The IP needs of the pharmaceutical industry vary and are always changing. Protection for pharmaceutical compounds has become more complex and less uniform. Unlike some other areas of technology, there are significant differences in the laws in various countries and jurisdictions that effect what can be protected by patents in the pharmaceutical industry.

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 some countries, actual preclinical data is required.  Such 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. The requirements for patenting new uses of old products also differ among jurisdictions.

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.

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.

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.

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.

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.

The steps for bringing a product, process or method to market often require different types of agreements including material transfer agreements and licenses. The agreements, for example, may be with contract research organizations or companies or organizations who will conduct clinical trials and prepare the documents for obtaining marketing approval.

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.

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.  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 throughout the world.