The Federal Circuit recently issued an important decision in In re: Cellect, LLC (Fed. Cir. Aug. 28, 2023) regarding how Patent Term Adjustment (PTA) interacts with terminal disclaimers and obviousness-type double patenting (ODP). This case establishes binding precedent that a terminal disclaimer cuts off any extended patent term granted through PTA.
This holding contrasts with the court’s prior rulings regarding Patent Term Extension (PTE), where the extended term is calculated from the disclaimed expiration date, not the original expiration date. Thus, PTE extends beyond a disclaimed term, while PTA does not.
This result was expected by many patent experts, although some in the pharmaceutical industry had pushed for PTA to extend beyond disclaimed terms similarly to PTE. In the end, the statutory language expressly addressing disclaimers in the context of PTA proved decisive. This precedent will apply to all patents already in-force as well as those issued in the future. Thus, applicants will want to carefully consider PTA and terminal disclaimer strategy for patent families.
The publicly traded Australian company IPH Limited continues expanding its global intellectual property services empire. IPH’s latest acquisition is the Canadian IP firm Ridout & Maybee for $65 million Canadian dollars. This comes just 10 months after IPH purchased Canada’s largest IP firm, Smart & Biggar. (more…)
The U.S. Court of Appeals for the Ninth Circuit recently issued a pair of decisions in the qui tam case Silbersher v. Valeant Pharmaceuticals concerning the False Claims Act’s (FCA) public disclosure bar. The case sets significant precedent in linking FCA claims to patent prosecution and fraud upon the patent office. The case can be contrasted with Silbersher v. Allergan, Inc., 21-15420, — F.4th — (9th Cir. Aug. 25, 2022) [21-15420], that Silbersher lost.
Bald Girls Do Lunch (“BDGL”) is a nonprofit organization dedicated to improving the quality of life for females living with alopecia areata (“AA”). AA has been described as “an autoimmune skin disease resulting in partial to complete hair loss on all hair-bearing areas of the body, including, for example, on the face, resulting in loss of eyebrows and eyelashes.” According to BDGL, “AA is not a simple cosmetic problem—it is a chronic, often devastating condition that has substantial and wideranging implications, affecting patient’s physical, mental, and emotional health. Indeed, in severe cases, AA can lead to chronic depression.” (more…)
In a recent tax appeal, the Third Circuit court of appeals afformed that legal expenses incurred by generic drug makers to defend against patent infringement suits brought under the Hatch-Waxman Act are deductible as ordinary and necessary business expenses. This aligns with longstanding precedent treating patent litigation defense costs as deductible for the alleged infringer. (more…)
The nexus requirement serves as a threshold that must be met before secondary indicia will be even considered as relevant to the obviousness inquiry. In its recent Volva Penta decision, the Federal Circuit found that the PTAB had (1) created too high of a burden to prove nexus and (2) been unduly dismissive of the patentee’s evidence of commercial success and copying. The case reinforces the notion that patentees should attempt to include some claims that are largely coexistive with its product line, especially in today’s world of likely copying. The case also serves as a reminder that product copying still caries significant weight in the obviousness analysis. Volvo Penta of the Americas, LLC v. Brunswick Corp., 22-1765, — F.4th — (Fed. Cir. August 24, 2022). (more…)
By: Suzanne Harrison, Chair of the Patent Public Advisory Committee (PPAC) at the USPTO. This post is part of a series by the Diversity Pilots Initiative, which advances inclusive innovation through rigorous research. The first blog in the series is here and resources from the first conference of the initiative are available here.(more…)
By: Abhay Aneja, Assistant Professor of Law, University of California, Berkeley, Diversity Pilots Initiative Researcher, Gauri Subramani, Assistant Professor in the Department of Management, College of Business, Lehigh University and Diversity Pilots Initiative Researcher, and Oren Reshef, Assistant Professor of Strategy, Washington University in St. Louis. This post is part of a series by the Diversity Pilots Initiative, which advances inclusive innovation through rigorous research. The first blog in the series is here, and resources from the first conference of the initiative are available here.(more…)
Steuben Food recently lost its infringement case against Shibuya Hoppmann with the district court holding (1) the doctrine of equivalents (DOE) cannot extend to cover the accused aseptic bottle filling technique and further (2) the reverse doctrine of equivalents shields the defendant against charges of literal infringement. Steuben Foods, Inc. v. Shibuya Hoppmann Corp., No. 1:19-cv-02181-CFC, 2023 WL 2498810 (D. Del. Mar. 14, 2023) (U.S. Patent Nos. 6,209,591; 6,536,188; and 6,702,985) (Chief Judge Connolly). The case is now pending on appeal at the Federal Circuit with the successful defendant’s responsive brief due in mid-September. (more…)
The Supreme Court’s landmark 1950 decision in Graver Tank & Mfg. Co. v. Linde Air Products Co., 339 U.S. 605 (1950) is one of the court’s most cited patent cases. The decision established important guideposts for applying the doctrine of equivalents (“DOE”), including consideration of the prior art and a focus on the substantiality of differences. While courts today emphasize evaluating equivalence on an element-by-element basis, Graver Tank‘s substantive analysis remains highly influential. (more…)
I’m getting ready to teach my Fall 2023 Patent Law class, and that means updating the granted utility patents graph that I do every few years. This year’s version shows U.S. utility patents granted per year from 1840-2022:
This was a consolidated appeal from two Patent Trial and Appeal Board (PTAB) decisions affirming the rejection of claims from Universal Electronics, Inc.’s (UEI) U.S. Patent Application Nos. 12/645,037 and 16/279,095 as obvious under 35 U.S.C. § 103. On appeal, the Federal Circuit has affirmed. (more…)
A federal court has dealt a blow to the prospect of granting copyright protections to works created entirely by artificial intelligence systems. In their recent decision, Judge Howell ruled that because AI systems lack human authorship, their output is ineligible for copyright. (more…)
Incept LLC v. Palette Life Sciences, Inc., No. 21-2063 (Fed. Cir. Aug. 16, 2023) (Majority by Judges Schall and Taranto; Dissent-in-part by Judge Newman)
The most interesting line in the case for appellate attorneys (and legal scholars) is probably the court’s law/fact distinction in the context of obviousness analysis. The majority wrote: “We see no reversible error … whether viewed as a factual one about the level of [commercial] success or a legal one about the weight of any such success in the overall obviousness analysis.” The law/fact divide is important because of the evidentiary requirements in the first instance and the standard for review on appeal. Here, the court makes clear that the weight given to any objective indicia of non-obviousness is a question of law rather than a question of fact. The result then is that its analysis can generally be based upon reason rather than evidence, and that issue is one that will be heard de novo on appeal. (more…)
On August 15, 2023, the Judicial Conference Advisory Committee on Civil Rules published proposed amendments to Rules 16 and 26 of the Federal Rules of Civil Procedure. One of the goals of these amendments is to encourage parties to address issues relating to claims of privilege and work product protection early in litigation. This could be particularly impactful for patent cases, which frequently involve extensive disputes over these very issues. The proposal would also retitle Rule 16(b) to include both scheduling and case management (the current version just focuses on scheduling). (more…)
One-E-Way, Inc. v. Apple Inc., 22-2020 (Fed. Cir. Aug. 14, 2023) (nonprecedential) (Opinion by Chief Judge Moore, joined by Judges Lourie and Stoll).
The district court sided with Apple on summary judgment, finding no infringement. On appeal, the Federal Circuit has affirmed, holding that Apple’s accused Bluetooth products do not infringe One-E-Way’s patents. Although the parties had agreed to the construction of the “unique user code” term, they disagreed over the construction-of-the-construction. On appeal, the court treated this meta-construction effectively as a form of claim construction — looking for the ordinary meaning rather than a contract-like interpretation that would have looked more toward discerning the intent of the parties. (more…)
In re Theripion, Inc., 2022-1346 (Fed. Cir. Aug. 10, 2023) (nonprecedential) (Opinion by Judge Stark, joined by Judges Hughes and Cunningham).
ApoA1 is a key component of HDL, also known as “good cholesterol.” The founders of Therapin created a synthetic “fusion protean” of ApoA1 linked to the Fc portion of an antibody (the stem). That fusion extends the half-life of injected HDL and allows it to be a better potential drug treatment. The claims require a specific linker protein of 10-40 amino acids between the ApoA1 and Fc portions. Theripion discovered that this longer linker improved cholesterol efflux activity compared to fusion proteins having shorter 2 amino acid linkers or no linker. So the essence of the invention as claimed is an ApoA1-Fc fusion protein with an optimized 10-40 amino acid linker that enhances the fusion protein’s ability to remove cholesterol from cells as compared to a much shorter or absent amino acid linker. To be clear, the prior art (including some work by the inventors here) had created ApoA1-Fc fusions, but with a short linkage. And, various types of connectors of the claimed length were also known. (more…)
The Federal Circuit’s new decision in Rembrandt Diagnostics, LP v. Alere, Inc., 2021-1796 (Fed. Cir. Aug 11, 2023) complements the court’s recent decision in Axonics, Inc. v. Medtronic, Inc., 2022-1532 (Fed. Cir. Aug. 7, 2023). Ordinarily, an IPR petitioner must stick to the arguments and reasoning that it sets forth in the original petition. These two cases take a contrary position and permit the petitioner to shift as late as the final reply brief. The court permits these changes only if responsive to new arguments by the patentee and sufficiently linked to previously raised arguments.
Rembrandt was previously before the Federal Circuit on the full-institution issue that the Supreme Court addressed in SAS Institute. The PTAB had originally instituted Alere’s IPR petition on some but not all grounds presented. In its 2019 decision, the Federal Circuit affirmed the PTAB’s claim construction but remanded for the PTAB to consider non-instituted grounds. On remand, the PTAB instituted on all grounds and eventually concluded that additional claims were also unpatentable as obvious. On appeal this time, the Federal Circuit has affirmed — finding that the PTAB had properly found the claims obvious.
Rembrandt owns U.S. Patent No. 6,548,019 related to assay test strip devices for testing biological fluids. As the figure shows, the setup is quite simple and allows for multiple strips to be tested at once.
One of the key issues raised on appeal was the presentation of new theories mid-stream by the petitioner Alere. In particular, Rembrandt pointed to Alere’s reply brief as offering new theories.
Rembrandt argued Alere raised new theories about cost/time savings as a motivation to modify the MacKay reference to hold multiple test strips. However, the Federal Circuit found this was responsive to Rembrandt’s argument that there was no motivation to modify MacKay. Further, the cost/time savings was viewed as properly expanding on Alere’s previous “efficiency” argument.
Alere’s reply argument discussing cost and time savings has a nexus to Rembrandt’s prior argument and is responsive. It refutes Rembrandt’s assertions that there is no motivation to add multiple test strips or an expectation of success. And by discussing time and cost savings as a form of efficiency, it also properly expands on and is a fair extension of its previously raised efficiency argument.
Slip Op.
The Federal Circuit found an alternative reason to affirm — holding that forfeited its argument. Before the PTAB, Rembrandt had generally objected to new theories presented by Alere. However, the Federal Circuit concluded that generic objection was insufficient to timely assert its right. The Federal Circuit’s position was bolstered by the fact that Rembrandt had made a very specific objection regarding another new-theory issue that is not on appeal. “We hold that Rembrandt’s generic objection is insufficient to constitute a proper objection—especially because Rembrandt expressly objected to other allegedly new theories without doing so here.”
In addition to these procedural issue, the court also concluded that the Board’s conclusions were supported by substantial evidence. A key here is that Rembrandt did not provide expert testimony to rebut Alere’s expert. The prior art and expert testimony provide substantial evidence to support the PTAB’s findings on the teachings of the prior art and motivation to combine.
Shamoon v. Resideo Technologies, Inc., No. 2021-1813 (Fed. Cir. Aug. 8, 2023) (opinion by Judge Newman; joined by Judges Reyna, and Cunningham) (non-precedential)
Charles Shamoon is the inventor and owner of U.S. Patent No. 8,064,935. The patent relates to a remote access system that allows users to monitor and control “environmental devices” like alarm and HVAC systems in their home using a base control unit and a remote unit. Resideo challenged the patent in a pair of IPR petitions, and the PTAB eventually found the challenged claims unpatentable as obvious over a combination of two/three prior art references.
On appeal, the Federal Circuit affirmed and rejected Shamoon’s three challenges.
The claims require a microcontroller, and Shamoon argued that the term should be construed as requiring a particular type of microcontroller that included certain memory elements. That narrowed definition might have helped Shamoon avoid the prior art. But, the Federal Circuit upheld the PTAB’s broad claim construction of “microcontroller” — finding that it was broadly used both in the claims and the specification.
Some of the claims required a confirmation message be sent once an instruction had been executed, and Shamoon argued that the prior art failed to teach a confirmation message related to an environmental device command. On appeal though, the court found that it was proper to combine the teaching of a confirmation message from a reference not related to environmental devices. “Because Oinonen and Whitley disclose the environmental devices and commands, it does not avail Mr. Shamoon to complain that Menard does not.” Slip Opinion. Shamoon’s argument here
Finally, Shamoon argued that applying AIA proceedings to his pre-AIA patent was impermissible taking by the United States without just compensation, in violation of the Fifth Amendment. The court quickly rejected this argument based upon its prior precedent in Celgene Corp. v. Peter, 931 F.3d 1342 (Fed. Cir. 2019) (“retroactive application of IPR proceedings to pre-AIA patents is not an unconstitutional taking under the Fifth Amendment.”).
The Federal Circuit’s recent Axonics decision reflects an ongoing tension between IPR petitioners and patent owners concerning litigation strategies and procedural fairness. A prevalent patentee strategy aims to force the petitioner to lock in specific arguments, only to provide a game-changing response later on.
In Axonics, the patentee offered a new claim construction proposal in its post-institution response. On appeal, the Federal Circuit determined that it was only just, and mandated by the APA, for the petitioner to present new responsive arguments and evidence in its reply briefing. Additionally, the court suggested that the patentee should then have the opportunity to submit further evidence in a sur-reply. The PTAB had adopted the patentee’s claim construction proposal and refused to consider Axonics reply arguments and evidence — finding them to represent improper new arguments. The Federal Circuit vacated that decision and sent the case back down for reconsideration.
Sandbagging Risk and the Need for Balance
In his opinion for the court, Judge Dyk quotes from the oral argument transcript after getting an admission from Medtronic’s attorney (Naveen Modi from Paul Hastings) that the PTAB approach risks sandbagging by the patentee:
The Court: “But isn’t there a risk here of sandbagging, that you realize there’s a good claim construction argument, [and] you leave it out of your preliminary response. If you argued it in your preliminary response, then maybe institution would be denied and there would
be no estoppel. But if you hold back on the argument and wait to make it until the response, then you get the estoppel. Isn’t there a risk of that?”
Medtronic’s counsel: “Certainly, your honor, there is a risk of that . . . .”
Oral Arg. at 14:24–51. Modi went on to explain that the risk could also affect the petitioner. The new rule permits the petitioner to provide an unreasonable initial claim construction, then present new evidence later if challenged. Here, the court explicitly concluded that petitioners are not bound to preemptively address all potential reasonable claim interpretations.
Important Caveats and Ongoing Questions
The case has some important caveats regarding what argument/evidence can be provided in reply. The court made clear that a petitioner cannot raise entirely new prior art references in a reply to a patent owner’s response: “a petitioner may not in reply rely on new prior art to teach a claim limitation.” And, the court refused to decide an intermediary question of whether the petitioner can rely upon “new embodiments” from the already presented prior art in order to counter a new claim construction proposal. “We leave for another day the question of whether, when presented with a new claim construction, a petitioner can rely in its reply on new embodiments from the prior art references that were relied on in the petition.” That particular situation was not at issue because “Axonics, in the reply, relied on the same embodiments as it relied on in the petition.”
In essence, while a petitioner cannot introduce entirely new prior art references in a reply, it remains an open question whether new portions or embodiments from the same preexisting references can be cited to address a new claim construction proposed post-institution.
Striking a Middle Course
In this frame, the decision shows the Federal Circuit steering a middle course – allowing petitioners to respond to changed claim constructions with arguments tied to the same prior art, while prohibiting entirely new prior art in replies. Ongoing cases will likely continue to shape the precise boundaries between fair response and improper new arguments in this contentious field.
Citation:Axonics, Inc. v. Medtronic, Inc., 2022-1532 (Fed. Cir. Aug. 7, 2023) (opinion by Judge Dyk, joined by Judges Lourie and Taranto).
In July 2023, the same panel released a separate decision involving the same parties and also siding with the petitioner Axonics in holding that Board erred in its obviousness analysis by improperly framing the motivation-to-combine inquiry. [LINK]
The result: Although the Board sided with the patentee on the four challenged patents, the Federal Circuit vacated those holdings and given the petitioner another chance to prove its case. and See U.S. Patent Nos. 8,036,756, 8,457,758, 8,626,314, and 8,738,148. As with most Medtronic patents, the inventions are super interesting. One set relates to implanting a neurostimulation lead and the second set relates to transcutaneous charging of implanted medical devices.
