Life Sciences, Biotechnology, and Medical Devices

Positioned at the intersection of innovation, science, and business, life sciences companies must act swiftly and proactively to protect and exploit their intellectual property. Our practitioners have helped some of the world’s most sophisticated companies in the life sciences sector to develop global IP growth strategies and have guided these clients through complex intellectual property, business, and regulatory issues to maintain a competitive edge.

Our team includes attorneys with advanced degrees in biochemistry and organic chemistry, who have a deep understanding of the business and science behind our clients. We have a uniquely global patent practice with practitioners admitted to practice before the United States Patent and Trademark Office, European Union Patent Office, and British Patent Office, including several of whom are admitted in multiple jurisdictions. Our deep expertise across the breadth of life sciences industry sectors allows us to serve both public and private companies, based in the United States and abroad, spanning from biotechnology and pharmaceuticals to medical devices and agricultural chemicals.

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+ Patentability in the Global Landscape

Our attorneys have earned the position as trusted and strategic advisors to multinational corporations and emerging companies alike, and have expertise in determining the various levels of patent protection available throughout the world.

In the United States, pharmaceutical and biotechnology companies face tremendous challenges regarding patent eligibility in light of the Supreme Court decisions in Mayo v. Prometheus and Association for Molecular Pathology v. Myriad Genetics.

Our clients face equivalent patent-eligibility concerns abroad, particularly with issues of determining the right time to file a patent application due to conflicting data and disclosure requirements throughout the world. In Canada, for example, Canadian Supreme Court decisions have effectively heightened disclosure requirements in the case of pharmaceutical patents. Similar issues arise in Eastern Asia, where Patent Offices will reject patent applications that have claims to pharmaceutical compounds due to lack of data in the specification as it was filed. On the other hand, in Europe, the disclosure requirement is generally met, so long as the data shows that the desired effect of a particular drug is “plausible,” and further data to support the patent may be accepted post-filing. We counsel our clients through these conflicting systems to help determine the best timing to file in each jurisdiction, ensuring that disclosure requirements are supported with adequate experimental data, while limiting the risk of a competitor beating them to filing. We believe that the only way to properly serve our cutting-edge clients in such a competitive and rapidly-developing area as the life sciences, is to be at the forefront of the patent law development throughout the world.

+ Patent Duration for Life Sciences Products

Throughout the world, regulatory approval can be a lengthy process, not only for pharmaceuticals, but also for products spanning from medical devices to agricultural chemicals. Our international patent prowess allows us to advise clients on the possibility of extending the life of a patent, which many countries allow as compensation for the time it took to receive regulatory approval. The form and availability of these extensions vary from country to country, for instance, in many countries the extension will be limited to the aspect of the patent for which the approval was required, not the patent as a whole. In the European Union, rather than extending the life of the patent, a holder of an eligible patent may apply for a Supplementary Protection Certificate. While all member countries of the EU are required to provide these Certificates, no unified cross-country recognition exists; each must be filed and approved on a country-by-country basis.

We bring superior knowledge that allows us to help our clients overcome ever-increasing hurdles due to regulatory approvals, so that they may maximize the value of their ever-important innovations.

+ Rights in Data and Research

Testing and development of new life sciences products can take years and tens of millions of dollars. Regulatory authorities throughout the world require enormous amounts of data and research in order to grant approvals of new products to go to market. We guide our clients through the complex framework of ownership and rights in this data. For example, legal regimes vary widely as to whether manufacturers of generic drugs must produce independent research or whether they may use original data developed by the brand name manufacturer. Additionally, various countries differ as to whether such data is capable of being “owned” at all. Some countries do not recognize any exclusivity for the person who originally generated the data, while others provide extensive rights and protection of such information. These rights (or lack thereof) can run independently of any patent rights that exist. Our clients rely on our global experience to determine the extent of rights that they may own in their data and research, as well as where they may be allowed to rely on existing data to support their own submissions to regulatory authorities.

+ Regulatory Approval for Pharmaceutical Trademarks

Before a proposed trademark can be used in connection with a prescription or over-the-counter drug in many countries, it must be reviewed and approved by a regulatory agency, in addition to normal trademark registration processes. We advise our pharmaceutical clients regarding the timing and procedure for submitting a proposed trademark, which in the United States, is usually done around the middle of the clinical trials. We guide our clients through the process of selecting proposed trademarks, and preparing proposed labeling for submission with the application. Additionally, after the mark is approved, we counsel our clients regarding the additional trademark evaluation that many countries require prior to formal approval of the drug.

+ Commercialization and Marketing of Life Sciences Products

Our team of life sciences attorneys advise multinational clients on issues relating to licensing of pharmaceuticals, biotechnology products, medical devices, and medical test kits in the United States and abroad.

We also have assisted developing life sciences companies by devising development strategies for their inventions, including when to license and when to consider forming joint ventures. We also counsel clients on issues relating to the marketing of products. In some cases, the first step to commercialization may include transferring ownership or licensing rights in the underlying intellectual property from the inventor to the company. Our experienced attorneys in our Intellectual Property Transactions group have handled transfers of numerous life sciences IP throughout all phases of a company’s development.

+ Domain Names for Life Science Companies

Companies in the life sciences area may wish to explore the option of reserving their trademarks and other keywords on new generic Top Level Domains (gTLDs) that relate to their market, such as .pharmacy, .bio, or .medical, where permissible.  We provide our clients with domain name registration services through our affiliated brand monitoring services and ICANN accredited domain name registrar subsidiary, Principium Strategies.  Principium Strategies also provides watch services to monitor third-party attempts to register domain names of terms similar and identical to our clients’ trademarks on any top level domain.  Our vast experience handling domain name conflicts through negotiation, dispute resolution, and litigation throughout the world enables us to support companies in the life sciences by protecting their rights in the throughout the world.