Banner Witcoff attorneys Apurv Gaurav and Kirk Sigmon have been recognized in the 2019 edition of Managing Intellectual Property Rising Stars.
The guide features up-and-coming IP practitioners from more than 20 jurisdictions who contribute to the success of their firms and clients. Apurv and Kirk — who are both based in Banner Witcoff’s Washington, D.C., office — are two of only about 100 attorneys across the nation named to the United States (National) list.
The Rising Stars list is based on information Managing IP collected during its research for the 2019 edition of IP STARS, an annual guide to leading IP firms and senior IP practitioners worldwide. Several Banner Witcoff attorneys were recognized in the 2019 edition of IP STARS.
An article written by Banner Witcoff attorneys Azuka Dike and Kirk Sigmon was featured in The Licensing Journal, a publication focused on intellectual property and entertainment law.
In the article, Azuka and Kirk discuss the wearables market and various intellectual property issues to consider with wearables (electronics that are worn on the body, like smartwatches and fitness trackers). They also offer tips for building a strong IP portfolio and stress the importance of strategic planning.
“Once you have built a targeted ‘IP’ portfolio, prepare for the worst, and be ready to cross-license with and/or litigate against competitors,” the authors note, later adding that “[i]n the wearables market, as in many areas of business and law, an ounce of prevention is worth a pound of cure.”
Click here to view their article, “How to Play (and Win) in the Wearables Market.” It appeared in the August 2019 edition of The Licensing Journal, a publication issued 10 times a year by Wolters Kluwer Publishers.
By Sarah A. Kagan, Ph.D.
Earlier this fall, a German research organization convinced the U.S. Court of Appeals for the Federal Circuit that the U.S. District Court of Delaware had mistakenly dismissed its infringement suit against Sirius XM Radio Inc. (SXM) based on the broadcasting company’s defense that it had a sublicense to use the patents.
In its recent ruling, the Federal Circuit vacated and remanded the suit to the district court so that Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung E.V. (FH) and SXM could establish an appropriate record and the district court could make factual findings. 
FH — a government sponsored, nonprofit research organization — developed and patented multicarrier modulation technology for transmitting multiple data streams. In 1998, it exclusively licensed the technology to WorldSpace International Network Inc. (WS), giving WS the right to sublicense. WS soon after exclusively sublicensed the technology to SXM for use in the United States only. SXM used the technology to develop its digital audio radio system. FH also served as technical consultant to SXM in its development of the system.
Ten years later, WS filed for bankruptcy, during which it rejected the master license agreement from FH. As part of the bankruptcy process, WS and SXM entered a settlement agreement in which SXM agreed to pay WS for all its obligations under the sublicense and the parties agreed that the sublicense would remain in effect. Several years later, FH sent WS a letter purporting to terminate the master license agreement to WS. FH then sued SXM for patent infringement based on the theory that the master license agreement had been terminated, extinguishing the rights of sublicensee SXM. SXM maintained that its sublicense was still operative.
The district court focused its analysis on the sublicense and its durability, seemingly independent of the master license agreement. The Federal Circuit found error in the failure of the district court to construe the master license agreement.
Choice of Law
Although neither party raised the choice-of-law issue, it seemed to be what most animated the panel of judges of the Federal Circuit. Prior to oral hearing, the court advised the parties to prepare to address (1) whether the choice of law provision in the master license (“the Agreement shall be subject to, governed by, and construed in accordance with German law”) should govern interpretation of the master license and SXM’s rights, (2) whether SXM’s rights would survive termination of the master license under German law, and (3) whether the case should be remanded for proceedings to address German law.
At the oral hearing, FH urged that both parties had waived the application of German law by not raising it. Upon questioning, FH seemed to indicate that the sublicense would survive under German law but not under U.S. law. In its Oct. 17 opinion, the Federal Circuit agreed that the parties had waived the issue and that the law of the forum should be applied.
During oral arguments, the judges raised questions relating to interpretation of the master licensing agreement. U.S. Circuit Judge Timothy Dyk asked FH when the license had been terminated. Stating that WS’ rejection of the license during bankruptcy was not itself termination, but a breach that permitted FH to terminate, Judge Dyk pressed FH as to when it elected to terminate the master license agreement after the breach.
In response to SXM’s assertion that New York law should be applied to the sublicense, Circuit Judge Richard Taranto said that he thought the court needed to resolve the status of the master license agreement, because the sublicense was fully paid up at the time of the bankruptcy.
Judge Dyk also asked about the nature of the fees that FH asserted WS had not paid: Were they for U.S. prosecution? Were they for maintenance fees? Did they relate to the asserted patents? These issues will likely play into the district court’s interpretation on remand of the termination conditions in the master license agreement.
The Opinion of the Panel
The Federal Circuit opinion corrects a misapprehension of its precedent on which the district court’s dismissal rested: Federal Circuit law does not provide for automatic survival of a sublicense when the master license has been terminated. Rather, the court must interpret the particular master license to determine if a sublicense survives.
The Federal Circuit found the master license agreement equivocal on the issue of sublicense survival. Its opinion notes that the master license agreement was designated as irrevocable, but also contained provisions referencing termination. The court instructs the district court on remand to investigate extrinsic evidence of the circumstances surrounding the agreement to determine the intent of the parties. The Federal Circuit’s opinion lists six facts (some known and some not yet known) that should be considered by the district court in resolving the ambiguity:
- the fact that SXM had performed all its obligations under the sublicense agreement at the time of the alleged termination of the master agreement;
- FH’s knowledge of and agreement to the terms of the sublicense agreement and the amendments made to the sublicense agreement;
- whether the parties discussed SXM’s long-term reliance on the license’s validity;
- FH’s own role in constructing the allegedly infringing devices and the parties’ assumptions that a license would be required for SXM’s continued use of the devices;
- other discussions among FH, WS, and SXM before and after the execution of the relevant agreements that may shed light on the effect of a termination of the master agreement on the sublicense; and
- commercial practices and custom, particularly as it relates to the default rule that should apply if the agreement remains ambiguous after considering extrinsic evidence as to the parties’ conduct.
The Federal Circuit opinion sets up a logic flow chart for the district court that gives SXM two ways to win and FH just one. The court should ask first whether the master license agreement was properly terminated. If not, then SXM still has a valid sublicense. If the master license was properly terminated, then the court must determine if the sublicense nevertheless survives, based on the interpretation of the master license agreement. If the sublicense survives, SXM retains a valid sublicense. If the sublicense does not survive, SXM is subject to FH’s charges of infringement.
FH in its briefs repeatedly characterized SXM’s license defense as “not exactly
your plain vanilla license defense,” one wonders: why not? The license/sublicense combination seems
anything but exotic. Ditto an allegedly
defaulting party. Nonetheless, the
master license agreement left the fate of sublicenses unclear, at least
according to the three-judge panel of the Federal Circuit. License drafters are on notice to clarify
this crucial aspect in their future licenses.
 Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung E.V. v. Sirius XM Radio Inc., 2018-2400 (Fed. Cir.) (October 17, 2019)
 The panel consisted of U.S. Circuit Judges Timothy Dyk, Richard Taranto, and Richard Linn.
Banner Witcoff attorney Jason S. Shull and Xia Zheng, founder and president of AFD China Intellectual Property, examined the U.S. and Chinese patent law systems for a Dec. 2 Law360 expert analysis.
In their article, Jason and Xia analyze various aspects of the two systems and provide an overview of key prefiling considerations, legal standards, defenses, and available remedies for patent infringement in China.
The duo’s article also details several obstacles that patent owners will face in China as compared to litigation in the U.S., and stresses the importance of U.S. companies including China in their global patent litigation strategies.
“To maximize the likelihood of successfully enforcing its patent rights in China, a company should become familiar with the similarities and differences between the Chinese and U.S. systems as it develops an effective approach to its international strategy,” the authors note.
Their article, “Your Global Patent Litigation Strategy Should Include China,” is available online to Law360 subscribers.
By Sarah A. Kagan, Ph.D.
In early November, Merck Sharp & Dohme Corp. and Wyeth LLC presented oral arguments to the U.S. Court of Appeals for the Federal Circuit on an appeal from two inter partes reviews (IPRs) related to a vaccine to prevent pneumococcal diseases, such as pneumonia, meningitis, bacteremia, sepsis, and middle ear infection.
On Nov. 26, the court issued its non-precedential decision to vacate and remand the two IPRs to the Patent Office’s Patent Trial and Appeal Board (PTAB) for further proceedings. It found the PTAB’s decision “too cryptic to survive judicial review.”
Click here to read a previous Banner Witcoff IP Alert that summarizes the oral hearing and provides additional background information.
Although the court did not cite the Administrative Procedure Act (APA) in its decision, its reasoning was consistent with Merck’s assertion that the PTAB had violated 5 U.S.C. §§ 706(2)(A) and (E) of the APA in failing to explain its rationale. The court found that the record contained disputed issues of fact. Yet, rather than addressing those issues, the PTAB’s final written decisions avoided them.
Specifically, the court found conflicting evidence relating to whether a person of skill in the art would have been motivated to combine 13 serotypes into conjugates with CRM197 protein and whether the potential for “immune interference” would have dissuaded the person of skill in the art from making the 13-conjugate combination. The court stated that the PTAB’s differing conclusions on obviousness of claims that only differed by the number of serotype conjugates in the combination underscored the need for further explanation.
The court also instructed the PTAB on remand to consider a reference that it had disregarded as merely cumulative. Merck’s expert relied on the reference, a memorandum from Ireland’s Environmental Protection Agency, which indicated that Wyeth in 2003 intended to produce a 13-valent conjugate vaccine with only the CRM197 protein as the conjugate protein.
Merck had argued that the phenomenon of immune interference was irrelevant to obviousness because the PTAB construed the Wyeth claim as not requiring any specific level of immunogenicity. The court rejected that argument. It found immune interference relevant to motivation to conjugate all 13 serotype polysaccharides to a single carrier protein—CRM197.
Throughout the oral arguments and the opinion, the court made clear that the mere fact that the Peña reference did not show that a vaccine it was testing was successful was not sufficient to render the claimed subject matter non-obvious. Obviousness, the court stated, does not require that the prior art show success.
We will have to wait to see if the PTAB explains its initial decision more fully or, upon reconsideration in view of the court’s guidance, changes its opinion of the patentability of claim 18.
The court’s decision will likely embolden appellants in the future to attack PTAB decisions for failure to comply with the APA, in addition to attacking the merits of the decision.
 Merck Sharp & Dohme Corp. v. Wyeth LLC,(2018-2133, -2134) (Fed. Cir.) (Nov. 26, 2019)
 See footnote 4.
By Sarah A. Kagan, Ph.D.
Earlier this month, a panel of the U.S. Court of Appeals for the Federal Circuit consisting of Chief Judge Sharon Prost and Judges Timothy Dyk and Evan Wallach heard arguments in Merck Sharp & Dohme Corp. v. Wyeth LLC.
Merck petitioned and the U.S. Patent Trial and Appeal Board (PTAB) instituted two inter partes reviews (IPRs) of Wyeth’s U.S. Patent 8,562,999 on the basis of alleged obviousness. Merck prevailed in showing all claims obvious except dependent claim 18. Merck appealed the sparing of claim 18 to the Federal Circuit, asserting that the PTAB had erred (1) in its assessment of the evidence; (2) in the legal test it applied; and (3) in violating the Administrative Procedure Act’s (APA) requirement for reasoned decision-making.
The sole claim at issue — claim 18 of the ’999 patent — depends from claim 1, which recites a formulation which inhibits aggregation induced by a siliconized container. Claim 1 reads:
1. A formulation comprising (i) a pH buffered saline solution, wherein the buffer has a pKa of about 3.5 to about 7.5, (ii) an aluminum salt and (iii) one or more polysaccharide-protein conjugates, wherein the formulation is comprised in a siliconized container means and inhibits aggregation induced by the siliconized container means.
Claim 18 specifies the one or more polysaccharide-protein conjugates as 13 particular pneumococcal polysaccharide conjugates, each of which comprises the CRM197 polypeptide, a genetically detoxified form of diphtheria toxin. Claim 18 reads:
18. The formulation of claim 1, wherein the one or more polysaccharide-protein conjugate comprises an S. pneumoniae serotype 4 polysaccharide conjugated to a CRM197 polypeptide, an S. pneumoniae serotype 6B polysaccharide conjugated to a CRM197 polypeptide, an S. pneumoniae serotype 9V polysaccharide conjugated to a CRM197 polypeptide, an S. pneumoniae serotype 14 polysaccharide conjugated to a CRM197 polypeptide, an S. pneumoniae serotype 18C polysaccharide conjugated to a CRM197 polypeptide, an S. pneumoniae serotype 19F polysaccharide conjugated to a CRM197 polypeptide, an S. pneumoniae serotype 23F polysaccharide conjugated to a CRM197 polypeptide, an S. pneumoniae serotype 1 polysaccharide conjugated to a CRM197 polypeptide, an S. pneumoniae serotype 3 polysaccharide conjugated to a CRM197 polypeptide, an S. pneumoniae serotype 5 polysaccharide conjugated to a CRM197 polypeptide, an S. pneumoniae serotype 6A polysaccharide conjugated to a CRM197 polypeptide, an S. pneumoniae serotype 7F polysaccharide conjugated to a CRM197 polypeptide and an S. pneumoniae serotype 19A polysaccharide conjugated to a CRM197 polypeptide.
For much of the Nov. 7 oral arguments, the panel seemed to be chasing down the basis for the PTAB’s holding that claim 18 was not proven to be obvious. The judges repeatedly asked both Merck and Wyeth if it was obvious to select the particular 13 polysaccharides. Merck said that it did not think that was the basis of the Board’s decision to hold claim 18 not proven obvious, because one of the cited references, Peña, specifically taught the 13 polysaccharides recited in claim 18. Indeed, the PTAB’s final written decisions appear to acknowledge that the Peña reference taught the same 13 polysaccharides, and instead relied on the failure of Peña to teach whether and to what those 13 polysaccharides were conjugated.
In its final written decisions, the PTAB rejected an argument from Merck that a person of skill in the art would have been motivated to go from the prior art seven-valent, nine-valent, and 11-valent vaccines to the 13-valent vaccine of claim 18 by a “natural progression.” Merck explained the phrase during oral arguments as just another way of saying it would have been obvious. Chief Judge Prost noted that an explanation of motivation was needed to avoid use of improper hindsight. Wyeth countered Merck’s “natural progression” argument by noting that the prior art nine-valent vaccine was not in a buffer as required in the recited formulation and the prior art 11-valent vaccine used multiple carrier proteins, contrary to the disputed claim’s recitation of a single carrier protein—CRM197—conjugated to all 13 polysaccharides. As Wyeth argued in its brief, the prior art failed to teach a 13-valent conjugate vaccine.
Throughout the hearing, the panel repeatedly asked the parties to point to portions of the IPR records where an expert witness interpreted the prior art in the manner that supported their assertions.
Judge Dyk to Merck: Did you have expert evidence that said that?
Chief Judge Prost to Merck: Where’s your expert testimony?
Judge Dyk to Merck: Show us what and where your expert says that.
Judge Dyk to Merck: What you need is some expert testimony.
Chief Judge Prost to Wyeth: Did you have an expert testifying to that?
Judge Dyk to Wyeth: Did you have an expert say that?
Judge Dyk to Wyeth: Did your expert say that?
This drumbeat of questions reflects the appellate court’s need to assess whether substantial evidence supported the PTAB’s underlying factual determinations of its non-obviousness decision.
The court again focused on record evidence in response to Merck’s urging that the PTAB’s final written decision was defective under the APA. Judge Wallach noted that Merck’s problem [in making this argument] may be that although the opinion failed to specifically point to evidence to support its holding, nonetheless the record is full of evidence to support its holding.
In its rebuttal time, Merck tried to cast Wyeth’s ’999 patent as an improper attempt at “evergreening” its protection for its commercial product, Prevenar 13. Merck asserted that Wyeth already had protection for an effective 13-valent vaccine. Wyeth’s attempt to protect its formulation, Merck said, was merely an attempt to extend its initial protection of the vaccine by one year. The existence of a prior patent has been considered relevant to objective indicia of non-obviousness by the Federal Circuit; however, the PTAB did not reach the objective indicia of non-obviousness in its decision.
Merck asserted in its brief that the PTAB used the wrong test to analyze motivation to combine. It asserted legal error in the PTAB formulating the obviousness inquiry as whether a person of skill in the art would have been motivated to modify one reference with another, rather than whether a person of skill in the art would have understood that the teaching of the first reference could be applied to the second reference, citing Belden v. Berk-Tek. Merck urged that the Federal Circuit in Belden reversed the PTAB because it wrongly used a motivation-to-modify test rather than a motivation-to-apply test. Merck did not make this argument at the oral hearing.
The oral hearing focused on the PTAB’s assessment of evidence of obviousness, rather than Merck’s other asserted issues of using an erroneous legal standard and improper administrative agency decision-making. The panel’s insistent refrain of asking for citations to the evidentiary record highlights the Federal Circuit’s view of its role — to review the factual determinations underlying the obviousness determination to ascertain if the PTAB’s based its determination of non-obviousness on substantial evidence.
Click here to
listen to the arguments in Merck
Sharp & Dohme Corp. v. Wyeth LLC.
 Merck Sharp & Dohme Corp. v. Wyeth LLC,(2018-2133, -2134) (U.S. Court of Appeals for the Federal Circuit)
 Merck Sharp & Dohme Corp. v. Wyeth LLC,(IPR2017-00378) and (IPR2018-00380) (U.S. Patent and Trademark Office Patent Trial and Appeal Board)
 Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064 (Fed. Cir. 2015)
An article penned by Banner Witcoff attorneys Anna King and Heather Smith-Carra was featured in a recent issue of The Licensing Journal, a publication focused on intellectual property and entertainment law.
In their article, Anna and Heather discuss trademark portfolio audits and explore the goals and process of these audits. They also offer some tips and factors for brand owners to consider when conducting trademark audits.
“If a portfolio is regularly audited, brand owners and their counsel will be able to act more efficiently, both offensively and defensively, to protect brands,” the authors note.
Click here to view their article, “Trademark Portfolio Audits: How and Why you Should Do Them.” It appeared in the September 2019 edition of The Licensing Journal, a publication issued 10 times a year by Wolters Kluwer Publishers.
Banner Witcoff attorney Novaira Paul has been elected to the executive board of the South Asian Bar Association (SABA) of Chicago. She will serve as vice president of communications for a one-year term beginning on Jan. 1, 2020.
Novaira, who currently serves on the board as a general director, was sworn in during the association’s 10th Annual Gala and Foundation Benefit on Nov. 16. Banner Witcoff sponsored the event, which will feature a dinner and installation ceremony, as well as a cocktail reception and silent auction that will benefit the SABA Chicago Foundation.
SABA Chicago is a volunteer bar association serving Chicagoland’s South Asian community. The association works to provide its members with professional growth and development opportunities.
Click here for more information about SABA Chicago.
By Sarah A. Kagan, Ph.D.
As the legislative and executive branches of the U.S. government spar over their respective powers to carry out various acts of investigation, so too do other offices of the government jockey for authority. If a government entity takes an action without proper authority, that action can be nullified by a court. That recently happened in the appeal of two Post Grant Review (PGR) decisions to the U.S. Court of Appeals for the Federal Circuit.
On Oct. 1, the court issued its opinion in Honeywell International Inc. v. Arkema Inc., finding that the U.S. Patent and Trademark Office Patent Trial and Appeal Board (PTAB) had exceeded its authority by failing to permit Honeywell to file a motion for permission to file a petition for a certificate of correction with the director of the U.S. Patent and Trademark Office (USPTO).
Arkema filed two PGR petitions to review Honeywell’s U.S. Patent No. 9,157,017 (’017), asserting that the ’017 patent was not entitled to the benefit of its claimed 12-year chain of priority due to a lack of written description in the priority applications. Without benefit of those priority claims, Arkema asserted, intervening references and events anticipated or rendered obvious the challenged ’017 claims.
After institution of the PGR proceedings, Honeywell recognized that when it changed the subject matter of the original claims in the underlying application by preliminary amendment, it had not made a corresponding change to its priority claims. The original claims were directed to a method of producing a catalyst, a cleaning composition, a method of applying a medicament, a method of sterilizing, a method of extinguishing a fire, a flavor formulation, a fragrance formulation, and an inflating agent. The prosecuted and issued claims were directed to a method for producing an automobile air conditioning system.
During the PGR proceeding, Honeywell asked the PTAB for permission to file a motion for leave to request a certificate of correction from the director of the USPTO. Honeywell indicated that it intended to amend the priority claim to include different applications that provide support for the automotive air conditioning system. The PTAB rejected the request, explaining that Honeywell had failed to show during two telephone conferences that it had met the statutory requirements that the error be clerical or typographical or of a minor character for successfully obtaining a certificate of correction.
The criteria are specified in 35 U.S.C. 255, which states:
“Whenever a mistake of a clerical or typographical nature, or of minor character, which was not the fault of the Patent and Trademark Office, appears in a patent and a showing has been made that such mistake occurred in good faith, the Director may, upon payment of the required fee, issue a certificate of correction, if the correction does not involve such changes in the patent as would constitute new matter or would require re-examination. Such patent, together with the certificate, shall have the same effect and operation in law on the trial of actions for causes thereafter arising as if the same had been originally issued in such corrected form.”
The PTAB’s denial is puzzling because the USPTO has a history of permitting priority chain corrections via certificates of correction. Indeed, the Manual of Patent Examining Procedure (MPEP) contains a section that states that a certificate of correction can be used to add benefit claims. See MPEP Section 211.02(a)(II)(B).
The PTAB conducted a complete PGR process based on the uncorrected patent, ultimately finding that the ’017 patent as issued was not entitled to any of its existing priority claims and that, consequently, it was invalid for public use prior to the actual filing date of the application that matured into the ’017 patent.
Honeywell appealed to the Federal Circuit, which reviewed the PTAB’s actions under the Administrative Procedure Act. The Federal Circuit found an abuse of discretion in the PTAB’s denial of Honeywell’s request to file a motion for permission to file a petition to the USPTO’s director for a certificate of correction. The court reasoned that the PTAB had assumed authority that the statute expressly delegated to the director, i.e., to determine whether a certificate of correction would be proper.
The Federal Circuit found that the PTAB short-circuited the whole correction process by refusing to authorize the motion, apparently because the PTAB determined that the proposed petition should not be granted. The PTAB’s denial, the court concluded, usurped the director’s right to decide the issue of correction on its merits. The PTAB separately erred by making a decision on the merits without the benefit of a motion from Honeywell. The court found further PTAB error in its concluding without providing explanation or evidence that Arkema would be prejudiced by permitting Honeywell to file its motion.
The court specified that upon remand, the PTAB must authorize Honeywell’s motion and then review it. The PTAB may consider prejudice to Arkema.
If Honeywell is successful in correcting its priority claim, it may antedate the public uses previously held to render the claims unpatentable. It may also provide the ’017 patent with an effective filing date for all its claims that renders it ineligible for PGR challenge (pre-March 16, 2013).
The Federal Circuit’s decision is a demonstration of the
judicial branch keeping executive officers within their legislatively mandated
roles. Administrative agencies and
officers within the agencies may only act within the authority granted to
them. Affected parties can challenge actions
outside of granted authority in court and seek that such actions be set aside. As patent owners feel the force of the PTAB’s
power in striking down patents, they seem to be turning increasingly to
challenges to the authority of the PTAB, under the Administrative Procedure Act
as here, or under the U.S. Constitution, as in Arthrex, Inc. v. Smith & Nephew, Inc. (2018-2140) (Oct. 31,
 Honeywell International Inc. v. Arkema Inc., 2018-1151, 2018-1153 (October 1, 2019)
 Honeywell could not file a petition directly with the USPTO’s director, because the PTAB had exclusive jurisdiction over the patent during the PGR. Honeywell also could not file a motion to request leave to file the petition, because no motion may be filed with the PTAB without its pre-authorization to do so. To obtain a certificate of correction during a PGR, three steps are required. First, a party must gain pre-authorization to file a motion. Second, the party files a motion asking the PTAB to release its jurisdiction over the patent to the USPTO’s director. Third, the party petitions the director for a certificate of correction.
 The preliminary amendment and the application were filed on the same date.
 A patent owner has two ways potentially to fix a defective priority claim, according to the MPEP. A patent owner may petition for a certificate of correction or it may file a reissue application.
By Sarah A. Kagan, Ph.D.
Should a patentee be held to all statements it makes about its claims? Does prosecution history estoppel flow from a patentee’s arguments no matter when and where they are made in an administrative or judicial setting? Will a patentee’s statements limit a claim’s scope even if the Patent Trial and Appeal Board (PTAB) rejected the statements?
A panel of the U.S. Court of Appeals for the Federal Circuit consisting of Judges Alan Lourie, Kimberly Moore, and Kara Stoll grappled with these questions at an oral hearing on Sept. 5, 2019, in an appeal of Abbreviated New Drug Application (ANDA) litigation from the District Court of Delaware. The court has yet to issue its opinion.
Galderma Laboratories filed an infringement suit against Amneal Pharmaceuticals for its proposed generic version of Oracea® capsules, a once daily, 40 mg capsule for delivering doxycycline to treat acne rosacea. Galderma asserted eight patents against Amneal’s proposed generic version. One set of the patents relates to a pharmaceutical composition of doxycycline with an immediate release and a delayed release component. The second set of the patents relates to a method of treating rosacea with doxycycline in an amount that results in no reduction in skin microflora. Here we focus only on the first set.
The first set of patents was challenged in an inter partes review (IPR) proceeding in which Galderma argued for a narrow claim construction of its claims but the PTAB did not adopt that construction. Instead, the PTAB interpreted the claims more broadly. Specifically, Galderma argued that “delayed release” means no substantial release of doxycycline in the acidic stomach environment. The PTAB rejected that claim construction because it found that it was not supported in the specification.
Amneal asserted during oral arguments that a patentee is liable for all its statements regarding the scope of its claims. Judge Moore pushed back against this assertion because the PTAB’s rejection of Galderma’s construction was so clear. Judge Moore was concerned that a person of skill in the art reading the record of the patent might be confused and think that the PTAB’s rejection of Galderma’s construction released Galderma from its statement. Amneal countered that a rule that always held a patentee to its statements would lead to less confusion. Galderma argued that no reasonable competitor could rely on Galderma’s statements about its claims because the PTAB so clearly rejected them.
Judge Stoll showed concern that a patentee has no formal mechanism to change a position that it took in an IPR because the PTAB controls the papers filed in an IPR and might not permit the filing of miscellaneous papers. Judge Stoll asked each party what mechanism a patentee might use to change its position on the record. Galderma simply stated that it was not aware of any such mechanism. Amneal said that a party could at least try to supplement the record to withdraw its prior position, noting that Galderma had not tried.
Galderma argued that if the court held Galderma to its statements, it would create the anomaly that Galderma would be held to both the accepted and rejected claim constructions. It further noted that Amneal’s position on estoppel leads to the anomaly that the literal scope of the claims is broader than the scope of the claims under the doctrine of equivalents because of the operation of the urged prosecution history estoppel.
The judges and parties discussed American Piledriving Equipment, Inc. v. Geoquip, Inc., 637 F.3d 1324 (Fed. Cir. 2011) as perhaps the most relevant precedent. In American Piledriving, the Federal Circuit held that applicant’s statements made during prosecution may lead to a disavowal of claim scope, regardless of whether the examiner agreed with or relied on them. The judges noted that American Piledriving involved a claim construction issue rather than a doctrine of equivalents issue as in Galderma v. Amneal. Will that difference lead to a different rule? If the rule is to lead to clearer understanding of a claim’s scope by influencing a patentees’ behavior during prosecution and post-grant proceedings, then distinguishing the effect based on the issue that is later litigated seems counterproductive.
 Galderma Laboratories, L.P. v. Amneal Pharmaceuticals LLC (2019-1021).