Patentee’s Lexicography Negates Infringement Despite Defendant’s Use of Claim Term in Product Literature
In Plastic Omnium Advanced Innovation and Research v. Donghee America, Inc., Appeal No. 18-2087, the patentee’s lexicography of “parison” excluded the allegedly infringing product even though the alleged infringer’s product literature specifically described a “parison.”
Plastic Omnium (“Omnium”) sued Donghee America and Donghee Alabama (“Donghee”) for patent infringement. The two patents at issue described a method of manufacturing plastic fuel tanks. In the district court, the parties disputed the construction of the term “parison.” Omnium argued that the patentee acted as its own lexicographer, so the plain meaning of the term “parison”—i.e., “a hollow plastic tube exiting the die of an extrusion head”—did not apply. The district court agreed and adopted a narrowing construction of “parison” as “referring to a plastic tube … that … is split either immediately upon exiting the die or at some point thereafter.” Donghee moved for summary judgment of noninfringement based on this narrowing construction. The court granted the motion, finding that the accused product splits the alleged “parison” inside the extrusion equipment rather than outside as the construction required.
The Federal Circuit held that the district court properly applied its narrowing claim construction to the accused product. Omnium disputed neither the construction nor the facts concerning the operation of the accused product. The Federal Circuit acknowledged that Donghee’s literature says the accused product includes a “parison,” but explained that “the patentee’s definition of ‘parison’ in the specification and as construed by the court—not Donghee’s product literature—controls whether the accused product falls within the scope of the claim.” Thus, the Federal Circuit affirmed grant of summary judgment.
Judge Clevenger dissented, stating that the claim construction was not dispositive because the accused product included two structures that could be “the die” to which the construction referred. Omnium alleged that a parison cut after exiting the first die but before exiting the second die would satisfy the construction. According to the dissent, Omnium presented sufficient evidence to create a genuine dispute about whether the first alleged die could be “the die” the construction required. Thus, the dissent concluded that summary judgment was inappropriate.
Patent Applicant Not Required to Pay PTO’s Attorneys’ Fees – It’s Only American
Under Peter v. Nantkwest, Inc., Appeal No. 18-801, a patent applicant appealing an adverse decision of the Patent Trial and Appeal Board (“PTAB”) under 35 U.S.C. § 145 in a civil action in the District Court of the Eastern District of Virginia is not required to pay the Patent and Trademark Office’s (“PTO’s”) attorneys’ and paralegals’ pro rata salaries.
NantKwest filed for a patent directed to a method for treating cancer. The PTO rejected the application, which was affirmed by the PTAB. NantKwest appealed to the U.S. District Court for the Eastern District of Virginia under § 145. The district court granted the PTO’s motion for summary judgment. For the first time, the PTO submitted a motion to recover attorney’s fees under § 145, which states that “[a]ll the expenses of the proceedings shall be paid by the applicant.” The district court denied recovery of attorneys’ fees, finding that the statute did not clearly rebut the American Rule, which presumes that parties are responsible for their own attorneys’ fees.
In an opinion by Judge Prost, the Federal Circuit reversed. The Federal Circuit panel held that, even if the American Rule applied, “expenses” as used in § 145 included attorney’s fees. The Federal Circuit voted sua sponte to rehear the case en banc. The en banc Federal Circuit reversed, affirming the district court. The en banc Federal Circuit applied the American Rule to § 145 and found that the statute lacked the “specific and explicit” congressional authorization needed to displace the rule.
The Supreme Court unanimously affirmed the en banc Federal Circuit. The Supreme Court held that the American Rule’s presumption against fee shifting applied to all statutes, not just those which authorize fee shifting to prevailing parties. In analyzing whether Congress intended to depart from the American Rule, a court first looks to the language of the section at issue. Further, while the absence of a specific reference to attorney’s fees is not dispositive, Congress must provide a sufficiently “specific and explicit” indication of its intent to overcome the American Rule’s presumption against fee shifting. The Supreme Court held that § 145’s references to “all” and “expenses” did not invoke attorneys’ fees with sufficient clarity to overcome the presumption. The Supreme Court also held that other statutes using both the terms “expenses” and “attorneys’ fees” indicate that Congress understood the terms to be distinct and not inclusive of one another. Lastly the Supreme Court held that the history of the Patent Act also indicates that Congress did not intend to shift attorneys’ fees in § 145 actions. Thus, because the American Rule’s presumption against fee shifting applied to § 145 and was not overcome by the statute’s text or Congressional intent, the PTO could not recover the pro rata salaries of its legal personnel under § 145.
Specification’s Narrow Description of the Invention Results in Disavowal of Claim Scope
In Techtronic Industries Co. Ltd. v. ITC., Appeal No. 18-2191, the consistent description in the specification of a particular embodiment as the inventive aspect solving a problem in the prior art amounted to disavowal of claim scope, even in the absence of an express concession excluding alternative embodiments.
The Chamberlain Group filed a complaint at the U.S. International Trade Commission (“Commission”) alleging several companies, including Techtronic Industries, imported products that infringed its patent directed to a garage door opener. Although the Administrative Law Judge (“ALJ”) granted a summary determination of non-infringement, the Commission reversed the ALJ’s claim construction of the term “wall console” and vacated the initial determination of non-infringement. The ALJ then found the accused products infringed the patent and the Commission adopted the determination.
At issue before the Federal Circuit was whether the claim term “wall console” included wall-mounted garage door control units without passive infrared detectors. The court found it did not because the patent specification disclosed the invention as an improvement achieved by moving the passive infrared detector from the head unit to the wall console. The court noted the specification’s background section described the problems with the prior art garage door openers having the passive infrared detector in the head unit. The court then found the rest of the specification presented moving the detector to the wall console as the solution to the problem, and that the “entire specification focuses on enabling placement of the passive infrared detector in the wall console.”
The Federal Circuit rejected arguments that the disclosure did not amount to a disavowal when the specification did not state that it was “impossible” or “infeasible” to place the detector elsewhere. The Federal Circuit explained that, because the specification “plainly represents the scope of the invention to the exclusion of some embodiments,” such explicit statements were unnecessary to find disavowal. The Federal Circuit then reversed the Commission’s construction of “wall console” and final determination of infringement.
Safe Harbor Defense Under 35 U.S.C. §271(e)(1) Requires that the Accused Activity Is Solely for Uses Reasonably Related to Submitting Information to the FDA
Under Amgen Inc. v. Hospira, Inc., Appeal No. 19-1067, biological engineering activity that would otherwise constitute patent infringement is protected under a safe harbor, if the activity is solely for uses reasonably related to submitting information to the FDA. If the relevant patent is a method of manufacture, the relevant inquiry is whether the act of manufacture is solely for submitting information to the FDA. The relevant inquiry is not whether the products of the manufacture are for uses related to submitting information to the FDA.
Amgen accused Hospira of infringing a patent covering a method of manufacture for producing EPO—a protein that regulates red blood cells—based on Hospira preparing twenty-one batches of EPO. A jury determined that seven batches were subject to a safe harbor, but the remaining fourteen batches were not. The protected batches included two used to qualify Hospira’s process and equipment, and five batches used for mandatory pre-approval inspection by the FDA. The remaining batches were for various types of testing, revisions to release specifications, stability testing, and continued process verification.
On appeal, the Federal Circuit found that substantial evidence supported the jury’s finding that fourteen batches were not manufactured “solely for uses reasonably related to the development and submission of information” to the FDA. The court rejected Hospira’s argument that the safe harbor always applies in the pre-approval context. The court also rejected Hospira’s argument that simply submitting information about a drug substance lot to the FDA brings the manufacture of that lot within the safe harbor. Evidence showed that preparing the additional batches was not an activity required for FDA approval, but was to meet post-approval stability requirements or to prepare for commercialization. The Federal Circuit also affirmed the $70 million damages verdict that was based on the profit Hospira could have earned by being in place to launch its EPO as soon as the patents expired.
Defendant Awarded Attorney Fees After NPE Dismissed Frivolous Case With Prejudice
In Blackbird Tech LLC v. Health In Motion Llc., Appeal No. 18-2393, a court found a frivolous case was exceptional and awarded more than $360,000 in attorney fees, after the plaintiff persisted with the case for nineteen months and then dismissed the case with prejudice before trial.
Blackbird Tech, a non-practicing entity, sued Health in Motion for patent infringement related to exercise equipment. Health-in-Motion refused multiple settlement offers including a “walk away” settlement offer that would have provided a royalty-free license to the asserted patent. Blackbird refused Health-in-Motion’s counter offer that included payment from Blackbird, on the grounds that Health-in-Motion would ultimately be awarded attorney fees. After claim construction, discovery and fully briefing a motion for summary judgment of noninfringement, Blackbird voluntarily dismissed the suit with prejudice, executed a covenant not to sue, and moved to dismiss for lack of subject matter jurisdiction. The district court then awarded Health in Motion $363,243.80 in attorney fees.
The Federal Circuit affirmed the attorney fees award. The court agreed that Blackbird’s claim construction and infringement contentions were meritless. The court agreed that Blackbird litigated in an unreasonable manner. The court found multiple problems that supported the exceptional finding, including: (1) Blackbird’s multiple settlement demands were far less than the anticipated cost of defense, (2) Blackbird unreasonably delayed in producing documents, (3) Blackbird waited until pretrial submissions were due to file a notice of dismissal without first giving notice to opposing counsel. The Federal Circuit also held that the district court did not abuse its discretion in considering the need to deter future abusive litigation. The appellate court noted that Blackbird “has filed over one hundred patent infringement lawsuits, and none have been decided, on the merits, in favor of [Blackbird].”
New Arguments Presented for the First Time During PTAB Oral Hearings Are Not Always Waived
Under The Chamberlain Group, Inc. v. One World Technologies, Inc., Appeal No. 18-2112, new arguments may be raised during PTAB oral hearings so long as they clarify an earlier position, are responsive to arguments presented in the opponent’s reply, and do not raise entirely new issues or evidence.
One World petitioned for inter partes review of a patent owned by Chamberlain directed to programmable garage door and gate operator systems. One World argued the limitation “activities to be completed by a user” should be construed to mean “establishing which of the pre-determined activities a user must complete.” Chamberlain argued the term should be construed to require identifying multiple activities. In its reply, One World argued for the first time that the prior art also identifies multiple activities. At the hearing, Chamberlain argued for the first time that the claim requires identifying multiple activities before a transmitting step. The Board held that Chamberlain waived the new argument by raising it for the first time at the oral hearing, and also found the argument unpersuasive on the merits. Chamberlain appealed.
The Federal Circuit held the Board erred in finding waiver because the new argument merely clarified Chamberlain’s earlier position, did not raise new issues or present new evidence, and was responsive to an argument in One World’s reply. Nonetheless, the Federal Circuit affirmed because the new argument was not persuasive and the Board’s decision was supported by substantial evidence.
Single-Entity Requirement for Infringement Under § 271(a) Does Not Apply to § 271(g)
In Syngenta Crop Protection, LLC v. Willowood, LLC, Appeal No.18-1614, the Federal Circuit held that infringement under § 271(g) does not require a single entity to perform, direct, or control all of the steps of a patented process for infringement liability to arise from the importation into the United States, or the offer to sell, sale, or use within the United States of a product made by a process patented in the United States.
Syngenta filed a lawsuit against Willowood for infringement of patents covering a chemical compound, and a process for making the chemical compound. Willowood claimed that it did not infringe the process patent, and moved for summary judgment with regard to this patent. The district court, in interpreting 35 U.S.C. § 271(g), determined that, in order for infringement to occur, all steps of the claimed process must be performed by or attributable to a single entity. The district court determined that there was a genuine dispute of material fact as to whether Willowood’s supplier performed both steps of the process patent, and permitted the issue to proceed to trial. At trial, the jury found that Syngenta did not prove both steps of the claimed process were performed by or attributable to a single entity. Syngenta appealed the district court’s conclusion that § 271(g) requires every step of a claimed process to be performed by or attributable to a single entity.
The Federal Circuit reversed the district court’s judgment that one Willowood entity did not infringe the process patent under § 271(g). The Federal Circuit concluded that the district court incorrectly used § 271(a) jurisprudence to impose a single-entity requirement on the performance of a patented process under § 271(g). The Federal Circuit emphasized that liability under § 271(g), based on the language of the statute, is not predicated on practicing the claimed process, but instead is based on importing, offering for sale, selling, or using a product resulting from a patented process, and, therefore, the single-entity requirement does not apply to § 271(g).
Presumption of Nexus is Improper When a Commercial Product Includes Unclaimed But Functionally Relevant Features
Under Fox Factory, Inc. v. Sram, LLC, Appeal No. 18-2024, when a commercial product contains unclaimed features, a presumption of nexus between the claims and secondary consideration evidence can be assumed only if unclaimed features of the commercial product do not materially impact the functionality of the product.
Fox filed two petitions for inter partes review (“IPR”) of a patent owned by SRAM directed to a chainring structure for bicycles. The Board found that a combination of two references disclosed every limitation of the independent claims, and that a skilled person would have been motivated to combine the references. However, the Board found that Fox had not shown that the challenged claims would have been obvious in view of evidence of secondary considerations. In making this determination, the Board assumed that SRAM was entitled to a presumption of nexus between the challenged claims and SRAM’s X-Sync chainring commercial product. Fox appealed.
The Federal Circuit affirmed the Board’s determination that a skilled artisan would have been motivated to combine the asserted prior art; however, the Federal Circuit vacated the Board’s obviousness determination and remanded for reevaluation of the evidence of secondary considerations with the burden of proving nexus on SRAM. In its decision, the Federal Circuit found that the Board erred in presuming a nexus because no reasonable fact finder could find SRAM’s commercial chainrings to be coextensive with the claims. In reaching this conclusion, the Federal Circuit relied on undisputed evidence that SRAM’s commercial chainrings included unclaimed features that SRAM described as critical to the function of the product. The Federal Circuit explained that, on remand, SRAM would have the opportunity to prove that the evidence of secondary considerations is attributable to the claimed combination of features rather than prior art features or unclaimed features.
Exceptional-Case Findings Must Consider the Full Case
In Intellectual Ventures I LLC v. Trend Micro Incorporated, Appeal No. 19-1122, the Federal Circuit ruled that an exceptional case finding may be based on a single isolated act, but the court must still find the case as a whole is exceptional.
Intellectual Ventures (“IV”) sued Trend Micro for patent infringement. The district court found IV’s expert changed his opinion and offered conflicting opinions in a co-pending action involving the same patents. After prevailing on the merits, Trend Micro moved for an exceptional case finding under Section 285. The district court found the case as a whole was not exceptional, but the circumstances surrounding the expert’s testimony were exceptional. The district court awarded attorneys’ fees to Trend Micro and IV appealed.
The Federal Circuit held that a district court may find a case exceptional based on a single isolated act and not a pattern of acts. Further, the amount of attorneys’ fees must “bear some relation to the extent of the misconduct.” However, the court must still find that the case as a whole is exceptional, not just a portion of the case. Because the district court did not find the overall case exceptional, the Federal Circuit vacated and remanded for a decision under the proper legal standard.
Drug Treatment May Be Obvious Even When the FDA Is Unconvinced That It Is Safe and Effective
In Persion Pharmaceuticals LLC v. Alvogen Malta Operations Ltd., Appeal No. 18-2361, the FDA’s acceptance of safety data for a prior-art drug when evaluating a claimed drug treatment was evidence of obviousness even though the data was insufficient to establish the safety and efficacy of the claimed treatment.
Persion Pharmaceuticals LLC (“Persion”) sued Alvogen Malta Operations Ltd. for infringement of patents directed to treating pain with an extended-release hydrocodone-only formulation in a patient with hepatic impairment (i.e., compromised liver functionality).
The district court found the asserted claims invalid as obvious in view of (1) prior art that disclosed the same hydrocodone-only formulation as the asserted patents, but for treating patients without hepatic impairment, and (2) prior art that disclosed treating patients with hepatic impairment using hydrocodone in combination with other active ingredients. The district court reasoned that one of ordinary skill in the art would have been motivated to administer the hydrocodone-only formulation to patients with hepatic impairment and would have had a reasonable expectation of success when doing so.
When evaluating the motivation to combine the prior art, the district court relied on evidence that the FDA accepted safety data for a hydrocodone-combination drug when it was evaluating the appropriate administration of the hydrocodone-only drug. On appeal, Persion argued that the district court’s reliance on this evidence was clearly erroneous because the FDA found that data insufficient to establish the safety and efficacy of the hydrocodone-only drug for treating hepatically impaired patients.
The Federal Circuit found no clear error in the district court’s analysis. The district court explained that the standard to find a motivation to combine in an obviousness analysis is far below what is sufficient to prove safety and efficacy to the FDA. Thus, the FDA’s finding that the data for the hydrocodone-combination drug was insufficient to prove the safety and efficacy of the hydrocodone-only drug did not undermine the conclusion of obviousness. The Federal Circuit went on to address other attacks on the district court’s judgment but ultimately rejected them and affirmed the judgment that the asserted claims were invalid as obvious.