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European UPC All Set for Set Up as Protocol Enters into Force

by and | Jan 27, 2022 | ,

On January 18, 2022, after recently joining the protocol on a European Unified Patent Court (UPC) on provisional application (PPA) as the decisive 13th EU Member State, Austria deposited its instrument of accession to the PPA. Thus, the countdown to the grand opening of the UPC has now started. (The actual opening may take place in late 2022 or—more likely—in early 2023.)

Austria’s deposition marked the beginning of the Provisional Application Phase as of January 19, 2022, which will last at least eight months and includes preparatory work, particularly recruiting 90 legal and technical judges and administrative staff, testing the file management system, setting up the IT system, hosting inaugural meetings of the governing bodies and confirming the UPC’s budget. As Alexander Ramsay, chairman of the UPC Preparatory Committee, said in a press release issued January 19, 2022, the Provisional Application Phase will start with the inaugural meetings of the Administrative Committee, Advisory Committee and Budget Committee. In addition, following the United Kingdom’s withdrawal from the project, the Preparatory Committee must decide where to locate the UPC’s central division for pharmaceutical and chemical cases as the seat of this division was initially set to be in London.

As soon as the UPC member states are confident that preparations have progressed to the point where the UPC is functional, Germany will deposit its ratification of the UPC Agreement. Germany’s deposition will set the date for the start of the UPC’s operations and trigger the countdown to the UPC Agreement’s entry into force, which will be on the first day of the fourth month after the deposit. At that point, unitary patents (or European patents with unitary effect) will be available at the European Patent Office (EPO).

Once the Provisional Application Phase ends, a transitional period of seven years is triggered for European patent (EP) applicants and holders to decide whether they want to opt out of UPC jurisdiction and continue to pursue national patent litigation. Within this transitional period, EP applicants can opt in if their application is granted or even after the EP is granted—if no legal action has commenced before a national court.

The UPC will thus have competence for already existing EPs (if not opted out) and for the newly introduced unitary patents granted by the EPO. Both invalidity and infringement proceedings will be conducted before the UPC, which will consist of regional, national and central divisions as well as an Appeals Court and a Mediation Centre.

In a statement shared January 19, 2022, the EU Internal Market Commissioner Thierry Breton welcomed the start of the Provisional Application Phase, stressing the cost benefits of unitary patents: “For instance, a Unitary Patent covering a territory of potentially up to 25 Member States will cost less than €5,000 in renewal fees over 10 years, instead of the current level of around €29,000. The Unitary Patent will also reduce the gap between the cost of patent protection in Europe compared with the [...]

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Power Play: District Court Properly Transferred Bad Faith Anticipatory Suit

by | Jan 27, 2022 |

The US Court of Appeals for the Federal Circuit denied a petition for mandamus relief from an order transferring a first-filed declaratory judgment action from the District of New Jersey to the Western District of Texas, finding that the district court did not abuse its discretion in departing from the first-to-file rule. In re Amperex Tech. Ltd., Case No. 22-105 (Fed. Cir. Jan. 14, 2022) (Lourie, Prost, Taranto, JJ.) (per curiam).

Maxell, Ltd. owns patents related to lithium-ion battery technology. To facilitate licensing discussions regarding Maxell’s patents, Maxell and Amperex entered into a non-disclosure agreement (NDA) stipulating that neither party would sue the other for one year. At the end of the one-year period, Amperex proposed extending the NDA because the parties had not reached an agreement. Maxell replied that Amperex’s products infringed Maxell’s patents and cautioned that if “Maxell and Amperex are not able to enter into a licensing agreement by Friday, April 9, 2020, Maxell will be left with no choice but to pursue litigation.”

After some discussion, Maxell’s counsel expressed interest in having another meeting and requested Amperex’s presentation materials in advance. Amperex’s counsel replied, “I will be in touch as soon as I can get the materials,” just two hours before filing a 90-page complaint seeking a declaratory judgment of noninfringement in the US District Court for the District of New Jersey. Two days later, Maxell filed an infringement action in the US District Court for the Western District of Texas. Maxell moved the New Jersey court to decline jurisdiction over the declaratory judgment action or transfer the action to the Western District of Texas. Amperex subsequently moved to enjoin Maxell’s action, and Maxell filed a motion to dismiss or transfer Amperex’s complaint, arguing that the action was brought in bad faith and in anticipation of Maxell’s actions.

Departing from the first-to-file rule, the district court granted Maxell’s transfer request. The district court acknowledged that a “first-filed action is preferred . . . unless considerations of judicial and litigant economy, and the just and effective disposition of disputes, require otherwise.” The district court then addressed several factors, including whether Amperex’s suit was anticipatory and the relative convenience of the forums. The district court concluded that Amperex’s suit was anticipatory because “when one party gives a deadline by which a dispute must be resolved non-judicially and the other party quickly files a declaratory action, the declaratory action is anticipatory.” Moreover, while neither bad faith nor ongoing negotiations are required for a suit to be anticipatory, bad faith actions that “disrupt the non-judicial settlement of disputes or . . . string the defendant along so that the plaintiff can win the race to the courthouse . . . weigh strongly in favor of transfer or dismissal.” Thus, the district court found that Maxell’s clear ultimatum coupled with Amperex’s “feigned cooperation” weighed heavily in Maxell’s favor.

The district court next noted that neither district was more convenient for the parties or witnesses, whereas Amperex’s failure to properly serve Maxell [...]

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Magazine Reload: Claim Construction Error Requires Reversal and Remand

by | Jan 20, 2022 |

The US Court of Appeals for the Federal Circuit reversed a district court’s summary judgment ruling based on a claim construction error because nothing in the claims or specification of the asserted patent supported the district court’s overly narrow interpretation of the disputed claim term. Evolusion Concepts, Inc. v. HOC Events, Inc. d/b/a Supertool USA, Case No. 21-1963 (Fed. Cir. Jan. 14, 2021) (Prost, Taranto, Chen, JJ.); Evolusion Concepts, Inc. v. Juggernaut Tactical, Inc., Case No. 21-1987 (Fed. Cir. Jan. 14, 2021) (Fed. Cir. Jan. 14, 2021) (Prost, Taranto, Chen, JJ.).

Evolusion owns a patent directed to a device and method for converting a semi-automatic rifle with a detachable magazine to one with a fixed magazine. A detachable magazine allows a user to fire the weapon until the magazine is depleted, then release the magazine, insert a new magazine and resume firing. In contrast, a fixed magazine can be removed and replaced only by disassembling certain nonmagazine parts of the firearm, which slows the rate of fire. The specification states that firearms with detachable magazines are likely to face increased legal restrictions, noting that bills recently introduced in US Congress would have banned semi-automatic weapons with detachable magazines. The claims of the patents recite, among other limitations, a “magazine catch bar.”

Evolusion sued Juggernaut for infringement. Juggernaut asserted invalidity and noninfringement. The parties cross-moved for summary judgment relating to infringement of the device claims, agreeing that the question of infringement depended entirely on whether the claimed “magazine catch bar” included a factory-installed (OEM) magazine catch bar. The district court concluded that the term “magazine catch bar,” as used in the claims and specification, excluded an OEM magazine catch bar. The court’s conclusion was based primarily on the sentence in the specification that states: “The invention is a permanent fixture added to a semi-automatic firearm by removing the standard OEM magazine catch assembly and installing the invention.” The court reasoned that the “magazine catch bar” of the invention could not be an OEM magazine catch bar since the OEM magazine was one of the components removed to install the invention. Based on the construction, the court concluded that Juggernaut did not literally infringe the patent. The court also found that Juggernaut could not infringe under the doctrine of equivalence because Evolusion had dedicated a factory-installed magazine catch bar to the public by disclosing, but not claiming, this embodiment.

Evolusion also sued Supertool for infringement. When Supertool failed to respond to the complaint, the district court clerk entered a default under Rule 55(a) of the Federal Rules of Civil Procedure. With the requests for relief not yet adjudicated, Evolusion moved for a “default judgment” under Rule 55(b), but the court denied the motion. In its denial, the court, citing its ruling in the Juggernaut case, stated that Evolusion failed to state a viable claim for infringement against Supertool because its products also required reusing the factory-installed magazine catch bar. Evolusion appealed the Juggernaut and Supertool rulings.

The Federal Circuit reversed the noninfringement [...]

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Silence May Be Sufficient Written Description Disclosure for Negative Limitation

by | Jan 13, 2022 |

Addressing the issue of written description in a Hatch-Waxman litigation, the US Court of Appeals for the Federal Circuit affirmed the district court’s finding that the patent adequately described the claimed daily dose and no-loading dose negative limitation. Novartis Pharms. v. Accord Healthcare Inc., Case No. 21-1070 (Fed. Cir. Jan. 3, 2022) (Linn, O’Malley, JJ.) (Moore, CJ, dissenting).

Novartis’s Gilenya is a 0.5 mg daily dose of fingolimod hydrochloride medication used to treat relapsing remitting multiple sclerosis (RRMS). HEC filed an abbreviated new drug application (ANDA) seeking approval to market a generic version of Gilenya. Novartis sued, alleging that HEC’s ANDA infringed a patent directed to methods of treating RRMS with fingolimod or a fingolimod salt at a daily dosage of 0.5 mg without an immediately preceding loading dose.

The specification described the results of an Experimental Autoimmune Encephalomyelitis (EAE) experiment induced in Lewis rats showing that fingolimod hydrochloride inhibited disease relapse when administered daily at a dose of 0.3 mg/kg or administered orally at 0.3 mg/kg every second or third day or once a week, and a prophetic human clinical trial in which RRMS patients would receive 0.5, 1.25 or 2.5 mg of fingolimod hydrochloride per day for two to six months. The specification did not mention a loading dose associated with either the EAE experiment or the prophetic trial. It was undisputed that loading doses were well known in the prior art and used in some medications for the treatment of multiple sclerosis.

The district court found that HEC had not shown that the patent was invalid for insufficient written description for the claimed 0.5 mg daily dose or the no-loading dose negative limitation. The district court also found sufficient written description in the EAE experiment and/or prophetic trial and credited the testimony of two of Novartis’s expert witnesses. HEC appealed.

The Federal Circuit affirmed the district court’s decision. Turning first to the daily dose limitation, the majority held that the prophetic trial described daily dosages of 0.5, 1.25 or 2.5 mg and found no clear error by the district court in crediting expert testimony converting the lowest daily rat dose described in the EAE experiment to arrive at the claimed 0.5 mg daily human dose. Reciting Ariad, the Court explained that a “disclosure need not recite the claimed invention in haec verba” and further, that “[b]laze marks” are not necessary where the claimed species is expressly described in the specification, as the 0.5 mg daily dose was here.

Turning to the no-loading dose negative limitation, the majority disagreed with HEC’s arguments that there was no written description because the specification contained zero recitation of a loading dose or its potential benefits or disadvantages, and because the district court inconsistently found that a prior art abstract (Kappos 2006) did not anticipate the claims because it was silent as to loading doses. The Court explained that there is no “new and heightened standard for negative claim limitations.” The majority acknowledged that silence alone is insufficient disclosure but emphasized that [...]

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PTO Proposes Deferred Responses for Subject Matter Eligibility Rejections

by | Jan 13, 2022 |

In a January 6, 2022, Federal Register notice, the US Patent and Trademark Office (PTO) announced its intention to implement a pilot program to evaluate the effects of permitting applicants to defer responding to subject matter eligibility (SME) rejections in certain patent applications. Under this pilot program, applicants may receive invitations to participate if their applications meet the program’s criteria, including a criterion that the claims in the application necessitate rejections on SME and other patentability-related grounds. An applicant who accepts the invitation to participate in this pilot program must still file a reply addressing all the rejections except SME rejections in every office action mailed in the application but is permitted to defer responding to SME rejections until the earlier of final disposition of the application or the withdrawal or obviation of all other outstanding rejections.

Invitations to participate in the Deferred Subject Matter Eligibility Response pilot program will be mailed during the period between February 1, 2022, and July 30, 2022. The PTO may extend, modify or terminate the pilot program depending on the workload and resources necessary to administer the program, feedback from the public and the program’s effectiveness.

Because satisfaction of non-SME conditions for patentability (e.g., novelty, nonobviousness, adequacy of disclosure and definiteness) may resolve SME issues as well, the pilot program may result in improved examination efficiency and increased patent quality.

An examiner may invite a prospective applicant to participate in the pilot program by including a form paragraph in the first office action on the merits. An applicant receiving an invitation to participate in the pilot program may elect to accept or decline the invitation. If an applicant wishes to participate in the program, they must file a properly completed request form PTO/SB/456 concurrently with a timely response to the first office action on the merits. The request form must be submitted via the PTO’s patent electronic filing systems.

The limited waiver permits the applicant to defer addressing the SME rejections until the earlier of final disposition of the participating application or the withdrawal or obviation of all other outstanding rejections. A final disposition is the earliest of the following:

  • Mailing of a notice of allowance
  • Mailing of a final office action
  • Filing of a notice of appeal
  • Filing of a request for continued examination
  • Abandonment of the application.

Applicants must address the SME rejections in a response to a final rejection or the filing of a request for continued examination.

The public is invited to submit comments, which must be received by March 7, 2022, to ensure consideration.



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Improper Claim Construction Requires Partial Remand of Obviousness Determination

by | Jan 6, 2022 |

The US Court of Appeals for the Federal Circuit issued decisions in two separate inter partes reviews (IPRs), one involving a patent related to radio frequency communication systems and the other involving a patent related to multi-processor systems. Intel Corporation v. Qualcomm Incorporated, Case No. 20-1664 (Fed. Cir. Dec. 28, 2021) (Prost, Taranto, Hughes, JJ.); Intel Corporation v. Qualcomm Incorporated, Case Nos. 20-1828, -1867 (Fed. Cir. Dec. 28, 2021) (Prost, Taranto, Hughes, JJ). Based on issues of claim construction and obviousness, the Court affirmed in part and vacated in part the Patent Trial and Appeal Board’s (Board) decision in the radio frequency communication systems patent IPR and vacated the Board’s decision in the multi-processor systems patent IPR.

Radio Frequency Communication System Patent IPR (1664)

In the IPR related to the radio frequency communication systems patent, Intel proposed that the claim term “radio frequency input signal” should take its ordinary meaning of an input signal having a radio frequency. Qualcomm argued that a person of skill in the art reading the patent would understand the phrase to reference the radio frequency signal that is received before down-conversion, and thus proposed that the term should mean “a signal centered at a carrier frequency at which the signal was transmitted/received.” The Board agreed with Qualcomm based on the intrinsic evidence.

Intel argued before the Board that certain claims of the radio frequency communication systems patent would have been obvious in light of the Der reference and the Valla reference. Qualcomm argued that a skilled artisan would not have been motivated to combine Der and Valla, because Der’s transistor would defeat the intended purpose of Valla’s amplifier. The Board agreed with Qualcomm. Qualcomm also submitted substitute claims. The Board accepted the substitute claims after finding that a skilled artisan would have lacked reason to combine Der and the Burgener reference to achieve the substitute claims. Intel appealed.

The Federal Circuit first addressed the threshold question of whether it had jurisdiction since no lawsuit had been filed against Intel. Despite the absence of any lawsuit against Intel itself, the Court found that Intel had standing because it had engaged in acts that previously resulted in assertion of the patent against one of Intel’s customers. Because Intel continues to sell the relevant products to that customer and others, it must address the risk of an infringement suit by Qualcomm. Qualcomm also refused to offer a covenant not to sue or stipulate that it would not reassert its prior infringement allegations involving the Intel products. The Court found that this refusal made Intel’s risk more than “mere conjecture or hypothesis.” Therefore, the Court found that Intel had standing to pursue the appeal.

Turning to the merits, the Federal Circuit affirmed the Board’s construction of “radio frequency input signal.” The Court explained that while both parties’ proposed constructions had appeal when considered in a vacuum, the proper inquiry required analysis of the surrounding claim language and specification. The Court found that linguistic clues in the claims suggested that [...]

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Rounding Error: Intrinsic Evidence Informs Plain and Ordinary Meaning

by | Dec 16, 2021 |

Vacating a stipulated infringement judgment based on an incorrect claim construction, the US Court of Appeals for the Federal Circuit explained that it is improper to isolate claim language from the intrinsic evidence when determining the plain and ordinary meaning of a disputed term. AstraZeneca AB v. Mylan Pharms. Inc., Case No. 21-1729 (Fed. Cir. Dec. 8, 2021) (Stoll, J.) (Taranto, J., dissenting).

AstraZeneca sued Mylan Pharmaceuticals for infringement of three patents listed in the US Food and Drug Administration’s (FDA) orange book covering the Symbicort® pressurized metered-dose inhaler for the treatment of asthma and COPD. 3M submitted an abbreviated new drug application (ANDA) to the FDA to manufacture and sell a generic version of the Symbicort® inhaler and certain interests to the ANDA were later transferred to Mylan. After receiving a Paragraph IV letter from Mylan, AstraZeneca filed an infringement suit.

Shortly before trial, the district court held a claim construction hearing to determine the meaning of “0.001%,” the claimed concentration of PVP (one of the active ingredients). The district court construed the term based on its “plain and ordinary meaning, that is, expressed with one significant digit.” Based on this definition, Mylan stipulated to infringement and the district court entered judgment. The district court held a bench trial on invalidity, ultimately determining that Mylan did not prove that the claims were invalid as obvious. Mylan appealed the stipulated judgment stemming from the claim construction determination and the judgment of no invalidity.

First, Mylan challenged the district court’s claim construction of “0.001%.” AstraZeneca argued that the district court improperly construed the term to encompass a range from 0.0005% to 0.0014%. Mylan contended that, in view of the specification and the prosecution history, the term was to be defined precisely at 0.001% with only “minor variations” allowed. The Federal Circuit agreed, finding that Mylan’s proposed construction was more properly aligned with the patent’s description as further informed by the prosecution history.

The Federal Circuit stated that the proper construction of 0.001% only allowed minor variations from 0.00095% to 0.00104%. There was no dispute that the term 0.001% would ordinarily encompass the range of 0.0005% to 0.0014%. AstraZeneca argued that this “ordinary meaning” would control absent lexicography or disclaimer. The Court disagreed, finding that it would improperly isolate the term from the claim language, specification and patent prosecution history. The Court explained that the “ordinary meaning” is not the ordinary meaning in the abstract but is instead the “meaning to the ordinary artisan after reading the entire patent,” and therefore the claims must be read in view of both the written description and the prosecution history. The Court’s rationale for narrower construction was based on the intrinsic record reflecting that the written description and prosecution history showed that very minor differences in PVP concentration would impact stability.

The Federal Circuit found that the written description explained that stability was one of the most important factors and that even very minor differences in PVP concentration could impact stability. The written description also [...]

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Shots Fired: Challenger Must Have Requisite Standing Before Appealing Unfavorable IPR Decisions

by | Dec 16, 2021 |

The US Court of Appeals for the Federal Circuit found, in the context of an appeal from an inter partes review (IPR) decision, that the appellant had Article III standing and affirmed a Patent Trial & Appeal Board (Board) decision, holding the challenged claims unpatentable as obvious. ModernaTX, Inc. v. Arbutus Biopharma Corporation, Case No. 20-2329 (Fed. Cir. Dec 2, 2021) (Lourie, J.)

Arbutus owns a patent pertaining to “stable nucleic acid-lipid particles (SNALP) comprising a nucleic acid (such as one or more interfering RNA), methods of making the SNALP, and methods of delivering and/or administering the SNALP.” Moderna petitioned for IPR of the patent, asserting three grounds:

  1. Moderna alleged that all claims of the challenged patent would have been anticipated and/or obvious in light of International Pat. Publ. WO 2005/007196 (‘196 PCT) or US Pat. Publ. 2006/0134189 (‘189 publication).
  2. Moderna alleged that all claims of the challenged patent would have been obvious over a combination of the ‘196 PCT, the ‘189 publication, Lin and Ahmad.
  3. Moderna alleged that all claims of the challenged patent were anticipated by US Pat. Publ. 2006/0240554 (‘554 publication), and alternatively that the claims would have been obvious over the ‘554 publication.

The Board rejected each of Moderna’s allegations, finding that the claims were not unpatentable as obvious. Moderna appealed.

Before addressing Moderna’s appeal on its merits, the Federal Circuit addressed whether Moderna had proper standing to challenge the Board’s decision. The Court stated that well-established precedent dictates that an appellant seeking review of a Board decision in an IPR must have suffered an injury in fact that is fairly traceable to the challenged conduct of the appellee and is likely to be redressed by a favorable judicial decision. The Court underscored that under IPR statute, there is no standing requirement for petitioners to request institution of IPR by the Board, meaning that a requester need not have a concrete stake in the outcome. Additionally, where the statue itself grants judicial review (such as in the case of an IPR), standing criteria of immediacy and redressability may be “relaxed.” Nonetheless, the Court explained that a party’s participation in the underlying IPR alone does not confer standing on that party to appeal the Board decision before an Article III court such as the Federal Circuit. The party seeking review (in this case Moderna) must show that it possesses requisite injury for standing to appeal.

Moderna asserted that substantial risk existed that Arbutus would bring an infringement suit against Moderna based on Moderna’s COVID-19 vaccine if the challenged patent was to remain valid. In support, Moderna submitted a declaration from its senior vice president and deputy general counsel that Moderna was working to harness proprietary mRNA technology and planned on releasing and applying for emergency use authorization for a COVID-19 vaccine in December 2020. The declaration also described how Arbutus’s conduct created a substantial risk that it would bring subsequent infringement action against Moderna. An example of such conduct was a series of public statements [...]

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Post-AIA Patents Are Not Shielded from Interferences

by | Dec 16, 2021 |

Addressing the applicability of interference proceedings to patent applications filed after the Leahy-Smith America Invents Act (AIA) was enacted, the Patent Trial & Appeal Board (Board) found it proper to declare an interference between a patent application with a priority date before March 16, 2013, the AIA implementation date, and a patent with a priority date after March 16, 2013. SNIPR Technologies Limited v. The Rockefeller University, Pat. Interf. No. 106,123 (DK) (PTAB Nov. 19, 2021) (Katz, APJ).

The AIA switched the US patent system from a “first to invent” to a “first inventor to file” system. In line with this change, the AIA eliminated the patentability requirement under 35 U.S.C. § 102(g), regarding whether another inventor made the invention first, and the interference proceeding under 35 U.S.C. §135 for determining who invented the claimed invention first. Section 3(n)(2) of the AIA provides a timing provision relating to this change. Under this section, the interference proceeding “shall apply to each claim of an application for patent, and any patent issued thereon, for which the amendments made by this section also apply, if such application or patent contains or contained at any time, a claim [having a priority date before March 16, 2013].”

The US Patent & Trademark Office (PTO) declared an interference between several patents owned by SNIPR and a pending application to The Rockefeller University. The claims involved were drawn to a method of killing or modifying specific bacteria in a mixed population of bacteria with different species using the CRISPR-mediated gene editing technology. The Rockefeller application asserted a priority date of February 7, 2013 (i.e., pre-AIA), while the SNIPR patents asserted the priority date of May 3, 2016 (i.e., post-AIA). SNIPR argued that the interference proceeding was improper since all involved patents were filed after the AIA was enacted.

The Board rejected SNIPR’s argument, explaining that Section 3(n)(2) provides for continuation of interference under certain circumstances. The Board noted that the patentability requirement under 35 U.S.C. §102(g) and interference still apply to each claim having a priority date before March 16, 2013, such as the claims of Rockefeller’s involved application. Accordingly, when the Rockefeller claims would otherwise be allowable, except for the existence of an interference with other claims such as SNIPR’s claims, Section 3(n)(2) necessarily calls for an interference proceeding between the Rockefeller application and the SNIPR patents. Otherwise, the PTO would not be able to determine whether Rockefeller was entitled to a patent under 35 U.S.C. §102(g).

The Board further reasoned that, instead of ending all interferences at the implementation of the AIA, US Congress enacted Section 3(n)(2) to continue the interference proceeding as applicable to certain cases after AIA. Congress also did not explicitly require that cases involved in interferences must all have priority dates before March 16, 2013. Therefore, the Board found that Congress contemplated interferences between pre-AIA and post-AIA applications and patents. Accordingly, the Board ruled in Rockefeller’s favor, finding it was the first to invent the claimed technology.



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Obvious to Try Requires Reasonable Expectation of Success Tethered to Claimed Invention

by | Dec 16, 2021 |

Addressing obviousness in the context of method of treatment claims using particular drug dosages, the US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board (Board) final written decision holding that Teva failed to prove obviousness because it failed to show a reasonable expectation of success. Teva Pharms., LLC v. Corcept Therapeutics, Inc., Case No. 21-1360 (Fed. Cir. Dec. 7, 2021) (Moore, C.J.)

Corcept filed a New Drug Application (NDA) for Korlym, a 300 mg mifepristone tablet administered to certain patients with Cushing’s syndrome. The US Food and Drug Administration (FDA) approved Corcept’s application but required a drug-drug interaction clinical trial to determine drug safety when co-administered with strong CYP3A inhibitors such as ketoconazole (Lee memorandum). Corcept conducted the drug-drug interaction study and received a patent relating to methods of treating Cushing’s syndrome by co-administering mifepristone and a strong CYP3A inhibitor based on the data from the Lee memorandum.

Teva sought post-grant review of the patent after Corcept asserted it against Teva in district court. Teva argued that the patent would have been obvious in view of Korlym’s label and the Lee memorandum and submitted a supporting expert declaration. The Board held that Teva failed to prove that a skilled artisan would have had a reasonable expectation of success for safe co-administration of more than 300 mg of mifepristone with a strong CYP3A inhibitor, and thus failed to prove that the patent was obvious. Teva appealed, arguing that the Board erroneously required precise predictability rather than reasonable expectation of success in achieving the claimed invention, and that the Board did not apply Federal Circuit prior art range precedents.

The Federal Circuit affirmed the Board’s decision. Turning first to reasonable expectation of success, the Court explained that the analysis must be tied to the scope of the claimed invention. Because the patent required safe administration of a specific amount of mifepristone, the Board did not err in requiring Teva to show a reasonable expectation of success for a specific mifepristone dosage. Applying this correct standard, the Court found that the evidence supported that a skilled artisan would have had no expectation as to whether co-administering dosages of mifepristone above the 300 mg/day threshold set forth in the Korlym label would be successful. The Federal Circuit also agreed with the Board that Teva’s expert testimony supported a finding of no expectation of success in achieving the claimed invention based on inconsistent testimony before and after institution.

Turning next to the applicability of Federal Circuit prior art range precedents, the Federal Circuit found that Teva had failed to prove that the general working conditions disclosed in the prior art encompassed the claimed invention. Substantial evidence supported the Board’s finding that there was no overlap in ranges because the prior art (Korlym label and industry publications) capped the range of co-administration dosages at 300 mg/day. The Court also noted that Teva’s reliance on mifepristone monotherapy dosages to create an overlap in the claimed ranges failed because the patent claims [...]

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