Horowitz & Co. has an outstanding record representing clients on the full range of contentious and non-contentious intellectual property and regulatory issues affecting the pharmaceutical industry. Our work in this field has been recognised by all the major legal directories which have, year after year, ranked us in the top tier for pharmaceuticals and life science – the only major commercial law firm in Israel to receive this distinction.
We act for clients across the entire range of the industry – including both innovative and generic pharmaceutical companies, medical device companies, industry trade associations, medical and healthcare start-ups, founders, academic institutions and other entities that provide services and financing to the sector such as research organisations, hospitals, venture capital funds and financial institutions.
In addition, members of the team have been involved in drafting legislation influencing the entire pharmaceutical and life science industry and have often represented the pharmaceutical industry as a whole, at both the government and local levels.
Our lawyers are specialists with in-depth knowledge of the evolving legal, regulatory and business issues applying to pharmaceuticals, medical devices, healthcare and nutritional supplements and, in particular, the issues that underpin and influence the drug development cycle. Our expertise includes advising on:
- The protection, use and exploitation of intellectual property rights, in particular patent infringement disputes, opposition procedures, patent validity disputes, and patent term extension disputes.
- Freedom to operate analysis and validity opinions.
- Claims for compensation by current and former employees in respect of inventions created during the course of their employment.
- Ownership and inventorship disputes.
- Parallel import issues surrounding biotechnology and bio-similar products, their relabeling and sale to HMOs and pharmacies.
- Patent licencing and patent licence disputes.
- Compliance matters, including advising on the necessary regulatory approvals required from the Israel Ministry of Health for the importation, production and marketing of pharmaceutical products and medical devices in Israel.
- Regulatory and intellectual property aspects of e-Health and telemedicine.
- Financing and development of pharmaceutical and biotechnology companies.
- The sale, distribution and promotion of pharmaceutical products in Israel.
- Drug development agreements, including research and other collaborative agreements.
- Clinical trial agreements.
- Product liability and regulatory matters relating to product safety with respect to recalls, health professional communications and adverse events.
- Class actions relating to product liability for pharmaceuticals and medical devices.