Five stories that made 2023 a momentous year for life sciences IP
The past 12 months have seen several high-profile developments that life sciences IP strategists must take note of. Not only have there been landmark legal disputes and momentous policy developments, several important disputes, exemplifying new strategic paradigms, have produced interesting developments throughout the year.
Here are five of the most important life sciences stories of 2023.
New era for CRISPR patent strategy
Though 2023 did not produce as many important developments in the worldwide patent office disputes between major CRISPR innovators as 2022, this year nevertheless saw the beginning of a new era for CRISPR Cas9 patent strategies.
The past 12 months saw the first ever regulatory approval of a Cas9 human therapeutic as well as several other prospective CRISPR gene-editing treatments make progress in clinical trials. This has caused an intensification of licensing efforts, and augurs the first patent infringement suits in the fragmented and contested Cas9 patent landscape.
Casgevy, a treatment belonging to Vertex Pharmaceuticals and its partner CRISPR Therapeutics, received the green light for the treatment of sickle cell disease from the UK Medicines and Healthcare products Regulatory Agency in November, becoming the first Cas9 therapeutic to be approved in any country. This month, it became the first such treatment to gain approval from the US Food and Drug Administration, clearing the way for launch in the world’s largest market.
Because Vertex lacked a licence to any of the Cas9 patents not owned by the ‘CVC’ (the University of California, University of Vienna and Emmanuelle Charpentier), the prospect of approval provoked rival patent owners and their partners to ramp up their licensing efforts.
ToolGen’s IP chief Yoori Kim told IAM readers in an exclusive interview in early November that Vertex “should deal with patent matters early”, because if it waited until after its drug achieves commercial success, she warned, “they will have to give more money to the patent holders”. ToolGen was willing to offer Vertex good terms so that “patent matters are not a headache for them”, was said, urging the company to do a deal.
Editas Medicines, the exclusive licensee of major cas9 patentees the Broad Institute and Harvard University, also revealed that it was in discussion with Cas9 drugmakers about potential licensing agreements.
Against the expectations of some commentators, Editas and Vertex reached a $100 million-plus licensing deal just days after the FDA’s green light, without the need for litigation. Whether Vertex will be able to avoid a legal dispute with other patentees, such as Sigma-Aldrich and ToolGen, remains to be seen. And as more Cas9 products come move towards launch, the prospect of the first litigation in this area increases.
There may even emerge cas9-related patent litigation outside the human therapeutics space. ERS Genomics, the exclusive licensee and sub-licensor of Emmanuelle Charpentier’s patents for uses outside human therapeutics, is “very willing to litigate to protect our licensees”, said the company’s licensing boss Michael Arciero, in a 2023 IAM interview concerning ERS’s ramped up licensing efforts.
US Supreme Court’s first enablement ruling in a half-century
The highest court in the jurisdiction with the world’s most valuable pharmaceuticals market this year handed down an opinion on a strategically vital legal question that had not been addressed for seven decades. The US Supreme Court’s ruling in Amgen v Sanofi spelled out the court’s much sought-after views on the enablement requirement under section 112a of the Patent Act.
Prior to the decision, prevailing Federal Circuit interpretations of the enablement requirement had been the basis for the invalidation of large numbers of valuable pharmaceuticals patents in recent years. Scholars had argued that this strict interpretation had contributed to what they called “the death of the genus claim”, making it very difficult to have a valid claim covering a broad range of different potential drugs. Merck & Co, for example, had a $2.54 billion damages award cancelled when its patent was invalidated for lack of enablement and written description.
Amgen appealed to the Supreme Court against a Federal Circuit decision to uphold a lower court’s finding that two of its broad, functionally-defined patents were invalid for lack of enablement. The patentee sought to overturn the Federal Circuit’s view that the patents’ “roadmap” for sorting operative from inoperative embodiments of the claimed genus requires undue experimentation despite using only well-known and routine techniques.
The Supreme Court unanimously ruled against Amgen in May 2023, finding that the patents had made wider claims than they had enabled. It reaffirmed the case law that others have alleged caused the “death of the genus claim”, but also offered some additional guidance for patentees (see here for more details).
However, the apex court chose this year not to address similarly important questions regarding the closely related written description requirement. At the start of 2023, it declined to hear an appeal on this topic in Juno Therapeutics v Kite Pharma.
mRNA patent wars continue to multiply
Patent fights over the blockbuster revenues from the two approved covid-19 mRNA vaccines have continued to proliferate this year, producing several interesting developments along the way.
Moderna Therapeutics has experienced a mixed bag of successes and failures in its various mRNA spats in 2023. Its attempts to deflect liability onto the US government for alleged infringement of patents belonging to Arbutus Biopharma/Genevant Sciences and Alnylam Pharmaceuticals took a knock in March 2023, when Judge Goldberg of the US federal District Court for the District of Delaware rejected Moderna’s motion to dismiss the Arbutus/Genevant suit, and expressed doubts about the validity of its arguments.
However, the company won a major victory as a defendant in late-August, when a US district court found that Moderna’s covid jab does not infringe two key patents asserted by Alnylam, causing the patentee to abandon one of its two lawsuits against the vaccine maker.
It has also been a busy year for Moderna in its capacity as plaintiff. Having sued rival jab makers Pfizer and BioNTech in the US, the UK, Germany and the Netherlands in late-2022, it filed several further suits in the Republic of Ireland and Belgium in May 2023.
It has suffered setbacks in these enforcement efforts, however. In November, the European Patent Office revoked a Moderna patent – EP 3 718 565 – asserted in the UK, the Netherlands and Germany against Pfizer/BioNTech. And in the final month of this year, the District Court of the Hague found another asserted Modern patent – EP 3 590 949 – to be invalid.
There have also been developments this year in CureVac’s patent assertion against Pfizer/BioNTech. Having sued in Germany based on five European patents in mid-2022, CureVac and the defendants went to trial in August 2023 at the Dusseldorf Regional Court, which subsequently suspended proceedings pending patent validity decisions.
In May 2023, CureVac expanded its campaign to the US, where it filed several infringement counterclaims against Pfizer/BioNTech at the US District Court for the Eastern District of Virginia in response to a motion for declaratory judgment filed to the same court by the vaccine makers.
Pfizer/BioNTech found themselves on the receiving end of yet another lawsuit in April 2023, when erstwhile partners Arbutus and Genevant took action against them at the District Court for the District of New Jersey following failed licensing negotiations.
Finally, a patentee called Promosome made a brief cameo appearance in the mRNA wars this year. Having sued both Moderna and Pfizer/BioNTech in the US District Court for the Southern District of California in June, the company moved to dismiss the Pfizer lawsuit with prejudice in October following “a confidential agreement”, and to dismiss the Moderna case without prejudice for unknown reasons in late-September.
President Biden threatens to bypass drug patents
The rhetoric of the US government shifted further towards an anti-pharma-patent position this year. Having taken the surprise decision to endorse the TRIPS covid-19 IP waiver in 2021, President Joe Biden laid out a new framework for the potential use of ‘march-in rights’ to bypass drug patents with the intention of lowering the cost of drugs.
A drug being priced at an unreasonably high level is a ground that can be invoked in favour of forcibly licensing patents, the proposed framework states, in an apparent shift from previous US government policy. “My Administration is proposing that if a drug made using taxpayer funds is not reasonably available to Americans, the government reserves the right to so-called march in and license that drug to another manufacturer who could sell it for less,” Biden declared, adding that this would be an important step towards ending "price gouging" by large pharma companies.
If the government seeks to use march-in rights in this way, it could have major ramifications for drug innovators. Moreover, uncertainty resulting from the government’s threats against pharma patents could undermine the value of life sciences IP discourage investment in medical R&D.
However, as IAM pointed out, the President’s rhetoric on this subject has been somewhat more radical than the substance of the proposed framework he unveiled. Despite its position on drug pricing, the government framework acknowledges several compelling reasons not to use march-in rights in the vast majority of circumstances, and does not even consider typical originator-versus-generic/biosimilar scenarios in its list of potential use cases.
Moreover, any attempt to use march-in rights in this way will inevitably be challenged the courts, where the US government will need to defend its controversial interpretation of the Bayh-Dole Act.
10x Genomics and NanoString’s cross-border spat produces series of ‘firsts’
A transatlantic dispute between RNA detection rivals 10x Genomics and NanoString Technologies has made waves this year, producing several important “firsts”.
The spat saw the first ever life sciences anti-anti-suit/enforcement injunction, issued by the Munich Regional Court in May following NanoString’s attempt to persuade a US court to prevent 10x from enforcing a German preliminary injunction.
10x also became the first company ever to assert a unitary patent, when it sued NanoString on the first day of the Unified Patent Court in June. In September, the UPC issued a 17-country preliminary injunction on the basis of the same patent – the first UPC injunction to be granted after a full hearing.
Earlier that month, the UPC held its first ever preliminary injunction hearing, which related to another 10x patent. This did not result in an injunction being issued, however.
The dispute has also seen what are apparently the first ever antitrust defences in a UPC patent dispute, which relate to promises, allegedly made by 10x’s partner Harvard University, not to enforce patents in return for US federal funding.
And, as IAM analysed here, 10x’s victories in Europe, plus several wins in the US, have contributed to the recent decimation of NanoString’s stock price.