Overview

We have developed unique expertise in the medical devices industry which derives from our deep understanding of, and long track record in, the pharmaceuticals and healthcare sectors, and the experience of our specialists in the corporate, commercial, IP and litigation practice groups. Our Medical Devices Group has in-depth experience and knowledge, alongside an ongoing involvement in legislation and regulation proceedings. The Group also contributes to the development of Ministry of Health regulations and policies.

We advise clients on all matters relating to this industry, including: development consultancy; licensing and partnering; regulatory issues such as export, import and marketing certificates, labeling and promotion and advertisement activity; hazardous materials permits from the Ministry of Environmental Protection; enforcement, defence and challenge of intellectual property rights; filing and prosecution of patents; manufacturing and distribution; antitrust and competition; and litigation.

Our team has unrivalled expertise advising medical device developers and manufacturers, ranging from large international corporations to start-ups, on the full spectrum of legal, transactional and commercial issues relating to the industry. Our expertise spans the whole technological cycle of a medical device company, ranging from research and development to financing and investments, and from regulatory issues to marketing. We are one of the few law firms in Israel that can offer medical device companies, as well as their investors, a one-stop shop addressing all issues they face during the entire life span of a medical device, including:

  • Acting for founders on the formation, investment, operation and eventual sale of medical device companies.
  • Advising on regulatory issues arising from the R&D and testing stage, including registration, marketing and commercialization of medical devices in Israel. We regularly act for clients on complex product registrations and clearances involving Israel’s Ministry of Health.
  • Regulatory matters relating to product recalls and adverse events.
  • Ownership and royalty entitlements regarding underlying rights with respect to medical devices.
  • Product liability claims (including defence against individual and class action claims).
  • Protection, licensing and commercial exploitation of medical device technology.
  • Distribution and manufacture, anti-trust and competition, brand protection, exploitation.
  • Acting for strategic and financial investors and acquirers, including corporate ventures and PE/VC funds, on all transactional matters regarding their investment in, and acquisition of, medical device companies, including unique capabilities in conducting overall legal due diligence review of medical device companies, particularly regulatory and IP aspects thereof.

 

 

 

 

Experience

  • Representing Teva, the world’s largest manufacturer of generic medicines, listed for trading on both NASDAQ and the Tel Aviv Stock Exchange, in the enforcement of its patents in the medical device sector
  • Representing Neusoft Group Ltd. (China’s largest IT and software company) on its acquisition of a controlling interest in Aerotel Medical Systems Ltd., a leading medical device company which designs and manufactures digital patient monitoring systems
  • Representing Spectranetics Corporation, a world leading manufacturer and supplier of medical equipment for use in minimally invasive interventional procedures, in its acquisition of Upstream Technologies Ltd., an Israeli company which specialises in developing new technologies for the manufacturing of medical equipment
  • Representing the Manufacturers Association of Israel in discussions with the Ministry of Health and in connection with the drafting of Israel’s new law on the registration of medical devices
  • Representing Amtac Certification Services Ltd., a UK Notified Body under the EC Medical Devices Directive, against a third party notice filed against it by the Israel Standards Institute for allegedly issuing CE Standard certification for a substandard transfusion pump.  A settlement was negotiated within eight months of the filing, providing the client with a waiver form against any further suit with respect to the faulty products and a substantially lower payout than anticipated by the plaintiff
  • Representing Photothera Inc., a California-based company, which develops medical devices for the treatment of strokes, in multi-jurisdictional litigation in Israel and California (the latter in cooperation with local counsel
  • Representing Medial Cancer Screening Ltd., a medical device and analytics start up:

(i) on a US$ 15 million (based on a company pre-money valuation of US$80 million), Series A Preferred round financing made by the Chinese VC fund Horizon Ventures;

(ii) on a US$ 5 million Series B Preferred round financing; and

(iii) on all the company’s day-to-day corporate and commercial legal requirements

  • Representing Worthy Venture Resources LLC on its Series D Preferred investment in EarlySense Ltd., a medical-device company which developed a patient monitoring system