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PTO Proposes New Guidelines for Director Review in Board Proceedings

The US Patent & Trademark Office (PTO) proposed new rules governing the process for Director review of Patent Trial & Appeal Board decisions in America Invents Act (AIA) proceedings. Rules Governing Director Review of Patent Trial and Appeal Board Decisions, 89 Fed. Reg. 26,807 (proposed Apr. 16, 2024) (to be codified at 37 C.F.R. pt. 42).

The Notice of Proposed Rulemaking (NPRM) proposes adding 37 C.F.R. § 42.75, which includes rules addressing the following issues:

Limited Availability of Director Review. The NPRM proposes that Director review in AIA proceedings would only be available to a party from institution decisions, final written decisions or panel decisions granting rehearing of a decision on institution or a final written decision. However, the Director would have authority to review any interlocutory decisions rendered in reaching such decisions. The NPRM also proposes that the Director may sua sponte review institution decisions, final written decisions or decisions granting rehearing.

Timing, Format and Content of Requests for Director Review. The NPRM proposes that requests for Director review would have to be sought within the time period set forth by 37 C.F.R. § 42.71(d), comply with the formatting and length requirements of 37 C.F.R. §§ 42.6(a) and 42.24(a)(1)(v), and would not be allowed to introduce new evidence. Any sua sponte Director review would have to be initiated within 21 days after the deadline to seek rehearing.

Effect of Director Review. The NPRM proposes that a decision on institution, a final written decision or a decision granting rehearing would become final agency action unless Director review was timely sought or timely initiated sua sponte or a request for Director review was denied.

Director Review Process. The NPRM proposes that Director review would not stay the underlying proceeding, but if the Director grants review, the review would conclude with the issuance of a decision or order that provides the reasons for the Director’s disposition of the case. A party would be permitted to appeal a Director review decision of either a final written decision or a decision granting rehearing of a final written decision (not institution decisions or decisions granting rehearing of institution decisions) to the Federal Circuit in accordance with the procedures set forth in 35 U.S.C. §§ 141(c) and 319. A request for Director review would be treated as a request for rehearing and would reset the time for appeal until Director review was resolved.

Delegation. The NPRM proposes that delegation of Director review would be permitted, subject to conditions set forth by the Director.

Communications With the PTO. The NPRM proposes that communications from a party concerning a specific Director review request or proceeding would have to copy counsel for all parties. Other than authorized amicus briefings, communications from third parties would not be allowed.

Comments are due by June 17, 2024, and can be submitted through the federal eRulemaking portal here.

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PTO Seeks Permanent Rules Regarding Motion to Amend Practice Before Board

On March 4, 2024, the US Patent & Trademark Office published a Notice of Proposed Rulemaking seeking to revise its Motion to Amend (MTA) pilot program practice in connection with certain America Invents Act (AIA) proceedings. 89 Fed. Reg. 15531 (Mar. 4, 2024). The PTO set a May 3, 2024, deadline for stakeholders to submit written comments in response to the proposed rules.

The MTA pilot program has evolved since its inception nearly five years ago and has been extended to September 16, 2024. The proposal seeks to make permanent certain provisions of the pilot program in response to the PTO’s May 2023 request for comments. The rules would apply to the existing consolidated set of rules relating to trial practice for inter partes review (IPR), post-grant review (PGR) and derivation proceedings in trial proceedings under the AIA.

Under the existing MTA pilot program, patent claims challenged during an AIA trial proceeding provide the patent owner with two options when proposing substitute claims in response to a petitioner’s opposition. The first option gives the patent owner the ability to file an MTA so that the Patent Trial & Appeal Board can issue preliminary non-binding guidance regarding the likelihood of an invalidation decision. The PTO proposes to revise its rules of practice to provide for the issuance of preliminary guidance in response to an MTA and to provide a patent owner with the option of filing one additional revised MTA.

The Board’s preliminary guidance typically would come in the form of a short paper issued after a petitioner files its opposition to the MTA and typically would provide the Board’s preliminary views on the MTA, specifically whether the MTA meets the statutory and regulatory requirements for an MTA, whether the parties have met their respective burdens of proof and whether the substitute claims are likely to be found unpatentable. However, the preliminary guidance would not be binding on the Board.

The proposed provisions would also provide the Board with greater authority to raise new grounds of unpatentability based on a preponderance of evidence standard. The new grounds of unpatentability could rely on the entirety of the record, including all prior art of record. The guidance would be accompanied by citations to the evidence in support of these new grounds. Further, where no opposition is filed or other circumstances constitute a lack of opposition, the prior art of record may further include references obtained from the PTO (i.e., examiners) in response to a request from the Board.

The proposed provisions would allow a patent owner to file a revised MTA after receiving a petitioner’s opposition to the original MTA or after receiving the Board’s preliminary guidance. Under the current pilot program, a revised MTA must be preauthorized for “good cause.” Under the revised provisions, the patent owner would be able to file a revised MTA without preauthorization. A revised MTA would replace the original MTA and must include new proposed substitute claims in place of the originally proposed claims. [...]

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Delay Is Okay: Final Written Decisions Can Be Issued After Statutory Deadline

In a matter of first impression, the US Court of Appeals for the Federal Circuit concluded that the Patent Trial & Appeal Board has the authority to issue a final written decision (FWD) in a post-grant review (PGR) proceeding after the statutory deadline has passed. Purdue Pharma L.P. v. Collegium Pharm., Inc., Case No. 22-1482 (Fed. Cir. Nov. 21, 2023) (Dyk, Hughes, Stoll, JJ.)

Purdue owns a patent directed to a pharmaceutical formulation meant to prevent or deter the abuse of opioid analgesics through the use of an aversive agent. On March 13, 2018, Collegium filed a PGR petition asserting that the patent claims were invalid. On September 24, 2019, Purdue filed a notice of bankruptcy and imposition of automatic stay, after which the Board stayed the PGR proceeding. The Board’s one-year deadline to issue an FWD under 35 U.S.C. § 326(a)(11) and 37 C.F.R. § 42.200(c) expired on October 4, 2019. After the bankruptcy court lifted the stay on the PGR proceeding on September 1, 2020, Purdue argued that the Board no longer had the authority to issue an FWD because the 18-month statutory deadline to do so had passed. The Board disagreed and issued an FWD finding the challenged claims unpatentable. Purdue appealed.

Purdue argued that the Board did not have authority to issue an FWD after the deadline established by 35 U.S.C. § 326(a)(11) and 37 C.F.R. § 42.200(c) had passed. Purdue advanced four arguments in favor of its proposed interpretation of § 326(a)(11):

  1. The use of “shall” and “requiring” deprives the Board of the authority to issue an FWD.
  2. The “negative words” of “not later than 1 year” and “by not more than 6 months” indicate a loss of authority.
  3. The statutory language in § 326(a)(11) requires PGR proceedings to be conducted “in accordance with” the Board’s jurisdictional grant in 35 U.S.C. § 6, and therefore the Board’s jurisdiction expires when the deadline in § 326(a)(11) expires.
  4. The exceptions in § 326(a)(11) for “good cause” and “joinder” demonstrate that those are the only limited instances where the Board may issue an FWD after the statutory deadline.

None of Purdue’s arguments persuaded the Federal Circuit. The Court reasoned that § 328(a) plainly requires the issuance of an FWD and that “[h]ad Congress meant to deprive the agency of power in § 326(a)(11), it knew how to do it” vis-à-vis the use of specific language, like the language it used in other sections of the America Invents Act (AIA), such as 35 U.S.C. § 315(b) and 35 U.S.C. § 321(c), both of which specifically deny agency power after a temporal deadline.

The Federal Circuit also considered the legislative history of § 316(a)(11), recognizing that Congress created PGR and inter partes review (IPR) proceedings when enacting the AIA to, among other things, replace the “lengthy and inefficient” reexamination proceeding. The Court reasoned that prohibiting an FWD after the statutory deadline would “force” parties to commence district court litigation—an act contrary to the purpose of the AIA, which [...]

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Distinguishing Drinkware—Provisional Priority Determined Differently in Pre- and Post-AIA Patents

In a precedential final written decision, the Patent Trial & Appeal Board concluded that a patent does not need to contain a claim supported by a provisional application’s disclosure to draw priority to that provisional for prior art purposes post America Invents Act (AIA). Penumbra, Inc. v. RapidPulse, Inc., IPR2021-01466, paper 34 (PTAB Mar. 10, 2023) (designated precedential Nov. 15, 2023) (Melvin, Cotta, Wisz, APJs).

Penumbra filed an inter partes review (IPR) petition targeting a patent directed to a “thrombectomy system,” which is a system for removing blood clots in the brain. Penumbra challenged the claims on four different grounds, and each included the Tiegen reference. Therefore, the petition would fail if the Tiegen reference was not prior art.

The challenged patent was filed on July 18, 2019, and drew priority to a provisional application filed on October 24, 2018. Tiegen drew priority to two provisional applications—one dated December 12, 2018, and another dated July 24, 2018. Whether Tiegen was prior art thus depended on whether the challenged patent could draw priority to its provisional application, and whether Tiegen could draw priority to its July 24, 2018, provisional. RapidPulse challenged Tiegen on both bases.

First, the Board assessed the proper priority date for the challenged patent. The Board explained that in order for the patent to draw priority to its provisional application, that provisional application had to provide written support for the challenged patent’s claims. Penumbra argued that the challenged patent’s provisional application did not have written support for the claimed “prevent[ing] forward flow.” RapidPulse responded, arguing that the disclosure of a “minimal amount of momentum from the fluid column” disclosed the claimed “preventing forward flow.” Forward flow generates momentum from the fluid column, so minimizing momentum required preventing fluid flow, according to RapidPulse. RapidPulse also pointed to embodiments that had substantially no forward flow from the distal end of the system.

Penumbra responded by explaining that the provisional application required forward flow in some embodiments, and nothing in the specification stated that the flow should be prevented. The Board agreed, explaining that the provisional application included embodiments with forward flow, and while the provisional recited some embodiments with small amounts of forward flow, the provisional did not indicate that the low forward flow was significant. The Board observed that “one cannot disclose a forest in the original application, and then later pick a tree out of the forest.”

Having determined that the priority date of the challenged patent was July 18, 2019, the Board turned to the priority date of Tiegen. The Board distinguished the present case over Dynamic Drinkware, a 2015 US Court of Appeals for the Federal Circuit case. Dynamic Drinkware states that for prior art purposes, a prior art patent can only draw priority to a provisional application if the prior art patent contains a claim supported by that provisional application. The Board explained that Dynamic Drinkware does not apply post-AIA. Instead, the Board found that, based on the language of AIA 35 [...]

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Status Quo Has Few Defenders at PREVAIL Act Senate Subcommittee Hearing

On November 8, 2023, the US Senate Judiciary Subcommittee on Intellectual Property heard testimony from four witnesses on the proposed Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. Although the PREVAIL Act includes several provisions regarding transparency and independence, its thrust is its dramatic alteration of Patent Trial & Appeal Board post-grant review (PGR) and inter partes review (IPR) proceedings, including their relationship to co-pending district court litigation, with the goal of incentivizing innovation by reducing costs and making such challenges less likely to be successful.

We previously reported on the provisions of the proposed PREVAIL Act when it was introduced. The biggest changes under consideration include the introduction of a standing requirement, a heightened burden of proof from preponderance-of-the-evidence to clear-and-convincing evidence, a stronger estoppel to thwart costly and unnecessary co-pending actions in court and at the Board, and the separation of the Board’s institution and decision-making functions.

Three witnesses spoke in favor of the PREVAIL Act before the subcommittee, emphasizing that the Board failed to live up to the purposes and intentions of the America Invents Act (AIA). These witnesses were Representative Lamar Smith, a co-sponsor of the AIA; Michelle Armond, co-founder of the law firm Armond Wilson LLP and a practitioner before the Board; and Joseph Kiani, founder of Masimo Industries.

Smith testified that Congress enacted the AIA because it recognized the potential for Board proceedings to be abused, and according to Smith, that is exactly what has happened. Each of the three witnesses testified that well-funded litigants have exploited Board procedures to overwhelm small businesses by forcing them into expensive duplicative proceedings in multiple forums. For example, Kiani posited that the Board posed an existential threat to startups, attributing findings of invalidity against his company’s patents to the AIA’s invalidation-friendly procedures.

Armond explained to the subcommittee how the PREVAIL Act would streamline Board proceedings and harmonize them with district court and International Trade Commission (ITC) litigation. According to Armond, in the wake of the AIA, both the Board and district courts have failed to offer uniform standards for deciding whether to stay a proceeding in their forum pending resolution of a parallel proceeding in the other. The PREVAIL Act would resolve this problem by requiring litigants to select only one forum in which they may raise their invalidity arguments. Armond argued that using the same clear-and-convincing-evidence standard in Board review proceedings and other litigation would harmonize the Board with district courts and the ITC by ensuring that different forums reach the same invalidity decision.

Joseph Matal, former US Patent & Trademark Office interim director and acting solicitor, and current principal of Clear IP, LLC, was the lone dissenting witness at the hearing. According to Matal, the PREVAIL Act’s proposal to require a clear-and-convincing-evidence standard in Board review proceedings is misguided because Board judges possess the requisite agency expertise to second-guess patent examination decisions. Additionally, Board judges often have more time to evaluate the patents and more information than the examiner. According to Matal, [...]

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Sins of the Fathers? Grandparent IPR Factors into Current Institution Decision

US Patent & Trademark Office (PTO) Director Kathi Vidal vacated and remanded a Patent Trial & Appeal Board decision denying institution of an inter partes review (IPR) because the Board improperly applied the precedential Advanced Bionics framework in rendering its decision. Keysight Tech., Inc. v. Centripetal Networks, Inc., IPR2022-01421 (PTAB Decision Review Aug. 24, 2023) (Vidal, Dir.)

Keysight Tech. petitioned for an IPR proceeding against a patent owned by Centripetal Networks, challenging the validity of all claims. After the Board denied institution, Director Vidal issued a sua sponte director review decision, vacating and remanding the Board’s decision.

The Centripetal patent is the great-grandchild of, and shares the same disclosure as, an earlier Centripetal patent that was subject to an IPR proceeding during the pendency of the presently challenged patent. The Final Written Decision (FWD) in the earlier IPR found all claims of the patent unpatentable. The patent owner included that FWD in an Information Disclosure Statement (IDS) submitted during the prosecution of the presently challenged patent, and the examiner initialed it as having been considered.

In its decision denying institution, the Board cited the guidance of Advanced Bionics, which articulates a framework that requires that the Board determine the following:

  • Whether the same or substantially the same prior art or arguments made in the petition were previously presented to the PTO during prosecution of the challenged patent
  • Whether the PTO erred in a manner material to the patentability of the challenged claims when it allowed the claims of the patent.

If both factors are met in the affirmative, the Board should not exercise its discretion to deny institution.

Here, the Board found that the first factor of the Advanced Bionics framework was met because the petitioner’s arguments in its petition were the same or substantially the same as those in the FWD in the IPR of the grandparent patent. However, the Board found that the second part of the framework was not satisfied and therefore denied institution.

Although Director Vidal agreed with the Board’s findings under the first factor, she vacated the Board’s findings pursuant to the second factor after determining that this factor was also met. Director Vidal found that the PTO erred in a manner material to the patentability of the challenged claims for the following reasons:

  • The challenged patent and the grandparent were directed to the same subject matter.
  • The prior art references submitted to the PTO during the prosecution of the challenged patent were the same as those asserted in earlier IPR and were considered by the examiner through the patent owner’s IDS.
  • In the grandparent IPR, the Board held all of the claims of the patent unpatentable due to these same prior art references.
  • The examiner’s statement of reasons for allowing the challenged patent was that the claims were directed to limitations that appeared in both the currently challenged claims and the claims found unpatentable in the grandparent patent.

As the director noted, the overlap between the claim limitations in the [...]

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No Snipe Hunting: AIA Adherence Means No Interference (Proceedings)

The US Court of Appeals for the Federal Circuit concluded that patents and applications that have only ever contained claims with an effective filing date after March 16, 2013—i.e., pure America Invents Act (AIA) patents—may not be subjected to an interference proceeding by the US Patent & Trademark Office (PTO) Director. SNIPR Techs. Ltd. v. Rockefeller Univ., Case No. 2022-1260 (Fed. Cir. July 14, 2023) (Chen, Wallach, Hughes, JJ.)

SNIPR Technologies owns a family of five patents directed to methods of selectively killing bacteria using clustered regulatory interspaced short palindromic repeats (CRISPR) gene editing. SNIPR was involved in an interference proceeding with Rockefeller University, which filed a patent application for technology also directed to selectively killing bacteria. The SNIPR patents claimed priority to a Patent Cooperation Treaty application filed on May 3, 2016, thus placing the SNIPR patents squarely within the scope of the AIA. The Rockefeller application claimed priority to, among other things, a US provisional application filed on February 7, 2013, making the Rockefeller application a pure pre-AIA application. The Patent Trial & Appeal Board initially declared an interference between claims 20 to 33 of the Rockefeller application and all claims of the SNIPR patents. The Board ultimately identified Rockefeller as the senior party and canceled all of SNIPR’s claims. SNIPR appealed.

The issue before the Federal Circuit was whether the Board had the authority to cancel SNIPR’s pure AIA claims for lack of invention priority under pre-AIA § 102(g), and more broadly, whether pure AIA patents may, as a matter of law, be part of an interference proceeding.

First, the Federal Circuit examined the plain language of AIA § 3(n) and the statutory purpose and history of the AIA. The Court reasoned that “AIA § 3(n) makes clear that [unless Congress provides otherwise,] only pure pre-AIA and mixed patents may be part of an interference.” As the Court stated, AIA § 3(n)(1) does not permit the AIA’s amendments to apply retroactively and the AIA repealed the statutory grant of power to hear interferences (pre-AIA § 135), instead providing for derivation proceedings.

Next, the Federal Circuit addressed Rockefeller’s and the Director’s arguments that the statutory language of pre-AIA § 135(a) authorizes the Director to declare an interference for “any unexpired patent”—including unexpired pure AIA patents. Unpersuaded, the Court concluded that pre-AIA § 135(a), read in conjunction with the AIA, excludes pure AIA patents for the following reasons:

  • The AIA replaced interference proceedings with derivation proceedings.
  • The AIA deleted all other references to interferences.
  • The AIA repealed the first-to-invent system of patentability, rendering interference proceedings superfluous.
  • Permitting interferences for pure AIA patents would subject AIA patents to interferences “for over twenty years after the AIA’s effective date,” which would be contrary to the purpose of the AIA—to implement the first-to-file system of patentability.

Moreover, such a statutory construction would belie AIA § 3(n)(2), which expressly allows for interferences for mixed patents (i.e., patents and applications that contain, or contained at any time, at least one claim with [...]

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Speculative Injury from Rulemaking Petition Denial Doesn’t Confer Standing

The US District Court for the District of Columbia affirmed the dismissal of a case alleging that the US Patent & Trademark Office (PTO) violated the Administrative Procedure Act (APA) by denying the plaintiffs’ rulemaking petition. The district court found that the plaintiffs’ alleged injury was too speculative to confer Article III standing. US Inventor, Inc. v. US Patent and Trademark Office, Case No. 22-2218 (D.D.C. July 12, 2023) (Bates, J.)

Under the America Invents Act (AIA), the Patent Trial & Appeal Board may hear challenges to the validity of patents through inter partes review (IPR) and post-grant review (PGR). The decision to initiate a review is made at the discretion of the PTO on a case-by-case basis. US Inventor, Inc., and National Small Business United (collectively, NSBU) filed a rulemaking petition with the PTO, arguing that the PTO unlawfully designated cases as precedential or informative without putting those considerations through notice-and-comment rulemaking, as required by the APA. NSBU expressed the same position in a previous lawsuit filed in the Eastern District of Texas that was dismissed for lack of standing—a decision upheld by the US Court of Appeals for the Fifth Circuit. NSBU subsequently filed a lawsuit in the District of Columbia. The PTO filed a motion to dismiss for lack of standing.

In a motion to dismiss, a court will accept facts alleged in the complaint as true but will not assume the truth of legal conclusions. The District of Columbia noted that not every denial of a rulemaking petition confers standing on the petitioner. Standing is established by claiming an injury in fact that can be traced to the defendant’s actions and is likely to be redressed by the court. Therefore, a plaintiff must show that the denial of the petition caused a concrete injury in fact. Injury in fact must be concrete, particularized and not conjectural or hypothetical. Standing can be established via associational standing or organizational standing. Here, the court found that NSBU could establish neither.

In finding no associational standing, the District of Columbia agreed with the PTO that NSBU’s theory of injury was too speculative and not concrete. NSBU proposed an “uncertain series of events” that could lead to an alleged injury, but the court rejected the claim as attenuated conjecture based on the actions of independent third parties (similar to the fact pattern in the Supreme Court’s 2013 decision in Clapper v. Amnesty Int’l USA.)

The District of Columbia heavily criticized the first step of NSBU’s proposed series of events, which was that a valid IPR or PGR would have to be filed on behalf of a patent held by a member of NSBU’s organizations. The court found that identifying potential members that might face IPR or PGR proceedings if a third party decided to bring a claim against them was too hypothetical and relied entirely on the actions of a third party.

The District of Columbia also disagreed with NSBU’s reliance on statistics. NSBU argued that patent cancellation is more likely [...]

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District Court Finding Doesn’t Preclude PTAB Proceeding

The Patent Trial & Appeal Board refused to terminate an inter partes review (IPR) proceeding, finding that collateral estoppel and claim preclusion do not apply to previous findings from a district court proceeding. Patent Quality Assurance, LLC v. VLSI Technology LLC, IPR2021-01229, Paper No. 128 (PTAB June 3, 2023) (Melvin, Giannetti, McNamara, APJs).

Patent Quality Assurance filed a petition for IPR on July 7, 2021, against a patent owned by VLSI. The Board granted institution. The Board later instituted on a substantively identical petition filed by Intel and granted Intel’s motion for joinder to add Intel to the Patent Quality Assurance IPR proceeding. Prior to the July 7, 2021, petition, litigation between VLSI and Intel resulted in a jury verdict that Intel infringed certain claims of the challenged patent. Invalidity was not presented to the jury. On May 10, 2022, the district court entered final judgment, including a finding that Intel had not proven invalidity. Based on the district court’s judgment, VLSI asserted that claim preclusion barred Intel from challenging validity of the asserted patent in IPR and sought termination of the IPR as to Intel.

VLSI argued that the elements of claim preclusion were met because both VLSI and Intel were parties to both cases, the district court entered a final judgment for infringement and no finding of invalidity, and the effect of Intel’s IPR was to collaterally attack the final judgment in the first case. Intel responded, arguing that claim preclusion does not apply to IPRs from the district court under the America Invents Act (AIA).

The Board agreed with Intel that estoppel did not apply. Intel argued that if Congress had intended for IPRs to be precluded by claims in a parallel district court, it would have identified that as one of the estoppel circumstances in the AIA. VLSI argued that the Supreme Court’s 1991 decision in Astoria Federal sav. & Loan Ass’n v. Solimino applies only when an agency decision precludes a later court decision and, therefore, common-law claim preclusion would apply to the IPR proceeding barring a plain statement from Congress showing intent to overcome preclusion.

The Board disagreed, noting that the cited case law related to statutes where a later statute superseded the earlier one and required a clear and manifest intent to repeal the earlier statute. The Board found that there was no express intent to repeal the earlier statute regarding estoppel, and the jurisprudence constantly counsels against repeal “by implication.” The Board also crucially noted that there was no statutory conflict between the earlier and later statutes, and the question, therefore, was whether (under Astoria) the AIA showed congressional intent that common-law claim preclusion should apply to IPRs.

Reading 35 U.S.C. § 315(e), the codification of the AIA’s estoppel provision, the Board noted that the statute clearly imposes estoppel on future agency and district proceedings but says nothing about applying adjudications in district court proceedings at the Board. As the Board explained, there would be no reason for § 315(e) to spell [...]

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Analogous Art Must Be Compared to Challenged Patent

The US Court of Appeals for the Federal Circuit reversed a Patent Trial & Appeal Board obviousness decision, finding that a prior art reference relating to automotive engine parts was not analogous art to the challenged patent, which related to injection devices used for drug delivery. Sanofi-Aventis Deutschland GMBH v. Mylan Pharmaceuticals Inc., Case No. 21-1981 (Fed. Cir. May 9, 2023) (Reyna, Mayer, Cunningham, JJ.)

Sanofi-Aventis owns a patent directed to a drug delivery device that can be configured to allow for the setting of different dose sizes. The main independent claim of the patent recites a spring washer element with “at least two fixing elements configured to axially and rotationally fix the spring washer relative to the housing.”

Mylan initiated an inter partes review (IPR) proceeding against the patent, arguing that the challenged claims were obvious based on a combination of three prior art references: Burren, Venezia and de Gennes. Burren described a drug injection device that used a coiled spring, while Venezia described a hypodermic syringe with a spring washer having a tongue that fit into a collar to prevent the washer from rotating relative to the collar. The third prior art reference, de Gennes, disclosed a large spring-washer-like device used in automobile engines to maintain the alignment between the engine and the transmission. Sanofi argued that de Gennes was non-analogous art because it was not in the same field of endeavor as the injection devices described in the patent and was not reasonably pertinent to a problem faced by the inventor of the challenged patent.

The Board adopted Mylan’s definition of the problem to be solved, which was “axially fixing two components relative towards each other.” Under this broad definition, the Board found that de Gennes was reasonably pertinent to the challenged patent and that claims were obvious in view of Burren in combination with Venezia and de Gennes. Sanofi appealed.

Sanofi argued that the Board erred in determining that de Gennes was analogous art. The Federal Circuit explained that in evaluating whether a reference is analogous, a patent challenger must compare the reference to the challenged patent. Applying this test, the Court found that substantial evidence did not support the conclusion that de Gennes was analogous to the challenged patent. Although Mylan had mapped de Gennes to certain elements of the challenged claims, there was no evidence that de Gennes—an automobile-related patent—was analogous to the challenged patent—a drug delivery device. The Court also found that statements that de Gennes and the challenged patent were “both interested in solving the same issue . . . [of] accommodating various cartridge lengths” were insufficient to show that de Gennes was analogous to the challenged patent.

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