Justia U.S. Supreme Court Opinion Summaries

LDL cholesterol can lead to cardiovascular disease, heart attacks, and strokes. PCSK9 is a naturally occurring protein that degrades LDL receptors responsible for extracting LDL cholesterol from the bloodstream. In 2011, Amgen and Sanofi each obtained a patent for the antibody employed in a PCSK9-inhibiting drug, describing the relevant antibody by its unique amino acid sequence. Amgen obtained two additional patents in 2014 that relate back to its 2011 patent and purport to claim “the entire genus” of antibodies that “bind to specific amino acid residues on PCSK9,” and “block PCSK9 from binding.” Amgen identified the amino acid sequences of 26 antibodies that perform those functions and described “roadmap” and “conservative substitution” methods for making other antibodies that perform the described functions.Amgen sued Sanofi for infringement. Sanofi argued that Amgen’s relevant claims were invalid under the “enablement” requirement, which requires a patent applicant to describe the invention “in such full, clear, concise, and exact terms as to enable any person skilled in the art” to make and use the invention,” 35 U.S.C. 112(a), characterizing the methods Amgen outlined for generating additional antibodies as a trial-and-error process.The district court, the Federal Circuit, and the Supreme Court sided with Sanofi. If a patent claims an entire class of processes, machines, manufactures, or compositions of matter, its specification must enable a person skilled in the art to make and use the entire class. The claimed class of antibodies does not include just the 26 that Amgen described by their amino acid sequences, but many additional antibodies. The “roadmap” and “conservative substitution” approaches are little more than research assignments. View "Amgen Inc. v. Sanofi" on Justia Law

Truckai invented NovaSure to treat abnormal uterine bleeding using a moisture-permeable applicator head to destroy targeted cells. Truckai filed a patent application and assigned the application and future continuation applications, to his company, Novacept. Novacept and its patents and patent applications were acquired by Hologic. Truckai founded Minerva and developed a supposedly improved device to treat abnormal uterine bleeding, using a moisture-impermeable applicator head to remove cells. The Patent and Trademark Office (PTO) issued a patent; the FDA approved the device for sale. Hologic filed a continuation application, seeking to add claims to its NovaSure patent--one claim encompassed applicator heads generally, without regard to whether they are moisture permeable. The PTO issued the altered patent.Hologic sued Minerva for infringement. Minerva argued that Hologic’s patent was invalid because the new claim did not match the written description. Hologic invoked the assignor estoppel doctrine: Because Truckai had assigned the original application, he and Minerva could not impeach the patent’s validity. The Federal Circuit agreed.The Supreme Court vacated. Assignor estoppel is a valid defense, based on the need for consistency in business dealings, but applies only when the assignor’s claim of invalidity contradicts explicit or implicit representations made in assigning the patent. Concerns with the assignor taking contradictory positions do not arise when an assignment occurs before an inventor can make a warranty as to specific claims, such as when an employee assigns to his employer patent rights in future inventions; when a later legal development renders irrelevant the warranty given at the time of assignment; and when a post-assignment change in patent claims can remove the rationale for applying assignor estoppel. The Federal Circuit failed to recognize these boundaries, deeming “irrelevant” the question of whether Hologic had expanded the assigned claims. If Hologic’s new claim is materially broader than what Truckai assigned, Truckai could not have warranted its validity. View "Minerva Surgical, Inc. v. Hologic, Inc." on Justia Law

Administrative Patent Judges (APJs) conduct adversarial proceedings for challenging the validity of an existing patent before the Patent Trial and Appeal Board (PTAB), 35 U.S.C. 6(a), (c). The Secretary of Commerce appoints PTAB members, including APJs, except the Director, who is nominated by the President and confirmed by the Senate. APJs concluded that Arthrex’s patent was invalid. The Federal Circuit concluded that the APJs were principal officers who must be appointed by the President with the advice and consent of the Senate; their appointment was unconstitutional. To remedy this violation, the court invalidated the APJs’ tenure protections, making them removable at will by the Secretary.The Supreme Court vacated. The unreviewable authority wielded by APJs during patent review is incompatible with their appointment by the Secretary to an inferior office. Inferior officers must be “directed and supervised at some level by others who were appointed by Presidential nomination with the advice and consent of the Senate.” While the Director has administrative oversight, neither he nor any other superior executive officer can directly review APJ decisions. A decision by the APJs under his charge compels the Director to “issue and publish a certificate” canceling or confirming patent claims he previously allowed. Given the insulation of PTAB decisions from executive review, APJs exercise power that conflicts with the Appointments Clause’s purpose “to preserve political accountability.”Four justices concluded that section 6(c) cannot constitutionally be enforced to prevent the Director from reviewing final APJ decisions. The Director may review final PTAB decisions and may issue decisions on behalf of the Board. Section 6(c) otherwise remains operative. Because the source of the constitutional violation is the restraint on the Director’s review authority not the appointment of APJs, Arthrex is not entitled to a hearing before a new panel. View "United States v. Arthrex, Inc." on Justia Law

Inter partes review (IPR) permits a patent challenger to ask the U.S. Patent and Trademark Office to reconsider the validity of earlier granted patent claims. If a request comes more than a year after a patent infringement lawsuit against the requesting party, IPR “may not be instituted,” 35 U.S.C. 315(b). The agency’s determination of whether to institute IPR is “final and nonappealable” under section 314(d).Thryv sought IPR of Click-to-Call’s patent. The Patent Trial and Appeal Board rejected Click-to-Call’s argument that the suit was untimely, instituted review, and canceled 13 of the patent’s claims as obvious or lacking novelty. Treating the Board’s application of section 315(b) as judicially reviewable, the Federal Circuit concluded that the petition was untimely and vacated the Board’s decision.The Supreme Court vacated. Section 314(d) precludes judicial review of the agency’s application of section 315(b)’s time prescription. A challenge based on section 315(b) constitutes an appeal of the agency’s decision “to institute” an IPR. Allowing section 315(b) appeals would unwind agency proceedings determining patentability and leave bad patents enforceable. Section 314(d)’s text does not limit the review bar to section 314(a)’s question of whether the petitioner has a reasonable likelihood of prevailing. Click-to-Call’s contention is, essentially, that the agency should have refused to institute IPR. View "Thryv, Inc. v. Click-To-Call Technologies, LP" on Justia Law

The Patent Act provides two methods for challenging an adverse decision by the Patent and Trademark Office (PTO): direct appeal to the Federal Circuit, 35 U.S.C. 141, or a new civil action against the PTO Director in the Eastern District of Virginia, section 145. Under section 145, the applicant must pay “[a]ll the expenses of the proceedings.” NantKwest filed a section 145 civil action after its patent application was denied. The Federal Circuit affirmed summary judgment in favor of the PTO, which moved for reimbursement of expenses, including the pro-rata salaries of PTO attorneys and a paralegal who worked on the case. The Federal Circuit and the Supreme Court affirmed the denial of the motion, concluding that the statutory language referencing expenses was not sufficient to rebut the “American Rule” presumption that parties are responsible for their own attorney’s fees. Reading section 145 to permit an unsuccessful government agency to recover attorney’s fees from a prevailing party “would be a radical departure from longstanding fee-shifting principles adhered to in a wide range of contexts.” The phrase “expenses of the proceeding” would not have been commonly understood to include attorney’s fees at the time section 145 was enacted. The appearance of “expenses” and “attorney’s fees” together across various statutes indicates that Congress understands the terms as distinct and not inclusive of each other. View "Peter v. NantKwest, Inc." on Justia Law

The Leahy-Smith America Invents Act (AIA) of 2011 created the Patent Trial and Appeal Board, 35 U.S.C. 6(c), which conducts administrative review proceedings that enable a “person” to challenge the validity of a patent post-issuance: “inter partes review,” “post-grant review,” and “covered-business-method review” (CBM review). The Board either confirms or cancels the patent claims. Any dissatisfied party may then seek judicial review in the Federal Circuit. A patent can also be reexamined either in federal court during a defense to an infringement suit or in an ex parte reexamination by the Patent Office.USPS introduced an enhanced service to process undeliverable mail, which Return Mail asserted infringed its patent. USPS petitioned for ex parte reexamination. The Patent Office confirmed the patent’s validity. Return Mail then sued, seeking compensation for the unauthorized use of its invention. USPS petitioned for CBM review. The Patent Board concluded that the subject matter of Return Mail’s claims was ineligible to be patented. The Federal Circuit affirmed.The Supreme Court reversed. The government is not a “person” capable of instituting AIA review proceedings. Absent an express definition of “person” in the patent statutes, the Court applied a longstanding interpretive presumption that "person" does not include the sovereign, citing common usage, and the Dictionary Act. There are many references to “person[s]” in the Patent Act and the AIA: Sometimes “person” plainly includes or excludes the government, but sometimes it might be read either way. The mere existence of some government-inclusive references and the government's ability to obtain a patent do not overcome the presumption that the government is not a “person” eligible to petition for AIA review. Congress may have had good reason to authorize the government to initiate a hands-off ex parte reexamination but not to become a party to the AIA’s full-blown adversarial proceeding. View "Return Mail, Inc. v. United States Postal Service" on Justia Law

Helsinn makes a treatment for chemotherapy-induced nausea using the chemical palonosetron. While developing that product, Helsinn granted another company the right to market a 0.25 mg dose of palonosetron in the United States; that company was required to keep proprietary information confidential. Nearly two years later, in 2003, Helsinn filed a provisional patent application covering a 0.25 mg dose of palonosetron. Helsinn filed four patent applications that claimed priority to the 2003 date. Helsinn’s fourth application, filed in 2013 (the 219 patent), is covered by the Leahy-Smith America Invents Act (AIA). In 2011, Teva sought approval to market a generic 0.25 mg palonosetron product. Helsinn sued for infringement. Teva countered that the 219 patent was invalid under the “on sale” provision of the AIA, which precludes a person from obtaining a patent on an invention that was “in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention,” 35 U.S.C. 102(a)(1), arguing the 0.25 mg dose was “on sale” more than one year before Helsinn filed the 2003 application.The Federal Circuit held, and the Supreme Court unanimously agreed, that the sale was publicly disclosed, regardless of whether the details of the invention were publicly disclosed in the agreements. A commercial sale to a third party who is required to keep the invention confidential may place the invention “on sale” under section 102(a). The patent statute in force immediately before the AIA included an on-sale bar. Supreme Court and Federal Circuit precedent interpreting that provision indicated that a sale or offer of sale need not make an invention available to the public to constitute invalidating prior art. The Court applied the presumption that when Congress reenacted the “on sale” language in the AIA, it adopted earlier judicial constructions. View "Helsinn Healthcare S. A. v. Teva Pharmaceuticals USA, Inc." on Justia Law

WesternGeco owns patents for a system used to survey the ocean floor. ION sold a competing system, built from components manufactured in the U.S., then shipped abroad for assembly into a system indistinguishable from WesternGeco’s. WesternGeco sued for patent infringement, 35 U.S.C. 271(f)(1) and (f)(2). The jury awarded WesternGeco royalties and lost profits under section 284. The Supreme Court reversed the Federal Circuit, holding that WesternGeco’s award for lost profits was a permissible domestic application of section 284 of the Patent Act, not an impermissible extraterritorial application of section 271. To determine whether the case involves a domestic application of the statute, courts must identify the statute’s "focus” and ask whether the conduct relevant to that focus occurred in U.S. territory. If so, the case involves a permissible domestic application of the statute. When determining the statute’s focus, the provision at issue must be assessed in concert with other provisions. Section 284, the general damages provision, focuses on “the infringement.” The “overriding purpose” is “complete compensation” for infringements. Section 271 identifies several ways that a patent can be infringed; to determine section 284’s focus in a given case, the type of infringement must be identified. Section 271(f)(2) was the basis for WesternGeco’s claim and damages. That provision regulates the domestic act of “suppl[ying] in or from the United States,” and vindicates domestic interests, The focus of section 284 in a case involving infringement under section 271(f)(2) is the act of exporting components from the U.S., so the relevant conduct occurred in the U.S. Damages are not the statutory focus but are merely the means by which the statute remedies infringements. The overseas events giving rise to the lost-profit damages here were merely incidental to the infringement. View "WesternGeco LLC v. ION Geophysical Corp." on Justia Law

SAS sought inter partes review (35 U.S.C. 311(a)) of ComplementSoft’s software patent, alleging that all 16 of the patent’s claims were unpatentable. The Patent Office instituted review on some of the claims and denied review on the rest. The Federal Circuit rejected SAS’s argument that section 318(a) required the Board to decide the patentability of every claim challenged in the petition. The Supreme Court reversed. When the Patent Office institutes an inter partes review, it must decide the patentability of all of the claims the petitioner has challenged. Section 318(a), which states that the Board “shall issue a final written decision with respect to the patentability of any patent claim challenged by the petitioner” is mandatory and comprehensive. The Director’s claimed “partial institution” power (37 CFR 42.108(a)) appears nowhere in the statutory text. The statute envisions an inter partes review guided by the initial petition. While section 314(a) invests the Director with discretion on whether to institute review, it does not invest him with discretion regarding what claims that review will encompass. The Director’s policy argument—that partial institution is efficient because it permits the Board to focus on the most promising challenges and avoid spending time and resources on others—is properly addressed to Congress. View "SAS Institute Inc. v. Iancu" on Justia Law

Oil States sued Greene's Energy for infringement of a patent relating to technology for protecting wellhead equipment used in hydraulic fracturing. Greene’s challenged the patent’s validity in court and petitioned the Patent Office for inter partes review, 35 U.S.C. 311-319. The district court issued a claim-construction order favoring Oil States; the Board concluded that Oil States’ claims were unpatentable. The Federal Circuit rejected a challenge to the constitutionality of inter partes review. The Supreme Court affirmed. Inter partes review does not violate Article III. Congress may assign adjudication of public rights to entities other than Article III courts. Inter partes review falls within the public-rights doctrine. Patents are “public franchises” and granting patents is a constitutional function that can be carried out by the executive or legislative departments without “judicial determination.’ Inter partes review involves the same basic matter as granting a patent. Patents remain “subject to [the Board’s] authority” to cancel outside of an Article III court. The similarities between the procedures used in inter partes review and judicial procedures does not suggest that inter partes review violates Article III. The Court noted that its decision “should not be misconstrued as suggesting that patents are not property for purposes of the Due Process Clause or the Takings Clause.” When Congress properly assigns a matter to adjudication in a non-Article III tribunal, “the Seventh Amendment poses no independent bar to the adjudication of that action by a nonjury factfinder.” View "Oil States Energy Services, LLC v. Greene's Energy Group, LLC" on Justia Law