“This year, the Federal Circuit will decide whether a judge-made doctrine can truncate the legislative permission for patent term adjustments…. We may create a clear rule that the time extensions granted under the statute cannot be cut off.”
The Patent Term Adjustment (PTA) was designed to serve the important purpose of compensating patent owners for time lost during prosecution due to United States Patent and Trademark Office (USPTO) delays. Most industries rely heavily on patent portfolios to drive business strategies that ultimately impact bottom line. The impact of patent life is particularly acute in the pharmaceutical and biotech industries, where companies spend billions of dollars developing new drugs. For these companies, every day a patent is in force is important, generating millions in additional revenue. With so much at stake, companies are striving to obtain all the patent terms they are entitled to under the current statutory system, including the PTA.
confusion begins
Codification of PTA and Patent Term Extension (PTE) (Right to Compensation for Delays Caused by Regulatory Approval Process) Towards End of 2020th The century has created a strange conundrum in light of the 100-year-old common law doctrine of obvious double patenting (OTDP). Honestly, the Court of Appeals for the Federal Circuit is to blame for the confusion. First, in 2007, the court upheld the validity of the patent. Merck v. Hi Tech Pharmacal Co.. It contained 1,233 days of PTE. In reaching conclusions on important issues unrelated to OTDP, the Court made a candid comparison of the statutory language of the PTE and PTA. This dissuaded the lower courts from wondering whether the comparison was more than meets the eye. 7 years later, to add fuel to the fire Merck Federal Circuit Court of Appeals AbbVie vs Matilda, invalidated the patent by ignoring the PTA’s 750 days without even addressing whether the PTA could be properly invalidated under the OTDP. An example is a 2015 Michigan court ruling invalidating a patent that expired after the referenced patent. thanks to the PTA. Magna Elecs., Inc. v. TRW Automotive Holdings Corp., (WD Mich. Dec. 10, 2015). The court blatantly discounted the PTA on the grounds that, in the absence of a final disclaimer, the “earliest expiry date of any patent” should prevail.
To this day, courts remain confused on this issue. Unlike other areas of law where courts respect the separation of powers doctrine, some courts and his USPTO’s Patent Trial Board (PTAB) AbbVie It began to increasingly infringe on legislative power by reading between the lines of the statute. At least one of them was whether the jurisprudence made by the judge, whether the PTE or he was the PTA, could truncate the statutory term extension grant. Determined to rectify the ongoing problem, the Federal Circuit said:Novartis Case. however, Novartis The case was limited to PTE. In 2018, the Federal Circuit issued two opinions on whether OTDP would invalidate PTE.of Novartis vs. Breckenridge, the court upheld the validity of a patent with a five-year PTE. On the Lower Court’s Opinion “There Is” [was] No case law supports Novartis claim to extend term [immunized] patent from [OTDP] I will challenge you,” the court reversed. The court Novartis V. Ezra what it means Breckenridge By upholding the lower court’s ruling that if the contested patent lapsed after submission solely because of the PTE, the OTDP did not revoke the contested patent’s PTE. Ezra The court held that the impartial concern underlying “potential gamesmanship” was [by the patentee] . . . through the structuring of the priority claim, the contested patent was valid because ”was not present here.
After the Federal Circuit settled the issue over OTDP and PTE, a New Jersey court extended its reasoning to OTDP and PTA.of Mitsubishi Tanabe Pharma vs. Sandoz, Inc., Judge Wolfson first addressed whether a patent could serve as an OTDP reference if the only reason the challenged patent expired after the reference was due to the PTA. The court said,[a] A judge-made doctrine cannot cut off the time extensions granted by law. In 2021, Judge Shipp from the same district tackled a similar issue. Amgen, Inc. v. Sandoz Inc.Whether both PTA and PTE operations invalidate patents expiring under the OTDP. The court said,[a] The difference in the expiry date of the two patents [arose] Only from statutory time extensions. . . [could not] . . . as the basis for the application of [OTDP]So, since 2018, lower courts appear to have looked at both the PTA and the PTE through the same lens.
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However, in December 2021, the PTAB took the opposite view when deciding whether PTAs and PTEs should be treated the same under OTDP.of Ex Parte Cellect, the inventor developed and patented a complementary metal oxide semiconductor imaging technique. All challenged patents claimed priority to the same application and received varying PTA periods during prosecution.
Cellect patents challenged and their respective PTA terms.
The challenged patent family has been involved in several lawsuits.Patentee filed four appeals one-sided Reexamination decision under OTDP. The question posed to the Board was whether the examiner erred in applying his OTDP rejection to expired challenged patents that had different expiration dates only because the PTA terms were different. The board upheld the examiner’s decision. It distinguished PTAs from PTEs, he opined, and unlike §156, the statutory language of §154(b) is limited to the case where a final disclaimer is filed. According to the board, just as the terminal disclaimer applied after the PTA, so should the OTDP. Alternatively, the panel argued that even though OTDP was applied before PTA, it was a clear transformation and two patents that expired on the same date would require a final disclaimer to enforce common ownership. Therefore, we decided that the dismissal was still appropriate. The challenged patent remained invalid because the patentee did not submit it during prosecution. To justify its fairness rationale, the Commission said, “The extra term of the second patent is itself unfair.”
Cellect, LLC has appealed to the Federal Circuit, raising the following issues. (b) if the two patents expired at different times solely because of her PTA, could the patents be the basis for an OTDP against the related patents; (c) Whether the Board erred in finding that the OTDP raised substantial new issues of patentability. Cellect argued that the board’s separate treatment of her PTA and PTE was erroneous and contrary to Congress’ intent and Federal Circuit precedent. EzraThe Commission’s suggestion that the relevant patents could be converted to OTDP references by adjustment rather than by extension was erroneous, as time extensions from the PTA and PTE are both properly recognized by statute. Cellect reminded the court that the equitable concerns underpinning the OTDP doctrine do not exist in the underlying case. Instead, the Board unfairly addressed a hypothetical concern of potential harassment by multiple assignees. Finally, Cellect argued that: [had] already . . . determined at the previous closing review. “
In response, the USPTO argued that the Board acted appropriately because the statutory language contrast between §§ 154 and 156 made it clear that the final disclaimer severed the PTA, not the PTE. The Secretariat advised that applicants in a similar situation may submit a preemptive terminal disclaimer to avoid OTDP decisions in the future. Finally, according to the USPTO, there was insufficient evidence that OTDP was considered during examination. Cellect further argued in its reply: . . should be voided simply because the PTA has extended the expiration date. According to Cellect, the patent office has “congressed [in addressing terminal disclaimers] Intended to address double patenting by proxy. The parties, including several Amici Curiae, have completed filing briefs in December 2022.
big decision
This year, the Federal Circuit will decide whether a judge-made doctrine can truncate the PTA’s legislative grant. It is likely that the Federal Circuit will overturn the commission’s decision. In doing so, it could create a clear rule that the statutory granted time extension, whether it be the PTE or the PTA, cannot be cut off by a judge-made doctrine. Such a clear decision Novartis Consistently read both PTA and PTE statutory language and repeat justification for “lack of gamesmanship” in OTDP analysis. But if the court upheld the board’s decision, it would essentially determine that, without a final disclaimer, the OTDP could be grounds to invalidate the claim regardless of her PTA. Such a ruling would leave prospective applicants with the ridiculous option of filing a preemptive disclaimer.But even if the Federal Circuit did resolve the issue, the court’s decision In re Cellect, LLC Every day of patent life will have a major impact on the critical pharmaceutical and biotech industries.
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