The Danish company SNIPR Biome, which researches and develops CRISPR-based microbial gene therapy, has obtained a favorable decision in defense of its patents. The U.S. Court of Appeals for the Federal Circuit has overturned the decision of the PTAB which had ruled in favor of Rockefeller University and canceled five of the company’s patents on the grounds that they were anticipated by a prior patent owned by the university.
CRISPR technology (Clustered Regularly Interspaced Short Palindromic Repeats) has revolutionized biotechnology in the last few years, particularly in connection with gene editing. Thanks to this tool, it is possible to modify a DNA sequence precisely and it can be used –among other purposes– to correct or eliminate genes related to inherited diseases.
In this case, the PTAB issued a decision on the so-called “interference process” –a procedure that determines, between two or more patents in dispute, which has priority according to the “first-to-invent” system–. Under this system, which has traditionally been applied in the US, the first person to invent has “priority”, even if they were not the first to file the patent application in question.
Following the entry into force of the America Invents Act (AIA), the patent system was transformed into a “first-inventor-to-file” system, through which the first person to file a patent application has priority, even when another inventor can establish an earlier invention date. However, this new system is not retroactive and is applicable to patents or patent applications containing claims with a filing date as from March 16, 2013. For this reason, the system creates three distinct categories of patents, as the court held in its decision:
- Pure pre-AIA patents and applications (Pre-AIA Patents): their claims are prior to March 16, 2013, subject to the requirements and provisions pre-AIA, including the “interference process”.
- Pure AIA patents and applications: (AIA Patents): their claims are subsequent to March 16, 2013, so they are subject to the requirements and procedures established in the AIA.
- Mixed patents and applications: they contain claims with a filing date prior to March 16, 2013 and other claims filed after that date. These patents are subject both to the AIA and to the regulations prior to its entry into force, including the “interference process”.
SNIPR’s five patents claimed priority from a PCT application filed on May 3, 2013, and were therefore AIA Patents. Rockefeller University’s patent, on the other hand, claimed priority from two PCT patents, one of which had an earlier date to March 16, 2013 and was therefore a Pre-AIA Patent.
Since Rockefeller University’s patent was Pre-AIA, the Appeal Board applied the “interference process” and invalidated SNIPR’s patents.
The Danish company appealed the decision on the grounds that the “interference process” was not applicable because its patents had been filed under the “first-inventor-to-file” system.
The Court of Appeals agreed with SNIPR, reversed the previous decision and overturned the cancellation of its patents. Furthermore, its assessment of the case has also clarified the interpretation of the US courts when deciding which patents are still subject to the pre-AIA system and the “interference process”.
This decision is of paramount importance for the development of CRISPR gene-editing technology which has continued to evolve since 2005 when the Alicante resident Francisco Mojica addressed this matter in one of his publications. Proof of the importance of this tool, is the Nobel Prize in Chemistry 2020 awarded to Emmanuelle Charpentier and Jennifer Doudna.