Life science leaders
Recognising business model innovation, policy leadership and IP value creation in biotech and pharma
IAM’s longstanding annual ranking of IP Market Makers has tended to focus on the leading IP dealmakers from the high-tech, telecoms and semiconductor spaces, who very much operate in a market unto themselves. This means that we have not always recognised the key figures and companies that shape our coverage of life sciences. IP value creation looks very different in pharma and biotech, where companies face their own distinctive legal and strategic IP challenges.
To put this right, we have compiled a separate list of IP leaders from the life sciences industries. This identifies 10 key figures who – along with their teams – have shaped the most important legal, strategic, commercial or policy trends relevant to biotech and pharma IP value creation in recent years.
IAM’s life sciences luminaries comprises a mixture of legal and commercial figures. Given that direct comparisons are often impossible in this field, these individuals are not ranked but all of them are key leaders putting in the work behind the sector’s biggest IP-related stories.
Vice president, intellectual property, AbbVie
Heading the IP group at AbbVie, where she been part of the team since 2005, Johanna Corbin has risen to become one of the most influential professionals in the life sciences patent arena in recent years. AbbVie’s strategy of acquiring and enforcing a hefty patent estate related to its best-selling drug franchise, Humira, has generated more than its fair share of controversy, becoming the go-to example of patent evergreening in US media and politics.
Putting aside these broader debates, there can be little doubt that the IP strategy implemented by Corbin and her team has been a success for AbbVie, securing it a clean sweep of favourable patent litigation settlements with at least eight producers of biosimilar versions of the drug. Although Humira’s active ingredient patent expired in 2016, it will not face US biosimilar competition before 2023.
The Humira disputes have caused ripples well beyond the political realm too, producing several of the earliest examples of originator-versus-biosimilar litigation under the framework of the Biologics Price Competition and Innovation Act 2009, with its distinctive patent dance. The skirmishes have also sparked several novel antitrust claims and unclean hands patent law defences against AbbVie’s alleged thicketing strategy, which Corbin and team have succeeded in fending off thus far.
CEO, Roivant Sciences
Matt Gline recently took over the reins from Vivek Ramaswamy as CEO of Roivant Sciences, the trail-blazing company that pioneered an innovative new approach to buying and commercialising life sciences IP rights. As the Roivant group continues to go from strength to strength, its unique model sets an increasingly significant precedent for dealmakers across the sector.
Just 30 years old when he established the business in 2014, former hedge fund partner Ramaswamy sought to find new ways to monetise IP rights lying fallow in pharmaceutical companies and academia. Roivant achieves this by establishing agile new biotechs (or ‘vants’) to house a small group of purchased or in-licensed patents and then uses these to develop a limited number of drugs or even just a single treatment. Vants receive a degree of centralised drug-development support, but each have distinctive ownership and incentive structures, generating their own investments from the marketplace.
In 2015, Forbes described Ramaswamy as the man “conjuring drug companies from thin air”. This was the year that subsidiary Axovant Sciences raised $360 million on the back of a drug patent bought in for $5 million months earlier. Since then, Roivant and companies under its umbrella have raised billions in further investment. In December 2019, the business sold its stake in five vants to Sumitomo Dainippon Pharma for $3 billion. Roivant biotechs now own at least 24 clinical-stage assets being tested across a range of therapeutic areas.
Roivant has demonstrated the commercial viability of creating a diverse range of patent-centred biotech companies with small teams assembled from scratch. Since the 2019 deal, Sumitomo has even replicated the model with its Sumitovant group.
Earlier this year, Ramaswamy took a step back to become executive chair, installing Gline as the new CEO. Now, Gline is setting his own stamp on the life sciences IP landscape.
Under his stewardship, the Roivant group has already made some important plays in the data space. Recently, Datavant announced that it is joining forces with Ciox Health, with the combined company valued at $7 billion. In May, Roivant Sciences also declared that it plans to go public by merging with a special acquisition company – the deal will value Roivant at $7.3 billion and is expected to generate more than $600 million in new cash for the umbrella company.
James Ryan and Julie Anne Gillespie
General counsel and head of intellectual property respectively, BioNTech
It is difficult to think of a life sciences IP team that has had more clout in recent times than that of German mRNA innovator BioNTech. Led by general counsel James Ryan – joined in May 2020 by head of intellectual property Julie Anne Gillespie – BioNTech’s IP group found itself the focus of global attention last year when it became a front runner in the race to develop an approved vaccine for covid-19.
The team “worked at triple speed” to help acquire patent protections relating to the company’s vaccine candidate, BNT162b2, Ryan and Gillespie told IAM in an exclusive interview. The drive for transparency at all stages of the vaccine’s development meant that BioNTech’s IP professionals had to work around the clock to file patents quickly, thus enabling the swift publication of vital new information.
During Project Lightspeed – the accelerated R&D programme which took the invention from pre-clinical candidate to the first approved covid inoculation in less than 12 months – the IP group found itself designing and implementing a patent strategy that would usually take over a decade. At the same time, Ryan and Gillespie had to manage relationships with IP and non-IP colleagues at Pfizer, with which BioNTech partnered to develop, manufacture and distribute its vaccine.
As if this were not enough, the pair were also responsible for blending two patent teams into one cohesive IP group following BioNTech’s merger with Neon Therapeutics in 2020, and for creating a new strategy for the combined business.
Vice president, head of legal and intellectual property for biosimilars, Fresenius Kabi
Dr Rachel Moodie has emerged as one of the most important IP professionals operating in the burgeoning biosimilars space. As Fresenius Kabi’s global head of IP for biosimilars, she is responsible for prosecution and litigation strategy relating to the company’s biosimilar versions of pegfilgrastim, adalimumab and tocilizumab. Before joining the firm in 2018, she cut her teeth working on biosimilars IP issues at Teva and Merck.
Moodie is at the forefront of tackling new and challenging strategic questions raised by the drug type. Because the development of biosimilars involves significant opportunities to acquire IP rights for innovations around manufacturing and purification processes, IP professionals must plan not only for potential disputes with originators, but also consider how they can leverage IP rights to gain advantage against competitors.
Indeed, not only has Moodie led pre-litigation settlements with Amgen and AbbVie, she also spearheaded Fresenius’s European patent suits against Amgen and Samsung Bioepis in two of only three biosimilar-versus-biosimilar litigations to have arisen to date.
Senior vice president, intellectual property, Moderna Therapeutics
Moderna Therapeutics – with its IP team ably captained by Debra Milasincic – has been one of the most dynamic companies on the life sciences patent landscape over the past couple of years.
Most notably, it was the sole owner of an approved covid-19 vaccine to make a blanket pledge not to enforce any of its relevant patents during the pandemic – a shrewd PR move at a time when enforcing vaccine IP rights would likely have prompted a public outcry. While it is impossible to ascertain what precise role Milasincic and team played in this decision – the green light would have come from Moderna’s CEO – we do know that it did not open the door to generic companies to reproduce Moderna’s jab, because of the importance of proprietary know-how and active tech transfer for manufacturing mRNA vaccines.
The fact that the mRNA vaccine landscape contains many (potentially overlapping) platform technologies means that the most likely IP disputes are between innovators. Indeed, Moderna has already found itself in a stand-off with Arbutus Biopharma, whose patent allegedly underpinning Moderna’s jab was upheld last year. It will be interesting to see how Milasincic handles any litigation over vaccine royalties.
Founder and chief executive, Royalty Pharma
Heading up Royalty Pharma, which he founded back in 1996, Pablo Legoretta is arguably the most important individual in the drug royalty market right now. Sales of royalty rights have become an increasingly valuable means of monetising innovation for universities, charities and small biotechs over the past 10 years. Much of this has been driven by the efforts of Legoretta’s company, by far the largest purchaser of drug royalties, which continues to lead the expansion of this specialist investment market.
In 2020, Royalty Pharma struck a record seven new deals and, more significantly, generated $2.18 billion in an initial public offering that achieved an overall valuation of $17 billion. This reflected the growing value of the royalty rights owned by the company, which saw an uptick from $10 billion in 2013 to $16 billion in 2019.
Recently, Royalty Pharma has struck a $1.7 billion royalty agreement to help fund MorphoSys’s buyout of Constellation Pharmaceuticals – highlighting the growing flexibility and sophistication of royalty transactions, as well as their widening appeal among companies seeking a lump sum for their rights to patented drugs.
This was just the latest of Royalty Pharma’s billion-dollar-plus deals, the first of which it cut in 2014 when it paid $5 billion for sales revenues on Vertex Pharmaceuticals’ cystic fibrosis treatments. Since then, the company has ploughed $1.25 billion into the University of California’s rights to Xtandi in 2016, while in 2017 it splurged $2.85 billion on royalties for Tysabri.
Former chief operating officer, Oxford University Innovation (now senior vice president, Academic Partnerships, Evotec)
Adam Stoten and his team at Oxford University Innovation (OUI) were pivotal in shaping the IP and partnerships strategy for the Oxford/AstraZeneca vaccine. Back in April 2020, OUI was one of a slew of universities to commit to expediting access to its covid 19-related IP rights. Speaking to IAM at the time, Stoten said that the university’s default approach during the pandemic would be to offer non-exclusive royalty-free licences to support at-cost or cost plus limited margin supply of patented products and services to address the effects of the coronavirus. However, he added that if a different approach would achieve better outcomes, OUI would consider that too.
In the event, OUI struck a somewhat different type of arrangement with AstraZeneca. The Anglo-Swedish firm received exclusive rights to the university’s vaccine, albeit on the basis of a commitment to sell at-cost. AstraZeneca then issued sub-licences for the manufacturing and supply of the jab to dozens of organisations around the world. These included a licence to India’s Serum Institute to produce over a billion doses for 57 poorer countries.
Stoten has now moved over to head up academic partnerships at drug discovery and development company Evotec.
Eldora L Ellison
Director, Sterne Kessler & chief IP strategist for CRISPR-Cas9, University of California, Berkeley
The only private practice lawyer to appear on this list, Eldora L Ellison is included not only because she is one of the United States’ leading life sciences patent practitioners, but because of her role as chief CRISPR-Cas9 IP strategist for the University of California (UC), Berkeley.
The latter has seen Ellison take command of the university’s long-running, high-stakes war with the Broad Institute over rights to use the gene-editing technology in eukaryotic cells. There have been many twists and turns in this keenly watched dispute. After a failed bid by UC Berkeley to overturn a PTAB interference decision at the Federal Circuit, the USPTO initiated a second interference (still ongoing) between the parties in 2019, following a new spate of applications by the university. To complicate matters further, the office then launched two more interferences involving a third party, ToolGen, last year.
UC Berkeley has so far turned down the opportunity to settle with the Broad. An expert in post-grant proceedings, Ellison is fighting tooth and nail to prove that the university was the first to invent CRISPR-Cas9 in eukaryotic cells. The next 12 to 18 months could see some major developments in this battle.
Ellison has also taken on a prominent spokesperson’s role in the CRISPR wars, often providing public comment on behalf of UC Berkeley. Her other clients include ImmunoGen and Amgen.
Vice president of law and IP officer, Amgen
Spearheading Amgen’s IP team, Stuart Watt has been involved in several groundbreaking US IP battles in the past couple of years, with some notable wins. Perhaps most significantly, Amgen subsidiary Immunex last year won a split Federal Circuit decision against Sandoz over its biologic blockbuster Enbrel, raising questions about the circumstances in which double-patenting rules apply. This year’s Supreme Court decision not to intervene in the case clears the way for eight more years’ exclusivity on a product that earns Amgen $5 billion per year.
The life sciences leader has had less success in its long-running dispute with rival PCSK9 inhibitors marketed by Sanofi and Regeneron. After several early victories in the international antibody patent war, Amgen suffered a substantial EPO revocation for a Repatha patent at the end of 2020, followed by a Federal Circuit decision invalidating its broad claims to all PCSK9 inhibitors. Nevertheless, the matter has produced crucial new enablement case law regarding broad functional claims.
Watt and his team have handled the many challenges that go hand in hand with Amgen’s distinctive place in the US originator-versus-biosimilar litigation landscape. The company is notable for having several products on both sides of the divide, and for its involvement in many of the early spats under the fledgling Biologics Price Competition and Innovation Act framework.
Especially worth mentioning in this respect are Amgen’s recent wins over its biosimilar versions of Genentech’s Avastin and Herceptin. In both cases, the Californian company adapted game-changing launch-at-risk strategies and was able to prevent the patentee from obtaining an injunction – decisions upheld by the Federal Circuit last year. Vindicating Amgen’s approach, the appellate rulings were followed by litigation settlements.
Senior vice president and deputy general counsel, Bristol-Myers Squibb
Taking charge of all IP issues at one of the world’s largest pharmas, Henry Hadad has also played a key role in public discourse around life sciences IP rights. As president of the IP Owners Association in 2018 and 2019, he testified before the US Senate Judiciary’s IP sub-committee about proposed legislation on patentable subject matter. In addition, he has remained a prominent advocate for pharmaceuticals patents throughout the covid-19 pandemic, arguing against the notion that IP rights are barriers to medical solutions.
Bristol-Myers Squibb’s IP team have been busy of late, inking several litigation settlements with would-be producers of generic Revlimid – the best-selling drug and cornerstone of its $74 billion purchase of Celgene in 2019 – and helping to navigate the dangerous patent cliff facing the business. In 2020, a US judge also increased to $1.2 billion the damages owed to Bristol-Myers by Gilead, following infringement of a patent licensed to the former’s Juno Therapeutics division.