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Court of Appeals for the Federal Circuit Rules Harvard Oncomouse Patent Expired

By Michelle Goldring – Edited by Paulius Jurcys President & Fellows of Harvard v. Lee, No. 2013-1628 (Fed. Cir. October 29, 2014) Slip Opinion The United States Court of Appeals for the Federal Circuit affirmed the United States District Court for the Eastern District of Virginia, which had granted summary judgment to the Patent and Trademark Office. Slip op. at 2. On de novo review, the Court of Appeals upheld the district court’s finding that Harvard’s third patent on a gene sequence used to make research animals more susceptible to cancer had expired and was not eligible for new claims under 37 C.F.R. § 1.530(j). Id. at 4. In affirming the grant of summary judgment, the United States Court of Appeals for the Federal Circuit applied the arbitrary and capricious standard in the Administrative Procedure Act to prior court’s determination that the second patent had expired. Id. at 5. Harvard had filed a terminal disclaimer with the second patent, which was intended to run with the patent and any related patents. Id. at 3. It “disclaimed any portion of the term ‘of any patent granted on the above-identified application or on any application which is entitled to the filing date of this application under 35 U.S.C. § 120.” Id. (citing J.A. 1271–72). However, Harvard then argued that the disclaimer was invalid because Harvard had never paid the related fee and the PTO had not properly entered it. Id. at 5–6. The court reasoned that the rational basis standard had been met, based on the evidence Harvard provided. Id. at 9. provides a detailed overview of the decision and the underlying patents. Harvard held a number of patents on similar gene sequences in non-human mammals. Id. at 2–3. The first patent was U.S. Patent No. 4,736,866, col. 1, ll. 31–42, and the second was No. 5,087,571, col. 1, ll. 35–46; ’803 patent, col. 1 ll. 35–39. Id. at 3. The patent in this case is a third one, No. 5,925,803. Id. The second patent was filed with a terminal disclaimer. Id. The PTO examiner who considered Harvard’s third patent found that it was subject to the terminal disclaimer and therefore was expired. Id. As such, Harvard was not permitted to file new claims on the third patent. Id. at 4. On petition, the PTO director reviewed and dismissed Harvard’s contention that the terminal disclaimer was improperly recorded, instead upholding the examiner’s finding. Id. Following that, Harvard filed the action in the district court. In its holding, the court first noted that the arbitrary and capricious standard requires ample deference and only rational basis review. Id. at 7. It then reasoned that Harvard had “expressly stated, in the terminal disclaimer itself, that ‘accompanying this disclaimer [was] the fee set forth in 37 C.F.R. § 1.20(d).’” Id. (citing J.A. 1272). It also noted that an objection to the patent was rescinded after the disclaimer was filed, suggesting the PTO believed it was proper and would be implemented. Id. at 8. Lastly, the court stated that any errors in how the PTO carried out procedures when recording the disclaimer did not affect the factual findings. Id. at 8. Michelle Goldring is a 3L at Harvard Law School.