Regeneron Antibody Cocktail Patent Suit—A Taste of What’s to Come?

Allele Biotechnology’s high profile lawsuit against Regeneron for allegedly using its mNeonGreen protein in developing a Covid-19 antibody cocktail used to treat President Trump, shines a light on the complex web of technologies, market players, and business models in the life sciences arena.

It is no real surprise that the race to find treatments for Covid-19 is starting to produce lawsuits. Advances in medical treatments draw upon multiple interlinked licensed platform technologies, which can take a long time to knit together, both technically and commercially.

Tough Choices Ahead?

In the current environment, companies are racing to find effective treatments and questions will inevitably arise about whether patented technologies are involved without being properly licensed. If licensing discussions do not quickly produce agreement, it is easy to see why smaller biotechs may decide to litigate if they believe their rights are being infringed.

The pressure to deliver Covid-19 treatments has only intensified the complexities surrounding IP due diligence, freedom to operate assessments, and deal practicalities; and as new therapeutics get increasingly close to market, there could be many more similar legal challenges ahead.

Of course, nobody in the arena wants to obstruct potential solutions. Consequently, important conversations are happening after the event, rather than before. This is where problems could arise, as under normal circumstances the rules of engagement would be established at the outset.

For now, even if the finer details are not ironed out, companies that start the conversation early with potential collaborators and set out the IP framework are more likely to avoid disputes later.

The Art of Collaboration

If disputes do arise, resolving things pragmatically and sensitively is likely to be of long-term benefit. We are already seeing evidence of this approach in the case of biotech company, Moderna, which recently announced they would not be enforcing their Covid-19 vaccine patents during the pandemic.

Companies will of course be mindful of the reputational damage that could ensue from acting in a way that could be perceived to be obstructing research. They will also want to avoid being left out of important developments that could have myriad possibilities beyond the immediate crisis.

Those who adopt a more collaborative and open approach to making their technologies available are, arguably, putting themselves in the best position for the longer term. This is a fine line to tread, especially for small and medium sized players who may not have the resources effectively to give their innovation away in the short term without clearly defined parameters.

Regulatory and IP Complexity Abounds

The global nature of the pandemic brings different IP and regulatory regimes into play, adding further challenges for innovators. For example, in the U.S., the ‘experimental use’ exemption from patent infringement is generally limited, but there are further exemptions in relation to drugs and medical devices subject to FDA approval that potentially cover a wide range of R&D activities. With the boundaries of these “safe harbor” exemptions not entirely clear, this creates the perfect conditions for disputes to arise.

Regarding research tools (such as Allele’s fluorescent protein), exemption from patent infringement may depend on what stage in research the tool is used in. If used in early stage screening of uncharacterized compounds, then that may not be an exempted use whereas later use in the process for regulatory pre-clinical testing may more likely be exempt.

In Europe, activities may also be exempt from being patent infringement if they relate to seeking regulatory approval. What counts as seeking regulatory approval, and what acts by what parties are potentially exempt, varies across European territories.

At present the U.K. may have one of the widest exemptions. For research tools, U.K. Intellectual Property Office (UKIPO) guidance concludes that: “Research tools may be an integral part of a drug therapy and when they are used in, or for, the purposes of a medicinal product assessment, they are within the scope of the amendment.” But, in practice, things may not be straightforward to determine.

A Pragmatic Way Forward

IP rights can facilitate collaboration and provide a structure where value can flow across a complex network of players. But perhaps the current circumstances would suggest that greater clarity on issues like experimental use would be beneficial and could potentially be achieved through legislation rather than relying on developing case law.

As life science companies around the world focus their resources on identifying solutions to the pandemic, their work is firmly in the spotlight. The way they rise to the immediate challenge and forge partnerships will undoubtedly shape their long-term future and, for now at least, pragmatism and a holistic view may well be the order of the day for what might otherwise be fiercely fought disputes.

This column does not necessarily reflect the opinion of The Bureau of National Affairs, Inc. or its owner

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Stephanie Pilkington is a partner, board member, and patent attorney at IP law firm Potter Clarkson LLP. A specialist in molecular biology, her clients range from start-ups and university spinouts to established international corporations.