News & Analysis as of

Intellectual Property Protection Life Sciences Manufacturers

Gardner Law

Why Every Manufacturer Needs a Robust Information Security Program

Gardner Law on

Drug and device manufacturers are increasingly targeted by cyber threats that can compromise patient safety, intellectual property, and other critical data and systems, while also facing new regulatory demands. As regulators...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

IP Hot Topic: Federal Circuit Affirms Small U.S. Investments Can Satisfy Domestic Industry Requirement

A domestic industry may never be too small so long as the commercial product is 100% American-made according to the latest Federal Circuit opinion. In Wuhan Healthgen Biotech v. ITC, the Federal Circuit affirmed the...more

Ankura

eDiscovery and Life Sciences Industry - Challenges and Solutions

Ankura on

The life science industry is a significant contributor to the global market, with companies developing and manufacturing a wide range of medical products and devices. However, due to the complex and highly regulated processes...more

Hogan Lovells

Successful product launches across the EU, UK, and U.S.

Hogan Lovells on

We were pleased to welcome industry leaders to our Life Sciences and Health Care Horizons event in Boston for the first time since the pandemic. At the event, Hogan Lovells attorneys Eliza Andonova, Ina Brock, Kristin...more

McDermott Will & Emery

[Webinar] Contracting in Biotech and Pharmaceutical Manufacturing - March 31st, 2:30 pm - 3:30 pm CET

McDermott Will & Emery on

Companies frequently encounter challenges in the manufacture and supply of their innovative products, in particular with respect to process development and production capacity. In our latest webinar, we review how key...more

American Conference Institute (ACI)

[Event] Global Legal and Regulatory Summit On Biosimilars - December 3rd-4th, Munich, Germany

Legal, Regulatory and Commercial Perspectives on the International Biosimilars Marketplace - The Global Biosimilars market is expected to grow robustly. Market watchers anticipate that Europe in particular will experience...more

McDermott Will & Emery

European SPC Manufacturing Waiver Goes into Force

McDermott Will & Emery on

Newly issued EU Regulation 2019/933 provides supplementary protection certificate exemptions for exporting and stockpiling active pharmaceutical ingredients and medicinal products if certain anti-abuse requirements are met....more

McDermott Will & Emery

Proactive Due Diligence Considerations for Life Sciences Dealmakers

In today’s competitive and fast-paced life sciences dealmaking environment, buyers and investors are often unable to spend as much time on due diligence as they might like. Market players are often highly focused on the...more

Hogan Lovells

EU: New developments in the SPC manufacturing waiver legislative process

Hogan Lovells on

Following the European Commission’s draft proposal for implementing the so-called SPC manufacturing waiver the Committee on Legal Affairs of the European Parliament published a draft report on presenting its suggested...more

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