Vidal was confirmed in April and quickly worked to reform PTAB policies. Let’s take a look at the five most significant developments involving the PTAB this year.
In our previous blog post, we covered claim construction, Markush Groups, and dependent claim invalidation. As stated previously, while it is impossible to cover all of the various issues related to claim drafting for biotech, chemical and pharma patent applications, in Part II we will highlight some more of the most common issues that may come up, including changes to the law around indefiniteness; product-by-process and means plus function claims; and negative claim limitations.
The Constitution empowers Congress to enact federal copyright laws because the Founders recognized that the best way to advance the public interest is by enabling creators to pursue their own private interests. The copyright system secures uniform property rights to creators across the nation as a reward for their productive labors and as incentive for them to profit in the marketplace. The incredible selection of creative works available to consumers today, in terms of quantity and quality, shows that copyright law is working well. Of course, that doesn’t stop the detractors from throwing as many monkey wrenches as they can. However, looking back over this past year, there’s good reason to think that the naysayers are becoming less relevant. There’s cause to be hopeful that the plight of all creators, big and small, is improving and will continue to get better in the years to come.
It’s that time again. As 2022 has come and (almost) gone, it’s time to look back at the exciting grants and surprising denials of certiorari petitions involving patent and trademark matters by the Supreme Court of the United States, and what to look forward to from the Court in 2023. In 2022 the Supreme Court docket was relatively light on intellectual property matters. After numerous denials of some highly anticipated patent and trademark cases, the Court kept us in suspense by granting certiorari in new cases in November 2022.
[To the tune of Rudolph]: You know Mayo and Markman and Alice and Fintiv; Juno and Axle (American) and Amgen and Teva. But do you recall … the handful of Federal Circuit decisions that got little press but may be important to your practice, at all? Didn’t think so. (Although this may be exaggerated—it depends on how much you read and what you remember from it.) Neither did I, so I searched through the last year of precedential U.S. Court of Appeals for the Federal Circuit opinions to find those that may have important nuggets in them, even though they weren’t high-profile or didn’t involve billions in damages.
Trade secret jurisprudence, originally conceived in the common law of torts as a way to enforce confidential relationships, now has a sharper focus directed at the property interest of businesses in the data that forms the major portion of their asset base. In the process, trade secrets have taken their place of respect alongside the “registered rights” of patents, copyrights, trademarks and designs. But just because we now enjoy statutory guidance through the Uniform Trade Secrets Act (“UTSA”), enacted with some variations in every state but New York, and national uniformity in federal courts through the Defend Trade Secrets Act of 2016 (“DTSA”), the law continues to evolve much as it did a century ago—that is, through the opinions of judges deciding individual cases on their facts.
The past year has proven a difficult one for many. Russia’s invasion of Ukraine and the death of the UK’s longest reigning monarch are among the things for which the year will be remembered. But amid those dark days, one less known event shines like a tiny candle of hope: the end of the Whisky War. For 50 years, Canada and Denmark have been in dispute over the ownership of Hans Island: a battle in which the principal weapons have been strong drink and a sense of humor….. The standard essential patent (SEP) wars may feel like they have been going on for almost as long as the Whisky war. They are not as close to resolution, but 2022 has seen some progress.
The fields of patent prosecution and patent litigation are ever-evolving, and with every new court decision there are lessons for patent practitioners. While it is impossible to cover all of the various issues related to claim drafting for biotech, chemical and pharma patent applications, here, and in future blog posts, we will cover a range of claim drafting topics of interest.