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Notification Date of Marketing Approval to be Used in Calculating PTE Duration in Israel

The Israeli Patent Office (IL PTO) recently accepted the marketing authorization notification date from the European Medicines Agency (EMA) as the date to be used when calculating the duration of an Israeli patent term extension (PTE). This decision represents a change from previous practice in which the EMA marketing authorization grant date was used to calculate PTEs.

The Israeli PTE system is unique as it is based on a series of linkages to the expiration date and extension periods of an U.S. PTE and any Supplementary Protection Certificates (SPCs) granted in any of the European Union “five” (EU-5) countries (United Kingdom, Italy, France, Spain and Germany). Additionally, an Israeli PTE expires no later than 14 years from the earliest date in which a regulatory approval was obtained in the U.S. or in one of the EU-5 countries.

Prior to this change, a petition for a PTE was filed with the IL PTO for apixaban (Eliquis®). The Israeli Commissioner of Patents (Commissioner) held that the EMA marketing authorization grant date, not the EMA marketing authorization notification date, should be used to calculate the PTE. As a result, the PTE for Eliquis® would have expired in Israel two days earlier than it would have if the notification date were used to calculate the extension period. The Commissioner justified his decision by referring to the lack of uniformity between the different European Patent Offices on the issue of whether the EMA authorization grant or notification date should be used to calculate the duration of SPCs. The IL PTO reached the same conclusion when deciding the PTE petition for secukinumab (Cosentyx®), holding that an IL PTE period is calculated based on the EMA marketing authorization grant date. In this case, the PTE would have expired four days earlier than it would of if the notification date were used.

However, the IL PTO was required to reevaluate its position after the Court of Justice of the European Union (CJEU) published a binding decision in Seattle Genetics Inc. v Österreichisches Patentamt  (case C-471/14) holding that the EMA marketing authorization notification date must be used to calculate the expiration period of SPCs. The patentee argued that the IL PTO was bound to follow the final decision of the CJEU holding that the EMA marketing authorization notification date should be used rather than the grant date. As a result, the IL PTO reevaluated its position and followed the CJEU ruling.

Liad Whatstein is co-author of this article.

©2020 MICHAEL BEST & FRIEDRICH LLPNational Law Review, Volume VI, Number 64

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About this Author

Lisa Mueller, Michael Best, Patent application Attorney, intellectual property lawyer,
Partner, Industry Group Chair, Life Sciences

Lisa provides strategic counsel on complex patent issues to clients in the pharmaceutical, biopharmaceutical, biotechnology and chemistry sectors. She brings an in-depth knowledge and extensive experience to her work advising clients on patent protection, freedom to operate and invalidity of blockbuster drugs they aim to produce and distribute.

Lisa’s advice on the full spectrum of global intellectual property portfolio management includes patent prosecution, opposition and other post-grant proceedings

312-596-5812
Rikki A. Hullinger Ph.D., Patent Scientist, Michael Best, Life Sciences Lawyer
Patent Scientist

Rikki applies knowledge and training she received while earning a Ph.D. in neuroscience to science-based strategies for life sciences and biotechnology patent prosecution.

Her broad experience in neuroscience, as well as biochemistry, cell culture, animal models, molecular biology, electrophysiology, and surgical techniques gives her a unique perspective on the challenges facing developers of cutting edge technologies and inventions.

Prior to joining Michael Best, Rikki was a National Science Graduate Research Fellow at the University of Wisconsin-Madison, where she studied the role of metabotropic glutamate receptors and downstream signaling cascades in successful cognitive aging in the rat. She has also studied the secretory pathway of the endoplasmic reticulum (ER) and identified a novel role for the ER membrane acetyl-coA transporter AT-1 in the development autism spectrum disorder in a mouse model. 

608-257-3068