The firm has a team of professionals with backgrounds reflecting the diversity of
legal and technological
fields required to support pharmaceutical product development.
Our specialist activities include advising on IP strategy, obtaining and enforcing patents, registered designs and trade marks to protect all aspects of pharmaceutical product development from drug discovery to formulation, packaging and brand protection. We also have considerable experience in IP portfolio management and corporate transactions involving transfers, licences, mergers and acquisitions.
Pharmaceutical research plays a decisive role in the continuing improvement in public health and economic growth. Drug development involves lengthy and costly R&D, clinical trials and regulatory procedures, such that it is not uncommon that ten to fifteen years elapse from the initial candidate compound screening to marketing approval. Each year, vast amounts of capital are invested in pharmaceutical research, yet only a minute percentage of the screened compounds make it to the market as medicinal products. Unsurprisingly, many companies choose to increase and diversify their portfolio through the purchase of smaller entities with proven track records of successful R&D and/or through the development of generic products.
Intellectual property is an essential requirement for pharmaceutical companies to invest in the development of innovative life-changing and life-saving treatments and proves to be a valuable asset.
Patent provides an exclusive right that prevents others from making, keeping, using, importing, marketing or selling the patented invention during a protection period (usually 20 years) without the patent owner’s permission. Patents can protect not only the drug compound itself, but also a variety of inventions arising from the research including for example drug synthesis and analysis, drug formulations, medical uses, packaging, medical devices and, in some jurisdictions, treatment and administration methods. Our experienced IP advisors can assist you in developing an IP strategy suited to your specific requirements.
Supplementary Protection Certificates (SPCs)
A patent application would normally be filed at the initial stages of research and because medicinal products will undergo rigorous assessment and clinical trials before a marketing authorisation is finally granted, there is a risk that the patent expires before the pharmaceutical company has had time to make some return on its investment. To compensate for the short effective life of a patent, most jurisdictions have provisions for supplementary protection certificates, which can extend the period of protection of a medicinal product for up to 5 years (or up to 5.5 years for paediatric medicinal products). This extension is a considerable asset, especially when relating to blockbuster drugs generating significant profits.
Other Useful Rights
Other types of intellectual property rights are available to the pharmaceutical industry. These include utility models registered and unregistered designs for example for the drug presentation and packaging and trademarks for the brand and/or product name. Related rights are also available, including trade secret and know-how, data exclusivity and orphan drug exclusivity. These rights can offer non-negligible protection to delay generic competition.
Generics and off-patent drugs
A growing number of companies specialise in or consider expanding into the generics market. It is essential for these companies to check that they are not infringing third party IP rights before starting a project. In addition, today’s research is increasingly directed to new uses, new formulations and new combinations of known compounds and care should be taken when experimenting and investigating before patent expiry.
Over the years, our firm has gained considerable experience in advising pharmaceutical companies, universities, institutes and drug researchers worldwide. If you are developing a new medicinal product and would like us to investigate how to obtain optimum protection or if you require advice on any aspect of pharmaceutical IP protection, then please do not hesitate to contact a member of our team.