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Exploring the Latest in Intellectual Property Law
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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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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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Change the Look of the Room: Appeal Transferred to Federal Circuit

by | Jan 6, 2022 | ,

The US Court of Appeals for the Second Circuit transferred an appeal of a preliminary injunction enjoining alleged copyright and trademark infringement to the US Court of Appeals for the Federal Circuit because the operative complaint included six counts of patent infringement and thus arose under patent law. Hudson Furniture, Inc. et al. v. Lighting Design Wholesalers Inc., Case No. 20-3299 (2d Cir. Dec. 21, 2021) (Livingston, CJ; Kearse, Lee, JJ.) (per curiam).

Hudson filed a complaint against Lighting Design alleging patent, trademark and copyright infringement. The district court granted Hudson’s preliminary injunction and enjoined Lighting Design from alleged infringement of Hudson’s copyrights and trademarks. The district court also denied Lighting Design’s motion to dismiss for lack of personal jurisdiction and its motion for reconsideration permitting alternative service of process. Lighting Design appealed the rulings to the Second Circuit.

Hudson asked the Second Circuit to dismiss the appeal, arguing that the appeal arose from a complaint involving patent law claims and thus fell under the exclusive jurisdiction of the Federal Circuit. Under 28 U.S.C. §§ 1292 and 1295, the Federal Circuit has exclusive jurisdiction over interlocutory appeals involving any action that arises under any act of US Congress relating to patents. An action arises under patent law when a well-pleaded complaint establishes that (1) federal law creates the cause of action or (2) the plaintiff’s right to relief necessarily depends on resolution of a substantial question of federal patent law.

The Second Circuit agreed that exclusive jurisdiction rested with the Federal Circuit, explaining that the operative complaint included six counts of patent infringement, and the appeal concerned the district court’s ruling on a motion for injunctive relief involving patent law and non-patent law claims. The Court rejected Lighting Design’s argument that patent law did not constitute a substantial part of the overall success of the case since Hudson failed to secure preliminary injunctive related to the patent law claims. The Court explained that Lighting Design’s argument focused on only the second basis for Federal Circuit jurisdiction (whether the right to relief depends on a “substantial question” related to patent law). The Court found that even if it accepted Lighting Design’s argument, the fact that federal patent law created the cause of action was sufficient to establish Federal Circuit jurisdiction under the first basis of jurisdiction. While the Second Circuit agreed with Hudson, it declined to dismiss the appeal and instead opted to transfer the appeal to the Federal Circuit because the original appeal was timely filed in good faith and transferring the appeal was in the interest of justice.



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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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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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Exclusive Licensee Has Constitutional but Not Statutory Standing

by | Dec 9, 2021 |

The US Court of Appeals for the Federal Circuit vacated the dismissal of an exclusive licensee’s complaint for lack of statutory and constitutional standing, despite affirming that the licensee had no statutory standing where the district court erroneously found no constitutional standing. Univ. of So. Florida Res. Found., Inc. v. Fujifilm Med. Sys. U.S.A., Inc., Case No. 20-1872 (Fed. Cir. Nov. 23, 2021) (sealed opinion issued Oct. 22, 2021) (Stoll, J.)

In April 1997, the University of South Florida (USF) received an invention disclosure related to a workstation-user interface for digital mammography. In September 1997, the inventors, USF and the USF Research Foundation (USFRF) entered into a revenue allocation agreement assigning all rights in the invention to USF. The inventors also entered into a separate assignment agreement in 2002. The patent issued in 2003. The revenue allocation agreement was later followed by a nunc pro tunc license agreement, which recited an effective date of July 1997.

In May 2016, USFRF sued Fujifilm Medical Systems for infringement of the issued patent. USFRF pled that USF assigned its rights in the issued patent to USFRF such that USFRF was “currently the owner” of the patent. In June 2019, Fujifilm moved for summary judgment, arguing that USFRF lacked statutory standing because USF had not fully assigned the patent to USFRF. Five days later, USFRF amended its complaint to state that it was an exclusive licensee (i.e., it was not the assignee).

In May 2020, the district court dismissed the case, finding that USFRF lacked both statutory and constitutional standing. Analyzing the nunc pro tunc license agreement, the district court found a lack of statutory standing because the agreement was silent on (and thus did not transfer to USFRF) the right to sue to enforce the patent. The district court also found that USFRF lacked constitutional standing because USFRF had not established that the invention disclosure number in the license agreement corresponded to the issued patent and had not shown that the nunc pro tunc agreement was signed before the complaint was filed. USFRF appealed.

The Federal Circuit analyzed both statutory and constitutional standing and affirmed the district court’s finding with respect to statutory standing, reasoning that this case was analogous to others in which an exclusive licensee lacked statutory standing because the right to sue was either not transferred or only partially transferred. The Federal Circuit found that the district court had clearly erred with respect to constitutional standing, however. First, the Court held that there had been sufficient evidence tying the invention disclosure identified in the assignment agreement to the issued patent. Second, the Court found that it did not matter when the nunc pro tunc agreement was signed because the original revenue allocation agreement was signed before the complaint was filed and conveyed at least one exclusionary right to USFRF—enough for USFRF to have constitutional standing.

Because “the district court’s dismissal was predicated on constitutional standing,” the Federal Circuit remanded for further proceedings, including determination of whether USFRF may join USF.

[...]

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IPR on Written Description? Claims Found Unpatentable Based on Lack of Entitlement to Priority Date

by | Dec 9, 2021 |

The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board (Board) ruling, based on a written description analysis, that certain claims were invalid as anticipated by an earlier priority application from the same family. Indivior UK Ltd. v. Dr. Reddy’s Labs. S.A., Case Nos. 20-2073, -2142 (Fed. Cir. Nov. 24, 2021) (Lourie, J.) (Linn, J., concurring in part and dissenting in part).

Indivior’s patent, which issued from a fifth continuation application claiming priority back to 2009, claimed orally dissolvable films with therapeutic agents. Some of the claims recited numeric ranges, such as “about 40% wt to about 60% wt of a water-soluble polymeric matrix.” Instead of a range, one claim recited a specific amount of “about 48.2% wt” of the polymeric matrix. The patent’s specification did not expressly mention the claimed ranges or the specific 48.2% amount, but it did contain tables comprising quantities of polymer from which Indivior contended a person of ordinary skill in the art could calculate the percentage of polymer by weight.

Indivior argued that the polymer weight percentage limitations were supported by the priority application and, therefore, the patent was entitled to that priority date. Dr. Reddy’s contended that since the polymer weight percentage limitations were added later, an intervening patent publication (Myers) was prior art and anticipated the claims. Indivior did not contest that if Myers was prior art, it anticipated the claims. As a result, the Board’s decision on anticipation under 35 U.S.C. §102 turned on the priority analysis which, in turn, hinged on written description. The Board found that the tables disclosed formulations from which the “48.2% wt” could be calculated and, thus, claims reciting that limitation were not anticipated by Myers. However, the Board found that the claimed ranges (i.e., about 40% wt to about 60% wt) were not disclosed in the specification, and those claims were therefore anticipated by Meyers. Indivior appealed the Board’s anticipation finding, and Dr. Reddy’s appealed the no anticipation finding.

The Federal Circuit first analyzed the specification and concluded that there was no written description support for the broader range of “about 40% wt to about 60% wt.” The Court explained that the range was not disclosed in the specification, the specific values of 40% and 60% were not disclosed and there was another “inconsistent” teaching for weights of “at least 25%.” The Court noted that two specific tables in the specification “do not constitute ranges; they are only specific, particular examples. For written description support of a claimed range, more clarity is required.” The Court explained that “[h]ere, one must select several components, add up the individual values, determine the aggregate percentages, and then couple those aggregate percentages with other examples in the [] application to create an otherwise unstated range. That is not a written description of the claimed range.” The Court applied similar analysis in finding lack of written description for other claims reciting a slightly different range. Ultimately, the Court agreed that there was no written [...]

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