Life Sciences Patent Infringement Cases become complex as laws become stringent

Publisher: The Insight Partners

Patent Infringement cases in the Life Sciences sector have been rising. This has made the laws and policies more stringent for both, the applicants as well as the patent office. In one of the major cases of 2019, the PTA was challenged by Intra-Cellular Therapies, Inc. The long pending case came to rest last month. Read on to know what happened:

Case Study: In the case of Intra-Cellular Therapies, Inc. v. The United States Patent and Trademark Office, the Federal Circuit declared the district court’s concluding decision and confirmed the patent term adjustment (PTA) that was first determined by Patent Office.

The concerned Patent Office had issued a final rejection for certain claims as well as objections made by the prosecution of Intra-Cellular. After the 3 months deadline for reacting, Intra-Cellular filed a comeback that wasn’t successful in terms of meeting the regulatory requirements of Patent Office for an appropriate “response” to the final action. It took more 21 days for Intra-Cellular to come back with the second response that accepted an assessor’s suggestions and also resulted in successfully overcoming all the outstanding rejections as well as objections. The patent was issued and the Patent Office calculated a PTA of 264 days.

Intra-Cellular had an issue with the number of days calculated and felt that the Patent Office was unjust in accounting in 21 days. As part of that calculation, the Patent Office determined that the extra 21 days it took Intra-Cellular to file a proper “reply” constituted applicant delay.

Standard of review

A district court’s summary judgment granted has been reviewed under the law of the regional circuit. Within the 4th Circuit law, the review for grant of summary judgment de novo has been made. Furthermore, decisions by the Patent Office “are studied in conformity with the Administrative Procedure Act” (APA). Within the Administrative Procedure Act, the Patent Office’s actions is set aside only in case of “arbitrary, capricious, an abuse of discretion, or else not in line with law.” Also, while reviewing an agency’s statutory analysis, the two-step framework established in Chevron was applied.

Read more: The two-step framework.

Intra-Cellular filed a district court complaint in quest of review of the PTA determination, nevertheless district court affirmed the decision of Patent Court. After all the challenging trials and considering the both the parties, it was discovered that the determination of Patent Office for applicant’s delay has been held by an approved interpretation of the PTA statute. Besides, Intra-Cellular’s outstanding arguments were found unpersuasive.

Therefore, it is been concluded that the district court did not make any mistake while granting the summary judgment in favor of Patent Office.