By Kevin E. Noonan –

It is fair to say (no matter what else can be said) that the current administration is outcome- rather than process-driven. This general inclination is true of the Department of Health and Human Services and the agencies contained thereinunder, and the Food and Drug Administration exhibited this tendency in a recent Draft Guidance regarding the requirements for a biosimilar-producing applicant to obtain approval for an abbreviated Biologic License Application (aBLA).

Here the outcome is lower drug prices, as expressly stated by Secretary Kennedy in a press release. Characterizing the change as an illustration of “bold action,” the press release attributes the lower number of approved biosimilar drugs (76) compared to conventional small molecule generic drugs (over 30,000) as the result of “a burdensome approval process” (ignoring the difference between the over forty years that have elapsed since passage of the Hatch-Waxman Act and fifteen years since the BPCIA was passed as part of the Affordable Care Act, as well as the recognized differences in technology and costs/efforts for bringing a biosimilar drug to market (see “No One Seems Happy with Follow-on Biologics According to the FTC” and “Emerging Health Care Issues: Follow-on Biologic Drug Competition“). FDA Commissioner Marty Makary M.D., M.P.H. echoes his boss’s theme, stating that “[b]y streamlining the biosimilar development process and helping advance interchangeability, we can achieve massive cost reductions for advanced treatments for cancer, autoimmune diseases, and rare disorders affecting millions of Americans” (Dr. Makary’s philosophy can be found in his book, Blind Spots: When Medicine Gets It Wrong, and What It Means for Our Health). Now-former Director, FDA Center for Drug Evaluation and Research, George Tidmarsh, M.D., Ph.D. in more measured tones characterized the changes as being due to the FDA’s commitment “to advancing common-sense policies that further promote efficient and effective biosimilar and interchangeable biosimilar development, without compromising safety and effectiveness,” a worthy aspiration but perhaps being less than expected or hoped-for. The economic and political impetus is also set forth in the press release, which notes that “[e]xpensive biologic medications make up only 5% of prescriptions in the U.S. but account for 51% of total drug spending as of 2024. FDA-approved biosimilars are as safe and effective as the branded drugs, yet their market share remains below 20%.” There is little to no recognition that perhaps the reason approved biosimilar drugs are “as safe and effective as the branded drugs” is because of the “burdensome approval process” (a blind spot shared by many; see “Interchangeable Biosimilars: In a Battle of Safety vs. Cost, Where Does Sen. Lee Stand?“).

The press release states simply the point of the new Guidance: based on “the agency’s accrued data and experience since the first biosimilar was approved in 2015” (the same evidence excoriated as being “unduly burdensome” earlier in the press release), “comparative efficacy studies generally have low sensitivity compared to many other analytical assessments,” and touts that the new Guidance “reduces this unnecessary resource-intensive requirement for developers to conduct comparative human clinical studies” in favor of such analytical studies. Also denigrated are testing requirements for interchangeability, which has been the subject of earlier Guidance changes.

The Guidance is remarkably brief in view of the purported sea change it is promised to produce in biosimilar approval requirements. The Guidance itself reiterates some of these policy-based (as opposed to science-based) rationales for the changes set forth therein. The Introduction section of the Guidance sets forth an earlier Guidance (Scientific Considerations in 37 Demonstrating Biosimilarity to a Reference Product) from 2015 providing information related to satisfaction of the statutory requirements under Section 351 of the PHS Act for biosimilarity and FDA’s interpretation thereof (including “comparative analytical studies, an assessment of toxicity, comparative human PK and PD studies (if there is a relevant PD measure(s)), and a clinical immunogenicity assessment.” The devil being in the details, the Guidance announces that the substantive changes are a consequence of the “significant experience in evaluating analytical differences between proposed biosimilar products and their reference products and understanding the impact of those analytical differences on clinical performance.” According to the Guidance, “currently available analytical technologies can structurally characterize highly purified therapeutic proteins and model in vivo functional effects with a high degree of specificity and sensitivity using in vitro biological and biochemical assays” and “comparative analytical assessment (CAA) is generally more sensitive than a [comparative efficacy study,] CES to detect differences between two products” relevant to biosimilarity.  Under circumstances where a CAA indicates biosimilarity as defined in the statute, “FDA recommends that sponsors consider a streamlined approach where a CES may not be necessary to support a demonstration of biosimilarity,” which may include “an appropriately designed human pharmacokinetic similarity study and an assessment of immunogenicity.” In a specific recommendation the Guidance provides that:

A streamlined approach should be considered when:

• The reference product and proposed biosimilar product are manufactured from clonal cell lines, are highly purified, and can be well-characterized analytically;

• The relationship between quality attributes and clinical efficacy is generally understood for the reference product, and these attributes can be evaluated by assays included in the CAA; and

• A human pharmacokinetic similarity study is feasible and clinically relevant.

The Guidance also recognizes “there may remain” instances and circumstances where a CES may be appropriate, and sponsors are “encouraged” to discuss such instances and circumstances with the Agency.

As with all draft Guidances, this one sets forth immediately before the Introduction the caveat that:

Whether the requirements in this Guidance improvidently expose the public to inadequately tested/screened/examined biosimilar drugs will depend on how the Guidance is implemented and (with even more uncertainly) the particular biologic drug for which the biosimilar is approved. And it remains questionable whether any such changes will significantly impact the number, time to market, or cost savings of new biosimilar drugs.

By Joshua R. Rich –

Usually, when an issue is actually considered and resolved after a full and fair opportunity to litigate, the doctrine of issue preclusion can bar the losing party from relitigating the issue in another case.  That is, judicial economy is best served by not allowing a losing party a second bite at the apple on questions it had every reason to fight over, but failed.  But as Inland Diamond Products shows, there can be an exception:  in certain circumstances when the earlier decision was made based on a lower standard of proof, courts will not honor that earlier decision by applying issue preclusion and will make later parties prove their case from whole cloth.

The Inland Diamond Products case was the second round of fighting over the two patents-in-suit (U.S. Patent Nos. 8,636,360 and 9,405,130).  In 2017, Inland brought a patent infringement lawsuit against Hoya Optical Labs of America in the U.S. District Court for the Eastern District of Texas alleging infringement of claims of the two patents.  Hoya responded by filing petitions for inter partes review against the two patents in late 2017 and early 2018.  The district court litigation and IPRs continued in parallel until August 2018, when the parties settled the litigation.  Importantly, however, the settlement expressly did not moot the IPRs.  Instead, they carried forward to resolution, with some of the claims (including the independent claims) being found invalid for obviousness in mid-2019.  But some of the claims survived.

With those surviving claims in hand, Inland sued Cherry Optical for patent infringement in the U.S. District Court for the Eastern District of Wisconsin.  After almost three years of hard-fought litigation, Cherry Optical moved for summary judgment of invalidity due to obviousness.  It based its motion in part on the earlier IPR decisions, reasoning that Inland should be bound to the earlier finding that the independent claims of the asserted patents were obvious and Inland should only be permitted to argue that the additional elements of the dependent claims rendered them nonobvious.  The District Court agreed, applying issue preclusion to narrow Inland’s possible arguments to only those additional elements.  But those differences were not enough to overcome the prior art references and arguments that Cherry Optical asserted and the District Court granted summary judgment of invalidity.

While the appeal from the District Court’s decision in the Inland Diamond Products case was pending, the Federal Circuit decided two cases that dictated its decision here.  In ParkerVision, Inc. v. Qualcomm Inc., 116 F.4th 1345 (Fed. Cir. 2024), the PTAB found apparatus claims invalid in an IPR; the patentee then asserted the method claims of the same patent in district court litigation.  The accused infringer cited the same invalidating art in the litigation and the District Court barred the patentee from providing expert witness testimony on the same factual issues that were resolved in the IPR.  Because the PTAB’s decision was made under the preponderance of the evidence standard, not clear and convincing evidence (the standard for invalidation in litigation), the Federal Circuit ruled that estoppel could not apply.  Similarly, in Kray IP Holdings, LLC v. Groupon, Inc., 127 F.4th 1376 (Fed. Cir. 2025), the Board held claims of the relevant patent invalid in an IPR.  When Kray sought to assert immaterially different claims in litigation, the District Court dismissed its complaint due to issue preclusion.  Again, the Federal Circuit refused to apply issue preclusion and reversed the dismissal based on the different burdens of proof on invalidity in the Patent Office and district court.

Given the precedent of the ParkerVision and Kray decisions, the Federal Circuit’s reversal of summary judgment in the Inland Diamond Products case was preordained.  But as the court noted, the earlier cases had to distinguish the decision in XY, LLC v. Trans Ova Genetics, L.C., 890 F.3d 1282 (Fed. Cir. 2018).  In that case, the Federal Circuit applied issue preclusion to bar relitigation of the validity of a claim that had been invalidated in an IPR when the appellate court concurrently decided the two appeals.  It held the appellate decision means “the claim no longer exists and cannot be asserted as a basis for infringement.”  But given the later precedent of ParkerVision and Kray, it seems to be a thin reed to distinguish between the two situations:  only if the Federal Circuit decides the two appeals on the same day (or invalidates the patent claims earlier) does the reasoning even apply?[1]

The Federal Circuit did provide some guidance for the District Court – and future litigants – after reaching its conclusion.  First, in a footnote, it indicated that there would be another reason to ignore issue preclusion in early IPRs.  Specifically, it said claim constructions rendered based on the “broadest reasonable interpretation” cannot preclude relitigation because the claim construction standards are different.  In this case, that would be another reason that applying issue preclusion was erroneous, beyond the distinction in standard of proof of invalidity and the asserted claims themselves not having been invalidated.  Furthermore, even if the same prior art was asserted as invalidating closely related claims, the District Court could not rely on the PTAB’s decision to shorten its analysis; the patent challenger would carry the burden of proof and the patentee must be allowed to mount a full challenge to the invalidity arguments.

The Inland Diamond Products case limits the value of a successful IPR.  Coming at almost exactly the same time as proposed rules that limit the availability of IPRs[2] and the Director’s decision to resolve all institution issues himself,[3] it is another blow to IPRs as an option for resolving validity issues.  The intent in creating IPRs was to avoid the need for fulsome litigation of validity issues if the Patent Office could resolve them more quickly and inexpensively.  The Inland Diamond Products case eliminates all of those efficiencies.

Inland Diamond Products v. Cherry Optical (Fed. Cir. 2025)
Panel: Circuit Judges Prost, Reyna, and Chen
Opinion by Circuit Judge Prost

[1] Given the reasoning of these cases, it isn’t clear if the Federal Circuit would apply issue preclusion to allow a PTAB finding of invalidity to prevent assertion of infringement of the same claim in a district court or if the IPR appeal were still pending when an infringement appeal were decided.

[2] https://patentdocs.org/2025/10/19/uspto-proposed-new-rules-limiting-the-availability-of-inter-partes-review-but-are-they-legal/

[3] https://patentdocs.org/2025/10/19/new-director-overturns-ptab-procedural-precedents-part-i/

By Michael S. Borella –

The U.S. Patent and Trademark Office (USPTO) is trapped in a perpetual battle on two fronts.  First, there is their application backlog, which can extend patent pendency by months or years.  Second is the systemic challenge of patent quality.  These two problems are not independent of one another. Low-quality examination is characterized by incomplete searches and rushed analysis, which can lead to rounds of Requests for Continued Examination (RCEs), appeals, and even costly post-grant litigation.  Conversely, under pressure to reduce pendency, examiners may conduct less-thorough examinations, thereby harming quality.

For decades, the solutions have been incremental, bureaucratic, or both.  Examiner interviews, accelerated examination programs, and various pilot programs have nibbled at the edges of the problem.  The most recent, the “Streamlined Claim Set Pilot Program,” continues this tradition by offering a simple, but flawed bargain: trade your claims for a spot at the front of the examination queue.

These solutions misdiagnose the illness.  The problem is not the number of claims; instead, it is the profound inefficiency of the first substantive interaction between the applicant and the examiner.  A first non-final office action is often the output of many examiner hours being spent on cold-start prior art searches. In many cases, this office action contains prior art rejections that could have been avoided.  If the applicant had known of the closest prior art, they likely would have narrowed their claims to focus examination on more protectable aspects of the invention.

With the rise of generative artificial intelligence (AI), there are new options on the table.  One that we’d like to propose for discussion is what we call AI-First Triage (AIFT).  This change would fundamentally restructure the examination front-end to accelerate prosecution, improve patent quality, and create a more collaborative, efficient process for applicants and examiners alike.  Particularly, AIFT is designed to front-load information sharing between the USPTO and the applicant and incentivize early, substantive amendments where appropriate.  The process would be simple, universal, and mandatory, updating the current examination procedure.  Further, it would be provided at no charge for all new applications.

The main principles of AIFT would be as follows.

• AI Search (The “Zeroeth” Office Action): Upon filing and completion of formalities, every new patent application would be processed by an in-house, private generative AI search engine. This tool would analyze the specification, drawings, and, most critically, the as-filed claims.
• The AI Advisory Action: Within a few weeks of filing, the applicant would receive an initial AI advisory action.  This office action would not contain statutory rejections.  Instead, it would be an AI-generated search report.  The report would contain the results of the AI search, mapping the most relevant prior art references found by the AI search to specific claim elements.  For example, the report might include a claim chart mapping each claim element to a specific location in a prior art document where the AI search engine contends that it found disclosure of the element.  Notably, the AI search would only identify prior art and would not provide any legal reasoning.  In other words, the AI search would not provide a § 101 or § 112 analysis, nor would it provide a motivation to combine should it use multiple references against a claim.
• The Applicant’s Choice: The applicant would then have a two-month, non-extendable window to respond to this AI advisory action.  There would be two simple options.  The first would be to file a preliminary amendment that makes a substantive narrowing amendment to at least one independent claim in view of the AI search.  The applicant would have the option of including remarks explaining why the narrowing amendment results in claims that the cited art does on read on.  The second would be to take no action and not file a response. In the latter case, the applicant can still file a preliminary amendment at any time before the first action on the merits.
• The Examination Queue: If the applicant chooses the first option, the application is placed into a prioritized queue for examination by a human patent examiner.  If the applicant chooses the second option, the application is placed in the standard (slower) examination queue.
• The Non-Final Action: Regardless of which option the applicant chooses, the next office action is issued by a human examiner and is a non-final office action.  The examiner is free to use or discard the AI search results, conduct their own search, and formulate their own rejections.  This preserves the applicant’s established right to respond to a complete, human-led examination on the merits.

AIFT addresses a bottleneck in the examination process by speeding up the prior art search.  This creates a virtuous incentive for applicants to engage with prior art and improve patent quality from the start.  This up-front sharing of information and incentive for early amendment is likely to more quickly to disposal of an application (i.e., allowance or abandonment) by identifying prior art before the examiner lifts a finger.  Additionally, we expect that such a procedure would reduce the rate of RCEs, which are one of the greatest contributors to pendency, making the entire examination process more efficient.

AIFT can also improve patent quality.  First, it would augment examiners by providing an AI search across extensive databases.  Examiners could then spend less time looking for needles in haystacks and more time conducting an analysis of the prior art.  Second, by presenting applicants with relevant prior art early, applicants are encouraged to amend broad or vague claims early in the process.  Third, the initial AI advisory action could act as a filter, prompting applicants to abandon clearly anticipated or clearly obvious inventions early, freeing up examiner resources for other applications.

Despite AIFT having advantages, there are several concerns that may hinder its deployment.  Applicants would face a significant dilemma if presented with low-quality or irrelevant AI-cited prior art, forcing them to either make an unnecessary amendment to gain docket priority or be penalized with a longer wait time for challenging the AI’s findings.  Thus, the quality of the AI search would be key and some degree of human oversight may be needed.  Further, filing a preliminary amendment in response to an AI advisory action would create prosecution history estoppel before the applicant ever interacts with a human examiner.  This may incentivize some applicants to ignore the AI search results.  Moreover, some applicants might strategically file overly broad initial claims specifically so they can concede a narrowing amendment in response to the AI search.  This gaming of the system would result in a faster examination without having to file a focused claim set up front, effectively turning the collaborative step into a mere procedural hurdle to be cleared for a docketing advantage.

While potentially problematic, each of these issues could be mitigated.  AI is a learning technology and the USPTO’s AI search model could be updated with examples of when a human examiner successfully used the AI-cited prior art to motivate an applicant to amend their claims, as well as when the human examiner overrode the AI-cited prior art and used different art to reject the claims.  Applicants could mitigate the estopped issue by filing a response with minimal or no substantive remarks, relying on the claim amendments to speak for themselves.  Also, Applicants could make it clear on the record that the amendments were made without prejudice and merely to expedite prosecution.  Finally, if necessary, applicants can be disincentivized from gaming the system by modifying the procedure as follows.  The first human-produced office action can be final when the applicant does not amend the claims in response to the AI advisory action and the human examiner’s prior art rejections are based entirely and solely on the prior art references that were previously cited in the AI advisory action (if the human examiner adds any new prior art to the rejections, their action must be non-final).  It is recommended that the human examiner would need the head of their technical center to approve such a first-action final.

The USPTO cannot solve its dual pendency and quality crisis by merely repackaging old ideas or coming up with another pay-to-play docket manipulation approach that fails to improve search quality, claim clarity, or examiner decision making.  The proposed AIFT, in contrast, is a re-imagining of the examination process that places a powerful information technology tool at the very beginning, creating a collaborative triage step to help applicants produce better claims for human examination, and to help examiners conduct better searches. USPTO should stop tinkering with the queue and instead innovate at the core of the examination process itself.

The Biotechnology Innovation Organization (BIO) will be holding its 2025 IP Conference on November 17-19, 2025 in Palm Springs, CA.

The conference will offer presentations on the following topics:

• Navigating the Road of Joint Inventorship
• Public Disclosures and Patent Risks: US vs EP Perspectives
• Antibody Inventions: The Life and Times of the Genus Claim
• BPCIA Litigation Update: Key Cases, Trends, and Takeaways from 2024–2025
• Using AI In Patent Practice: Practical and Ethical Issues
• How to Talk to Policymakers about Biopharma Patent Portfolios: A Conversation Under Chatham House Rules

Patent Docs author Dr. Donald Zuhn of McDonnell Boehnen Hulbert & Berghoff LLP and Patent Docs contributor Joshua Rich of Lippes Mathias LLP will be participating as panelists on the session on “Using AI In Patent Practice: Practical and Ethical Issues”.  If you are a patent practitioner who uses AI tools in your practice and would be interested in attending the BIO IP Conference and participating on the above panel, please contact Dr. Zuhn at zuhn@mbhb.com.

In addition to the above sessions, there will be a welcome reception from 5:30 pm to 7:30 pm on November 17, and a dinner reception from 5:30 pm to 8:30 pm on November 18.  A program agenda for this conference can be found here.

Registration information can be found here.

The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled “Patent & Technology Law Developments: Personal Jurisdiction, Estoppel & Everything in Between” on October 30, 2025 from 2:00 pm to 3:00 pm (ET).  Aaron Chatterjee of Microsoft Corporation, Renée Fuller of Bristol Myers Squibb Company, and Paul McAndrews of McAndrews, Held & Malloy, Ltd. will explore recent intellectual property cases and examine their practical impact in light of key court decisions and proposed legislation.  Topics to be covered will include a discussion of recent prosecution laches decisions, the Federal Circuit’s resolution of a district court split on the scope of IPR estoppel, personal jurisdiction in certain patent cases, various aspects of patent invalidity, and the domestic industry requirement in ITC proceedings.  Panelists will also discuss the Patent Eligibility Restoration Act of 2025 and the RESTORE Patent Rights Act of 2025, outlining what these developments could mean for practitioners.

The webinar is free for IPO members.  Those interested in attending the webinar should register here.

By Joshua R. Rich —

Under President Trump, the U.S. Patent and Trademark Office has sought to encourage the issuance of more patents and limit the ability to challenge them in post-grant proceedings; since John Squires was sworn in as Director, that process has accelerated tremendously. On October 16, 2025, the Office issued proposed rules limiting the circumstances under which inter partes review can be instituted and conditioning institution upon a waiver of any other prior art challenge. There is no doubt that the proposed rules would limit the frequency and availability of IPR to challenge the validity of patents. But there is a real question whether the proposed rules are legal.

Importantly, notice of proposed rulemaking was not identified as the beginning of notice-and-comment rulemaking (and all of the administrative requirements that such a process would entail). Rather, the notice indicates that “[t]he changes proposed by this rulemaking involve rules of agency practice and procedure, and/or interpretive rules, and do not require notice-and-comment rulemaking.” It is questionable whether that assertion is correct, as the proposed rules would have a significant impact on accused infringers’ (and other patent challengers’) substantive rights, but the USPTO is seeking to push the rules through quickly by allowing only thirty days for the submission of any comments. As a result, the rules may be in place sooner, but there is a very real threat that their enforcement will be blocked if the rulemaking process is challenged under the Administrative Procedure Act.

There are four basic proposed changes in the IPR rules:

• Unless every petitioner submits a stipulation to the USPTO and “any other tribunal where it is litigating or later litigates regarding the challenged patent” indicating that it (and any privy or real party in interest) will forego any anticipation or obviousness argument in any other proceeding, inter partes review cannot be instituted or maintained.

• Inter partes review cannot be instituted or maintained if a challenged claim or an independent claim from which the claim depends has been found not anticipated or obvious in a district court (either upon trial or by summary judgment), the U.S. International Trade Commission (in either an initial or final determination), the Board itself (in an inter partes review or post-grant review), in ex parte reexamination, or in the Federal Circuit, even in proceedings not involving the petitioner.

• Inter partes review cannot be instituted or maintained if there is a parallel proceeding in a district court, the ITC, or another Board proceeding where it is more likely than not that a decision will be reached before the final written decision in the inter partes review, even in proceedings not involving the petitioner.

• If the Board finds there are extraordinary circumstances that would justify an exception to the rules above, they can refer a petition to the Director to decide whether to institute. But extraordinary circumstances are limited: they include a bad faith action to prevent review or a substantial change in the statute or Supreme Court precedent that renders the prior challenge irrelevant, but do not include new prior art or argument, Federal Circuit precedent, or a prior challenger’s failure to appeal. And sanctions can be imposed if a petition claiming extraordinary circumstances is found to be frivolous or abusive.

The first of these provisions appears to be the most legally suspect. The America Invents Act that created inter partes review identified circumstances under which such an inter partes review could prevent anticipation or obviousness challenges in other proceedings. Under 35 U.S.C. § 315(e)(1):

The petitioner in an inter partes review of a claim in a patent under this chapter that results in a final written decision under section 318(a), or the real party in interest or privy of the petitioner, may not request or maintain a proceeding before the Office with respect to that claim on any ground that the petitioner raised or reasonably could have raised during that inter partes review.

That estoppel is narrower than the proposed rule in several ways. Most importantly, it limits estoppel to any ground that the petitioner raised or reasonably could have raised in the inter partes review, not all anticipation and obviousness arguments. But it also only takes effect if a final written decision results from a proceeding; the proposed stipulation is required for institution. So there is a gap between the two forms of estoppel for review that settles before a final written opinion.

Given the carefully crafted scope of statutory estoppel, an administrative stipulation provision that would have the effect of creating a broader estoppel is likely to be held to exceed the USPTO’s discretion in implementing the statute. Under the statutory construction maxim “expressio unius est exclusion alterius,” Congress’s decision to provided only limited estoppel suggests it did not intend to bar all anticipation and obviousness challenges (and not in all instituted reviews). Any regulations on the same topic – like the stipulation requirement – of different scope would therefore likely be unlawful for the agency to implement.

But the regulations that would bar inter partes review based on another party’s challenge are legally suspect as well. To be clear, these regulations would not prevent inter partes review of just the same arguments or art, or arguments by the same party. They would prevent any inter partes review if a prior challenger failed in its challenge as well, even if also based on unrelated art. Effectively, this would give some level of offensive res judicata effect to a patent owner’s win against a prior art challenge. That is not the law. To the contrary, res judicata in patent cases is not mutual: patent challengers are not barred by another challenger’s failure, but a single finding of invalidity prevents assertion of invalidated claims against another accused infringer. That question was squarely considered and determined by the Supreme Court in Blonder Tongue v. Univ. of Ill. Found., 402 U.S. 313 (1971). While the decision did not involve whether administrative proceedings could have different rules (especially administrative proceedings that did not exist until decades later), it is hard to believe that courts would view contrary regulations to be appropriate.

While there appear to be substantial potential problems with the proposed rules, they may serve several beneficial purposes nonetheless. First, just as the bipartisan Patent Eligibility Restoration Act introduced by Senators Tillis and Coons has, they can provide a framework for discussion of potential changes to the Patent Act.  Second, they reinforce the seriousness that the USPTO has shown in trying to strengthen patent eligibility. Further, they may discourage (or sensitize courts) to some of the abusive use of inter partes review. And there is always the possibility that courts will not invalidate the proposed rules, if adopted. But most likely, they are most useful as pushing Congress into action to restore patent protections that have been narrowed over the years.

By Kevin E. Noonan —

The advent of a new administration always carries with it changes in how the laws are executed and applied, and patent law is both no exception and tends (at least in recent years) to appear to be fraught with dramatic changes in emphasis (at least on certain aspects of the law). This can be appreciated by a consideration of Director Dudas and the (infamous) “claims and continuation” rules fracas in the mid-aughts; a return to the Office’s more convention role of modulating application of legal precedent under Director Kappos; the more stringent application of the Mayo/Alice principles to subject matter eligibility under Director Lee; changes in such applications under Director Iancu; and DEI efforts and cooperation with FDA over drug patents under Director Vidal.

Under the second Trump administration, the sea change in inter partes review (IPR) before the Patent Trial and Appeal Board (involving Director discretionary denials of such challenges) began this spring under Interim Director Stewart, and with confirmation of Director John Squires these changes have increased in significance and extent.

On Friday, October 17, the Office released a Memorandum to all PTAB judges and an Open Letter to “Colleagues, Inventors, and Americans” announcing that from October 20, the Director will determine whether to institute IPR proceedings  and post-grant review (PGR) proceedings under the statutory authority provide by 35 U.S.C. §§ 314 and 324, respectively.*  According to the Letter, Congress has vested the Director with sole statutory authority to render such decisions, despite provisions under 35 U.S.C. § 3(b)(3)(B) for the Director to be able to delegate such authority, which has been the practice since IPRs and PGRs were instituted under the Leahy-Smith America Invents Act in 2012.  Such delegation typically has been to three-judge panels of PTAB judges (although expanded panels, including the Director and other PTO officials have made such decisions from time to time, there having been 21 instances to date).

The Letter announces that “initial operational choices” had been the reason for delegation by earlier Directors, but that “experience has raised structural, perceptual, and procedural concerns inconsistent with the AIA’s design, clear language, and intent” and as a consequence the public’s “rightful expectation of impartiality” had been affected (negatively, presumably)(emphasis in Letter). These concerns included a seeming preference for IPRs over PGRs and a “very high” rate of invalidation. The Letter includes as additional concerns that there was a “perception of self-incentivization” (i.e., creating an appearance that institution decisions were made for the Board to “fill[] its own docket” (although the Letter is quick to emphasize that this perception “may be unfounded”). Further, so-called “bifurcated processes” (i.e., a preliminary review prior to Board referral), which the Letter asserts were both smart and necessary at the beginning of the AIA’s post-grant review regime were not intended to be permanent and “appears to have inadvertently produced extraordinarily high institution rates” (~95%). The Letter also makes the point that Congress had charged the Director to make institution determinations by statute and this mandate should not be easily circumvented.

The benefits of these changes enumerated in the Letter are said to include “eliminat[ing] the appearance of self-interest,” “remov[ing] perceived referral-signal bias,” “enhanc[ing] transparency and public trust,” and “re-align[ing] the duties and responsibilities of the Director as a “Presidentially appointed and Senate-confirmed officer.”

The Letter concludes with the following exhortation:

In closing, the mission of America’s Innovation Agency is to lead the world in intellectual property protection. We can do so and serve the public interest only by maintaining a patent system that is fair, predictable, and respected. Returning institution authority to the Director bolsters our mission because it restores the statutory framework mandated by Congress in the America Invents Act.

The contents, proposals, and changes in the other announcements will be the subject of following posts.

* 35 U.S.C. § 314 reads in pertinent part:

The Director may not authorize an inter partes review to be instituted unless the Director determines that the information presented in the petition . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.

35 U.S.C. § 324:

The Director may not authorize a post-grant review to be instituted unless the Director determines that the information presented in the petition . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.

To paraphrase Chicago Bulls legend, Michael Jordan, Patent Docs would like to announce that we are back! A few of our readers have noticed that it has been awhile since we last posted, and you may have noticed that there were a few “issues” with the way Patent Docs appeared on your browser earlier this month (see screenshot below) – as well as a few differences with the way the weblog currently appears on your browser.

These issues and differences are due to a change in the software that we use to maintain the weblog. Since Patent Docs began publishing on October 22, 2006 – and up until today – we had been using the TypePad blogging platform. Unfortunately, TypePad announced last month that it was shutting down, effective September 30, 2025, and that bloggers would have to export their content or permanently lose that content. We have therefore moved Patent Docs to the WordPress blogging platform, and note that it may take some time before we have adjusted the settings so the weblog looks somewhat like it looked on TypePad. So we ask that you please pardon our “dust” while we get used to the new digs.