2024 Post-Grant Annual Report

Fish & Richardson’s 2024 Post-Grant Report takes a deep dive into the cases, trends, and statistics that shaped Patent Trial and Appeal Board (PTAB) practice throughout the year and how they might affect practitioners going forward.  

Table of contents  

Rulemaking at the USPTO 

All Quiet on the Fintiv Front?

Standing and Jurisdiction in IPR

The Scope of Prior Art

Objective Indicia in IPR

The PREVAIL Act

USPTO Leadership in Transition

Fee Changes at the USPTO

The Year in Biopharma at the PTAB

Rulemaking at the USPTO

2024 was a busy year for rulemaking at the U.S. Patent and Trademark Office (USPTO), with the Office issuing several major final rules or Notices of Proposed Rulemaking (NPRMs).

Director Review

Delegated Rehearing Panel update

Director Review continued to be available in 2024 and enabled parties in post-grant proceedings to request the Director’s review of certain PTAB decisions. In October 2024, new rules governing the Director Review process were codified at 37 C.F.R. § 42.75, which generally reaffirmed several of the prevailing practices and procedures involving Director Review. In particular, the codified rules state that:

1. Director Review is available for final written decisions, institution decisions, and decisions granting rehearing of final written decisions or institution decisions 
2. A party may request either Director Review or a rehearing request (but not both)
3. The Director may order review sua sponte
4. The Director may delegate review to the Delegated Rehearing Panel (DRP)

The DRP has issued two decisions to date, both of which are summarized below. (For further information about the DRP and its decisions, please see our July 2024 article “Six PTAB Events to Know From the Last Six Months.”)

First, in DK Crown Holdings Inc. v. Diogenes Limited, IPR2023-00268, the Board had denied institution based on its narrow understanding of the claim term “continuously” to mean “ongoing at all times,” rather than more broadly encompassing a pattern of events happening at discrete points over time. The claim language at issue recited a system having a processor that, inter alia, (i) “receive[s] . . . a wager on a wagering event”; (ii) “continuously retrieve[s] . . . data in real time relating to a progress of the wagering event”; (iii) “recalculate[s] . . . the wager information in real time based on the continuously retrieved data”; and (iv) "continuously evaluate[s] . . . the recalculated wager information.” Paper 14, 4-5.

In requesting Director Review, the petitioner argued that the Board had “improperly read[] all discrete time points out of the claims.” Id. at 11. Director Vidal issued an order delegating review of the inter partes review (IPR) institution denial to the DRP. See Paper 11. Director Vidal asked the DRP “to review the fact-intensive issues presented in this case,” and permitted the DRP to “request additional briefing if necessary.” Paper 11, 2.

Following the grant of Director Review, the petitioner asked the DRP to accept new evidence — namely, recent testimony of the patent owner’s expert about the meaning of the term “continuously.” Paper 13, 2. The DRP denied the petitioner’s request, explaining that the Director’s order did not expressly permit the introduction of new evidence into the record, id. at 1-2, and that the DRP “ha[d] sufficient evidence in the record” to address the issue “without recourse to new evidence,” id. at 5.

Addressing the merits, the DRP vacated the Board’s institution denial and remanded for further proceedings. Paper 14, 5. It reasoned that the Board had “misapprehended the meaning of the claim term ‘continuously’ and misapprehended both the petitioner’s mapping of the claim to the prior art and the scope and content of the prior art.” Id. at 2. It further explained that the Board had misapprehended the asserted Scott reference as teaching a system that shows a player a current cash value for the player’s game and then waits for the player to accept or reject that cash value before continuing the game. Id. at 22. The DRP instructed the panel to reconsider its institution decision with those errors having been corrected. Id. at 4. On remand, the panel reversed course and granted institution. Paper 20.

Second, in SynAffix B.V. v. Hangzhou DAC Biotech Co., Ltd., IPR2022-01531, Director Vidal asked the DRP to review a decision denying institution by issuing a DRP delegation order similar to that issued in DK Crown. See Paper 19, 2-3. And once again, the issue touched upon claim construction — namely, whether and the extent to which the patentee had disclaimed subject matter during prosecution. Paper 23, 16. The DRP affirmed the panel’s finding that the patentee had disclaimed a specific compound (the “first version” of the disclaimer), but vacated the panel’s finding that the patentee had disclaimed certain embodiments (the “second version” of the disclaimer). Id. at 10-13. On remand, the Board granted institution in light of the DRP’s analysis. Paper 25.

When considering both DK Crown and SynAffix, it appears that the DRP is unlikely to permit the introduction of new evidence, and that the DRP delegation procedure may be leveraged when the underlying decision turns on claim construction issues. While it may be hard to extrapolate much from this limited sample of two DRP cases, it seems that the Director may be inclined to delegate review to the DRP for case- or fact-specific issues while retaining review of decisions that raise important policy or legal questions.

Exemplary Director Review cases

MAHLE Behr v. Catalano - decision on expert testimony

MAHLE Behr Charleston Inc., v. Frank Amidio Catalano, IPR2023-00861, Paper 15 (PTAB Apr. 5, 2024), illustrates the important role that expert testimony can play in evaluating whether a drawing can be understood to meet dimensions recited in claims.

In this case, the petitioner asserted a Godefroy reference as disclosing a claim element requiring a sacrificial anode to be installed “within ten inches” of a radiator’s hot liquid inlet. The petitioner relied on Godefroy’s figures to demonstrate this limitation, as the specification was otherwise silent about that distance measurement. Id. at 4.

The Board denied institution, citing Hockerson-Halberstadt, Inc. v. Avia Group International, Inc., 222 F.3d 951, 956 (Fed. Cir. 2000), for the proposition that “patent drawings do not define the precise proportions of the elements and may not be relied on to show particular sizes if the specification is completely silent on the issue.” Id. at 7.

Director Vidal vacated the institution denial and remanded because the Board had not adequately addressed the petitioner’s expert testimony that Godefroy’s figures “explicitly” show the sacrificial anode located “at” the inlet in satisfaction of the claim language. Id. at 7-8. In particular, the Director noted that, “because the relevant expert testimony relies on features of the drawing itself, it was not insufficient for lacking ‘additional supporting evidence or . . . technical reasoning to support [the expert’s] statement.’” Id. at 8.

On remand, the Board again denied institution because the petitioner’s expert testimony was contrary to Godefroy’s figure itself, as interpreted by petitioner. Paper 18, 9. In particular, the petitioner had agreed that the anode is “against the internal wall” of a pipe, whereas the inlet is at the “center axis” of the pipe. Id. As a result, the expert testimony that the anode was “at” the inlet was incorrect and did not adequately account for the gap between the two points. Id.

As a takeaway, MAHLE Behr suggests that drawings in the prior art can be leveraged as disclosing claimed dimensions, especially when paired with competent expert testimony. The apparent reason why the drawings and expert testimony did not carry the case past institution in MAHLE Behr is that — perhaps avoidably in most cases — the petitioner’s expert testimony of a figure did not align with the petition’s analysis regarding the same figure.

Videndum v. Rotolight - decision on discretionary denial under the General Plastic framework

In Videndum Production Solutions, Inc. v. Rotolight Limited, IPR2023-01218, Paper 12 (PTAB Apr. 19, 2024), Director Vidal clarified the proper application of discretionary denial under General Plastic and Valve in cases where multiple petitioners serially challenge the same patent via IPR.

As a refresher, General Plastic Industrial Co. v. Canon Kabushiki Kaisha, IPR2016-01357, Paper 19 (PTAB Sept. 6, 2017) (precedential as to § II.B.4.i) (General Plastic), set forth various non-exclusive factors the Board should consider when determining whether to discretionarily deny institution of a second or subsequently filed petition against a particular patent. The Board subsequently extended the applicability of the General Plastic factors by permitting discretionary denial where a current petitioner and previous petitioner are not identical but nevertheless have a “significant relationship . . . with respect to [the challenged patent].” Valve Corp. v. Elec. Scripting Prods., Inc., IPR2019-00062, Paper 11 at 2, 9 (PTAB Apr. 2, 2019) (precedential) (Valve).

In Videndum, the Board applied the General Plastic factors in denying institution on discretionary grounds. Paper 9. Director Vidal vacated the denial, finding that the petitioner in question had no significant relationship to the previous petitioner — even though the previous petitioner had already challenged the same patent claims based on the same prior art. Videndum, Paper 12, at 2-7. In vacating the institution decision, the Director placed a heavy weight on factor one — “whether the same petitioner previously filed a petition directed to the same claims of the same patent.” Id. at 4. The Director explained that “where, as here, the first and second petitioners are neither the same party, nor possess a significant relationship under Valve, General Plastic factor one necessarily outweighs the other General Plastic factors.” Id. at 5-6.

Videndum thus clarifies that a lack of a “significant relationship” between the current and previous petitioners can be dispositive under the General Plastic framework — irrespective of whether other factors might counsel in favor of denial.

Motions to amend

In 2024, final written decisions on Motions to Amend (MTA) were issued in 33 IPR or post-grant review (PGR) challenges before the PTAB. Twenty-seven of the MTAs requested substitution of new claims, and six motions requested cancellation of claims. The PTAB denied five MTAs as moot, granted six motions to cancel claims and three motions to substitute claims, denied in part and granted in part four MTAs, and denied the remaining 15 MTAs.

Additionally, on October 18, 2024, final rules went into effect governing MTA practice before the PTAB in IPR, PGR, and derivation proceedings. The final rules largely adopted proposed rules from an NPRM from March 2024, including making permanent certain provisions of the Motion to Amend Pilot Program initiated in 2019, such as the ability to seek preliminary MTA guidance from the Board and file a revised MTA. The rules also clarified the burdens of persuasion and confirmed the Board’s ability to raise new grounds of unpatentability and extend final written decision deadlines.

Under the final rules, a patent owner may file an original MTA with a request for preliminary guidance from the Board and, without prior Board authorization, may file a response and/or revised MTA after receiving the guidance. It is the patent owner’s burden to show “by a preponderance of the evidence” that the MTA meets all requirements, including written description support for each proposed substitute claim, the MTA is limited in scope to amendments responding to a ground of unpatentability involved in the proceeding, and the MTA does not seek to broaden the scope of the claims or introduce new subject matter. The petitioner may file an opposition to the MTA containing arguments that the substitute claims are unpatentable. The opposition may raise new grounds of challenge based on new art and/or additional challenges based on §§ 101 and 112 (which may not otherwise be available in IPR challenges). The patent owner may respond to the guidance and/or to the petitioner’s opposition to an MTA, including responding with new evidence.

In the preliminary guidance, which is not binding on the Board in subsequent decisions in the preceding, the Board provides preliminary views on the MTA, including whether the parties have shown a reasonable likelihood of meeting their respective burdens of persuasion and notice of any new grounds of unpatentability discretionarily raised by the Board based on the proposed amendments. The final rules clarify that the Board must determine unpatentability based on a preponderance of the evidence in the record, including evidence in a related proceeding before the Office, or evidence that a District Court can judicially notice. To address public concerns about the compressed timeline for amendment under the MTA Pilot Program, the final rules confirm that the Board can request extension of the deadline for issuing a final written decision within one year of the trial institution date if needed.

The final rules further clarify that a petitioner can respond to a patent owner’s response to the guidance or revised MTA in a sur-reply, which is restricted to responding to any evidence filed with the reply and arguments made in the patent owner’s reply brief without raising any new evidence itself. If the patent owner does not file a reply to the preliminary guidance or a revised MTA, the petitioner can file a reply to the preliminary guidance but may not include new evidence.

Discretionary denials

Discretionary denial in IPR proceedings allows the PTAB to reject an IPR petition based on factors such as the Fintiv factors or 35 U.S.C. § 325(d). The NPRM, issued on April 19, 2024, proposed the following rules relating to the Director’s discretion during America Invents Act (AIA) proceedings and settlement practices before the Board.

New briefing process for discretionary denial

One major shift focuses on how discretionary denial issues are briefed. Currently, discretionary denial arguments are limited to the filed petition and the Patent Owner Preliminary Response (POPR), which consumes valuable word count that could otherwise be directed to addressing the asserted prior art mappings. Under the proposed rules, a patent owner can file a request for discretionary denial within two months of the date of the notice according filing date. A petitioner can respond with a petitioner's opposition, and a patent owner can then submit a reply to the opposition. The opposition and initial patent owner request for discretionary denial are limited to 10 pages. The patent owner reply to the opposition is limited to five pages. This new process will allow a patent owner to address discretionary denial issues separately from its POPR. Importantly, the proposed rules emphasize that this new briefing process should not include arguments on the merits of the case.

Discretionary denial regarding serial and parallel petitions

The NPRM also clarifies how the Board will classify serial and parallel petitions. A “serial petition” is a petition that (1) challenges overlapping claims of the same patent that have already been challenged by the petitioner, the petitioner’s real party in interest, or a privy of the petitioner; and (2) is filed after (a) the filing of a POPR to the first petition; or (b) the expiration of the period for filing such a response, or as otherwise ordered, if no preliminary response to the first petition is filed. “Parallel petitions” are two or more petitions that (1) challenge the same patent and (2) are filed by the same petitioner on or before (a) the filing of a POPR to any of the petitions, or (b) the due date for filing a POPR to the first petition (if no POPR to the petitions is filed). 

For serial petitions, the Board will consider a set of the factors originally set forth in the precedential General Plastic decision. Specifically, the Board will consider:

1. Whether, at the time of filing of the first petition, the petitioner knew of the prior art asserted in the second petition or should have known of it
2. Whether, at the time of filing of the second petition, the petitioner had already received the POPR to the first petition or had received the Board’s institution decision for the earlier petition
3. The length of time that elapsed between the time the petitioner learned of the prior art asserted in the second petition and the filing of the second petition, and
4. Whether the petitioner provided an adequate explanation for the time elapsed between the filings of multiple petitions directed to the same claims of the same patent 

For parallel petitions, the Board will look for a good cause showing as to why multiple petitions are necessary, including factors such as: 

1. A petitioner’s ranking of their parallel petitions in the order in which the petitioner wishes the Board to consider the merits
2. An explanation of the differences between parallel petitions
3. The number of claims challenged by the petitioner and asserted by the patent owner
4. Whether the parties dispute the priority date of the challenged patent
5. Whether there are alternative claim constructions requiring different prior art
6. Whether the petitioner lacked information at the time of filing the petition
7. The complexity of the technology in the case, as well as any other information believed to be pertinent to the good cause determination

Discretionary Denial for petitions raising previously presented art or arguments

Another key area of change is how the PTAB will handle petitions that raise previously presented prior art or arguments as governed by 35 U.S.C. § 325(d). The proposed rules replace the “previously presented” standard applied within the Advanced Bionics framework with a “meaningfully addressed” standard. This means the prior art or arguments must have been evaluated by the Office, with that consideration articulated in the record. While it is not entirely clear what “meaningfully addressed” encompasses, the proposed rules provide some guidance.

For instance, the mere presence of a prior art reference on an Information Disclosure Statement will not be sufficient to invoke § 325(d). A prior art reference must be used to argue a point that contradicts what the Office previously found. In these situations, the burden is on the patent owner to demonstrate that the prior art or related arguments were meaningfully addressed, and a petitioner may oppose this showing with several arguments, including showing that the prior art or related arguments are not the same or were not “meaningfully addressed” by the Office.

The proposed rules clarify that “previously presented to the Office” includes Office proceedings involving not only the challenged patent but also proceedings involving a “related” family member application or patent that has “substantially the same” claims of the challenged patent. Even so, the rules place the burden on the patent owner to identify in a request for discretionary denial where the prior art or arguments were meaningfully addressed. If the prior art or arguments are included in a record of a related application or patent, then the patent owner also has the burden to show that the prior art or arguments were evaluated with respect to “substantially the same” claims as the claims in the challenged patent. The proposed rules do not define “substantially the same” with respect to claims, and the NPRM does not provide examples.

The petitioner may file an opposition “to argue that the same or substantially the same prior art or arguments were not previously meaningfully addressed by the Office and/or to argue that there was material error by the Office.”

Discretionary denial considerations for joinder petitions

The proposed rules also address discretionary denial related to joinder petitions. Specifically, the Board will not consider arguments on discretionary considerations relating to parallel petitions or § 325(d) where the petition(s) sought to be joined was instituted and those discretionary considerations were available in the already instituted petition. The NPRM notes that “[i]n the scenario in which a joinder petitioner seeks to join multiple instituted IPRs, the need to justify multiple IPR trials is implicated by the already instituted petitions.” Similarly, “[a]rguments under section 325(d) were available to the patent owner in the context of the already instituted petition,” and therefore are considered to have already been addressed in the institution of the petition to which joinder is sought. 

Discretionary denial considerations for settlement agreements

Finally, the proposed rules address settlement agreements. Parties will now be required to file all settlement agreements, including pre-institution agreements, with the Office, creating a new depository for them. This change is intended to help the USPTO work with the Federal Trade Commission and Department of Justice to monitor potential antitrust issues.

All Quiet on the Fintiv Front?

2024 was a relatively quiet year for Fintiv-based discretionary denials. In 2020, the PTAB introduced the Fintiv factors to guide judges in deciding whether to institute IPR or PGR in cases involving parallel District Court litigation. Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 (PTAB Mar. 20, 2020). The introduction of the Fintiv framework sparked a surge in discretionary denials and, in the ensuing years, led to significant developments in the law regarding discretionary denials. Indeed, between March 2020 and February 2023, the PTAB issued five precedential and two informative opinions related to Fintiv-based discretionary denials. In 2024, however, the PTAB did not issue any precedential or informative decisions on Fintiv, and the issue has quietly faded into the background for parties that regularly practice before the PTAB.

Impact of USPTO guidance and Sotera stipulations on Fintiv-based denials

In 2024, Fintiv-based discretionary denials represented approximately 17% of all decisions that substantively addressed the Fintiv factors, and less than 2% of all institution decisions, as illustrated in the chart below.

The drop in Fintiv-related activity appears to stem from the clarity brought by the interim guidance memorandum issued in June 2022 by Director Vidal, which narrowed the application of Fintiv in several ways. For example, the guidance memo confirmed that Fintiv does not apply to cases before the International Trade Commission (ITC). It also called for the application of median time-to-trial statistics for District Court cases rather than assessing schedules set early in District Court litigation that often change. Importantly, it further clarified that Fintiv would not apply where petitioners committed to Sotera stipulations — i.e., agreeing not to pursue in a parallel proceeding the same invalidity grounds or any grounds that could have reasonably been raised before the PTAB. Sotera Wireless, Inc. v. Masimo Corp., IPR2020-01019, Paper 12 (PTAB Dec. 1, 2020). With these developments, petitioners no longer had to address Fintiv for co-pending ITC litigation and, for District Court cases, had two paths to a certain outcome: (1) file before the expected trial date based on the median time-to-trial statistics for the relevant jurisdiction, or (2) file a Sotera stipulation.

With this increased clarity, Fintiv-based denials declined significantly in 2024 as petitioners opted for certainty even when it meant giving up rights by filing a Sotera stipulation. For example, in 2024, approximately 52% of cases where the PTAB granted institution and referenced the Fintiv framework included Sotera-type stipulations, as illustrated below. As this data suggests, most petitioners in 2024 opted to, when deemed necessary, give up rights in District Court litigation and submit Sotera stipulations to overcome the Fintiv framework, thereby gaining access to the PTAB for printed publication validity challenges.

Legislative and regulatory efforts targeting Fintiv

Despite the decline of Fintiv-based denials, legislative and regulatory efforts to modify or eliminate the Fintiv framework continued in 2024. The USPTO solicited feedback to its Advance Notice of Proposed Rulemaking (ANPRM) proposing to codify the Fintiv factors for discretionary denials. However, when the USPTO issued its NPRM of April 2024, it surprised many by omitting any direct reference to the Fintiv framework. Instead, the NPRM focused on procedural updates for handling discretionary denial arguments and harmonizing pre- and post-institution termination processes.

Meanwhile, the Senate Judiciary Committee advanced the Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act in November 2024. This legislation seeks to replace the Fintiv framework altogether to prevent duplicative proceedings. Under the PREVAIL Act, petitioners must choose between the PTAB and District Courts as the single forum for patent validity challenges. The Senate placed on calendar the further review of the PREVAIL Act and its influence on the interplay between post-grant and District Court litigation.

The path forward for Fintiv

The Fintiv framework remains relevant in 2025 despite efforts to challenge or reshape it. The PTAB continues to deny institution in cases involving late petitions, significant investments in parallel litigation, the absence of Sotera stipulations, and a lack of compelling merits. Although 2024 was relatively quiet on the Fintiv front, the change in administration could increase the potential for Fintiv-based discretionary denials to be more impactful in 2025 and years to come.

Standing and Jurisdiction in IPR

Standing for IPR appeals: Platinum Optics Technology Inc. v. Viavi Solutions, Inc.

In August 2024, the Federal Circuit dismissed a patent challenger’s appeal of an adverse PTAB final written decision because the challenger could not meet the “injury-in-fact” requirement for Article III constitutional standing. Platinum Optics Technology Inc. v. Viavi Solutions, Inc., 111 F.4th 1378 (Fed. Cir. Aug. 16, 2024).

The patent at issue related to optical filters, including layers of hydrogenated silicon, and to sensor systems comprising such optical filters. The patent was involved in two infringement lawsuits, both of which were dismissed with prejudice before conclusion of the IPR. In its final written decision, the PTAB found that the prior art asserted by the petitioner failed to establish unpatentability. The petitioner appealed.

In dismissing the appeal, the court clarified that constitutional standing is required to seek judicial review in an Article III federal court and found that the appellant had failed to satisfy the injury-in-fact requirement because of a lack of pending lawsuits involving the patent in suit.

The court rejected the appellant’s argument that the injury-in-fact requirement was satisfied based on potential infringement liability due to continued distribution of a product previously accused of infringing the patent and development of new models of the previously accused product. The court explained that mere speculation about the possibility of future suit, without more, is insufficient to meet the injury-in-fact requirement. The court perceived the appellant’s evidence as insufficient to establish that ongoing development activities created a substantial risk of infringement or were likely to cause Viavi to assert infringement. The court also rejected the appellant’s argument that a letter from the patent owner suggesting patent infringement provides a basis for standing because the letter was sent prior to the infringement lawsuits being dismissed with prejudice.

Practitioners (particularly those representing petitioners) should be mindful of standing when appealing an adverse PTAB final decision, especially in scenarios where (1) there is no co-pending patent litigation involving a challenged patent and (2) there is limited or no evidence of an actual threat of infringement with respect to the challenged patent. Also, when resolving a co-pending litigation, practitioners should be mindful of the impact of such resolution on appeal strategy for an IPR.

The PTAB retains jurisdiction until a final decision is issued: Purdue Pharma L.P. v. Collegium Pharmaceutical, Inc.

In November 2023, the Federal Circuit determined that the PTAB did not lose jurisdictional authority over a PGR despite a final written decision being issued after the statutory timeline specified by 35 U.S.C. § 326(a)(11) and 37 C.F.R. § 42.200(c). Purdue Pharma L.P. v. Collegium Pharmaceutical, Inc., 86 F.4th 1338 (Fed. Cir. Nov. 21, 2023).

The patent owner appealed a final written decision in a PGR proceeding finding the challenged claims unpatentable. The PTAB was statutorily required to issue a final written decision one year from institution, subject to a six-month extension for good cause. During the pendency of the PGR, the patent owner initiated bankruptcy proceedings and sought an automatic stay of the PGR under § 362 of the bankruptcy code. After the extended deadline passed, the bankruptcy court granted a request to lift the PGR stay. The patent owner then filed a motion to terminate the PGR, arguing that the PTAB lacked authority to issue a final written decision. Nearly 18 months after the extended deadline, the PTAB denied the patent owner’s motion and issued its final written decision. The patent owner then appealed.

In affirming the PTAB’s final decision, the court determined that neither § 326(a)(11) nor § 42.200(c) specifies consequences for non-compliance with the statutory deadline. Applying Supreme Court precedent, the court explained that without such consequences being specified in a statute, federal courts will not impose their own coercive sanction. The court therefore found that the PTAB retained its authority to issue a final written decision even after the statutory deadline had passed.

The court rejected various arguments by the appellant based on the statutory language of § 326(a)(11). Citing Supreme Court precedent, the court found that the statutory language failed to divest the PTAB’s jurisdiction after a deadline passes. The court also rejected the appellant’s legislative history arguments, noting that removing the jurisdictional authority of the PTAB for failing to meet a statutory requirement would hinder Congress’ intent to allow parties to challenge a granted patent through an expeditious and less costly alternative to litigation. The court noted that if it had adopted the appellant’s position, the parties would be forced to litigate the issues in a District Court proceeding, resulting in duplicative efforts by multiple branches of the government.

Despite holding that the PTAB maintained jurisdictional authority over the PGR even after missing the statutory deadline to issue a final written decision, the court clarified that the PTAB may not ignore statutory deadlines. The court explained that the procedure for a party seeking relief for the PTAB’s failure to timely issue a final decision under § 326(a)(11) is to seek a writ of mandamus immediately upon the deadline’s expiration.

Practitioners should be mindful that the PTAB’s failure to comply with statutory deadlines in IPR and PGR proceedings does not divest it of jurisdictional authority over such proceedings. Additionally, if the PTAB fails to meet a statutory deadline, parties can seek a writ of mandamus, although it is unclear what relief may be available in such instances other than compelling the PTAB to act with respect to the missed deadline.

The Scope of Prior Art

Two cases at the Federal Circuit in 2024 had post-grant practitioners on both sides of the docket questioning whether and to what extent certain documents may qualify as prior art. This question is particularly important in IPRs and PGRs, where the case-in-chief is presented in a word-limited petition, the asserted grounds of unpatentability cannot be changed during a proceeding, and broad estoppels attach to the petitioner as soon as the Board issues a final written decision.

Sanho Corp. v. Kaijet Tech. Int’l Ltd., Inc.

The Sanho case addresses whether an inventor’s non-confidential but private sale results in an invention’s subject matter being “publicly disclosed” for purposes of the prior art exemption under 35 U.S.C. § 102(b)(2)(B). On July 31, 2024, in a precedential opinion authored by Judge Dyk, the court affirmed the Board’s conclusion that such a “private sale does not qualify for the exemption.”

The sale in question occurred approximately five months before the priority date of the challenged patent and approximately one month before the effective filing date of the asserted prior art, an earlier-filed published patent application. Sanho, 108 F.4th at 1378–79. Finding Sanho’s contrary view at odds with the statute’s text, purpose, and legislative history, the court held that merely placing something “on sale” does not necessarily mean the device sold is “publicly disclosed.” See id. at 1380–84. “Turning to the facts of th[e] case,” the court deemed it “clear that the sale alleged by Sanho did not ‘publicly disclose’ the relevant subject matter” because “[t]he testimony established only that there was a private sale between two individuals arranged via private messages.” Id. at 1384–85.

To some, Sanho is more notable for what the court said it “need not decide exactly.” Sanho, 108 F.4th at 1385. Because the sale being private was case dispositive, the court left for another day the questions of (1) “what is necessary for demonstrating that a sale publicly disclosed the relevant subject matter,” (2) “whether to apply the prevailing standard for when a printed publication is sufficiently publicly accessible to qualify as prior art,” and (3) to what degree the inventor’s public disclosure must comport with the subject matter disclosed by the asserted reference.

As more and more patents subject to the AIA’s first-to-file regime are asserted in infringement suits and challenged at the PTAB, the metes and bounds of the prior art exemptions under 35 U.S.C. § 102(b) will become increasingly disputed and, ultimately, defined. The Sanho case is an important, albeit relatively incremental, step toward clarity.

Lynk Labs, Inc. v. Samsung Electronics Co., Ltd.

The Lynk Labs case asks whether published patent applications (as opposed to patents) filed before but published after the priority date of the challenged patent are within the permissible scope of IPRs under § 311(b).

For IPRs, the controlling statute — 35 U.S.C. § 311(b) — limits the scope of patentability challenges to “a ground that could be raised under section 102 or 103 and only on the basis of prior art consisting of patents or printed publications.” The patent owner in Lynk Labs argued that the term “printed publication” used in § 311(b) has a long-standing judicial construction that addresses both what types of publications count and the date on which those types of publications qualify as prior art. Drawing from the Federal Circuit’s case law that public accessibility is the touchstone of a printed publication, the Lynk Labs patent owner asserted that published patent applications are printed publication prior art only as of the date on which they are published (i.e., under only pre-AIA 35 U.S.C. §§ 102(a) and (b)), not the earlier date on which they are filed (i.e., not under pre-AIA 35 U.S.C. § 102(e)(1)).

The PTAB disagreed, holding in its final written decision that § 102(e) prior art is eligible for use in IPRs under § 311(b). In doing so, the PTAB juxtaposed the statutory language of § 311(b) for IPRs against that used for covered business method proceedings — only the latter “explicitly limits challenges based on ‘prior art that is described by section 102(a).’” Acknowledging that no prior Federal Circuit decision has directly addressed this issue, the PTAB nevertheless noted multiple non-precedential cases in which both the Federal Circuit and PTAB previously accepted published patent applications as qualifying prior art in IPRs.

On January 14, 2025, the Federal Circuit agreed that published patent applications are a special “printed publication” because pre-AIA 35 U.S.C. § 102(e)(1) creates a specific rule governing the date on which the published patent application is prior art — its filing date. The Federal Circuit noted that “Lynk Labs does not dispute that, due to § 102(e)(2), an IPR challenge under § 311(b) can include as a ‘prior art . . . patent[]’ a patent that did not become a patent until after the challenged patent’s priority date.” Slip Op. at 9. The Federal Circuit explained that § 102(e)(1) provides the same for published patent applications.

Beyond making a purely textual finding, the Federal Circuit’s opinion also explores the history of the phrase “patents or printed publications” in § 311(b) and in prior ex parte and inter partes reexamination statutes. Ultimately, through consideration of the statutory history and related case law, the Federal Circuit found that “[t]he ‘when’ issue in these cases was controlled by other, temporal language in [the § 102] subsections.” Thus, the date on which a publication is prior art is not inherent in the definition of the term “printed publication” itself.

With this decision, there has likely been a collective sigh of relief from many petitioners who have relied upon a published patent application in their already filed IPR petitions. Indeed, this same issue was raised by VLSI in its defense of IPRs filed by PQA and joined by Intel, and the Lynk Labs decision answers at least this question from VLSI’s appeal.

Objective Indicia in IPR

Objective indicia have increasingly become a focal point of obviousness disputes in IPR proceedings. While historically considered a secondary aspect of the non-obviousness inquiry, recent PTAB and Federal Circuit decisions highlight a growing reliance on secondary considerations to challenge obviousness arguments. The PTAB’s analysis of secondary considerations in two final written decisions issued in 2024 illustrate how PTAB panels may evaluate secondary considerations evidence in the IPR context, shedding light on the challenges and strategic implications of raising these arguments. See Envirotainer AB v. Doubleday Aquisitions LLC et al., IPR2022-00292, Pap. 83 (PTAB Feb. 1, 2024); Google LLC v. Ddc Technology LLC, IPR2023-00707, Pap. 80 (PTAB Nov. 14, 2024).

Successfully advancing secondary considerations arguments often requires compelling evidence of a nexus between the claimed invention and the asserted objective indicia. Nexus is presumed when the product evidence embodies and is coextensive with the claims. Fox Factory, Inc. v. SRAM, LLC, 944 F.3d 1366, 1373 (Fed. Cir. 2019).

Establishing nexus in IPRs can be challenging for patent owners due to the difficulty of identifying and presenting key evidence, such as detailed market data, licensing agreements, industry testimony, and contemporaneous business records. The limited discovery permitted in IPR proceedings further compounds those challenges, often forcing patent owners to rely on evidence gathered from related litigations.

The IPR2022-00292 decision illustrates how secondary considerations are evaluated when the evidentiary record is moderate but insufficiently developed. In that proceeding, the patent owner advanced commercial success arguments based on evidence of the strong market performance of its products. While the panel acknowledged some success, it found that competing products still dominated the market, diminishing the weight of this evidence. Similarly, while the patent owner claimed unexpected results — such as improved longevity and battery life — the panel was unpersuaded by these arguments, which relied primarily on anecdotal reports from a single customer. The industry praise argument was also dismissed due to a lack of substantial independent support. Ultimately, the panel determined that while some secondary considerations were present, they were not strong enough to overcome the prima facie case of obviousness.

In contrast, in IPR2023-00707, secondary considerations played a decisive role in the outcome. The panel credited the patent owner's alleged commercial success, supported by market data, licensing agreements, and customer demand. Further, the panel found industry recognition compelling given the multiple independent sources praising the patented virtual reality viewer technology. Most significantly, the patent owner also presented evidence of alleged copying — internal documents from the petitioner, which led the panel to believe the petitioner had incorporated key features of the patented product after observing its success in the market. This combination of factors tipped the scales against obviousness, leading the panel to uphold the patent.

The decisions in IPR2022-00292 and IPR2023-00707 underscore the difficulties involved in linking commercial success or industry praise to specific claimed features. Without a well-developed record, secondary considerations may be dismissed as speculative. However, when a patent owner provides multiple, mutually reinforcing pieces of evidence, such considerations can be decisive.

The PREVAIL Act

Legislative reform: The PREVAIL Act may prevail

2024 saw continued legislative interest in general patent reform, including a major revision aimed at changing PTAB practice. Three of the major bills receiving attention that were introduced in the Senate in the just-finished 118^th Congress (2023-2024) include the “Promoting and Respecting Economically Vital American Innovation Leadership Act” (PREVAIL Act) (S. 2220); the “Realizing Engineering, Science, and Technology Opportunities by Restoring Exclusive Patent Rights Act” (RESTORE Act) (S. 4840); and the “Patent Eligibility Restoration Act” (PERA) (S. 2140). While none of these bills made it out of the prior Congress, we are sure to see further activity relating to these measures with the start of the 119th Congress (2025-2027).

The most significant PTAB-related movement in 2024 occurred with the PREVAIL Act, which in December saw a flurry of activity as the Act was voted forward out of the Senate Judiciary Committee and on to the full Senate by a close committee vote of 11-10. Meanwhile, both the RESTORE Act (aimed at adding a rebuttable presumption in favor of patent injunctions) and PERA (aimed at revising tests for patentability as provided in 35 U.S.C. § 101) remained in committee.

The PREVAIL Act makes changes to PTAB practice in several ways, as noted below. Most of the legislative attention and committee comments prior to the committee vote reflected senators’ concerns that the PREVAIL Act would restrict the ability to challenge pharmaceutical patents perceived as affecting drug prices. In response, the sponsors of the PREVAIL Act amended the Act in December with a “manager’s amendment” in an attempt to loosen the changes to the standing requirement that had been proposed in the original bill. The bill otherwise remained largely unchanged from the prior year’s proposal.

The PREVAIL Act would change PTAB practice in the following ways:

• Add extra requirements to bring IPR petitions. Currently, anyone can bring an IPR challenge to a patent at the PTAB. The PREVAIL Act would change the rules to limit PTAB petitioners to entities that (i) would have District Court standing to bring a declaratory judgment action on the patent, (ii) have been sued on the patent, (iii) are engaging in (or have the intent to engage in) activity that reasonably could be accused of infringing the patent, or (4) are non-profit entities that do not have a member, donor, or funding source that is (or reasonably could be) accused of infringing the patent, and who are also “filing the petition for the sole purpose of ascertaining the patentability of the challenged claims of the patent and not to profit from or fund the operations of the petitioner.” (More below on the Act’s impact on standing at the PTAB.)
• Close dual-challenge opportunities. Currently, a defendant who is sued in District Court or a respondent in the ITC can raise invalidity — either as a counterclaim in District Court or as an affirmative defense in District Court or the ITC — and still later bring an IPR challenge at the PTAB. The PREVAIL Act closes off this dual-challenge opportunity; if an IPR is filed and instituted, the petitioner would need to drop any parallel invalidity case (based on patents or printed publications for IPR or on broader grounds for PGR).
• Change estoppel timing to attach at filing or institution. The PREVAIL Act would change the timing of when PTAB estoppel provisions are effective, moving up the estoppel to attach as soon as a petition is instituted (as to District Court and the ITC) or filed (as to other Office proceedings) rather than at the final written decision. As a corollary, early settlement of an IPR prior to a final written decision would no longer impact estoppel.
• Expand estoppel to ITC proceedings and tighten affirmative defense estoppel. Under current rules, neither a defendant’s affirmative defense in District Court nor the ITC starts the one-year time bar in which a defendant may seek IPR. Similarly, being named as a respondent at the ITC without being named in District Court does not start the one-year clock. The PREVAIL Act would effectively impose a time bar in both scenarios as a rule that once a District Court or the ITC reaches a final judgment as to the validity of a patent claim on grounds that could have been considered in IPR, a would-be petitioner cannot bring or maintain an IPR proceeding on that same patent claim.
• Limit challenges against the same patent. The PREVAIL Act would require the USPTO to "reject any petition that presents prior art or an argument that is the same or substantially the same as prior art or an argument that previously was presented to the Office" absent exceptional circumstances. As to a repeat petitioner, the PREVAIL Act would prescribe that a petitioner can file only a single petition against a patent absent special circumstances.
• Create a rebuttable presumption against joinder if joinder would violate the one-year filing bar. Under current law, a person who is barred from bringing an IPR petition because of a time bar — e.g., because they were sued more than a year prior to bringing a petition — may nonetheless join a third party's petition without being restricted by the time bar under 35 U.S.C. § 315(c). The PREVAIL Act would create a rebuttable presumption against such joinder. Moreover, such a person who is otherwise time-barred would not be able to continue the PTAB trial if the lead petitioner settles out of their portion of the case.
• Change presumption of validity and standard of review. The PREVAIL Act would impose the presumption of validity applicable in District Court to the PTAB and raise the bar to require a showing of invalidity by “clear and convincing” evidence, matching District Courts. This revised standard does not apply to proposed substitute claims that a petitioner proposes as part of a motion to amend.
• Require reassignment of the judicial panel between institution and final written decision. Under the PREVAIL Act, a PTAB administrative patent judge “who participates in the decision to institute an inter partes review or a post-grant review of a patent shall be ineligible to hear the review.”
• Add additional time/challenges after institution. The PREVAIL Act would amend 35 U.S.C. § 314 to potentially lengthen the time between institution and final written decision by adding a new subsection (e) setting forth a 45-day rehearing period for institution decisions that can be extended for good cause not more than an additional 30 days. The Act would also add a 90-day period for Director Review of a final written decision that can be extended for good cause not more than an additional 60 days.
• Potentially expand discovery as to real parties in interest. The PREVAIL Act would explicitly modify 35 U.S.C. § 316(a)(5) to add a category of named discovery: The Director must promulgate regulations to address discovery practice relating to “evidence identifying the real parties in interest of the petitioner.”
• End diversion of certain user fees collected for use by unrelated federal agencies. The PREVAIL Act would stop the practice of diverting fees collected by the USPTO for use by unrelated federal agencies.
• Establish a code of conduct for members of the PTAB. The PREVAIL Act would mandate the Director to establish a code of conduct and consider in its creation the Code of Conduct for United States Judges “and how the provisions of that [judicial] Code of Conduct may apply.”
• Make three big changes to ex parte reexamination (EPRx) practice, Including: (1) eliminate anonymous filings, (2) place restrictions on use of art considered in prosecution, and (3) remove reexamination as a “backup” to a failed IPR/PGR.

First, the PREVAIL Act would do away with anonymous EPRx requests. PREVAIL § 6(a) would eliminate anonymous filings by inserting the words into 35 U.S.C. § 302 “The request must identify all real parties in interest and certify that reexamination is not barred under section 303(d).”

Second, the Act would eliminate the third sentence of 35 U.S.C. § 303(a), which currently reads: “The existence of a substantial new question of patentability is not precluded by the fact that a patent or printed publication was previously cited by or to the Office or considered by the Office.” Congress added this sentence in 2002 to overrule In re Portola Packaging Inc., 110 F.3d 786 (Fed. Cir. 1997). The effect of striking this sentence presumably would reinstate the Portola Packaging decision, in which “old art” was precluded from being applied as the sole basis for providing a substantial new question of patentability if the old art was (1) relied upon to reject any claim in an earlier examination of the patent or (2) cited in an earlier examination and its relevance to the patentability of any claim was discussed in that examination.

Third, the PREVAIL Act attempts to close the door on a strategy of using a subsequent reexamination request after a failed IPR, i.e., explicitly removing the ability to use a “prior Office decision as a guide to correct or bolster a previous deficient request” (e.g., to fix problems identified in a prior IPR institution decision or final written decision).

The PREVAIL Act’s impact on standing at the PTAB

The PREVAIL Act would change the rules to limit petitioners to entities that (1) have been sued or threatened with a patent infringement suit or (2) real parties in interest of such entities. This generally matches the standing requirement needed to bring declaratory judgment actions in federal court. However, this represents a change to the existing practice before the PTAB, where parties can file IPRs even if no suit for patent infringement has been filed. In addition, while third party collective organizations can bring IPR challenges for the benefit of their members under current law, that would no longer be possible under the PREVAIL Act due to provisions that block repeat or proxy challenges.

To account for industries that rely on preemptive patent challenges, the PREVAIL Act provides a carve-out for generic drug makers and biosimilars. It allows companies to file a petition if they have specific plans to launch a competing product that could be subject to an infringement lawsuit. The rationale behind that provision is that pharmaceutical companies seeking to bring lower-cost generic alternatives to market should be able to challenge weak drug patents before launching their products. In the same vein, the Act also includes limited exceptions for nonprofit organizations that challenge patents in the public interest, such as those related to healthcare or essential technology.

The PREVAIL Act’s impact on appeals of PTAB decisions

The PREVAIL Act contains little language that relates directly to appeals. It does not, for example, modify any of the language of Title 35 of the U.S. Code that governs the right to appeal or procedures for appeal of a PTAB decision. The Act’s provision making the result of Director Review of a final written decision appealable to the Federal Circuit does not change the status quo, as such decisions are already appealable to the Federal Circuit under the same procedures for appealing other Board decisions in AIA proceedings. (Decisions on institution are not appealable.) When an appealed IPR or PGR decision is remanded to the PTAB, the PREVAIL Act does modify Sections 319 and 329 of Title 35 to require that the PTAB shall decide any remanded issue within 120 days, extendable by up to 60 days by the Director. This change to post-appeal procedure, however, is unlikely to affect any aspect of the appeal itself. Thus, any impact of the PREVAIL Act on appeals from PTAB decisions is likely to be less direct.

For example, the PREVAIL Act’s changes to standing requirements and estoppel rules might shift the relative volume of PTAB appeals before the Federal Circuit compared to appeals from other tribunals or courts. Although, as amended, the PREVAIL Act raises the requirements for a petitioner to have standing to participate in an IPR proceeding, those requirements are not the same for a petitioner to have standing to appeal an adverse final written decision. Therefore, there will still be petitioners who may challenge claims before the PTAB but may not take the matter further if the PTAB rules in the patent owner’s favor. The codification of Director Review might change the rate at which PTAB decisions are appealed to the Federal Circuit if parties increasingly (or decreasingly) seek Director Review. Overall, the PREVAIL Act’s changes to PTAB practice may change the number and kinds of appeals from the PTAB even though the Act generally does not address PTAB appeals directly.

USPTO Leadership in Transition

Leadership at the USPTO is in transition as of this writing. Kathi Vidal, who served as Director from 2022 to 2024, announced her resignation in November 2024 and stepped down the following month. Vidal focused her tenure on implementing a framework for Director Review consistent with the Supreme Court’s 2021 decision in U.S. v. Arthrex, as well as providing increased clarity surrounding discretionary denials. On January 20, 2025, just moments after President Trump took the oath of office, Coke Morgan Stewart was sworn in as Deputy Under Secretary of Commerce for Intellectual Property and Deputy Director of the USPTO, a position from which she also serves as Acting Director of the USPTO by statute. Stewart brings extensive IP experience to the role, including former service at the USPTO in several capacities over a 10-year period and a prolific career as a patent litigator. Rumors abound as to who President Trump might nominate as his permanent Director; while we will refrain from adding our voices to the cacophony, we will provide an update in due course.

Fee Changes at the USPTO

On November 20, 2024, the USPTO published a final rule regarding fee changes that took effect January 19, 2025. According to the Office, the new fee schedule will increase fee collections by approximately $440 million annually, which is necessary to grow its patent operating reserve to an optimal level (three months of operating expenses). The new fee schedule encompasses “targeted” fee adjustments for particular types of filings, but there is also an “across-the-board” fee increase of 7.5% for all other filings not addressed in the “targeted” fee increases.

While the USPTO will be instituting fee increases for various types of fees paid during patent prosecution, the fee increases for AIA trials are startling to some practitioners. Unlike the moderate fee increases related to patent prosecution (e.g., the fees related to filing, search, and examination fees for a new patent application increase a total of 10%), all fees associated with filing and initiating an AIA trial are increasing by 25%. See Final Rule, Section V.C.13. Notably, this includes both the “request” fee (pre-institution) and the “post-institution” fee that must be paid by a patent challenger at the time of filing an IPR or PGR petition:

See Final Rule, Section V.C.13 (Table 15). According to the final rule, these significant increases are necessary to “better align the fee rates charged to petitioners with the actual costs borne by the USPTO in providing these proceedings.”

But not everyone agrees. Indeed, some contend that the flat increase of 25% for all parts (pre-institution and post-institution) of a PTAB trial is a rather blunt approach that fails to account for important details, such as whether the PTAB resources devoted to pre-institution tasks have increased at a different pace over the past few years compared to the PTAB resources devoted to post-institution tasks. One commenter specifically questioned whether the 25% increase in fees for AIA trials “runs counter to congressional intent to make them cost-efficient.” See Final Rule, Section VI (comment 68). In theory, the fee schedule for AIA trials was reset roughly four years after significant work from those inside the USPTO. See Summary of FY 2020 Final Patent Fee Rule. Now, only a few years later, this 25% increase beyond the previously studied-and-approved fees has led some commenters to question where the earlier commission (resetting the fee schedules for AIA trials in 2020) went wrong. Alternatively, if there were no errors back in 2020, skeptics ask a different question: Why is there now an unusual divergence (by a margin of 25%) in the labor/costs required within the USPTO to complete AIA trials?

Here, the USPTO’s Final Rule attempted to shed light on this issue by providing “three years of historical cost data” for AIA trial proceedings. See Final Rule, Section VI (comment 65). At a minimum, this transparency offers an explanation for why the current costs borne by the USPTO in providing AIA trial proceedings are higher than the fees established in 2020. In other words, there is justification for some fee increase, lest the costs borne by the USPTO for AIA trials would need to be subsidized from elsewhere. This concern was reflected, for example, in one comment that suggested “the administrative costs of the USPTO for these services [AIA trials] should not be subsidized by all patent applicants.”  See Final Rule, Section VI (comment 69).

The Year in Biopharma at the PTAB

In calendar year 2024, there were a total of 82 post-grant petitions filed involving biopharma patents, which we define as those having issued in USPTO Technology Center 1600. Post-grant filings in the biopharma space were down 8%, a slight drop in filings from 2023 and 2022. The majority of petitions filed in 2024 were IPR petitions, at 71, compared to only 11 PGR petitions. Interestingly, while biopharma IPR petitions accounted for only ~5% of all IPR petitions filed in 2024, biopharma PGR petitions accounted for over a quarter of all 2024 PGR petitions. Of the biopharma cases that reached an institution decision in 2024, ~83% were instituted — an increase of about 20% compared to 2023 (62%), and surpassing the institution rate in 2022 (75%).

The most active biopharma petitioner in 2024 was Merck Sharp & Dohme, LLC, which filed 12 IPR petitions in total. The PTAB instituted Merck’s eight IPRs challenging patents related to methods of treatment with pembrolizumab (Keytruda®) held by The Johns Hopkins University, and final written decisions are expected in Q3 2025. Merck’s other four PGRs remain pending (with institution decisions expected in July 2025) and challenge patents held by Halozyme, Inc., relating to peptides with hyaluronidase activity that can be co-formulated for the injection of biologics.

The next four most active petitioners, each with five petitions each, are Curio Bioscience; Danahar Corp. and Integrated DNA Technologies, Inc.; Dr. Falk Pharma GmbH; and Dr. Squatch, LLC. Curio Bioscience has challenged Prognosys Biosciences’ patents (exclusively licensed to 10X Genomics, Inc.) relating to assays for analyzing spatial locations of biological molecules in tissue samples. Danahar and Integrated DNA Techs. have challenged Tecan Genomics’ patents relating to genetic sequencing kits and personalized diagnostic tests. Dr. Falk has challenged Ellodi Pharmaceuticals’ patents relating to orally disintegrating solid pharmaceutical compositions that deliver a topically administered corticosteroid These 18 challenges remain pending institution decisions. Additionally, the PTAB recently instituted two IPR challenges brought in 2024 by Dr. Squatch against two of Procter & Gamble’s patents relating to aluminum-free deodorant sticks. A final written decision is expected by January 27, 2026.

Activity in the biologics and biosimilars space (a subset of USPTO Technology Center 1600 identified by claims relating to “biological products” under 42 U.S.C. § 262(i)) at the PTAB in 2024 was down notably from 2023, with only 11 IPR petitions filed, roughly half the number filed in 2023 (23 petitions). These IPR petitions largely consist of Merck’s challenges related to the pembrolizumab method of treatment patents owned by Johns Hopkins noted above.

The most notable resolutions in the biologics space in 2024 were achieved with Regeneron’s patents related to aflibercept, marketed under the trade names Eylea® and Zaltrap®. Nine of Regeneron’s aflibercept patents were challenged by seven different petitioners over a three-year period, including Celltrion, Mylan, Samsung Bioepis, Apotex, Chengdu Kanghong Biotechnology, Biocon Biologics, and Formycon. Over this period, eight of the nine patents were either held unpatentable by the PTAB (appeals voluntarily dismissed) or statutorily disclaimed by Regeneron. The ninth patent challenge remains pending institution.

For more information about post-grant developments in biologics and biosimilars, see “Biologics and Biosimilars Landscape 2024: IP, Policy, and Market Developments.”

When it comes to post-grant practice, Fish’s history and presence are unmatched: We have handled more cases at the PTAB than any other firm, our attorneys routinely craft new law at the Federal Circuit, and we host the most innovative educational programs. For more information, please contact Practice Group Leader Karl Renner.