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Tag Archives: biosimilars

EU SPC Manufacturing Waiver now in force

The SPC Manufacturing Waiver (the “Waiver“) is now in force, effective from 1 July 2019 (Regulation 2019/933 amending the SPC Regulation 2009/469). The Waiver has been introduced with the stated aim of putting EU generic and biosimilar manufacturers on a level playing field with their competitors in third countries. The Waiver carves out of SPC

Life Sciences and Health Care Horizons 2019 publication: IP in the mix

Innovation in the life sciences and health care industries is occurring at a dizzying pace. Five years ago, anti-PD-1 antibodies from Merck and BMS had yet to be approved, CAR-T therapies were still in small-scale clinical trials, and digital health was seen as electronic step counters and little else. Today, cures are being found for

EU: New developments in the SPC manufacturing waiver legislative process

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 amendments to the Commission’s proposal. The Committee in essence supports the plan to introduce the manufacturing waiver but is asking for some clarifying amendments as

A changing competitive landscape: the role of the ITC in the biosimilars space

As biosimilar competition from companies outside the United States continues, innovator companies are increasingly likely to turn to the International Trade Commission as a first line of defense for protecting critical IP. Competition for innovator biologics companies has traditionally been relatively low, but since the FDA’s first biosimilar approval in 2015, the U.S. marketplace is