1. “Key Developments in Life Sciences IP Strategies Over the Past Year”
2. “CRISPR Patent Strategy Enters a New Era”
3. “US Supreme Court’s First Enablement Ruling in 50 Years”
4. “mRNA Patent Wars Continue to Escalate”
5. “President Biden’s Threat to Bypass Drug Patents”
6. “10x Genomics and NanoString’s Cross-Border Dispute Sets Precedents”

Over the past year, the life sciences sector has witnessed several high-profile developments that have significantly impacted intellectual property (IP) strategies. These developments, ranging from landmark legal disputes to policy changes, have set new strategic paradigms and produced interesting developments throughout the year. Here are five of the most important life sciences stories of 2023.

Firstly, 2023 marked a new era for CRISPR Cas9 patent strategies. The year saw the first-ever regulatory approval of a Cas9 human therapeutic and several other prospective CRISPR gene-editing treatments making progress in clinical trials. This led to an intensification of licensing efforts and the potential for the first patent infringement suits in the fragmented and contested Cas9 patent landscape.

Secondly, the US Supreme Court made its first enablement ruling in half a century. The court’s ruling in Amgen v Sanofi clarified the court’s views on the enablement requirement under section 112a of the Patent Act, a strategically vital legal question that had not been addressed for seven decades.

Thirdly, the patent wars over the blockbuster revenues from the two approved covid-19 mRNA vaccines continued to multiply. Moderna Therapeutics experienced a mixed bag of successes and failures in its various mRNA spats in 2023, while Pfizer and BioNTech found themselves on the receiving end of multiple lawsuits.

Fourthly, US President Joe Biden threatened to bypass drug patents. The President 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. This shift in rhetoric could have major ramifications for drug innovators and potentially undermine the value of life sciences IP.

Lastly, a transatlantic dispute between RNA detection rivals 10x Genomics and NanoString Technologies produced several important “firsts”. The spat saw the first ever life sciences anti-anti-suit/enforcement injunction, the first company ever to assert a unitary patent, and the first UPC injunction to be granted after a full hearing.

These developments have significantly impacted the life sciences IP landscape, setting new strategic paradigms and producing interesting developments throughout the year. As we move into 2024, it will be interesting to see how these developments continue to shape the sector.