International News: Spotlight on Life Sciences | Feb 2023


After the post-pandemic boom enjoyed by the Life Sciences sector in 2021, the keyword going into 2023 is uncertainty. On the investment side, it’s shifted dramatically from a seller’s to a buyer’s market, and uncertainty is impacting every aspect of business, including the new transition timelines announced for the EU and UK medical device regimes, and protection of sensitive patient and commercial data owing to the stratospheric rise in cybersecurity insurance premiums.

Never has it been more important for businesses to manage the issues that are within their control, such as ensuring robust compliance and proactively preparing for dispute resolution.

Some extremely positive messages did, however, emerge from panel discussions at McDermott’s Health and Private Equity (HPE) Europe 2022 and European Life Sciences and Healthcare Symposium. Businesses that deliver excellence, whether that’s in patient care or with good scientific assets or an advanced product, are likely to weather the current challenges. In addition, the launch in Spring 2023 of the Unified Patent Court and the European patent with unitary effect will revolutionise the way patents are enforced in Europe, finally delivering the option to enforce, attack, and defend a patent before a single court.


New Transition Timelines in EU and UK Medical Device Regimes

Sharon Lamb | Jana Grieb, LL.M. | Dr. Deniz Tschammler | Bella North

The European Union Medical Device Regulation (EU MDR) was first enacted in 2017. At the time, the implementation periods looked ambitious but achievable. The new law was intended to apply in the United Kingdom, and the UK regulators had played a key role in the drafting of the EU MDR.

In practice, implementation in both the European Union and United Kingdom was severely affected by a number of converging factors, including Brexit, COVID-19, supply chain issues, and a lack of designated notified bodies to certify devices. These issues reached a head in 2022.

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Healthcare Fraud Enforcement and the Importance of Ongoing Compliance Efforts

Laura McLane | Dana M. McSherry | Sarah E. Walters

As the Covid-19 pandemic recedes, we have seen healthcare fraud investigations by the US Department of Justice and other regulators in the healthcare and life sciences space surge, and there is no sign of this trend abating.

The False Claims Act (FCA) is the primary civil enforcement mechanism to police violations of laws and regulations applicable to healthcare and life sciences companies. Cases can be brought by the Government directly, or by whistleblowers (“relators” under the FCA), and damages and penalties for violations can be staggering.

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Arbitration: Agreeing How to Disagree

Michael Darowski

Life sciences projects tend to give rise to collaborative, complex, and long-term relationships, often involving multiple jurisdictions that require a large number of contractual arrangements to govern disparate sets of commercial agreements. These cross-border partnerships are often highly technical and, at their heart, will have valuable intellectual property (IP) rights. Although parties will start out their relationship with a common goal, their expectations and circumstances may diverge and change over time, providing fertile ground for disputes to arise.

When that happens, arbitration can be an attractive and preferred option for resolving disputes, reflecting both the increasingly cross-border nature of transactions being done in the industry, and the desire to keep valuable IP and commercial contracts confidential.

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The Impact of an Unpredictable Cybersecurity Insurance Market on Life Sciences Businesses

Robert Duffy

The cybersecurity threat landscape continues to evolve in ways that increase operational and legal risks to life sciences organisations. At the same time, the cybersecurity insurance markets have been rapidly evolving to respond to record losses in 2020, when carriers paid out 72.5% of their premiums. In response, premiums were up 122% by the end of 2021, and up 48% more in the first half of 2022.

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The Unified Patent Court and Unitary Patent Protection

Charles (Chuck) Larsen | Hon.-Prof. Dr. Henrik Holzapfel | Diana Pisani

Currently, European patents are granted by the European Patent Office (EPO) under a centralised procedure. This allows patent protection to be obtained in up to 39 countries, including all EU Member States, plus Switzerland, Turkey, the United Kingdom, and others, through a single application. However, current European patents result in a “bundle” of national patents that must be enforced on a country-by-country basis. Patent infringement across multiple countries results in multijurisdictional parallel litigation, which increases legal costs and may result in delayed proceedings and conflicting decisions.

For the initial 17 EU Member States that ratify the UPC Agreement, the UPC will make it possible to enforce, attack, and defend a patent before a single court.

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