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Intellectual Property.

Intellectual Property

Our intellectual property practice focuses on supporting the firm’s leading life sciences law practice in view of the critical importance of intellectual property, market exclusivity, and regulatory data protection matters to innovators in the pharmaceutical industry. We have extensive experience representing companies at various stages of growth, from start-ups to mega-cap public companies.  Our intellectual property practice involves complex commercial agreements, public company mergers and acquisitions, joint ventures, strategic alliances, licensing, and targeted biopharmaceutical research and innovation incentives, primarily orphan medicinal product incentives for the development of treatments for rare disease, and paediatric incentives for the development of medicines suitable for children. We work closely with our clients’ in-house counsel and advise clients across a wide range of regulated industries.

Supplementary Protection Certificates

We assist clients in filing, maintenance, and renewal of patent applications, supplementary protection certificates (SPCs), and paediatric extensions. Supplementary protection certificates protect intellectual property rights for a specific product and extend patent protection in compliance with EU Regulations, and the Patents and Designs Act (Chapter 417 of the Laws of Malta), Patents Regulations (SL 417.01), and the Patents (Medicinal Products) Regulations (SL 417.03).

The time between applying for a patent for a new pharmaceutical or plant protection product (PPP) and receiving the regulatory marketing authorisation to place it on the market reduces the effective period of patent protection. The supplementary protection certificate (SPC) aims to extend market exclusivity for medicinal or plant protection product (PPP) by up to 5 years determined on a case by case basis, effectively providing patent protection in biopharmaceutical research to promote innovation in the European Union.

Supplementary Protection Certificates

Supplementary Protection Certificates (SPCs) manufacturing waiver for export and for limited storing of products covered by SPCs.

EU regulations introduced a manufacturing waiver to the protection given by a supplementary protection certificate (SPC)for pharmaceutical products that allows EU-based companies to manufacture a generic or similar version of an SPC-protected medicinal product during the term of the certificate either for exporting to a non-EU market, or for stockpiling during the final 6 months of an SPC ahead of EU market entry.

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