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Exploring the latest in intellectual property law
IP UPDATE
Exploring the latest in intellectual property law
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Federal Circuit Tosses Shaw: IPR Estoppel Applies to All Grounds That Reasonably Could Have Been Raised

by | Feb 17, 2022 |

March 2022 Update: The Federal Circuit has issued an errata to this decision. Read about it here.

Addressing inter partes review (IPR) estoppel after the Supreme Court of the United States’ 2018 decision in SAS Institute, Inc. v. Iancu, the US Court of Appeals for the Federal Circuit overruled its decision in Shaw Industries Group v. Automated Creel Systems, stating that the only plausible reading of 35 U.S.C. § 315(e)(2) estops a party from raising all claims and grounds that reasonably could have been included in the party’s petition for IPR. The Court also rejected the district court’s two-tier damages model as contrary to customary patent damages calculations. California Institute of Technology v. Broadcom Limited, Case Nos. 20-2222; 21-1527 (Fed. Cir. Feb. 4, 2022) (Lourie, Linn, Dyk, JJ.) (Dyk, J., dissenting in part).

Background

California Institute of Technology (Caltech) filed suit against Broadcom and Apple, alleging patent infringement directed to the generation and repetition of information in a wireless data transmission system. Wireless transmission systems generally use data repetition so that the transmitted information may be decoded even when data loss occurs. The patented circuitry discloses a form of irregular data repetition in which portions of the information bits may be repeated a varying number of times.

Apple filed multiple IPR petitions challenging the validity of the claims at issue. The Patent Trial & Appeal Board (Board) concluded in all cases that Apple failed to show that the challenged claims were unpatentable as obvious. At the district court, Apple and Broadcom raised new arguments of obviousness not asserted in the IPR proceedings. The district court granted Caltech’s motion for summary judgment of no invalidity, precluding Apple and Broadcom from raising arguments at trial that they reasonably could have raised in their IPR petitions.

At trial, the district court instructed the jury that “repeat” means “generation of additional bits, where generation can include, for example, duplication or reuse of bits.” Apple and Broadcom argued that the Broadcom chips (which were integrated into Apple devices) did not infringe the asserted claims because they did not repeat information at all. With respect to one of the asserted patents, the district court did not provide a jury instruction relating to its construction that the claim language “information bits appear in a variable number of subsets” requires irregular information bit repetition. The jury found infringement of all asserted claims. Apple and Broadcom filed post-trial motions for judgment as a matter of law (JMOL) and a new trial, both of which the district court denied.

The district court adopted Caltech’s proposed two-tier damages theory, explaining that Broadcom and Apple’s products were different and therefore possessed different values simply because they were “different companies at different levels in the supply chain.” The district court ultimately entered judgment against Broadcom for $288 million and against Apple for $885 million. Broadcom and Apple appealed.

The Appeal

Broadcom and Apple argued that the district court’s construction of “repeat” was inconsistent with the claim language and specification. The Federal Circuit [...]

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IPR Petition Cannot Be Based on Applicant Admitted Prior Art

by | Feb 10, 2022 |

Addressing the type of prior art that may form the basis of an inter partes review (IPR) proceeding, the US Court of Appeals for the Federal Circuit vacated an unpatentability finding based on “applicant admitted prior art” in the challenged patent. Qualcomm Inc. v. Apple Inc., Case Nos. 20-1558, -1559 (Fed. Cir. Feb. 1, 2022) (Taranto, Bryson, Chen, JJ.)

Qualcomm owns a patent directed to integrated circuit devices having power detection circuits for systems with multiple supply voltages. The patent seeks to solve problems associated with stray currents causing level shifters in integrated circuits to trigger input/output devices for transmission, which results in erroneous output signals from the circuit. The patent describes various prior art methods for solving the stray current problem.

Apple filed IPR petitions based on two grounds. The first was based on the combination of four prior art references. In its final written decision, the Patent Trial & Appeal Board (Board) found that the combination of these four references did not render the challenged claims invalid. The second ground relied on the applicant admitted prior art disclosed in the specification of the challenged patent in combination with another prior art reference (Majcherczak). During the IPR proceedings, Qualcomm admitted that the combination of the applicant admitted prior art and Majcherczak taught every element of the challenged claims but argued that Apple’s use of the applicant admitted prior art as the basis for an invalidity ground is barred in an IPR proceeding. The Board disagreed with Qualcomm and found the challenged claims unpatentable based on Apple’s second ground. Qualcomm appealed.

Qualcomm argued on appeal that IPR proceedings may only be based on “prior art patents or prior art printed publications” and that 35 U.S.C. § 311(b), which governs IPR proceedings, does not allow for the use of “a patent owner’s admissions” that is contained in non-prior art documents. Apple countered, arguing that any prior art that is contained in “any patent or printed publication, regardless of whether the document itself is prior art, can be used as a basis for [an invalidity] challenge.”

The Federal Circuit agreed with Qualcomm, finding that applicant admitted prior art in a challenged patent may not form the “basis” for an invalidity claim in an IPR proceeding. The Court explained that invalidity grounds advanced in an IPR must be based on patents or printed publications that are themselves prior art to the challenged patent. In reaching this conclusion, the Court relied on the 2019 Supreme Court opinion in Return Mail, Inc. v. U.S. Postal Serv., which referred to “patents and printed publications” in the context of § 311(b) as “existing at the time of the patent application.” The Court also looked to its own interpretations of “prior art consisting of patents or printed publications” in the context of ex parte reexamination proceedings under 35 U.S.C. §§ 301 and 303, which “permits the Director to institute a reexamination after ‘consideration of other patents or printed publications.’” Accordingly, the Court vacated the unpatentability [...]

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The Net Is Tightening on European SEP Regulation

by and | Feb 10, 2022 | ,

The regulation of standard-essential patents (SEPs) has increasingly attracted the attention of policymakers in recent years. This includes the European Commission, which institutes multiple projects to profoundly review the European Union’s SEP and competition law framework. Some of these EU projects are still in the making, with the next public consultations coming up in early 2022.

EU review has been undertaken mainly for two reasons. The first is that the European Commission is responsible for the enforcement of European competition law. It is this set of rules that prohibits the abuse of a dominant market position in the European Union and, at least from an EU perspective, also obligates SEP holders to offer licenses on fair, reasonable and non-discriminatory terms (F/RAND terms). The second reason is the European Union’s goal to act as an international norm-setter in intellectual property (IP) protection.

In November 2017, the European Commission published an EU approach to standard-essential patents as part of its “IP Package.” The aim was to provide a clearer framework to incentivize and facilitate access to the key technologies enabling interconnection and connectivity.

These relatively narrow targets were made more concrete in November 2020 with the release of the “Intellectual Property Action Plan.” This plan sought to support the European creative and innovative industry sector in remaining a global leader. In the area of SEPs, the European Commission’s objective was to reduce friction and litigation between SEP holders and users by relying on potential regulatory reforms—in addition to industry-led initiatives—to clarify and improve the framework for SEP enrollment, licensing and enforcement. By providing incentives for good faith negotiations, the European Commission tried to reconcile the interests of SEP holders, standard development organizations (SDOs) and users of SEP-protected technologies.

In January 2021, the European Commission’s Group of Experts on Licensing and Valuation of SEPs published its contributions to the debate. This group, which consists of scholars, judges and stakeholders, proposed, inter alia, a number of principles for licensing SEPs, namely licensing at a single level of the value chain, a single F/RAND royalty, passing on F/RAND royalties downstream and establishing licensee negotiation groups. The European Commission’s next step in terms of a new framework for standard-essential patents is a public online consultation to be held in the first quarter of 2022.

Ahead of that event, on 2 February 2022, the European Commission presented its new Standardization Strategy, as well as a draft law amending EU Regulation No 1025/2012, with the aim of ensuring a balanced stakeholder representation within European SDOs and addressing the issue of agility and governance in the European standardization system. This strategy and the draft law highlight the European Union’s priority to defend its key position as a global standardization policymaker.

The EU Regulation of SEPs is also affected by the review of the EU Horizontal Block Exemption Regulation, which defines certain research and development (R&D) and specialization agreements that can be [...]

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PTO Launches New Patent Public Search Tool and Webpage

by | Feb 3, 2022 |

On February 1, 2022, the US Patent and Trademark Office (PTO) announced a new Patent Public Search tool similar to the search tools used by patent examiners to provide more convenient and robust full-text searching of all US patents and published patent applications.

The Patent Public Search tool is free to all users with internet access and is based on the advanced Patents End-to-End (PE2E) search tool used by patent examiners. It also combines the capabilities of four existing search tools scheduled to retire in September 2022: (1) Public-Examiner’s Automated Search Tool (PubEAST), (2) Public-Web-based Examiner’s Search Tool (PubWEST), (3) Patent Full-Text and Image Database (PatFT) and (4) Patent Application Full-Text and Image Database (AppFT). (In the past, the public could only access PubEAST and PubWEST at a PTO facility or a Patent and Trademark Resource Center.)

Additional benefits of the new search tool include:

  • Multiple layouts with several tools to provide more data at once
  • Multicolor highlighting that can be viewed across multiple gadgets and be turned on or off
  • Ability to tag documents into multiple groups that can be renamed and color coordinated
  • Ability to add notes, tags, relevant claims and highlights to an image
  • Use of the same searching syntax as PubEAST and PubWEST.

The PTO also introduced a new Patent Public Search webpage that includes FAQs, training resources and additional information to assist the public in using the new tool. The PTO is also planning on conducting public training sessions that will be posted on the webpage as soon as they are scheduled.



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Establishing Indefiniteness Requires More Than Identifying “Unanswered Questions”

by | Feb 3, 2022 |

The US Court of Appeals for the Federal Circuit reversed a district court finding of indefiniteness for focusing solely on the language of the claims and ignoring the specification and prosecution history. Nature Simulation Systems Inc. v. Autodesk, Inc., Case No. 20-2257 (Fed. Cir. Jan. 27, 2022) (Newman, Lourie JJ.) (Dyk, J., dissenting).

Nature Simulations Systems (NSS) asserted two patents against Autodesk that relate to packaging computer-aided data for three-dimensional objects. According to the patents, the claimed methods are improvements upon a “Watson” method known in the prior art. Following a Markman hearing that included technology tutorials from the named inventor and Autodesk’s expert, the district court considered whether two terms were indefinite: “searching neighboring triangles of the last triangle pair that holds the last intersection point” and “modified Watson method.”

The district court found both claim terms indefinite based on “unanswered questions” identified by Autodesk’s expert, who had raised three and four unanswered questions for the “searching” and “modified Watson” terms, respectively. NSS argued that all of the questions were answered in the specification, but the court held that “the claim language, standing alone” did not answer those questions. NSS appealed.

The Federal Circuit found flaws in the district court’s analysis because it adopted an incorrect “unanswered questions” analysis and analyzed the “claim language, standing alone.” The Court confirmed that the test for indefiniteness involves analyzing whether the claims provide reasonable certainty when viewed in light of the specification and prosecution history from the perspective of the person of ordinary skill in the art. Reviewing the specification, the Court observed that the text and figures of the specification of the asserted patents described the searching and intersection point process and the prior art Watson method and noted that the district court “declined to consider information in the specification that was not included in the claims.”

Reviewing the prosecution history, the Court further noted that both terms had been rejected during prosecution for indefiniteness, but that the examiner withdrew both rejections after amendments to the claims provided additional limitations. The Court faulted the district court for giving “no weight to the prosecution history showing the resolution of indefiniteness by adding the designated technologic limitations to the claims.” Instead, “PTO examiners are entitled to appropriate deference as official agency actions[.]” Ultimately, the Court observed that the claims were improvements to known methods, that it was undisputed the claims were described and enabled and that the examiner had held the claims to “define the scope of the patent subject matter.” For these reasons, indefiniteness was not established as a matter of law.

Judge Timothy B. Dyk dissented, stating that “[t]he fact that a patent examiner introduced the indefinite language does not absolve the claims from the requirements of 35 U.S.C. § 112.” Far from adopting a flawed “unanswered questions” analysis, Judge Dyk instead believed the court’s analysis was detailed and thorough, and that it was performed in view of the specification. Judge Dyk found the majority’s definition of the disputed terms inconsistent [...]

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Nailed It: Expert Must at Least Meet Ordinary Skill Level to Testify from POSITA Perspective

by | Jan 27, 2022 |

Addressing a US International Trade Commission (ITC) decision finding a § 337 violation as to one patent but no violation as to four other patents, the US Court of Appeals for the Federal Circuit reiterated that a technical expert must at least meet the level of ordinary skill in the art of the asserted patents to testify from the perspective of a person of ordinary skill in the art (POSITA), whether for claim construction, validity or infringement. Kyocera Senco Indus. Tools Inc. v. ITC, Case Nos. 20-1046, -2050 (Fed. Cir. Jan. 21, 2022) (Moore, C.J.; Dyk, Cunningham, JJ.)

In 2017, Kyocera filed a complaint at the ITC seeking a § 337 investigation based on infringement allegations for six patents directed to battery-powered gas spring nail guns. The investigation was assigned to the Chief Administrative Law Judge (ALJ), who, in the context of a Markman order, adopted Koki Holdings America Ltd.’s uncontested level of skill in the art as including “experience in powered nailer design.” After claim construction, Kyocera dropped one patent from the investigation and went forward with infringement under the doctrine of equivalents as the sole basis for violation for four other patents.

Prior to the evidentiary hearing, Koki moved to exclude Kyocera’s expert’s testimony due to their admission during deposition that they did not have the experience in powered nailer design required by the adopted level of ordinary skill in the art. The Chief ALJ held that the Federal Circuit’s decision in AquaTex Indus. v. Techniche Sols. expressly required that Kyocera’s expert’s testimony be excluded as to infringement under the doctrine of equivalents but permitted the expert to testify as to literal infringement on one patent and on claim construction. After the evidentiary hearing, the Chief ALJ issued an initial determination that relied, in part, on Kyocera’s expert to find a particular element satisfied on the one remaining patent where literal infringement was asserted, but ultimately found no infringement due to other claim limitations. The Chief ALJ’s noninfringement decision as to the one remaining patent was then overturned on review by the full ITC, which found a § 337 violation and issued a limited exclusion order.

Kyocera appealed the Chief ALJ’s exclusion of its expert’s testimony on doctrine of equivalents, and Koki cross-appealed on the Chief ALJ’s decision to allow Kyocera’s expert to testify as to literal infringement and claim construction. The Federal Circuit reversed the ITC’s decision, holding that it was error to permit any infringement testimony from Kyocera’s expert and explaining that a witness must at least have ordinary skill in the art to offer testimony from the perspective of a skilled artisan for claim construction, validity or infringement, whether literal or under the doctrine of equivalents.

Alexander Ott was a member of Koki’s ITC trial team and the Federal Circuit appeal team in this case.



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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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