Narrower Patent Means CRISPR Victory for Broad Institute

By: Smitha Gundavajhala

On February 28, 2022, the US Patent and Trademark Office (USPTO) handed down a ruling in one of the most bitterly fought patent turf wars in biotechnology: the battle over the use of CRISPR-Cas9 in humans. The two major groups that were vying for recognition were the Broad Institute, consisting of researchers from Harvard, and MIT and CVC, consisting of researchers from UC Berkeley, the University of Vienna, and Emmanuelle Charpentier. 

CRISPR-Cas9 is a revolutionary gene editing tool that has implications for healthcare, agriculture, and more. CRISPRs are DNA sequences with proteins that act like scissors. Originally derived from bacterial genomes, CRISPR technology has since been extended to apply to eukaryotes, which are multicellular organisms. Examples of eukaryotes include plants, animals, and humans. As one might imagine, the latest evolution in CRISPR technology is immensely lucrative. The technology could be used to prevent viral infections and chronic conditions in humans, as well as to genetically modify produce to carry more nutrients.  Both Broad Institute and CVC stood to lose a great deal in their hard-fought dispute about the CRISPR-Cas 9 patent.

The dispute between these parties was complicated by timelines, the change in US patent law, and the contradictory decisions of different jurisdictions across the world. Jennifer Doudna of UC Berkeley was the first to file a patent application in 2012, a few months before Feng Zhang and the Broad Institute filed their patent application. However, prior to 2013, the USPTO’s rules were different: the agency awarded patents to the entity that was the “first to invent,” rather than the entity that was “first to file.” 

Thus, when Doudna asked USPTO to declare an “interference” between the two patents in 2015, the office had to consider which group was the first to invent by “reducing the concept to practice.” CVC argued that Broad Institute’s patent for gene editing in eukaryotes was a mere extension of CVC’s seminal work on CRISPR-Cas9. In 2017, the Patent Trial and Appeal Board (PTAB) ruled that Broad Institute’s patents were not derived from CVC’s patents. In 2019, PTAB again declined to declare an interference regarding claims to CRISPR-Cas9 technology used in eukaryotes, and confirmed that the Broad Institute’s patents were properly issued.

Ultimately, Doudna’s patent application did not explicitly address CRISPR-Cas9 applications for eukaryotes, and Zhang’s patent application did. Thus, Zhang and the Broad Institute were determined to be the “first to invent” CRISPR-Cas9 gene editing for humans. This year’s USPTO decision represents potential losses of billions in licensing revenue for UC Berkeley and priority of invention for Broad Institute.

However, this turf war is far from over and recognition of the Broad Institute’s and CVC’s patents varies across jurisdictions. Currently, CVC maintains fundamental CRISPR-Cas9 patents in over 80 jurisdictions, including China, Japan, and the European Union. CVC and the Broad Institute also face challenges in other countries: South Korea’s ToolGen and Germany’s Sigma Aldrich still have open interference motions with the Broad Institute. From the looks of it, the international fight for CRISPR-Cas9 patent recognition won’t be over any time soon, even while the dust has seemingly settled in the United States.

NFTs: Coming Soon to a Patent Portfolio Near You?

By: Hannah Avery

At this point the craze surrounding NFTs is far from breaking news. NFTs (“non-fungible tokens”) have been created for everything from the “Disaster Girl” meme to the world’s first tweet. They have been the subject of numerous articles, publications, and blogs, including this blog by the Washington Journal of Law, Technology, and the Arts’ Associate Editor-in-Chief Joanna Mirsch, discussing video game-related NFTs. Despite NFTs’ widespread popularity, early “NFT craze” trends seemed at odds with established American intellectual property rights, with many works being minted as NFTs without the consent of the original creator. At the very least, ownership of NFTs was widely regarded as independent of ownership of the underlying intellectual property rights. But… what if they weren’t?

While the sale of an NFT by itself does not automatically confer the underlying IP rights, the use of self-executing contracts in conjunction with the sale of an NFT can. This is the exact type of transaction that IBM was betting on when it teamed up with IPwe to create a platform for block-chain-enabled IP transactions. The IBM/IPwe platform transfers patent rights by building a smart contract with standardized terms into the token. The patent owner is able to set the terms of that contract, including what information is public and what is not. With this big bet on patent NFTs by IBM, the launch of IPwe’s secure licensing & selling capabilities, and the first sale of a patent and the related patent rights as an NFT in April 2021, many forward-looking patent-holders may be wondering whether they should convert their patent portfolios to NFTs.

Unsurprisingly, the press release for the IBM-IPwe partnership touts a number of benefits of blockchain-based IP transactions including increased transparency, reduced transaction costs, and greatly improved capacity for patent-holders to manage, value, and transfer their IP assets. Additionally, blockchain-based patent transactions could help to prevent future SEP licensing disputes and/or to simplify their resolution. However, there are also a number of potential risks which could dissuade those who would otherwise be early-adopters.

Increased transparency of ownership

Since the introduction of blockchain technology, one of its most praised features has been the unique ability to create an indisputable record of a series of transactions. As applied to patent rights, this feature would allow users to track the ownership of patent NFTs and the transactions associated with patent license NFTs. This tracking mechanism would provide clarity of ownership of the patent rights. According to IPwe’s Chief IP Officer Cheryl Milone Cowles, “distributed network verification . . . provides the confidence of transacting with a clear current title and history.” While such assurance is undoubtedly appealing to potential investors, it may be too good to be true… at least for now. Given the nature of this technology and the current case law governing patent ownership disputes, situations could arise where a legal approach or remedy would be unclear. Some experts have raised concerns including: whether an owner of a patent whose NFT was stolen through a ransomware attack would be able to reestablish ownership through the legal system; whether a court would recognize transfer of a patent via NFT absent a more standard, written assignment; and, if courts do prove willing to recognize such an assignment via an NFT sale, what evidence will be considered sufficient to demonstrate ownership. Such uncertainties could easily lead to unfavorable, or simply unsatisfying,  outcomes for purchasers.

Cost-reduction

Historically, the costs of obtaining, maintaining, and licensing IP have been high. Therefore, the promise of a platform that could lower those costs, as IPwe claims, would be welcome news to many players in the IP space. While the technology behind the platform may be complicated, the theory of potential cost-savings is simple — the smart contracts included in token sales, as discussed above, would replace the current process of IP sales and licensing that is laden with attorneys fees, paperwork, and onerous contract negotiations. Such savings would be embraced by any organization accustomed to shouldering the burden, but it has the potential to be game-changing for small and medium-sized companies who may have previously been reluctant to engage in IP-related transactions because of current prohibitive costs.

Portfolio management

While tokenizing IP assets may interfere with a company’s existing portfolio management strategies, such disruption of existing strategies could also reap rewards for the first movers in this space. For example, the potential for easy resale of an IP asset could increase the value of that asset at the time of the initial sale. Or, standard essential patent holders could also utilize smart contracts to avoid expensive litigation while capturing licensing fees with each sale or resale. The possibilities are endless.

* * *

All in all, tokenizing patent assets may reduce the costs associated with patent licensing and streamline portfolio reporting. However, early adopters of this approach will have to navigate uncertain legal areas regarding the ownership of their tokenized IP rights. In our information-based economy, adopters could be risking some of their most valuable assets in their effort to become an industry leader. Is it worth the risk?

So You Want to Invalidate a Patent? The PTAB May Be Your Friend!

By: Mark Stepanyuk

Challenging the validity of a patent versus patent infringement

If you have a patent and you think somebody is infringing on that patent, you may be able to sue them for patent infringement. Alternatively, if you think somebody has an inadequate patent, you can prospectively challenge its validity. Although historically these two causes of action have largely overlapped, they are very much distinct. This blog post is about the rise of a relatively new mechanism for challenging patent validity in the United States.

What is the PTAB?

The Patent Trial and Appeal Board (PTAB) was formed in 2012 as part of the Leahy-Smith America Invents Act (probably most known for changing the U.S. Patent system from “first-to-invent” to “first-to-file.”) The PTAB replaced the Board of Patent Appeals and Interferences at the U.S. Patent and Trademark Office (USPTO). In general, PTAB handles appeals and conducts trials. Appeals proceedings mostly involve cases where applicants wish to review the examiner’s decisions regarding their patents or claims (such as rejections). 

PTAB trials, on the other hand, are where the magic happens in challenging patent validity. The PTAB’s trial division handles proceedings such as Inter-Partes Reviews (IPR) and Post Grant Reviews. They also used to handle Covered Business Method reviews, which was historically the second most popular proceeding, but that program sunsetted and ended in September 2020. The vast majority of trial petitions filed at the PTAB are IPR’s (which accounted for about 93% of PTAB trial proceedings in 2021.) 

How do you actually challenge patent validity?

If you’re a business competing with someone who holds a patent that you think is inadequate or you are worried that what you are doing may infringe on their patent, you can attempt to invalidate their patent(s) or claim(s). Generally speaking, this can be done by bringing a case either to Federal District Court or to the PTAB (also in some circumstances, you can go to the Court of Federal Claims or the International Trade Commission.) Sometimes parties also choose to bring their case to multiple courts, although there are notable limits. Each choice has its own set of requirements, costs, and benefits. For instance, filing in Federal District Court requires a “case or controversy.” At the PTAB, there is no such requirement. However, there is a petition phase and a trial phase. Not all petitions become instituted and make it to the trial phase, though parties may file multiple petitions (there are differences between institution rates by “petition” and “patent.”) Also notably, the USPTO has been cracking down on “serial petitioners” (i.e., parties filing multiple petitions targeting the same patent.) 

Why have PTAB trials gained traction as a tool to challenge patent validity?

In the last decade, initiating PTAB trials has become a viable strategy for some businesses seeking to invalidate or weaken the patent portfolios of their competitors. There are many reasons for this. First, the average cost of filing and prosecuting a PTAB trial proceeding (IPR) is averaging far less than doing so in Federal District Court. If the expected value of initiating an IPR proceeding exceeds its cost, the firm is more likely to undertake the proceeding. Second, it’s easier to invalidate a patent at the PTAB than in Federal District Court. The presumption that a patent is valid does not exist in the PTAB and challengers only need to show by a “preponderance of the evidence” that claims are unpatentable to invalidate. Whereas in Federal District Court, challengers need to overcome the much higher standard of “clear and convincing evidence” to invalidate the patent, due to the jurisdictional presumption that the patent is valid. Third, there has been broader claim construction at the PTAB which has led to increased invalidation under Section 103 (non-obviousness) because it allowed for more prior art to be considered – although now the PTAB uses the Phillips standard for claim construction (the same as in Federal District Courts.) Fourth, standing is not required to initiate a PTAB trial proceeding. In the case of IPRs, any third party that has not already filed and has not been served with a complaint alleging patent infringement more than one year prior may initiate the proceeding. Most other PTAB trial rules and standards can be found here. For these reasons and likely others, it’s become a relatively more popular tool in handling patent disputes for patentees and non-patent holders alike. 

The PTAB has been controversial since its inception as part of the AIA in 2012

The constitutionality of the PTAB has been challenged on multiple occasions and in each case it has been upheld. In Oil States Energy Services, the Supreme Court held that Congress has significant latitude to assign adjudication of public rights to entities other than Article III Courts (i.e., the PTAB). The closest constitutional challenge to the PTAB was probably in United States v. Arthrex. In that case, the Supreme Court held that the PTAB’s structure was unconstitutional (by violating the Appointments Clause in which Administrative Patent Judges were not appointed “principal officers”), but this was easily remedied by having the Director review final decisions at the PTAB. Other controversy stems from disparate economic consequences of PTAB trials. Many inventors that are patent-holders are not fans of this emergent mechanism to challenge patent invalidity. These inventors complain that the PTAB has turned into a predatory regime with a bias against unsophisticated patentees. Ultimately, they argue that PTAB trials have become an anti-competitive tool for large companies to bully or threaten start-ups. One inventor argues that in part due to repeatedly filed petitions, patents that have been subject to a PTAB final written decision have an 84% invalidation rate.

The goal of patent law and the way forward

The administrative tradeoff between expeditiousness and thoroughness in the U.S. patent law system has been evident from the time of the “Commissioners for the Promotion of Useful Arts.” In an early letter, Thomas Jefferson wrote, “[of the law of granting and refusing patents] I saw with what slow progress a system of general rules could be matured.” Indeed, the America Invents Act was yet another iteration aiming at maturity. Congress’s goals for the PTAB part of the America Invents Act was: to create a faster and less costly alternative to Article III court-based patent litigation; to sweep away low hanging fruit (weed out patents that probably should not have been issued in the first place); and to lighten the dockets of federal district courts, which have been overwhelmed with Non-Practicing Entity (i.e., “patent troll”) suits. To a significant extent, many of these goals were achieved, and pretty much any bright-line rule is bound to discriminate against edge cases. This is why we have general rules and specific rules, and specific rules are more easily changeable. 

As the specific rules within the PTAB will continue to evolve, many disagree about the direction and pace of change. Here’s a paper that argues for more specific reforms likely to be addressed within the USPTO. The authors argue that the current benefits of PTAB proceedings do not necessarily outweigh its costs and point out inefficiencies. They call for more changes to deal with “uncertain estoppel litigation rules” (i.e., serial IPR petitioners, and other costs associated with doubling-up.) Other arguments call for more drastic reform such as repealing the PTAB

Since its inception in the United States in 2012, the PTAB has risen in popularity as a tool to challenge the validity of patents. Despite parties being able to challenge patent validity in other forums, the PTAB’s advantages have made it an economically viable candidate for many patentees and non-patent holders alike. Although it has been the subject of controversy, the PTAB and the U.S. patent law system more generally will continue to mature and be shaped by American jurisprudence. As for now, exposure to the filter of the PTAB will continue to be part of the patent bargain between an inventor and society.

Patents 101: Making Cents Off Ideas

By: Mark Stepanyuk

Patent Law and Section 101 Overview

The Patent Act was enacted pursuant to Article I, Section 8, Clause 8 of the Constitution, which allows for Congress “[t]o Promote the Progress of Science and useful Arts, by securing for limited Times to  . . .  Inventors the exclusive Right to their  . . .  Discoveries.” This utilitarian basis underpins the modern patent system as codified in Title 35 of the United States Code. Among other requirements, to secure a patent, the subject matter of the patent must be eligible under Section 101. The Patent Act lists subject matter eligibility for patentability as the first step in the patent process, and some have even argued that it would be inefficient not to apply the subject matter patentability screen first in assessing the patentability of an invention or discovery. 

35 U.S.C. Section 101 states that “[w]hoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.” Congress intended for the eligible subject matter to “include anything under the sun that is made by man” (i.e., to be as broad as possible). Indeed, historically, the Supreme Court has concocted only three exceptions to this otherwise broad provision concerning subject matter patentability: laws of nature, physical phenomenon, and abstract ideas. 

Behind this subject matter patentability screen is the basic assumption that granting a patent on these relatively ineffable concepts would ultimately not “[p]romote the Progress of Science and useful Arts.” That is, since part of the patent bargain between an inventor and society includes the grant of a 20-year monopoly (from the date of filing), if that patent was given to an inventor for any of these conceptual exceptions, society would be getting the short end of the stick in the exchange. In Funk Brothers Seed Co., the United States Supreme Court uses fancy language to describe these concepts as “part of the storehouse of knowledge of all men” and “free to all men and reserved exclusively to none,” but functionally, the worry is one of pre-emption. As echoed by the Court on many occasions, the fundamental concern is inhibiting future innovation by “improperly tying up the future use of laws of nature,” and this reasoning is consistent with the utilitarian framework of the constitutional provision underpinning the patent system in the first place.

Section 101 and its Ambiguity

Since the dawn of the software and biotech age, it has become more difficult for courts to distinguish between patentable and unpatentable subject matter under section 101. Although courts have consistently struggled to assess the risk of preemption directly or indirectly, that task has become especially tricky for relatively novel, emerging, and dynamic industries such as software and biotechnology. From Mayo and Alice, the Supreme Court has devised a two-step test to determine patent subject matter eligibility under 35 U.S.C. § 101: the court determines (1) whether the claims at issue are directed to one of those patent-ineligible concepts; and if so, the court asks (2) what else is there in the claims? To answer that, the court considers elements of each claim both individually and “as an ordered combination” to determine whether the additional elements “transform the nature of the claim” into a patent-eligible application. In Alice, the court said that this second step amounts to a search for an “inventive concept,” and a court commonly ascertains an inventive concept by asking whether the step was “well-understood, routine, and conventional to a skilled artisan.” Berkheimer clarified that although patent eligibility is a question of law, whether the inventive concept is “well-understood, routine, and conventional to a skilled artisan” is a question of fact, leading to less invalidation of patents in early stages of litigation. As it stands, this Alice has proven to be quite confusing. 

What does it mean for a claim to be directed to a patent-ineligible idea? What exactly constitutes an inventive step? Nobody knows. The current state of section 101 jurisprudence is highly unpredictable and the main determinant for patent eligibility in this area seems to be the claim drafting skills of the prosecutor and the skills of the litigator in the courtroom. Courts have noted that since essentially every routinely patent-eligible invention of physical products and actions involve, in various degrees, some law of nature, natural phenomena, or abstract idea, it’s difficult to draw the line as to when that claim amounts to nothing more than ineligible subject matter. Some courts have dealt with this by considering the claims as a whole and asking whether their character is directed to the excludable subject matter. Again, this is an evolving area of law with no clear answers. In fulfilling patent law’s constitutional utilitarian imperative, courts will likely think about the field’s relative novelty and dynamism, the effect of granting the patent on market entry by competitors, invention and discovery costs borne by the patentee, whether the claims are directed to a genus or species, etc., all in an attempt to gauge the relative impact of preemption. 

The Patent Law System and the Future of Section 101

In the United States, the law is a disjointed field of outcomes and approaches, and its patent system is no different. Institutions playing a role in the U.S. patent system also shape section 101 judicial value judgments.  The Supreme Court of the United States (which generally has the final say on patent cases), the United States Court of Appeals for the Federal Circuit (established in 1982 and operated as an appellate-level court for patent cases), the United States Patent and Trademark Office (which usually operates as the first system to interface with patents), and district courts (which operate as the most common venues for resolving patent disputes) all leave indelible marks on the law of patents in the U.S. In interpreting rules such as section 101, these institutions do not necessarily work with the same set of interests; indeed, the political economy of operational processes (such as internal docket management), personnel’s relative expertise, the institution’s stated objective, and other functional mechanics, create a different set of incentives in approaching patents and disputes. Additionally, Congress tends to exist as a wild card player that can speak at any point to clarify an approach to interpreting section 101 of the Patent Act.

Whatever the reason for the current state of section 101 jurisprudence, many want some clarity–including the Federal Circuit. Section 101 litigation has drastically increased since the Alice ruling, and it looks like there is no end in sight. But there may be some hope! Currently, there is a case pending certiorari with the Supreme Court that involves a method for manufacturing driveshafts to reduce interior cabin vibration in vehicles. If granted cert. by the Supreme Court, this case could provide clarity on important questions like what is the appropriate standard for determining whether a patent claim is “directed to” a patent-ineligible concept? Although this clarification has some potential to help future courts make sense of which ideas are patent-eligible, it would also not be inconceivable for some other version of Alice to eventually come along and shake things up all over again in this dynamic field of law.

Artificial Nature: Will the astounding become common?

leafBy Robin Hammond

From artificial leaves to digital rodent brains, computer scientists are successfully implementing processes from the natural world. Does the Alice ruling on software patentability provide a glimpse into how these technologies will be treated in the future? In 15 years, will computer-implemented natural processes be patent-ineligible?

The utilization of natural processes in computing is astounding. Recently, researchers in Melbourne developed a solar-power device that is close to simulating photosynthesis. The Energy and Environmental Science journal published these details in an article; in the article, researchers claim “This simple and adaptable system addresses key criteria for the large-scale deployment of an artificial photosynthesis device” to “provide a cheap, clean and renewable source of hydrogen as the ultimately sustainable fuel.” In August, news broke that IBM had created a digital equivalent of a small rodent’s brain, a type of chip with neuro-synaptic architecture, called TrueNorth. Both the chips and subsequent software recreate a brain’s neurons and synapses. The TrueNorth chip is another leap forward for computing through ‘deep learning’. Deep learning operates in two stages: “First, companies … must train a neural network to perform a particular task. If they want to automatically identify cat photos, for instance, they must feed the neural net lots and lots of cat photos. Then, once the model is trained, another neural network must actually execute the task. You provide a photo and the system tells you whether it includes a cat. The TrueNorth, as it exists today, aims to facilitate that second stage.”

It has taken many years, but the courts are finally addressing the realities of software patentability. In Alice, the Supreme Court did an about-face in terms of the validity of business-method and software patents. No longer are ideas or processes patentable because a computer executes them. While the opinion did not itself mention software, it has heralded in a new age of hostility at the U.S. Patent and Trademark Office toward business-method and software patents, with many courts overturning patents under the new standard of Alice.

In 15 years, will natural processes that are merely implemented by computers be novel enough to qualify for patents? Or will the two-step inquiry applied in Alice be similarly interpreted once these processes become commonplace? The analysis under Alice begins with the question: does the invention consist in significant part of a patent-ineligible concept—for example, a law of nature, natural phenomenon or abstract idea? If so, the invention is patent-eligible only if the remaining parts of the invention have an “inventive concept”—one or more elements that ensure a patent on the invention amounts in practice “to significantly more than a patent upon the ineligible concept itself. In Alice, the patents at issue were for computerized escrow. The court decided that the abstract idea of escrow was patent-ineligible and performing escrow on a computer was not sufficient to provide an inventive concept: “A mere instruction to implemen[t an abstract idea] on … a computer … cannot impart patent eligibility.”

Does the shift in the patentability of software patents in Alice foretell the future of the patentability of artificial nature? One could foresee a future where the idea of brain functioning (arguably a natural phenomenon) is in itself not patentable, and the mere implementation of specific neuro-synaptic architecture by a computer would not rise to the level of inventive concept. Or will future courts embrace Judge Rader’s broad interpretation of the applicability of §101? Where natural laws are restricted to “universal constants created, if at all, only by God, Vishnu, or Allah”; “even gravity is not a natural law“; and the slightest bit of labor mixed with nature is property under Lockean reasoning.

Image source: http://maxmania.pl/nauka/syntetyczny-lisc-wytwarzajacy-tlen/.