+ Patentability in the Global Landscape
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.