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Full Speed Ahead: District Court Entitled to Explore Litigation Funding Arrangements

by Amol Parikh | Dec 15, 2022 | Patents

The US Court of Appeals for the Federal Circuit denied a patent owner’s mandamus petition, clearing the way for a district court to probe who is funding the patent owner’s infringement litigation. In re Nimitz Techs. LLC, Case No. 23-103 (Fed. Cir. Dec. 8, 2022) (Lourie, Reyna, Taranto, JJ.) (per curiam) (nonprecedential).

Nimitz filed a complaint for patent infringement against Buzzfeed in the US District Court for the District of Delaware. The case was assigned to Chief Judge Connelly. Judge Connelly has two standing orders that require parties to disclose third-party litigation funders and the name of every individual and corporation with a direct or indirect ownership interest in the party. Nimitz filed a disclosure statement identifying Mark Hall as the sole owner and LLC member of Nimitz, and a statement representing that Nimitz has not entered any arrangement with third-party funders.

The district court later became aware that an entity called IP Edge was arranging assignments of patents to various LLCs that were plaintiffs in other actions before the district court. Based on the review of the documents in the other cases, it appeared to the district court that Hall had a connection with IP Edge. The district court ordered Hall and Nimitz’s counsel to appear at a hearing. During the hearing, the district court explored the relationship between Nimitz and an entity called Mavexar. After the hearing, the district court ordered production of communications between Hall, Mavexar and IP Edge, and communication and documents relating to the formation of Nimitz, Nimitz’s assets, Nimitz’s potential scope of liability resulting from the acquisition of the patent, the settlement or potential settlement of the cases and the prior evidentiary hearing. The district court also ordered production of monthly bank statements from Nimitz. Nimitz appealed to the Federal Circuit by filing a petition for writ of mandamus seeking an order vacating the district court’s order.

The Federal Circuit initially stayed the district court’s order pending the Court’s decision. While the mandamus petition was pending, the district court issued a memorandum explaining that the records sought in its prior order were relevant to addressing several concerns, including the following:

Compliance with the Rules of Professional Conduct
Compliance with the district court’s orders
Determining whether real parties in interest other than Nimitz, such as Mavexar and IP Edge, were hidden from the Court and the defendants
Determining whether those real parties in interest perpetrated a fraud on the district court by fraudulently conveying to a shell LLC the patent-in-suit and filing a fictitious patent assignment with the US Patent & Trademark Office designed to shield those parties from the potential liability they would otherwise face in asserting the patent in litigation.

Nimitz had argued that the district court’s order was improper because it would require disclosure of highly confidential litigation materials, including material protected by the attorney-client privilege and work-product immunity. In its decision on mandamus, the Federal Circuit rejected that argument, finding that the district court order made clear that Nimitz [...]

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No Mulligans Here: PTO Rewinds Reexamination Based on Estoppel

by James M. Oehler | Dec 8, 2022 | Patents

The US Patent & Trademark Office (PTO) terminated a pending ex parte reexamination after finding that the challenger was estopped because the prior art references could have been raised in a prior inter partes review (IPR). In re Tyler, Reexam. No. 90/014,950 (PTO Nov. 15, 2022).

In 2017, GITS Manufacturing filed two IPR petitions against a patent owned by G.W. Lisk after Lisk asserted the patent against GITS in district court. In 2018, the Patent Trial & Appeal Board issued final written decisions in each IPR, finding some claims unpatentable and maintaining the patentability of other claims. The Federal Circuit affirmed both IPR decisions in 2021.

In February 2022, the PTO initiated an ex parte reexamination of one of the patents based on a request filed by GITS. The reexamination proposed multiple grounds of unpatentability based on four prior art references that were not involved in the IPRs. GITS included a lengthy discussion and an expert declaration describing the prior art searches GITS performed in support of the certification that it was not estopped under 35 U.S.C. § 315(e)(l) from asserting the grounds in the reexamination. Lisk filed a petition to vacate the reexamination proceeding, alleging that GITS was estopped because the reexamination references reasonably could have been raised in the previous IPRs. Lisk’s petition was supported by its own expert declaration describing prior art searches that a skilled searcher would have conducted.

A party is estopped under § 315(e)(1) from requesting a reexamination proceeding based on grounds that the party “raised or reasonably could have raised” during an IPR. The legislative history of § 315(e) defines “reasonably could have raised” as “prior art which a skilled searcher conducting a diligent search reasonably could have been expected to discover.” The PTO cited legislative history stating that “reasonably could have raised” does not require a “scorched-earth search,” leaving open the possibility that a diligent search may not discover a particular reference. But the PTO also distinguished the search an examiner or lawyer may conduct from the more robust search that a skilled searcher is assumed to conduct prior to filing a petition for a IPR proceeding.

The PTO evaluated each of the four references in GITS’s reexamination grounds based on the criteria described above. Two of the references were patent documents available in commercial databases that a skilled searcher could be expected to find. The third reference was a “seminal textbook” that GITS itself stated was used in the field to train those of skill in the art. The textbook reference was also found through standard citation searching of the patent at issue. The fourth reference was provided by a publisher that GITS stated “was an established publisher that was well known to those interested in the field,” and which maintained an online searchable database of its publications. The PTO determined that the fourth reference would have been found by a reasonably diligent search, despite the fact that a subscription fee was required to search the database.

The PTO also weighed [...]

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Another Kind of Term Limit: Delay Resulting from After-Allowance Amendments Deducted from PTA

by Kyle Sorenson, PhD | Nov 17, 2022 | Patents

The US Court of Appeals for the Federal Circuit affirmed the US Patent & Trademark Office’s (PTO) decision on a patent term adjustment (PTA), finding that it was appropriate to deduct days from a patent term when the applicant files an amendment after notice of allowance and could have completed prosecution earlier by withdrawing the amendment or abstaining from filing it in first instance. Eurica Califorrniaa v. Vidal, Case No. 22-1640 (Fed. Cir. Nov. 7, 2022) (Lourie, Dyk, Hughes, JJ.) (per curiam) (non-precedential).

Eurica Califorrniaa is the sole inventor of a patent application entitled “nondestructive means of ectopic pregnancy management,” which was filed on March 15, 2014. Near the close of an extended patent prosecution, the examiner identified minor additional changes to the claim language of the patent application that would place it in position for allowance. The examiner unilaterally made the amendments and provided Califorrniaa a notice of allowance. In response, Califorrniaa requested an interview with the examiner and provided a list of further proposed amendments that included changes to the examiner’s amended claim limitations as well as substantive changes unrelated to the Examiner’s Amendments. Following the interview, Califorrniaa formally submitted his proposed amendments for the examiner’s consideration. As a result, the PTO deducted 51 days from the adjusted patent term of the patent to account for the time it took the examiner to consider and accept Califorrniaa’s post-allowance amendments. Califorrniaa appealed the PTO’s calculations, first to the district court (which affirmed the PTO) and then to the Federal Circuit.

The PTO may extend the nominal 20-years-from-filing patent terms to account for each day of delay attributable to the PTO, minus the number of days of delay attributable to an applicant’s failure to engage in reasonable efforts to conclude prosecution. Congress has granted the PTO authority to define when this “reasonable efforts” standard is not met, and the PTO has created regulations to address the issue. In 2019, the Federal Circuit issued its decision in Supernus v. Iancu, finding that the PTO failed to properly consider whether the applicant reasonably engaged in efforts to conclude prosecution. In response, the PTO adjusted its regulations to distinguish between post-allowance amendments expressly requested by the PTO and those voluntarily made by the applicant, and to change the relevant timeframe for the calculation of a reduction in PTA. The PTO’s regulations state, in part, that an applicant’s decision to amend their patent application after the examiner has issued a notice of allowance is not a reasonable effort to conclude prosecution.

Unlike its ruling in Supernus, where no identifiable effort to conclude prosecution existed, here the Federal Circuit agreed with the PTO’s finding that Califorrniaa could have, at any time, withdrawn his post-allowance amendments and accepted the examiner’s amendments to conclude prosecution. As such, an “identifiable effort” existed by which Califorrniaa could have avoided additional delay and concluded prosecution. Therefore, the Court affirmed the 51-day deduction of the patent term.

The Federal Circuit also found that the PTO’s post-Supernus updates to [...]

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PTO Requests Comments on Initiatives to Expand Board Opportunities, Registration to Practice Criteria

by Amol Parikh | Oct 20, 2022 | Patents

In a pair of notices, the US Patent & Trademark Office (PTO) announced on October 18, 2022, that it is seeking public input on proposed initiatives directed at expanding opportunities to appear before the Patent Trial & Appeal Board, (Board) and expanding admission criteria for registration to practice in patent cases before the PTO. PTO Director Kathi Vidal explained that “[t]hese proposals are part of our broader initiatives to improve quality and participation.”

Regarding the expansion of opportunities to appear before the Board, the PTO requested comments on the following six questions:

Are there any changes to Board rules or procedures that the PTO or the Board should make to increase opportunities to appear and/or serve as counsel and/or the lead counsel in America Invents Act (AIA) proceedings?
1. If “yes” to question 1 as to the lead counsel, should the rules require that a non-registered practitioner have prior experience in AIA proceedings and/or have completed training before being designated as the lead counsel? What level of experience and/or type of training should be required?
Should any rule or procedure revised by the PTO that permits a non-registered practitioner to be designated as the lead counsel in an AIA proceeding also require that any such non-registered practitioner be accompanied by a registered practitioner as backup counsel? If not, are there any circumstances or events that might occur during an AIA proceeding (g., the contemplated or actual filing of a motion to amend) that might warrant requiring a registered practitioner to then appear as backup counsel?
Would a rule requiring that the lead counsel or backup counsel in an AIA proceeding be a registered practitioner have a significant impact on the cost of such a proceeding? If so, what would the impact be and would the impact be justified?
Should any of the changes discussed above, if adopted, be implemented as a pilot program?
Are there additional training and/or development programs the PTO should offer to increase opportunities for less experienced practitioners to appear as counsel and/or serve as the lead counsel in AIA proceedings?
Are there any changes to the Legal Experience and Advancement Program (LEAP) that the PTO should make to increase opportunities to appear and/or serve as the lead counsel in AIA proceedings?

Regarding expanding the admission requirements to practice in patent matters before the PTO, comments on the following five topics were requested:

The General Requirements Bulletin (GRB) lists three categories of scientific and technical qualifications typically used for eligibility for admission to the registration examination: (1) Category A, for specified bachelor’s, master’s and PhD degrees; (2) Category B, for other bachelor’s, master’s and PhD degrees with technical and scientific training; and (3) Category C, for individuals who rely on practical engineering or scientific experience and have passed the Fundamentals of Engineering test. The PTO is seeking comments as to acceptable degrees and whether it should add Category B degrees on a predetermined timeframe (g., every three years).
Should the PTO accept [...]

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Cloudy Skies: PTO Director Finds Abuse and Sanctionable Conduct

by Alexander Piala, PhD | Oct 13, 2022 | Patents

The US Patent & Trademark Office (PTO) Director issued a precedential opinion finding that filing an inter partes review (IPR) solely to extract payment in a settlement—without the intent to prosecute the IPR to completion—is a sanctionable abuse of process. OpenSky Indus., LLC v. VLSI Tech. LLC, IPR2021-01064 (Oct. 4, 2022) (Vidal, Dir.)

In 2019, VLSI asserted two patents against Intel. In response, Intel filed two IPRs against the allegedly infringed patents, but both IPRs were discretionally denied by the Patent Trial & Appeal Board (Board) based on the advanced stage of the underlying litigation and overlapping issues. The suit proceeded, and a jury awarded VLSI more than $600 million in damages in 2021.

OpenSky Industries was founded two months after the judgment. OpenSky filed a “copycat” IPR petition based on Intel’s previous petitions (including refiling the declarations of Intel’s expert without his knowledge) targeting VLSI’s two allegedly infringed patents. The Board instituted over VLSI’s argument, noting that patentability issues were raised that had not been resolved in the district court case. Initially, OpenSky attempted to settle the IPRs with VLSI, but VLSI refused. OpenSky then reached out to Intel, offering to let Intel collaborate if it agreed to pay a success fee. Intel refused and later filed its own IPR petition and joinder motion. After Intel’s refusal, OpenSky pivoted back to VLSI, offering to “refuse[] to pay [the] expert for time at deposition so [the] expert does not appear at deposition” in return for payment. VLSI reported the scheme to the Board.

Intel was joined as a party to the OpenSky IPR proceeding in June 2022 based on its later-filed petition. Once Intel joined, OpenSky threatened to forego both deposing VLSI’s expert and filing its reply brief unless Intel paid it for its “prior work in the IPR” plus “additional remuneration.” Intel refused. While OpenSky did notice VLSI’s expert, it declined to file a Petitioner Reply brief, forcing Intel to draft the reply. Later, at VLSI’s request (OpenSky missed the request date), oral argument in the proceeding took place before the Board. OpenSky did not meaningfully participate.

While all this was unfolding, the Director sua sponte initiated an investigation to determine “[w]hat actions the Director . . . should take when faced with evidence of an abuse of process or conduct that otherwise thwarts . . . the goals of the Office and/or the AIA.” To begin the investigation, the Director sent discovery requests to each of the three parties. VLSI and Intel complied. OpenSky, by comparison, either incompletely complied with or directly refused each request. Based on those evasions, the Director sanctioned OpenSky for discovery misconduct, applying adverse inferences against OpenSky on each request.

Discovery sanctions in place, the Director moved to the central question: Did OpenSky abuse the IPR process? The Director answered yes.

First, the Director found that OpenSky’s conduct violated its duty of candor and good faith to the Board. In its negotiations with VLSI, OpenSky offered to deliberately sabotage its own petition to hinder Intel. In its negotiations with Intel, OpenSky did [...]

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The Board Is Back in Town: Arthrex Can’t Save Untimely Motions to Terminate

by Mike Baldwin | Sep 29, 2022 | Patents

The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board (Board) unpatentability finding and denial of a motion to terminate, finding that the Board had already issued final written decisions that were not vacated at the time the Board denied the parties’ motion to terminate. Polaris Innovations Ltd. v. Derrick Brent, Deputy Under Secretary of Commerce for Intellectual Property and Deputy Director of The United States Patent and Trademark Office, Case No. 19-1483 (Fed. Cir. Sept. 15, 2022) (Prost, Chen, Stoll, JJ.)

Polaris owns two unrelated patents directed to computer memory. The first patent relates to improved control component configuration, and the second patent relates to a shared-resource system in which logical controls are used to manage resource requests. In 2016, Polaris filed a complaint accusing NVIDIA of infringing both patents. NVIDIA responded by filing petitions for inter partes review (IPR) against each patent. In 2017, the Board issued its final written decisions, finding the challenged claims of both patents unpatentable. Polaris appealed.

The Federal Circuit vacated the Board’s decision in view of Arthrex, Inc. v. Smith & Nephew, Inc. (Arthrex I). On remand, the Board administratively suspended the IPR proceedings pending potential Supreme Court review of Arthrex I. During the administrative suspension, Polaris and NVIDIA filed a joint motion to terminate the proceedings. While those motions were pending, the Supreme Court vacated Arthrex I, substituting an alternative remedy for violation of the Appointments Clause in United States v. Arthrex, Inc. (Arthrex II). In view of Arthrex II, the Supreme Court vacated the Federal Circuit’s vacatur of the Board’s final written decision, thus reinstating those decisions.

On remand to the Board, Polaris argued that the Board should grant Polaris’s then-pending motion to terminate. The Chief Administrative Law Judge responded that termination was not appropriate because the Supreme Court’s decision meant that the “final written decision in each of these cases is not vacated, and it is not necessary for the Board to issue a new final written decision in either of these cases.” Polaris filed a request for Director rehearing. The Director denied rehearing. Polaris appealed.

Polaris argued that the Board erred by failing to grant the joint motions to terminate filed in both proceedings before the Board on remand. Relying on 35 U.S.C. § 317, the Federal Circuit explained that motions to terminate should be granted “unless the Office has decided the merits of the proceeding before the request for termination is filed.” The Court found that the Board had already decided the merits of the cases in final written decisions that were not vacated at the time the Board made its decision denying Polaris’s motions to terminate. The Court therefore affirmed the Board’s decision that termination was inappropriate.

Polaris also raised two claim construction arguments. Polaris argued that the Board misconstrued the term “memory chip” in the IPR involving one of the challenged patents and misconstrued the term “resource tag buffer” in the IPR involving the [...]

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Sometimes Inactions Speak Louder Than Words

by Sarah J. Fischer | Sep 22, 2022 | Patents

The US Court of Appeals for the Federal Circuit affirmed a decision granting summary judgment in favor of the US Patent & Trademark Office (PTO) regarding the propriety of imposing a restriction requirement on a pre-General Agreement on Tariffs and Trade (GATT) patent. Hyatt v. PTO, Case No. 2021-2324 (Fed. Cir. Sept. 8, 2022) (Moore, Prost, and Hughes, JJ.)

This action arose from the prosecution of a pre-GATT application that claimed priority to applications filed as early as 1983. The issue stems from changes to US patent law limiting patent terms to 20 years from their filing date. The old law provided a grant that lasted 17 years from a patent issuance. As the Federal Circuit noted in early litigation involving Gilbert Hyatt, tying patent term to the grant date “incentivized certain patentees to delay prosecuting their patents by abandoning applications and filing continuing applications in their place.” But the change in law left a gap for so-called transitional applications—those filed but not yet granted before the new law took effect. This “‘triggered a patent application gold rush in the spring of 1995’ by applicants who wanted their patent claims to be governed under the [old law] … This gold rush is ‘often referred to as the ‘GATT Bubble.’’”

Hyatt, a prolific inventor, is named in a series of pre-GATT applications filed in 1995 during the GATT bubble. Since then, he has continued to prosecute these applications. As a result of various litigations, the PTO stayed the prosecution of many of these applications between 2003 and 2012. In 2013, over Hyatt’s objections, the PTO required him to select eight claims from an application containing 200 for prosecution. In 2015, the PTO issued a non-final rejection on said claims. Hyatt responded by essentially rewriting the claims in their entirety. The examiner then issued a restriction requirement between the original and amended claims, which would require Hyatt to submit a new application with the new claims, which would be subject to the new law. The restriction requirement was based on the “applicant-action exception,” which allowed the PTO to issue a restriction requirement when the examiner could not have previously made one because of the actions of the applicant. The authority for the PTO action was rooted in Rule 129 (b)(1) (ii), which in relevant part provides:

(1) In an application … that has been pending for

at least three years as of June 8, 1995 … no requirement

for restriction . . . shall be made or maintained

in the application after June 8, 1995, except where:

…

(ii) The examiner has not made a requirement for

restriction in the present or parent application

prior to April 8, 1995, due to actions by the applicant

…

After the PTO issued a restriction requirement, Hyatt filed an action in the US District Court for the Eastern District of Virginia, alleging that the PTO violated the Administrative Procedure Act because the restriction requirement was arbitrary, capricious, an abuse of discretion or otherwise not in [...]

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PTO Director Lays Out Limits on “Roadmapping” as Factor for Discretionary IPR Denials

by Brennen Baylor | Sep 15, 2022 | Patents

Exercising its discretion under 35 U.S.C. § 314(a), the Patent Trial & Appeal Board (Board) denied institution of two inter partes reviews (IPRs) based on its understanding of its own precedential 2017 decision in Gen. Plastic Indus. Co. v. Canon Kabushiki Kaisha. US Patent & Trademark Office Director Kathi Vidal subsequently reversed the Board’s ruling in a precedential sua sponte decision clarifying how to apply the seven factors set forth in General Plastic. Code200, UAB v. Bright Data, Ltd., IPR2022-00861; -00862, Paper 18 (PTAB Aug. 23, 2022) (Vidal, Dir. of PTO).

In General Plastic, the Board addressed the practice of filing seriatim petitions attacking the same patent, where each petition raises a new ground for invalidity. The Board considers the General Plastic factors when determining whether to deny IPR institution to ensure efficient post-grant review procedures and prevent inequity. The seven factors are as follows:

Whether the same petitioner previously filed a petition directed to the same claims of the same patent
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
Whether at the time of filing of the second petition the petitioner had already received the patent owner’s preliminary response to the first petition or had received the Board’s decision on whether to institute review in the first petition
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
Whether the petitioner provided adequate explanation for the time elapsed between the filings of multiple petitions directed to the same claims of the same patent
The finite resources of the Board
The requirement under 35 U.S.C. § 316(a)(11) to issue a final determination no later than one year after the date on which the PTO Director notices institution of review.

In denying institution in this case, the Board explained that the petitioner’s failure to stipulate that it would not pursue the same grounds in district court “weigh[ed] strongly in favor of exercising discretion to deny institution and outweigh[ed] the fact that the Board did not substantively address the merits of the prior petition.” Director Vidal disagreed, reasoning that when a first petition is not decided on its merits, a follow-on petition affords a petitioner the opportunity to receive substantive consideration. Director Vidal further explained that factor 1 “must be read in conjunction with factors 2 and 3.” Application of factor 1 in a vacuum strips context from a petitioner’s challenges and creates an inappropriate bright-line rule for denying institution.

Proper application of the General Plastic factors requires consideration of the potential for abuse by a petitioner. Director Vidal noted the problem of “roadmapping” raised in General Plastic (i.e., using one or more Board decisions to create a roadmap for follow-on filings until the petitioner finds a ground that results in institution). A denial decision based solely on the [...]

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Check Your Expert Skills and Standing

by Sarah J. Fischer | Sep 8, 2022 | Patents

The US Court of Appeals for the Federal Circuit dismissed a portion of an appeal from the Patent Trial & Appeal Board (Board) regarding obviousness because the patentee did not have standing to challenge the decision regarding one of the claims. The Court also affirmed-in-part because the definition of person of ordinary skill in the art applied by the Board was not unreasonable or unsupported by the evidence. Best Medical International, Inc. v. Elekta Inc., Case Nos. 21-2099; -2100 (Fed. Cir. Aug. 29, 2022) (Hughes, Linn, Stoll, JJ.)

Best Medical International (BMI) owns a patent directed to a method and apparatus for conformal radiation therapy of tumors using a pre-determined radiation dose. The Board instituted two inter partes review (IPR) petitions filed by Varian Medical Systems and Elekta. During the pendency of the IPR proceeding, a parallel ex parte re-examination was ongoing. After institution of the IPRs, the examiner in the re-examination rejected claim 1, which BMI subsequently cancelled “without prejudice or disclaimer.” After BMI cancelled claim 1, the Board issued its final written decision in the IPR proceedings. The Board noted that BMI had cancelled claim 1 during re-examination, but concluded that claim 1 had “not yet been canceled by a final action” because BMI had “not filed a statutory disclaimer of claim 1.” The Board therefore considered the merits of Elekta’s patentability challenge and determined that claim 1 was unpatentable as obvious. The Board issued a split decision as to the other claims, finding one claim patentable and the others unpatentable. BMI appealed.

The Federal Circuit began by analyzing whether BMI had standing to challenge the Board’s invalidation of the now cancelled claim 1. BMI attempted to invoke Munsingwear vacatur, which allows courts to vacate underlying decisions on issues that have become moot during their pendency. As an initial matter, the Court found that the Board had the authority to invalidate the claim because it was not finally cancelled at the time the Board issued its final written decision. Regarding BMI’s vacatur argument, Elekta argued that BMI lacked standing to challenge the decision related to the cancelled claim. BMI countered that it had suffered an injury sufficient to create Article III standing because it believed that collateral estoppel might be applied by the examiner regarding other claims in another patent subject to re-examination. The Court was unpersuaded by this argument, in part because BMI could not cite any case law where collateral estoppel was applied in that fashion. The Court found that Munsingwear vacatur was inappropriate because the mooting event did not happen during the pendency of the appeal—it happened before the appeal was filed. The Court therefore concluded that BMI lacked standing to challenge the Board’s decision regarding the now cancelled claim.

Turning to the other claims the Board found unpatentable, BMI challenged the Board’s finding that a person of ordinary skill in the art must have formal computer programming experience. The Federal Circuit recited the non-exhaustive list of factors used to determine the requisite level of [...]

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File Like an Eagle: ANDA pH Specification Rules Infringement Inquiry

by Nitya Anand | Sep 1, 2022 | Patents

The US Court of Appeals for the Federal Circuit affirmed a district court’s finding of noninfringement in a Hatch-Waxman case under 35 U.S.C. § 271(e)(2) and § 271(a)-(b). The Court found that the alleged infringer’s abbreviated new drug application (ANDA) specification controlled the § 271(e)(2) infringement inquiry, and that there were no clear errors by the district court that would warrant reconsideration of the § 271(a)-(b) ruling. Par Pharmaceutical, Inc. et al. v. Eagle Pharmaceuticals, Inc., Case No. 21-2342 (Fed. Cir. Aug. 18, 2022) (Moore, Prost, Hughes, JJ.)

Par is the maker of Vasostrict®, a vasopressin injection product used to treat patients with critically low blood pressure. Par sued Eagle, an ANDA filer seeking to market a generic version of Vasostrict®, asserting infringement of two Orange Book-listed patents. The claims of both asserted patents required a vasopressin composition with a rounded pH between 3.7 and 3.9 (i.e., a pH between 3.65 and 3.94 before rounding). Par argued that Eagle infringed because Eagle’s ANDA sought approval for a product with a pH of 3.64, just 0.01 beneath the claimed range, and because “real-world” evidence purportedly showed that the pH of Eagle’s product drifts up over time. Accordingly, Par asserted infringement under § 271(e)(2), based on the filing of Eagle’s ANDA, and also sought a declaratory judgment that Eagle’s planned generic product would infringe under § 271(a)-(b). The district court disagreed. Par appealed.

Turning first to the issue of infringement under § 271(e)(2), the Federal Circuit explained that because drug manufacturers are bound by strict statutory provisions to sell only those products that comport with their ANDAs, if an ANDA defines a proposed generic drug in a manner that directly addresses the issue of infringement, the ANDA controls the infringement inquiry. The Court stated, however, that if an ANDA specification does not speak clearly and directly to the question of infringement, courts may look to other relevant evidence, such as data or samples the ANDA filer has submitted to the US Food & Drug Administration (FDA), to assess whether a proposed product will infringe.

The Federal Circuit found that in Eagle’s case, “the inquiry begins and ends with Eagle’s ANDA specification.” Eagle’s ANDA contained both a release specification, requiring the generic product to have a pH range of 3.4–3.6 (i.e., up to 3.64 before rounding) at the time of distribution, and a stability specification, requiring that same pH range throughout the entirety of the product’s shelf life. Par argued that the stability specification was irrelevant to the infringement inquiry because the FDA cannot ensure that every product Eagle sells complies with the stability specification. The Court disagreed, finding that the district court did not clearly err in ruling that Eagle’s ANDA defined a product outside the scope of Par’s claims.

As to Par’s declaratory judgment claim under § 271(a)-(b), the Federal Circuit found that the district court did not commit clear error in its consideration of Par’s infringement arguments. The district court considered but did not find compelling Par’s evidence of an upward pH drift in Eagle’s post-release pH data [...]

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