In the last years the Costa Rican Patent Office (CRPO) has seen a significant increase in the number of biotech patents filed. Among these the number of antibody patents is relevant. What is needed to obtain a patent on an antibody in Costa Rica?
The Costa Rican Patent Law (CRPL) does not contain any specific provision with regards to antibodies or biotech patents in general. The Biodiversity Law makes a specific patentability exclusion of DNA as found in nature, but other than that no specific provision exists in Costa Rican laws or regulations.
Given that applications for antibody patents continue to be filed and examined regularly, and most important, granted (not as regularly), some informal guidelines have been taking shape in the last years. The process to obtain such patents, including interviews with examiners, has given us the necessary information to identify this set of informal guidelines in place now at the CRPO.
Costa Rican examiners are requiring the disclosure of the function and pharmacological effect of the antibody, not as its description, but mostly to overcome a rejection for lack of inventive step. The antibody must be described with its full sequence. Describing just a fragment of the sequence will usually trigger a rejection for lack of clarity or sufficiency. The affinity of the active site (CDR) must also be described. In a recent case the applicant was also required to disclose the rates of association and disassociation, and to identify whether the antibody was humanized, chimeric, etc. Finally, the practice to accept homology percentages was recently modified not to accept any homology, other than 100%.
Examination practice for biotech patents is constantly evolving making it a difficult practice, even for a firm like Castro & Pal –with one of the largest numbers of biotech patents filed in Costa Rica-. The difficulty increases if you include the fact that the first office action issued by the examiner is in fact a “last” office action in Costa Rica, with just a month to file amendments. There is no opportunity for trial or error discussions with the examiner.
Nevertheless, we know firsthand that having updated information about the current examination practices largely increases the chances of grant for patents on antibodies in Costa Rica.