Functional Claims: Morse, Halliburton & Amgen

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by Dennis Crouch

In the patent context, functional limitations describe inventions in terms of their function or intended use, rather than their specific structure or components. Such claims have been subject to much debate and litigation throughout the history of the US patent system. Notable Supreme Court cases like O’Reilly v. Morse, 56 U.S. (15 How.) 62 (1854) and Halliburton Oil Well Cementing Co. v. Walker, 329 U.S. 1 (1946) significantly impacted patent practice and the balance between functional and structural claim drafting.

The pending Supreme Court case of Amgen Inc. v. Sanofi, No. 21-757 (2023) is another example, with the potential to further shift the landscape regarding functional claim limitations. The title of my essay on the case following oral arguments, “Bye Bye Functional Claims,” hints at my outlook. Although the patentee focused on other issues in its briefing, the Justices repeatedly questioned the permissibility of broad functional claim limitations.

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Patent Law Primer: A Newsletter Series on Key Patent Law Topics

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I am happy to announce the launch of my newsletter series, “Patent Law Primer: A Short Introduction to Key Issues in Patent Law,” currently distributed through LinkedIn. This series is designed for a broader audience, making it accessible for anyone interested in the subject, not just patent attorneys.

Each essay delves into legal and practical aspects of various patent law topics while weaving in stories of notable court cases and patent disputes, in an attempt to provide readers with more memorable context.

I have already published the first three essays in the series:

  1. When to File a Patent Application
  2. A Primer on Obviousness
  3. Patent Claim Construction

Over the next year or so, I plan to explore an extensive list of about 50 topics. I welcome your thoughts and suggestions on this project, as well as any specific areas of interest you’d like me to cover in future essays.  Your input will help make this newsletter series a useful and engaging resource.

— Dennis

What Does it Mean to be an Inventor? The Inventor Diary Project and Kicking off the Diversity Pilots Initiative Blog Series

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Guest Post by Colleen V. Chien, Founder of the Diversity Pilots Initiative (DPI), Professor of Law and Co-Director the High Tech Law Institute, Santa Clara University School of Law

A down payment on a house, a sense of being seen, the pride of one’s parents and children, validation of one’s creativity, a permanent mark, and confidence – these are just some of the answers received to the question, “what does being an inventor mean to you?” Though the patent system exists to promote innovation, it also serves to promote inventors and innovators. Today, on World IP Day, this post shares the often-overlooked personal journeys of invention that patent professionals play a crucial role in, by encouraging idea submission, collaborating with engineers and innovators, managing outside counsel, and in patent drafting, prosecuting claims,  patent examining, and studying and teaching patenting. This post is the first in a series by the Diversity Pilots Initiative (DPI), which strives to advance inclusive innovation so that all may access its benefits – including the social, confidence, and economic boosts chronicled in these diaries –  through rigorous research.

The question in various forms was asked in a survey of inventors and recognized innovators carried out from April 15-24, 2023 by myself and the IP team at Pure Storage, a company partner of the Diversity Pilots Initiative doing innovative work in invention and innovation led by Elizabeth Morris (SCU Law ‘06), Frances Winkler, and Joseph Kucera.  (response rate of ~25%). For more stories, and to add your own story , visit the “Inventor’s Diary” at www.diversitypilots.org.

What did becoming an inventor mean to you?

“As an engineer you are usually stuck in an endless cycle of building the next billion-dollar product and in the world of every evolving and every updating software, most of our work is never permanent. But when you become an inventor and build something which no one ever thought of, you make a permanent mark of your existence in the tech industry. I still remember how happy I was when I filed my first patent back which was a moment of great joy and pride. And as time went by, I filed multiple patents and I felt more confident and more accomplished.” – Kshithij Iyer, became an inventor at age 27

“Being recognized as an inventor validates one’s creativity, empowering one to do more.” – Sujesha S.,  became an inventor at age 38

“My kids have bragged to their friends at school that I have a patent. My mom knows and I think I’m the first in my family to get one. So that’s pretty cool for her when she talks to her friends about her son. I sent her a copy so she knows it is real. It’s probably up on her wall next to the rabbit I finger-painted in school.” – Scott S., young-at-heart

What has becoming inventors meant to your team?

“Previous to our first invention being approved, my team had never really wanted to submit anything, due to concerns about the possible negative impact that may result if it was not a success.  With this first patent, we have put this concern behind us and are driving forward.  The help and advice of the patent team has massively helped give us confidence in our abilities, as has as the slick process they have developed. The team and myself believe we are seen and perceived as the go-to experts in many areas of technology and much of this could be attributed or linked to this first patent.” – Chris R, Senior Director of Engineering

What has being an inventor meant to your family and community?

“My family directly benefited from the patent awards I received … they helped increase the down payment on my home.  This helped me put down more permanent roots in my community.  We needed increased space at the time due to my third child on her way.  My family know that I have received patents, and they know that my employer is happy with me. I have applied my engineering mind to help solve problems in my condo community and church, and have seen some benefit there.”  – Randy S., became an inventor at age 28.

What has becoming a recognized innovator* meant to you?

“I would say that becoming a recognized innovator meant creativity for me. Often legal isn’t seen as a creative department but Pure Inclusive Innovation program that the IP Team at Pure has built proves that wrong. After my experience, I am more confident in my ideas and sharing them. Becoming a recognized innovator taught me that you don’t have to hold a specific title or have a certain tenure to make a difference. Everyone has something to offer, and change can come from the most unexpected places.” – Amber Winburn, Legal Operations Analyst,  first received company recognition for becoming an innovator at age 29.

“The IP team came to the office to do a presentation on the Innovator program. A couple weeks later, I was in a situation where I heard a customer’s struggle with the upgrade process due to his colorblindness. It seemed like there would be a simple fix for this accessibility issue and, while I thought it over, I thought I didn’t know where to go with it. And then when I came to the office, I remembered the team’s presentation and immediately reached out. The rest is history!”   – Jennifer A., first received company recognition for becoming an innovator at age 55.

For more stories, and to add your own story , visit the “Inventor’s Diary” at www.diversitypilots.org/diary.

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About the Diversity Pilots Initiative and DPI Blog Series

 Researchers with the Diversity Pilots initiative work with firms, organizations and others to conduct and produce empirical research, including surveys and rigorous (randomized or quasi-experimental) pilots, to produce insights to advance diversity and inclusion in innovation and invention. If you are interested in our work, we’d love to work with you too! We have expertise in econometric, observational, survey and other empirical methods, and are experts in topics ranging from mentoring to inequality in innovation to government policy. We intend for our blog to disseminate research findings on “what works” to advance diversity and inclusion in innovation and inventing. Watch this space for more blog posts from the Initiative, many of which will draw from last fall’s inaugural Innovator Diversity Pilots Conference, subscribe to our updates, and get in touch to share your own innovator or innovation journey with us at www.diversitypilots.org.

Professor Chien thanks Sydney Yang, SCU Law ’22, for her help with the blog post.

Are you an inventor? Share your story

 

Guidance on Patenting Inventions with AI Contributions

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The following are my remarks given on April 25, 2023 to the USPTO as part of their AI listening session:

by Dennis Crouch

Members of the USPTO, and fellow participants of this AI Listening Session, thank you for inviting me here today and for taking time to consider these important issues.  I want to also thank the prior speakers who have done a great job laying out many of the issues.  I am also happy to work with any of you to help figure this out and reach a workable system that truly encourages innovation.

My name is Dennis Crouch, and I am a law professor at Mizzou and author of Patently-O. It is my privilege to discuss the role of generative AI in the realm of intellectual property and the need for clear guidance from the USPTO.

As artificial intelligence progresses at an unprecedented pace, numerous cases have emerged where generative AI has played a crucial role in conceiving an invention. In certain instances, if the AI were human, it would be rightfully recognized as at least a joint inventor. This raises the question of whether it is appropriate to designate the human, who contributed to only a part of the invention and collaborated with the AI, as the sole inventor. This is particularly concerning in cases where the AI introduced concepts that the human had not conceived or even considered. Generative AI differs from traditional tools in that its responses are unpredictable and it produces results akin to those of a human inventor.

I would like to draw attention to a striking similarity between generative AI and biological models, particularly in the context of the pending Supreme Court case of Amgen v. Sanofi. In this case, researchers patented a genus of monoclonal antibodies, but the antibodies’ amino acid sequences were not designed by humans. Instead, a genetically modified humanized mouse generated the antibodies in response to a specific antigen. This scenario closely mirrors the role of generative AI in the invention process.

The parallel between the genetically modified humanized mouse and generative AI becomes apparent when we examine the prompt given to the mouse in the form of a PCSK9 injection and the subsequent response: antibodies collected from the mouse’s spleen. This analogy can be applied to generative AI, with a human providing the initial input or prompt, and the AI system generating an inventive output.

One key issue is the uncertainty patent attorneys face regarding the proper course of action. Innovators are seeking to protect their valuable inventions, but the lack of clear guidance creates potential ethical dilemmas for patent attorneys. I recently published an article on Patently-O titled “AI Inventor and the Ethics Trap for US Patent Attorneys,” highlighting this concern.

I believe the USPTO should promptly offer guidance, stating that patent applications may appropriately list the human contributor to the conception as the sole inventor, even in situations where an AI or other tool provided key elements of the discovery.

The US Copyright Office has taken steps to deny registration of AI-created works. It is essential for the USPTO to avoid the current pitfalls of the US Copyright Office in addressing AI-related issues.  Ideally, US intellectual property policymakers would consider all aspects of IP—patent, trade secret, and copyright in our situation here—as a unified whole. This might present an opportunity to contemplate the establishment of a US Intellectual Property Office that merges the PTO and Copyright Office, while also providing some authority to regulate trade secrecy.

As several speakers have noted, generative AI is expected to reduce the cost of inventing, which is a tremendous benefit. As Profs Levine and Feldman explained, AI has different incentives than human inventors and lacks the fundamental humanity that our inventorship laws respect.  Still, a valuable technological improvement by an AI (such as a new medical treatment) is something that we want to encourage.

For inventions without direct human contribution, it is timely to consider a special rights category for computer-generated inventions. This unique exclusivity could feature a reduced term and additional requirements to ensure clarity and patentability, such as pre-screening, limited claims, definitions, and the incorporation of born-digital aspects of the documentation.

In conclusion, it is imperative for the USPTO to provide guidance on how to handle generative AI’s role in the invention process – distinguishing between situations where a human inventor exists and those with in no or insufficient human originality.

Hrdy & Seaman: Are NDAs unenforceable when they protect more than trade secrets?

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Guest post by Camilla A. Hrdy, Professor of Intellectual Property Law at University of Akron School of Law

Are NDAs unenforceable when they protect more than trade secrets? The standard answer is no. NDAs can prevent disclosure of contractually-defined “confidential” information that is shared in the course of a confidential relationship, even if it is not technically a trade secret. NDAs can, in other words, go beyond trade secrecy.

NDAs have also not traditionally been treated as contracts in restraint of trade, like noncompetes are. An NDA’s purpose is, ostensibly, just to protect secrets. Similar to trade secret law, NDAs only prevent an employee from disclosing (and using outside authorization) specifically-defined information. They don’t prohibit competition per se. NDAs are thus seen as comparatively “narrow restraints” which, all else being equal, should be preferred to noncompetes.

Or at least that is the common wisdom.  Although there is some support for this viewpoint in treatises and judicial dicta, our new article, Beyond Trade Secrecy: Confidentiality Agreements That Act Like Noncompetes, shows that a growing contingent of courts across jurisdictions are finding NDAs in employment agreements to be unenforceable when they reach too far beyond trade secrecy.  Even Google’s NDA was recently found unenforceable by a California court, because it did not make sure employees could use or share skills they learned at Google with prospective employers. (That said, the Google opinion is quite extreme, even compared to others we reviewed. See pp. 8-11 of the opinion,  Doe v. Google, Inc., Case No. CGC-16-556034 (Cal. Super. Ct., Cty. of San Francisco, Jan. 13, 2022)).

The article is available on SSRN and is forthcoming in Yale Law Journal. It is co-authored by me and Chris Seaman.  This blog post is cross- posted on Patently-O

The Federal Trade Commission recently jumped into the deep end of this swimming pool by proposing a rule that would ban noncompete agreements in employment contracts nationwide. More surprising still, the proposed rule bans what the Commission is calling “de facto” noncompetes,” such as a “non-disclosure agreement between an employer and a worker that is written so broadly that it effectively precludes the worker from working in the same field after the conclusion of the worker’s employment with the employer.”

Our article shows that there is a long history in the courts of finding NDAs are unenforceable — and not just in California. The jurisdictional differences abound. It would probably be unwise to write a nondisclosure agreement today without consulting up-to-date statutes, cases, and regulations from the relevant jurisdiction. That said, from reading the case law, a few main problems stand out.

Confidentiality agreements are far more likely to be unenforceable when they:

(1) protect information that does not constitute trade secrets, in particular by protecting public or generally known information, or information that falls within (what a court is likely to perceive as) an employee’s general knowledge skill and experience;

(2) try to cover information that the employee already knew when they started the job or lawfully gained from a third-party source; or

(3) are so excessively broad that they have the effect of a noncompete, even if they are styled as a “nondisclosure” or “confidentiality” provision. For example, this hypothetical language in a NDA would almost certainly be unenforceable: “Anything you learn at the company that is used or usable in the business is confidential and can’t ever be shared or used by you again without our permission, and there are no meaningful exceptions.”

There is also an important empirical component to our article. These agreements are themselves often kept, or even required to be kept, secret. NDA skeptics like Orly Lobel and Sharon Sandeen have noted that a threshold challenge in assessing NDAs is simply finding them.  Thanks to Chris Seaman and his “army of RA’s” we have a dataset of 450 confidentiality agreements that were disclosed in trade secret litigation. These 450 contracts give a unique snapshot of what NDAs look like in practice. Some people may find the data points alarming. For example, most of the confidentiality provisions in our dataset cover far more than trade secrets, and around 40% of the agreements in our dataset had no carve-outs at all, even for public information. For people in practice, perhaps you will not be surprised at the breadth of the agreements, which is itself interesting. Either way, I hope you will check out our findings on SSRN.

AI Inventor and the Ethics Trap for US Patent Attorneys

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by Dennis Crouch

The Supreme Court denied certiorari in Thaler v. Vidal, a case involving inventor Dr. Stephen Thaler’s attempt to patent an invention created by his artificial intelligence (AI) system, DABUS. Thaler argued that DABUS, not himself or any other human, conceived the invention and identified its significance. However, both the United States Patent and Trademark Office (USPTO) and the Court of Appeals for the Federal Circuit  (CAFC) maintained that US patent laws require a human inventor, and as a result, they refused to consider Thaler’s patent application.

In his petition to the Supreme Court, Thaler asked if the Patent Act restricts the statutory term “inventor” solely to human beings. The current legal stance in the US remains that the answer to this question is “yes,” human inventors and only human inventors.

Moving forward, I am quite concerned for the role of patent attorneys and the upcoming ethical dilemmas — that patent attorneys will be prompted to bury the truth about AI contributions within their patent applications.  In particular, a growing number of inventive entities are developing new products and designs with significant AI input. And, many of the resulting claims will be directed to aspects that were generated by the AI and then first recognized as patentable by either the AI or the patent attorney.  In that situation, the patent attorney will be asked to list the human closest to the invention as the inventor — but, depending upon the circumstances, that listing might turn out to be fraud.

This situation calls for a guidance from the USPTO or the legislature on the definition of “inventor” in the context of AI-generated inventions. The current legal framework does not adequately address this evolving landscape of innovation driven by AI.

I particularly like to think about this situation in the joint inventorship context because the contribution and recognition requirements are much easier to meet than for a solo inventor.  In my experience, generative AI are regularly providing conceptual input that would easily require listing as a joint-inventor, except for the exclusion of non-human inventors.

What do you think here?

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USPTO is holding an AI listening session on April 25 at the USPTO (and webcast). See you there: https://www.uspto.gov/about-us/events/ai-inventorship-listening-session-east-coast

Amgen Scores Partial Victory in Efforts to Maintain OTEZLA Exclusivity

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By Chris Holman

Amgen Inc. v. Sandoz Inc., 2023 WL 2994166, — 4th —   (Fed. Cir. Apr. 19, 2023)

In 2019, Amgen acquired worldwide rights to apremilast (OTEZLA) from Celgene $13.4 billion in cash, in connection with Celgene’s merger with Bristol-Myers Squibb. Apremilast was the only oral, non-biologic treatment for psoriasis and psoriatic arthritis, and in 2020 apremilast generated $2.2 billion for Amgen.

At the time Amgen’s acquired apremilast, Celgene was involved in Hatch-Waxman litigation with numerous generic challengers, including Sandoz. Celgene had asserted three of its 11 Orange Book-listed patents against Sandoz, and in 2020 Amgen was substituted as plaintiff.

The primary patent asserted is U. S. Patent 7,427,638, which is directed to pharmaceutical compositions comprising stereochemically pure apremilast. The original expiration date of this patent was in 2024, but the patent received a patent term extension of more than three years, resulting in an effective patent expiration date of February 16, 2028, according to the Orange Book.

Celgene also asserted U. S. Patent 7,893,101, which is directed to enantiomerically pure solid forms (e.g., crystalline polymorphic forms) of apremilast. This patent is due to expire December 9, 2023.

The third patent asserted by Celgene was U. S. Patent 10,092,541, directed to methods for treating a patient using dose titration of apremilast. According to the Orange Book, this patent was set to expire on May 29, 2034.

The district court found the claims of the ‘638 and ‘101 patents to be infringed and not invalid, and enjoined generic apremilast until the expiration of the ‘638 patent in February 2028. On appeal the Federal Circuit affirmed, an outcome that Amgen characterizes as a win.

On the other hand, the district court found the asserted claims of the ‘541 patent to be invalid for obviousness, which reportedly “pleased” Sandoz because the ruling “enables Sandoz to launch [its] generic apremilast product in the U. S. in 2028, six years prior to the expiry date of the latest-expiring Amgen patent asserted in litigation.”  On appeal, the Federal Circuit affirmed with respect to the obviousness of the ‘541 patent.

Here is a brief overview of the court’s decision regarding the asserted obviousness of these patents.

The ‘638 patent claims apremilast, which is the stereochemically pure (+) enantiomer of a compound falls that within a class of molecules referred to as phosphodiesterase-4 (“PDE4”) inhibitors.  Sandoz’s obviousness argument was based primarily upon a prior art Celgene patent, U. S. Patent 6,020,058, which includes an Example 12 that describes a racemic mixture containing apremilast, but that does not disclose the purified (+) enantiomer. The Federal Circuit found that the district court had not erred in holding that Sandoz had not proven that a skilled artisan would have had sufficient motivation to purify the (+) enantiomer from the racemic mixture disclosed in Example 12, nor that a skilled artisan would have had a reasonable expectation of success in resolving that mixture into its enantiomeric components, given the unpredictable nature of resolving racemic mixtures.

The Federal Circuit further found that the district court had not erred in its finding of strong objective indicia of nonobviousness, particularly given the unexpected potency of apremilast relative to the apremilast-containing racemic mixture disclosed in Example 12. The court credited testimony from a Celgene researcher listed as an inventor on the ‘638 patent, who noted a 20-fold difference in potency between apremilast alone and the racemic mixture, and stated that the inventors “didn’t expect a 20-fold difference in potency… Normally, if a racemate is a 50/50 mixture of two enantiomers, you might expect a two-fold difference in potency, all things being equal.” The district court also did not err in determining that apremilast satisfied a long felt need for an improved psoriasis treatment suitable for oral administration, that others in the field had tried and failed to develop other PDE4 inhibitors as drugs, and that there had been a degree of skepticism about the safety of apremilast because of its structural similarity to thalidomide, a drug notorious for its teratogenic effects in fetuses leading to severe and debilitating birth defects.

The issue with respect to the ‘101 patent was whether it could rely upon the filing date of a provisional application to which it claims priority. The ‘101 patent claims crystalline Form B of apremilast, and the provisional application includes an Example 2 which discloses a synthetic procedure for preparing apremilast. Although Example 2 does not explicitly disclose that the resulting apremilast has the Form B crystalline structure, Amgen provided the court with the results of over a dozen experiments following the procedure of Example 2, all of which resulted in crystalline Form B of apremilast, while Sandoz had provided no evidence to establish that Example 2 was capable of producing a crystalline Form other than Form B. Although the district court had based its holding on its conclusion that the provisional application inherently disclose crystalline Form B of apremilast, the Federal Circuit found that it did not need to reach the issue of inherent disclosure because the evidence established that Example 2 actually disclosed crystalline Form B of apremilast, albeit without specifically disclosing the crystal structure of the resulting product.

The ‘541 patent claimed a method of treating a patient with apremilast that basically involves starting with a relatively low dose and, over a course of days, gradually increasing the dosage to arrive at a full dosage which is significantly higher than the initial dosage, i.e., a dose-titration schedule. The court found this to be an obvious method, in view of prior art disclosing a similar dosage schedule. The Federal Circuit observed that, as a general matter, varying doses in response to the occurrence of side effects is well-known and obvious to the skilled artisan.

Obviousness and Stereochemistry

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Amgen Inc., v. Sandoz Inc. 22-1147, — F.4th — (Fed. Cir. Apr. 19, 2023)

Jordan is a second-year law student at the University of Missouri and a registered patent agent.  He has an extensive background in chemistry and food science.

Amgen markets apremilast, a phosphodiesterase-4 (“PDE4”) inhibitor, which is used for treating psoriasis and related conditions, under the brand name Otezla® which is covered by three patents, U.S. Patents 7,427,638, 7,893,101, and 10,092,541. Sandoz submitted an Abbreviated New Drug Application (“ANDA”) seeking approval market a generic version of apremilast. Celgene, the original plaintiff, brought this Hatch-Waxman suit, asserting that Sandoz’s generic product would infringe the ’638 and ’101 patents. The Federal Circuit affirms the district court’s findings on all issues raised.

Sandoz asserts that U.S. Patent 6,020,358 renders the Amgen patents obvious. The ’358 patent is the first U.S. patent describing a racemic mixture containing apremilast. Enantiomers detail the orientation of the molecule around a chiral center and can have vastly different therapeutic outcomes and clinical results between the (+) and (-) enantiomers, particularly thalidomide analogues. The critical difference between the ‘358 and ‘638 patents is the composition of the mixture:

The ’358 patent is a racemic mixture comprised of 50% of the (+) enantiomer of 2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4acetylaminoisoindoline-1,3-dione and 50% of the (-) enantiomer.

Compare to an excerpt of Amgen’s language in claim three of ‘638:

A pharmaceutical composition comprising stereomerically pure (+)–2-[1-(3- ethoxy-4-methoxyphenyl)-2- methylsulfonylethyl]-4- acetylaminoisoindoline-1,3-dione, or a pharmaceutically acceptable salt, …

The ’638 Patent: Sandoz failed to provide clear and convincing evidence at the district court to show that a skilled artisan would have reasonably expected a benefit from separating the enantiomers or that the (+) enantiomer was the cause of the desirable properties of the ‘358 formulation. Sandoz’s appeal asserts that the district court erred in its findings.

At the Federal Circuit, Judge Lourie, writing for a unanimous panel of Judges Cunningham and Stark, focuses on the unexpected potency of apremilast discovered relative to the apremilast-containing racemic mixture during testing and experimentation. At the district court, the named inventor, Dr. Schafer, testified that the stereomerically pure apremilast reduces the production of tumor necrosis factor alpha (“TNFα”), the factor that is linked to psoriasis, 20 times more effectively than the previous patent.

Dr. Schafer also says that a skilled artisan would expect a twofold improvement in efficiency. The district court finds that the 20-fold difference, when an otherwise two-fold difference would have been expected by the skilled artisan was sufficient to support a finding of an unexpected result and subsequent nonobviousness. A 20-fold difference from the steromerically isolated formulation goes well beyond a difference in degree into a difference in kind.

It strikes me as interesting that the characteristics of apremilast were largely left undiscussed. Apremilast is a thalidomide analogue and safety concerns about the infamously teratogenic effects related to thalidomide were sufficient skepticism for a skilled artisan and the industry at large regarding stereomerically pure formulations. However, it would seem that this teratogenicity could cut both ways as a skilled artisan would have ample incentives to investigate the enantiomers separately for safety concerns in light of the thalidomide paradox.

The thalidomide paradox provides that racemic mixtures and pure enantiomers have different characteristics, despite in vivo racemization. If the molecule is sufficiently analogous to thalidomide, it seems that a skilled artisan would be inclined to be taught towards separating the enantiomers. Regardless, the unexpected result was found to be dispositive on appeal and the objective indicia weren’t necessary but the other findings of the objective indicia of long-felt need, others had tried and failed, industry skepticism, and commercial success were also affirmed.

           The ’101 Patent: Sandoz also alleges that the ’101 patent should have been found to be obvious. Sandoz says the ‘101 patent should not be entitled to the priority date of March 2002 because the  ’515 provisional application did not inherently disclose crystalline Form B of apremilast and therefore did not satisfy the written description requirements of 35 U.S.C. § 112. The district court relies on a finding that ‘515 application did inherently disclose the crystalline form.

The Federal Circuit did not find it necessary to delve into inherent disclosure because a review of the trial record shows Amgen provided multiple experiments, and expert testimony, showing that there was actual disclosure of the crystalline Form B. Absent any contrary evidence by Sandoz, the priority date and subsequent finding of nonobviousness were affirmed. Another win chalked up to Amgen’s excellent expert testimony.

            The ’541 Patent: On cross-appeal, Amgen asserts that the district court finding that the patent is obvious in light of prior art is erroneous. The district court found that the ’541 patent would have been obvious over the prior art or in crediting expert testimony stating that dose-titration modification would have been routine to a skilled artisan. Specifically, dose titration would be something that is regularly done in the treatment of psoriasis.

In re Charger Ventures: Federal Circuit Affirms TTAB Denial of Trademark Registration

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By Dennis Crouch

In re Charger Ventures, — F.4th. —, 22-1094 (Fed. Cir. 2023)

In this trademark case, the Federal Circuit affirmed a decision by the Trademark Trial and Appeal Board (TTAB) denying registration of the mark SPARK LIVING for residential real estate, based upon the prior registration of SPARK for commercial real estate. The prior registration is tied to Spark Co-working spaces that started in Baltimore and have now expanded to several other cities.

Charger presented several arguments centering on the du Point factors used to determine whether a proposed mark “so resemble a registered mark as to be likely, when used on or in connection with the goods or services of the applicant, to cause confusion, mistake, or to deceive.” Section 2(d).

An interesting discussion in the case focuses on the weakness of the prior mark. Although the tribunals agreed that it was potentially weak, it is still a registered mark and therefore subject to protection. Further, Charger’s trademark application proceeding is not a proper arena for challenging the validity of a trademark held by someone else. This is especially true here since the owner of the prior mark did not file an opposition.

A second, interesting aspect of the decision focuses on the “LIVING” portion of the proposed mark. That word is generic with regard to residential housing and, in addition, the applicant had disclaimed the word. Still, likelihood of confusion question should focus on comparing the entire proposed mark. The applicant argued that the TTAB had improperly given no weight to the LIVING portion. But, the appellate court affirmed, holding that the Office was correct to focus attention on the dominant portion of the mark. Here, the TTAB had quickly considered the impact of LIVING, but concluded that it offered no meaningful distinction.

Finally, the appellate court agreed that there was no reason to distinguish between commercial and residential real estate.

Throughout its entire review, the court appeared to agree with the TTABs conclusions, but noted that it would give deference to TTAB factual conclusions so long as supported by substantial evidence.

The Court did find one error by the TTAB, but concluded that it was harmless. In particular, the lower tribunal had failed to expressly indicate what weight it accorded to each of the du Point factors. Although the TTAB decision lacked clarity on this point, the appellate panel concluded it could sufficiently discern the agency’s path of reasoning.

Refusal Affirmed.

 

Claim Construction and Due Process: Examining NST Global v. Sig Sauer Inc. in the Supreme Court

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by Dennis Crouch

NST Global, LLC, dba SB Tactical v. Sig Sauer Inc. (Supreme Court 2023)

This case has a low chance of being granted certiorari, but it still has some interesting elements regarding claim construction and procedure.  This is a perfect case for the Supreme Court to issue a GVR (Grant-Vacate-Remand) with an order to the Federal Circuit to explain its reasoning.

The setup is common. Tactical sued Sig Sauer for patent infringement; Sig Sauer responded with an IPR petition that was eventually successful.  Tactical appealed based upon the PTAB’s sua sponte claim construction that found the preamble to be limiting, but the Federal Circuit Affirmed without opinion.

The Supreme Court petition asks three questions:

  1. Whether the claim construction finding the preamble limiting was improper.
  2. Whether the PTAB violated due process by construing the term sua sponte and failing to give the patentee with notice or an opportunity to present evidence.
  3. Whether the Federal Circuit’s use of Rule 36 violates constitutional guarantees  of due process and the statutory protections of 35 U.S.C. 144.

The Tactical patents cover a forearm stabilizing brace that can be attached to a pistol. U.S. Patent Numbers 8,869,444 and 9,354,021. Sig Sauer initially was a distributor of Tactical’s product, but later began making its own competing product. At that point Tactical sued.

In the IPR petition, Sig Sauer did not request any claim construction. Likewise, the petition decision granting the IPR stated that no claim terms needed any express construction.  “We agree—we need not expressly construe any claim term
to resolve the parties’ dispute.”  During briefing, neither party requested construction of any aspect of the claim preambles.  Eventually though, in its final written decision, the PTAB interpreted the preambles as limiting and then used that construction to conclude that the claims were invalid as obvious.

Yes, I said that the narrow construction led to the claims being found invalid.  That is unusual — usually the addition of limitations helps to avoid the prior art. In this case though the focus was on objective indicia of non-obviousness. NST’s sales; copying by Sig; praise; etc.  But, by giving weight to the preamble terms, the PTAB was able to destroy the presumed nexus between the claims and NST’s product.  The result, those secondary indicia were found wanting because NST had not provided additional evidence “commensurate with the claims” as newly construed.

For context, the claims are directed to the attachment, but the preamble recites “a handgun” and “a support structure extending rearwardly from the rear of the handgun:”

1. A forearm-gripping stabilizing attachment for a handgun, the handgun having a support structure extending rearwardly from the rear end of the handgun, the forearm-gripping stabilizing attachment, comprising: . . .

The PTAB ruled that the claims require the handgun and also the support structure  as recited in the preamble along with the forearm attachment described in the body.  The problem for the patentee is that its objective indicia evidence focused on the forearm attachment, not the whole package.  Thus, no nexus and no weight given to those secondary factors.  In its decision, the PTAB when through the whole life and meaning analysis: “we conclude that the preambles of claims 1, 3, and 5 are ‘necessary to give life, meaning, and vitality to the claim[s],’ and, as such, are limiting.”

The case was already close because there is a long history of this sort of stabilizer going back to the 19th Century, and so the absence of secondary considerations led to the obviousness conclusion.

During the IPR trial, Sig Sauer had argued that the high sales were due to an odd regulatory scheme against semi-automatic rifles, and the pistol attachment was actually popular primarily because it allowed the pistol to be shouldered.  On appeal, that was raised as an alternative justification for the judgment. But, in my view, the PTAB did not actually rule on that issue in the first place.

The patentee appealed, but the Federal Circuit panel of Judges Reyna, Schall, and Chen affirmed without opinion.

An AI Journey From Fractals to GPT

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By Dennis Crouch

I recently was thinking back to 1996 and the start of my senior year at Princeton University. Although I was a mechanical & aerospace engineering major, I had become fascinated with AI and so focused my senior thesis on developing a new AI model within the department of electrical and computer engineering. Instead of employing traditional layers, I utilized a fractal metaphor to design the neural networks. The main theoretical advantage of this approach was its potential to offer a deeper understanding of how the network operated, allowing us to peer into the brain and gain insights into its learning process based on the structure created. Furthermore, the model facilitated greater human control and direction.

This past weekend, computer law expert Van Lindberg reminded me of the Dartmouth Summer Research Project on Artificial Intelligence that had a game plan of solving AI during the summer of 1956. My senior thesis project took 8 months, and met with roughly the same (lack of) success. I’ll write more about this later, but the project was one of the first to use massive parallelism offered by human players across the internet as the learning model. That part was a big success — as well as the Applet front-end developed mostly by my partner Ryan Kotaro Akita. 

I feel like things are coming full circle for me, but this time the AI model has improved exponentially. The rapid progress in human-machine interaction and generative AI is astonishing. I find myself constantly exploring new, innovative technologies poised to disrupt bloated organizations. The venture capital landscape is necessarily shifting, as small teams rapidly develop and release disruptive products and services with higher speed but lower financial requirements.

Today’s exploration for me is autoGPT that allows users to stack various traditional and AI services to create the best autonomous assistant that I have seen so far.  After being provided with general instructions, autoGPT can generate a dynamic project plan that it executes through online interaction and GPT-4 training results. This technology has the potential to equalize expertise, much like what happened with chess several years ago. However, unlike chess, which relies on a fixed board and finite options, this new model addresses real-time, real-world problems. Indeed, it’s a fascinating time to be alive.

This setup is wonderful but also so scary. Awesome in all senses. The AI is ruthless and without emotion or wisdom. It empowers anarchists, terrorists, and reckless operaters to inflict significant harm. GPT layering enables more sophisticated attacks that exploit a combination of human-social and technological weaknesses in a massively parallel manner. Scams, both big and small, are becoming increasingly easier to execute. Of course, there will be those who use these tools to fight for good. As the battle of technology unfolds, life may begin to resemble a futuristic graphic novel more and more.

What are your thoughts on where we are headed?

Patently-O Bits and Bytes by Juvan Bonni

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Recent Headlines in the IP World:

Commentary and Journal Articles:

New Job Postings on Patently-O:

Overlapping Ranges in Claims and Prior Art Result in Invalidation of Patent on Transdermal Patch for Parkinson’s Disease

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By Chris Holman

UCB, Inc. v. Actavis Lab’ys UT, Inc., 2023 WL 2904757, — 4th —   (Fed. Cir. Apr. 12, 2023)

Rotigotine is a drug used to treat Parkinson’s disease. People with Parkinson’s disease experience significant gastrointestinal dysfunction, such as difficulty swallowing, which can frustrate the oral administration of drugs. However, the complications associated with oral treatment can be avoided by means of a transdermal patch that delivers the drug through the patient’s skin.  In order to cross the skin barrier, however, the drug must be in an “amorphous,” i.e., non-crystalline, form.  If the drug crystallizes in the patch, it will generally not be able to cross the skin barrier.

In 2007, UCB invented and marketed “original Neupro,” a transdermal patch for the treatment of Parkinson’s disease containing a dispersion of amorphous rotigotine and polyvinylpyrrolidone (PVP), with the PVP functioning as a stabilizer. Unfortunately, soon after original Neupro entered the market it was found that the rotigotine was crystallizing when stored at room temperature, rendering the drug ineffective.  This caused UCB to recall the product from the U.S. market in April 2008 (although it remained in limited use under a compassionate-use program). In Europe, regulators allowed original Neupro to stay on the market, under the condition that it would only be marketed under “cold-chain conditions,” i.e., it would be stored in a refrigerator.

The patent at issue in this case, U.S. Patent No. 10,130,589, is directed towards UCB’s solution to this problem, which was to essentially double the amount of PVP in the patch, from original Neupro’s weight ratio of rotigotine to PVP of 9:2 to the new, reformulated Neupro’s weight ratio of 9:4. In particular the ‘589 patent claims a method for stabilizing rotigotine by combining a non-crystalline form of rotigotine with PVP to form a solid dispersion, wherein the weight ratio of rotigotine to PVP is in a range from about 9:4 to 9:6. UCB re-entered the U. S. market with its reformulated Neupro in 2012.

In 2019, UCB sued Actavis for infringing the ‘589 patent in a Hatch-Waxman lawsuit.  The district court found the asserted claims to be invalid based on anticipation and obviousness, particularly in view of earlier-issued UCB patents, i.e., the “Muller patents,” which disclosed combinations of rotigotine and PVP present at a range of weight ratios from 9:1.5 to 9.5. Note that the Muller patents cover both original Neupro (9:2) and reformulated Neupro (9:4), while the ‘589 patent (claiming a range of 9:4 to 9:6) only covers reformulated Neupro. Significantly, UCB had successfully asserted a Muller patent in a previous ANDA suit that resulted in an injunction preventing approval of Actavis’s ANDA until the relevant Muller patent’s expiration in March 2021. The ‘589 patent would not have expired until December 2030, and thus could have delayed FDA approval of a generic version of Neupro by nine additional years.

On appeal, the Federal Circuit reversed the district court’s anticipation ruling, but affirmed on the basis of obviousness. The opinion, authored by Judge Stoll, begins by explaining that Federal Circuit precedent sets forth an established framework for analyzing whether a prior art reference anticipates a claimed range. If the prior art discloses a point within the claimed range, the prior art anticipates the claim. On the other hand, if the prior art discloses an overlapping range, the prior art anticipates the claimed range “only if it describes the claimed range with sufficient specificity such that a reasonable factfinder could conclude there is no reasonable difference in how the inventions operate over the ranges.”

In the case at hand, the prior art Muller patents disclose a range (9:1.5 to 9.5) that overlaps with the range claimed in the ‘589 patent (9:4 to 9:6). The Federal Circuit found that the district court had erred by failing to analyze this as an overlapping range case, but to instead treat this as a case in which the prior art discloses a point within the claimed range.  The Muller patents did not literally disclose any point within the range claimed in the ‘589 patent, but the district court had nonetheless concluded, based on expert testimony, that the range disclosed in the Muller patents would implicitly teach a person of skill “a few examples” of specific weight ratios, including 9:4 and 9:5 weight ratios of rotigotine to PVP. Nonetheless, the district court’s error with regard to its anticipation analysis was rendered moot when the Federal Circuit proceeded to affirm its obviousness finding.

Judge Stoll cited Federal Circuit precedent for the proposition that there is a presumption of obviousness when a claimed range overlaps with a range disclosed in the prior art. Although this presumption can be overcome if, e.g., the prior art teaches away from the claimed range, or the claimed range produces new and unexpected results, or other evidence demonstrates the nonobviousness of the claimed range, in this case the Federal Circuit agreed with the district court that UCB had failed to present evidence to rebut the presumption of obviousness.

For example, the district court had not erred in its decision to disregard the commercial success of reformulated Neupro, based on a lack of a nexus between the drug’s commercial success and the claimed invention. In particular, the Federal Circuit agreed that the existence of the Muller patents weakened UCB’s evidence of commercial success, because these patents operated as blocking patents, dissuading competitors from developing a rotigotine transdermal patch, at least until the Muller patents expired. While rejecting UCB’s suggestion that the court’s analysis had branded all co-owned patents as “blocking” patents, the court noted that in this case UCB had held exclusive worldwide rights to rotigotine for all therapeutic indications since 1998, and that until the Muller patents expired Actavis had been enjoined from marketing a generic version of reformulated Neupro.

Federal Circuit Confirms its Scrutiny of Judge Newman

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The recent controversy at the Court of Appeals for the Federal Circuit involving Chief Judge Kimberly Moore and Judge Pauline Newman has raised concerns and garnered attention. The Court has now confirmed the rumors about Judge Moore’s actions to remove Judge Newman from an active role on the bench. According to a statement of court and two published orders, it seems that Chief Judge Moore also has the support of her fellow judges in this matter.

The primary concern revolves around Judge Newman’s alleged failng to maintain a full workload due to health issues, taking an excessive amount of time to issue opinions, and showing signs of declining mental acuity. Despite these concerns, Judge Newman has refused to participate in the process or receive any documents related to it. Additionally, she has declined to submit to a medical examination or to take senior status or retire.  Her refusal to participate in the process serves as an additional cause in the complaint.

Judge Newman’s obstinance appears to be rooted in her belief that she is “the only person [on the Court] who care[s] about the patent system and innovation policy.”  Throughout her 39 years on the Court, Judge Newman has been a stalwart supporter of strong patent rights.

Judge Newman joined the court in 1984 and is now 95 years old. She has been the oldest member of the court since the death of Judge Giles Rich in 1999 at the age of 95.  Judges Dyk and Lourie are both in their 80s.  

The EU’s Response to National Judicial Determinations of FRAND Royalty Rates

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Guest Post by Professor Jorge L. Contreras

On March 28, 2023, Reuters reported that a proposed European Parliament and Council Regulation would empower the European Union Intellectual Property Office (EUIPO) to determine “fair, reasonable and non-discriminatory” (FRAND) royalty rates for European patents that are essential to industry standards (standards-essential patents or “SEPs”), and also to assess the essentiality of SEPs to the relevant standards.  In this post, I compare the leaked EU Proposal to last year’s Standards Essential Royalty Act (SERA) to which the EU Proposal bears a notable resemblance, with some important differences. Overall, I believe that the EU Proposal makes a positive contribution toward the efficient and fair resolution of FRAND disputes, though its most valuable role may be to nudge stakeholders toward the preferred solution of global rate-setting arbitration.

The Leaked Draft

Even before the official release of the EU Proposal, a significant amount of material has become publicly available. A leaked text of the draft was posted on Kluwer Patent Blog, a summary and detailed synopsis has been posted on FOSS Patents, and a 248-page Impact Assessment by the European Commission (EC) has been widely circulated among stakeholders. As reported by Reuters, the draft EU Proposal was scheduled to be announced by EC Vice President Margrethe Vestager on April 26, but the leaked draft has already sparked significant commentary and debate (see summaries, with links, posted by Tom Cotter and Florian Mueller). Needless to say, a pre-release draft of proposed legislation does not carry the force of law, and as noted by Intellectual Asset Management and others, a lengthy legislative process lies ahead during which the EU Proposal could substantially change or be scuttled entirely. Nevertheless, it is worth discussing some of its potential impacts today.

The Problem: National Judicial Determination of Global FRAND Royalty Rates

The ambitious EU Proposal addresses numerous lingering issues that are inherent in the underspecified world of FRAND licensing, including whether or not patents declared as “essential” to particular industry standards are actually essential (Title V) (issue discussed here and here) and how FRAND licensing commitments can bind subsequent owners of essential patents (Art. 3) (issue discussed and here and here). On a positive note, the EU Proposal clarifies that “royalty-free licensing policies do not raise concerns” (recital 10) – a welcome acknowledgement in view of recent complaints about royalty-free SEP licensing requirements (see, e.g., here). These important issues, however, are beyond the scope of this post.

The biggest issue that the EU Proposal seeks to tackle is the recent tendency of courts in China and the UK (and potentially other countries) to establish FRAND rates for a SEP holder’s entire global portfolio (the Global Approach), rather than only for SEPs issued in that jurisdiction (the National Approach) (discussed in detail here and here). This phenomenon has led to jurisdictional disputes, escalating anti-suit (ASI) and anti-anti-suit injunctions (AASI) (discussed here, here and here), and an international “race to the bottom” as jurisdictions vie to become preferred destinations for resolving global FRAND disputes. As noted in the cited articles, European courts, following civil law principles, have generally been averse to anti-suit injunctions in global FRAND cases, resulting in royalties for European patents largely being established elsewhere. In addition, the European Union, along with the United States and others, is currently involved in a dispute at the World Trade Organization (WTO) over China’s ASI procedures in these cases (a detailed discussion of China’s ASI landscape can be found here).

Summary of the EU Proposal

Some of the key elements of the EU Proposal concerning FRAND rate determination are the following:

1 – Art. 21 would require SEP owners to register their European SEPs with a new “competence centre” (the “Centre”) established within the EUIPO; SEPs must be registered in order to be enforced in European courts (including the new Unified Patent Court (“UPC”));

2 – Arts. 17-18 would permit participants in standards-development organizations (SDOs) to collectively negotiate the aggregate (“top-down”) royalty burden for a particular standard, which would then be published by the Centre – an approach that would significantly improve the transparency and predictability of FRAND licensing negotiations (see here);

3 – Art. 36 would require SEP holders and implementers of FRAND-encumbered standards to request a FRAND rate determination by the Centre prior to initiating litigation over SEPs in a European court;

4 – Art. 40-41 establishes procedures for selecting the “conciliators” who would make the FRAND determination, including the proposal of five qualified candidates by the Centre, from which the parties would select two (though the means by which that selection would be made is not specified);

5 – Art. 60 provides that the determination of the conciliators will be confidential to the parties (a serious mistake, in my view, given the need for greater transparency in this area, as discussed here and here);

6 – Art. 58(4) provides that no European court or the UPC may rule on a case involving a European SEP unless it is notified of the resolution of this rate setting procedure.  While the Centre’s rate determination is not binding on a court, and there is no stated procedure for introducing the FRAND determination in a judicial proceeding, one would hope that the Centre’s determination will be used as evidence in most European judicial proceedings concerning the affected SEPs.

Comparison to the Proposed U.S. Standards Essential Royalty Act (SERA)

As noted in the introduction, concerns over foreign (particularly Chinese) ASIs and judicial determinations of global FRAND rates have also motivated federal legislators in the U.S. to propose a variety of measures designed to reduce the impact of these foreign proceedings on U.S. patents.  In 2022, two such bills were floated within the Senate Judiciary Committee: the Defending American Courts Act (DACA) (discussed here and here) and the Standard Essential Royalty Act (SERA) (discussed here and here). SERA would establish a U.S. judicial tribunal for the determination of FRAND rates applicable to U.S. FRAND-encumbered patents, notwithstanding the findings of any foreign court.  The recent EU Proposal shares some characteristics with SERA, but also has notable differences.  The Table below summarizes some of the areas of commonality and divergence between the U.S. and EU proposals.

Table 1

Comparison of Recent U.S. and EU FRAND Tribunal Proposals

Proposed U.S. Standard Essential Royalty Act (SERA) (June 2022) Proposed EU SEP Regulation (Mar. 2023)
Tribunal A new federal court EUIPO, an EU administrative agency
Authorization of collective negotiation of aggregate royalty burden No Yes
Binding effect Binding in U.S. Non-binding
Effect on foreign FRAND determinations Overrides foreign FRAND determinations for U.S. patents None
Confidentiality of decision No Yes
Creation of SEP registry No Yes
Essentiality testing Possibly, though not required Yes

 

Assessing the EU Proposal

The EU Proposal will likely improve some aspects of global FRAND litigation. For example, it could diminish the force of “global” FRAND rate determinations by non-EU courts in countries like China and the UK, create a more authoritative SEP database than that maintained by the notoriously hands-off SDOs, and eliminate some of the current concern over collective negotiation of aggregate royalty burdens for particular standards.

This being said, the EU Proposal also has a few significant drawbacks.  First, the EU Proposal creates a rate determination structure that is non-binding, thus opening the door to further debate and “new” evidence that could be introduced by parties seeking to convince European courts to deviate from Centre-determined rates. More importantly, the confidential nature of the Centre’s findings eliminates much of their potential systemic benefit, as other market participants will not be able to use the information developed by the Centre in their own FRAND negotiations, reinforcing the non-transparent system that exists today.  The U.S. SERA proposal overcomes both of these weaknesses by proposing a binding rate determination that will be open and transparent.

Another Step Along the Road to Non-governmental Global FRAND Rate-Setting?

Despite their advantages, both the U.S. and EU proposals suffer from a focus on individual party disputes rather than the overall royalty burden for a particular standard.  The most efficient, fair and transparent approach to global FRAND rate determinations is to involve all concerned parties (SEP holders and stakeholders) in a multilateral, multinational rate-setting procedure that addresses all SEPs covering a particular standard and then makes that determination publicly available, much like the copyright royalty rates determined by rate-setting boards in the U.S., UK and other countries (see proposal here).

While the international community has not yet embraced such a comprehensive, multilateral approach to FRAND royalties, an important first step in rationalizing the FRAND royalty system is eliminating the ability of individual jurisdictions (e.g., China/UK) pre-emptively to set global FRAND rates for patents outside of their jurisdictions (see here).  Processes such as those set forth in the U.S. SERA and the EU Proposal would significantly limit the bite of such unilateral global rate-setting efforts. As I have previously written, “country-by-country rate adjudication need not be the end game for global FRAND rate setting”.  If stakeholders find that legislatively mandated rate proceedings in individual countries are burdensome, they may be more amenable to a truly global, yet fair, solution to the FRAND royalty conundrum.

[Disclosures: The author declares no conflicts of interest regarding the subject of this article.]

Judge Newman

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Gene Quinn is reporting that Chief Judge Moore has moved forward with proceedings to remove Judge Newman from the bench — filing a complaint under the Judicial Conduct and Disability Act.  The stage of the action is not clear from Quinn’s reporting, but the usual process allows for any person to file a complaint that is then reviewed by the Chief Judge of the circuit.  If the Chief Judge sees merit in the complaint then she forms a special committee of judges to make a further determination.

Judge Pauline Newman was appointed to the Federal Circuit by President Ronald Reagan in 1984 – 39 years ago. At the time, she was already 50+ years old with a successful career as a research scientist, patent attorney, and in-house counsel (chief of IP).  She is now 95 years old.   If I have done my counting correctly, Newman has authored over 2,800 majority opinions during her time on the bench; as well as 500 dissents.

Chief Judge Moore Said to Be Petitioning to Oust Judge Newman from Federal Circuit

 

Eligibility and the U.S. Solicitor General: Patenting the Scientific, Technological, and Industrial Arts

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by Dennis Crouch

A decade ago, the US Supreme Court issued a pair of decisions that upended substantial aspects of patent practice. Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012); and Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208 (2014).  These cases broadened scope of the “abstract idea” and “law of nature” exclusions in ways that largely overlap with other patent law doctrines, such as obviousness, indefiniteness, and even enablement.  But, unlike those doctrines, subject-matter eligibility jurisprudence is more of free-wheeling approach that typically does not require evidence.  In court, these cases are often decided at pleading-stage, before any evidence is introduced or considered.

Many thousands of patents have been denied or invalidated under the expanded doctrine.  Opponents of the change argue that it has created unpredictability, lack of respect for the law, and overreach that inhibits our culture of innovation historically fostered by the fuel of potential exclusive rights.

One difficulty with the law here is that it is entirely judge made.  The statute isclear that patents should be awarded to “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof” so long as the other requirements of patentability are met.  35 U.S.C. 101.  The Supreme Court added its admittedly atextual gloss of excluding “laws of nature, natural phenomena, and abstract ideas.”  And, although those limits have been longstanding, the court expanded their scope and simplified the procedures for invalidating patents in Mayo and Alice. A substantial number of prior petitions have asked the Supreme Court to clarify and revise its stance on Section 101 eligibility, but the Supreme Court has repeatedly denied certiorari.  We may be moving to the next step with the two pending cases discussed below.

Most recently, the Solicitor General has provided its views in two pending cases and has recommended that the court grant certiorari and revise its eligibility doctrine. “These cases would be suitable vehicles for providing much-needed clarification in this area.”

In its briefing, the SG ties itself to the idea of “technological inventions”; arguing that “quintessentially technological inventions” should be patent eligible. SG Brief. A positive SG amicus brief usually indicates a high likelihood that the Supreme Court will hear the case. The two parallel pending cases are:

  • Interactive Wearables, LLC, v. Polar Electro Oy, 21-1281.  Interactive Wearables asserts two patents covering a wearable content player connected to a screen-based remote control that permits users to view information about the song being played from the remote. U.S. Patent Nos. 9,668,016 and 10,264,311.  The district court dismissed the case with prejudice on the pleadings for lack of eligibility. On appeal, the Federal Circuit affirmed without opinion.
  • Tropp v. Travel Sentry, Inc., 22-22.  Tropp’s asserted patents claim a method of improving airline luggage inspection by selling TSA-labelled locks having a master key held by TSA authorities.  If TSA needs to open the luggage for inspection, they use their key rather than cutting the lock. U.S. Patent Nos. 7,021,537 and 7,036,728. The district court found the claims ineligible on summary judgment.  On appeal, the Federal Circuit affirmed with a non-precedential per curiam opinion. Importantly, Tropp does not claim to have created any new technology here, but rather a new process.  Of course, Section 100 of the Patent Laws defines process to “include[] a new use of a known process, machine, manufacture, composition of matter, or material.”

In its brief filed jointly in both cases, the Solicitor General distinguishes between the inventions in Interactive and in Tropp; arguing that only the first represents a patent eligible invention because it is directed to the “scientific, technological, [or] industrial arts” rather than “non-technological methods of organizing human activity.”

Properly construed, [the abstract idea] exception helps cabin Section 101’s reach to patent law’s traditional bailiwick of the scientific, technological, and industrial arts. The category of patent-ineligible abstract ideas thus does not encompass quintessentially technological inventions, like the improved content player that the patentee claimed in Interactive. By contrast, as the court of appeals correctly recognized, Section 101 excludes non-technological methods of organizing human activity like the luggage-inspection method claimed in Tropp.

SG Brief.  In looking at the court decisions, the SG also argued that the lower courts had unduly considered other doctrines such as novelty, obviousness, and enablement and overlayed them into the obviousness analysis.

A court at step two therefore should ask whether a claimed invention sufficiently transforms an abstract idea into the kind of innovation eligible for patent protection. Rather than undertake that inquiry, however, the Interactive court placed undue emphasis on considerations of novelty, obviousness, and enablement. Although those considerations may sometimes overlap with the abstract-idea inquiry, they are the purview of different statutory provisions and perform different functions. See 35 U.S.C. 102, 103, 112. By contrast, the Tropp court correctly held that nothing in the claimed method transforms it into a technological invention.

Id. Although not clear, the Supreme Court may consider whether to grant or deny certiorari in these cases as early as its May 18, 2023 conference.  Meanwhile, a third eligibility case of Avery Dennison v. ADASA is also pending and could be taken-up on the same date.

It is of some importance here that the USPTO also signed the brief – indicating that it is on board with creating a technological invention dividing line.

Federal Circuit: Construing the Term “A” once Again

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by Dennis Crouch

In Salazar v. AT&T Mobility LLC, the Federal Circuit affirmed the district court’s judgment of noninfringement. Once again, the Federal Circuit was called upon to interpret the claim term “a,” this time to determine if Salazar’s claim requiring “a microprocessor” was limited to a single microprocessor. While “a ___” is usually interpreted to include “one or more ___,” the court upheld Judge Gilstrap’s narrower singular construction in this case, finding it limited by later references to “said microprocessor.”

Salazar’s US Patent No. 5,802,467 claims a communication system for interacting with multiple external devices. The system comprises “a microprocessor” that generates reprogrammable communication protocols, a memory device for efficient storage of command code sets retrieved by “said microprocessor,” a user interface for user selections and menu displays rendered by “said microprocessor,” and an infrared frequency transceiver coupled to “said microprocessor” enabling bidirectional communication with external devices.

AT&T systems may have the capability to achieve all these steps, but the defendant argued that each step utilized different processors or multiple processors. Thus, as the District Court explained, the dispute centered on “whether the claims require one microprocessor that is capable of performing the recited ‘generating,’ ‘creating,’ ‘retrieving,’ and ‘generating’ functions.” According to the district court construction, the patentee needed to identify a single processor that performed “all the functional (and relational) limitations recited for ‘said microprocessor.'” As a result, the court found no infringement. The Federal Circuit affirmed this decision on appeal.

While the indefinite article “a” is generally interpreted broadly as not limited to one item, this presumption can shift when necessitated by the patent documents. In this case, the patentee repeatedly used “said microprocessor” to refer back to the already claimed term in a way that “reinvokes [the] non-singular meaning” of the word “a.” Slip Op. (quoting Baldwin Graphic Sys., Inc. v. Siebert, Inc., 512 F.3d 1338 (Fed. Cir. 2008). According to the court, an alternative interpretation would ignore the meaning of “said.”

The key takeaway is that each time the claim uses “said microprocessor,” it refers back to the originally identified microprocessor. This interpretation prevented the argument that the claim covers the use of multiple microprocessors working together to achieve the described functionality.  Non-infringement affirmed.

= = = =

The jury sided with the patentee on anticipation. AT&T also appealed this issue. However, the Federal Circuit declined to hear the question, holding that AT&T failed to move for a Rule 50(a) JMOL before the case was submitted to the jury, thus waiving its right to appeal the sufficiency of the evidence on that issue.

Federal Circuit Narrows Scope for Copyrighting Software Function

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by Dennis Crouch

The copyright lawsuit between the data-software company SAS Institute and its scrappy copycat World Programming has been interesting to follow over the past several years, and the Federal Circuit has now issued a controversial opinion in the case.  SAS Inst. v. World Programming Ltd., — F.4th — (Fed. Cir. 2023).  The majority opinion authored by Judge Reyna and joined by Judge Wallach affirmed the lower court ruling that SAS failed to establish copyrightability of its claimed program elements.  Writing in dissent, Judge Newman argued that the majority’s rejection of copyrightability represents a “far-reaching change” not supported by either precedent or good policy.  I called this outcome controversial. The outcome would also be controversial had Judge Newman’s position prevailed.

The case is properly seen as an extension of the Supreme Court’s decision in Google
LLC v. Oracle America, Inc., 141 S. Ct. 1183 (2021).  In that case, the Court found that Google’s use of Java API naming conventions in its Android operating system was fair use under copyright law.  Because its fair use decision decided the case, the court did not rule separately on whether the API was even copyrightable in the first place.  In SAS v. WPL, the Federal Circuit squarely addressed the copyrightability question.

To be clear, computer software can still be copyrightable.  But, parties asserting protection will need to do a much better job of showing how their creative authorial input survives the “abstraction-filtration-comparison test,” which the Federal Circuit  applied in its decision.

Copyright law’s abstraction-filtration-comparison (AFC) test is used to determine whether a particular work is entitled to copyright protection. The AFC test involves breaking down a work into its constituent parts, abstracting the unprotectable elements, filtering out any remaining unoriginal or unprotectable elements, and then comparing the remaining protectable elements to the allegedly infringing work. The AFC test has been previously adopted by the Second, Fifth, and 10th Circuits.

Here, the court did not delve into the comparison step — and instead simply held that there was nothing left to infringe after abstraction & filtration.

The decision is also substantially procedural.  The district court held a copyrightability hearing and followed a burden shifting procedure created by the 11th Circuit in Compulife Software Inc. v. Newman, 959 F.3d 1288 (11th Cir. 2020).  In particular, the court first assumed that the work was copyrightable based upon the registration documents.  It then allowed the defense to present its filtration argument to show a lack of copyrightability.  If that evidence is sufficient (as it was here), the burden then shifts back to the copyright holder to rebut — and “to establish precisely which parts of its asserted work are, in fact, protectable.”   The difficulty for SAS is that it offered no rebuttal and instead “refused to engage in the filtration step and chose instead to simply argue that the SAS System was ‘creative.'” Slip Op. SAS presented an expert witness on copyrightability, but the district court found it extremely unreliable and thus excluded the testimony.  (The expert had not seen anything to filter out — even clearly unprotectable elements).

The majority walked through each of these issues and ultimately affirmed on all grounds.

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Some background: SAS makes data analysis software. A key feature of the SAS product is that folks can write programs using SAS syntax in order to get certain results. Thus there are a number of data jockeys who are experts in SAS code.  WPL is a UK based software company who obtained several copies of SAS statistical software and made their own clone version by rewriting the code and by relying upon an early version of SAS that is not protected by copyright.  The WPL version allows folks to use SAS language to get the same results — but at a much lower price.   When I sa “same results” — the clone pretty much identically copied output styles so that a chart made with WPL looks basically identical to a chart made in SAS using the same code.

SAS sued in E.D.Tex for copyright infringement.  Judge Gilstrap dismissed the copyright claims — holding that the software was unprotectable.  Copyright infringement appeals are ordinarily not heard by the Federal Circuit, but in a case of what appears to be appellate-forum shopping, SAS had also included patent infringement allegations that they eventually stopped pursuing.  Under the rules of procedure, if patent claims were raised in the case at some point, then the appeal heads to the Federal Circuit.

The copyright case is not about copying code.  It appears rather to be about copying the input syntax format used by individuals to input their programs and the output design styles for outputting data in some particular style. In the filtration analysis, WPL provided a host of evidence to show that these features should be “filtered out” of the SAS copyrights.

  • WPL established that an earlier version of the SAS System, “SAS 76,” was in the public domain.
  • WPL showed that many Input Formats and Output Designs in the current SAS System are identical or nearly identical to those in SAS 76 and should be filtered.
  • WPL demonstrated that the SAS Language should be filtered because it is open and free for public use.
  • WPL’s expert identified various allegedly copied materials that contained unprotectable elements such as open-source, factual, data, mathematical, statistical, process, system, method, and well-known and conventional display elements.

Bringing these together the Federal Circuit concluded that the defense had presented sufficient evidence to show uncopyrightability and that the district court was justified in requiring SAS to directly and particularly rebut the evidence rather than simply allowing a trial on the copyright as a whole.

The district court was correct to exercise its authority and require SAS to articulate a legally viable theory on which it expected to base its copyright infringement claims. Conversely, it would be improper for a district court to permit a matter to proceed to trial on the basis of vague and unidentified theories.

Slip Op.

Writing in dissent, Judge Newman argued that Fifth Circuit law protects this sort of computer software architecture even from non-literal copying.  The key citation is likely to a the Fifth Circuit’s 1994 Engineering Dynamics case:

Most courts confronted with the issue have determined that copyright protection extends not only to the literal elements of a program, i.e., its source code and object code, but also to its “nonliteral” elements, such as the program architecture, “structure, sequence and organization,” operational modules, and computer-user interface.

Eng’g Dynamics, Inc. v. Structural Software, Inc., 26 F.3d 1335 (5th Cir. 1994).   Judge Newman noted that “computer programs” are expressly protected within the Copyright Act

Copyright protection subsists . . . in original works of authorship . . . including . . . (5) computer programs.

17 U.S.C. 102. As the Nimmer treatise explains, this 1980 amendment to the laws “dispels any lingering doubts as to the copyrightability of computer programs. It is
therefore now firmly established that computer programs qualify as work of authorship in the form of literary works, subject to full copyright protection.”
1 NIMMER ON COPYRIGHT § 2A.10(B) (2022 ed.).

Here, Judge Newman particularly noted that the collection of the various input functions and output designs is easily copyrightable. And, this is the same analysis done by the Federal Circuit in its original Oracle v. Google decision.

Judge Newman also concluded that the district court improperly shifted the burden of proof to the copyright holder.

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