Board IPR decisions finding conception and reduction to practice before critical date affirmed

Medtronic, Inc. et al. v. Teleflex Innovations S.À.R.L

Docket No. 2021-2356, -2358, -2361, -2363, -22365 (IPR2020-00126, -00128, -00132, -00135, -00137) (https://cafc.uscourts.gov/opinions-orders/21-2356.OPINION.5-24-2023_2131839.pdf)

LOURIE, LYNN, DYK (D)

May 24, 2023

Brief Summary:   Board IPR decisions finding patented invention was conceived and reduced to practice before the prior art critical date affirmed (e.g., “intended purpose”).

Summary (ChatGPT):  Medtronic, Inc. appealed five IPR final written decisions (FWDs) of the USPTO Board.  The decisions found that Itou, a prior art reference, did not qualify as prior art to certain patents owned by Teleflex.  The challenged pre-AIA (first-to-invent) patents relate to guide extension catheters that use a tapered inner catheter that runs over a standard coronary guidewire to reduce the likelihood that a guide catheter will dislodge from the coronary artery’s opening (i.e., ostium).  The patented catheter was conceived by Vascular Solutions Inc. (“VSI”) but the patents are now owned by Teleflex.  Medtronic filed 13 petitions for IPR challenging the validity of the patents, asserting U.S. Pat. No. 7,736,355 (“Itou”) as anticipatory under pre-AIA 102(e) (2012).  Teleflex argued “that Itou did not qualify as prior art because the claimed inventions were (1) conceived prior to Itou’s filing date of September 23, 2005 (i.e., the critical date), and (2) were (a) actually reduced to practice before the critical date or (b) diligently pursued until their constructive reduction to practice through their effective filing in May 2006”, submitting multiple declarations from inventors and non-inventors (lab notebooks, internal company  memoranda, invoices, sales orders, etc.). The Board agreed with Teleflex, and also “that the intended purpose of the claimed inventions was providing improved backup support for the guide catheter” and rejected “Medtronic’s suggestion that the intended purpose, or additional intended purpose, was providing backup support necessary for accessing and crossing tough or chronic occlusions.”  The FC panel explained that “[i]n an IPR, the petitioner bears the ultimate burden of persuasion on invalidity, which never shifts to the patent owner” (Dynamic Drinkware, FC 2015) except that “when a patent owner attempts to antedate an asserted prior art reference, the patent owner takes on a temporary burden of production”.  “Once that burden is met,” the FC panel wrote, “the burden shifts back to the petitioner.”  It reviewed “the Board’s factual findings on reduction to practice and diligence for substantial evidence, and its legal conclusion of priority de novo” (E.I. du Pont, FC 2019).  The FC panel also explained that “[t]o establish actual reduction to practice before the critical date, it must have been shown that “(1) [the inventors] constructed an embodiment or performed a process that met all the limitations of the [claimed invention]; and (2) [the inventors] determined that the invention would work for its intended purpose” (Cooper, FC 1998).  Medtronic argued the Board relied “on extrinsic evidence to determine the intended purpose when the patents’ specifications and claims are the proper source of information”, but the FC panel explained that “it is appropriate to consider extrinsic evidence, particularly when it does not contradict the patents themselves” and agreed with the Board’s conclusions (e.g., finding “Medtronic’s proposed intended purpose to be overly narrow”, “Teleflex’s evidence of actual reduction to practice is insufficiently corroborated” (Cooper; du Pont; Loral Fairchild, FC 2001; Knorr, CCPA 1982 (“rule of reason”)).  Judge Dyk’s dissent disagreed that the evidence was adequately corroborated, citing Elmore (CCPA 1960 (“any practical use of the invention”), Brown (FC 2002), and In re NPT (FC 2011).

SCOTUS concludes Amgen’s anti-PCSK9 antibody claims not enabled

Amgen Inc. v. Sanofi, et al.

Docket No. 2020-1074 (http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/20-1074.OPINION.2-11-2021_1731739.pdf)

PROST, LOURIE, HUGHES

November 7, 2022 Update (original decision on February 11, 2021)

Fourth Update (May 18, 2023):  SCOTUS concludes Amgen’s specification does not support “’the entire genus’ of antibodies that (1) ‘bind to specific amino acid residues on PCSK9,” and (2) ‘block PCSK9 from binding to [LDL receptors]’” as it only “identified the amino acid sequences of 26 antibodies that perform these two functions.”  Decisions cited in support of its conclusions include Bonito Boats, Inc. v. Thunder Craft Boats, Inc. (“[t]he patent “bargain” describes the exchange that takes place when an inventor receives a limited term of “protection from competitive exploitation” in exchange for bringing “new designs and technologies into the public domain through disclosure” for the benefit of all”), O’Reilly v. Morse (“claim covered all means of achieving telegraphic communication, yet Morse’s specification did not describe how to make or use them all”), The Incandescent Lamp Patent (“rather than confining their claim to carbonized paper, “made a broad claim for every fibrous and textile material”), and Holland Furniture Co. v. Perkins Glue Co. (“specification described the key input—the ‘starch ingredient’—in terms of its ‘use or function’ rather than its ‘physical characteristics or chemical properties’).  The Court stated that these decisions “reinforce the simple statutory command: If a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent’s specification must enable a person skilled in the art to make and use the entire class.”  Amgen’s claims, the Court concluded, “bear more than a passing resemblance to the broadest claims in Morse, Incandescent Lamp, and Holland Furniture” as “Amgen seeks to monopolize an entire class of things defined by their function—every antibody that both binds to particular areas of the sweet spot of PCSK9 and blocks PCSK9 from binding to LDL receptors—the record reflects that this class of antibodies does not include just the 26 that Amgen has described by their amino acid sequences, but a vast number of additional antibodies that it has not.”  The Court explained that “the Federal Circuit’s treatment in this case is entirely consistent with Congress’s directive and this Court’s precedents.”

Third Update (November 7, 2022):  SCOTUS granted certiorari regarding the second question raised in Amgen’s request regarding it functional anti-PCSK9 antibody-related claims and the District Court (DC) (Amgen Inc., et al. v. Sanofi, et al., Civ. No. 14-1317- SLR (D. Del.), judgment entered on January 3, 2017; Amgen Inc., et al. v. Sanofi, et al., Civ. No. 14-1317- RGA (D. Del.), judgment entered on October 3, 2019) and Federal Circuit (FC) (Amgen Inc., et al. v. Sanofi, et al., No. 2017-1480 (Fed. Cir.), judgment entered on October 5, 2017; Amgen Inc., et al. v. Sanofi, et al., No. 2020-1074 (Fed. Cir.), judgment entered on February 11, 2021) findings that those claims were invalid for lack of enablement.  SCOTUS will consider Question 2:  “Whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to ‘make and use’ the claimed invention, 35 U.S.C. § 112, or whether it must instead enable those skilled in the art ‘to reach the full scope of claimed embodiments’ without undue experimentation—i.e., to cumulatively identify and make all or nearly all embodiments of the invention without substantial “‘time and effort’”.  The DC’s finding of a lack of enablement of Amgen’s anti-PCSK9 antibody claims 19 (“binds to at least two of the following residues…listed in SEQ ID NO:3) and 29 (“binds to at least two of the following residues…listed in SEQ ID NO:3 and blocks the binding of PCSK9 to LDLR by at least 80%”) of US 8,829,165 and claim 7 (“wherein the epitope is a functional epitope”) of US 8,859,741 was affirmed by the FC in February 2021, and Amgen’s request for rehearing en banc was denied in June 2021.  Amgen’s petition for certiorari to SCOTUS on Nov. 18, 2021 asked for review of two questions:  1)  “Whether enablement is aa question of fact to be determined by the jury,’ Wood v. Underhill, 46 U.S. (5 How.) 1, 4 (1846), as this Court has held, or ‘a question of law that [the court] review[s] without deference’…as the Federal Circuit holds”; and, 2) “Whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to ‘make and use’ the claimed invention, 35 U.S.C. § 112, or whether it must instead enable those skilled in the art ‘to reach the full scope of claimed embodiments’ without undue experimentation—i.e., to cumulatively identify and make all or nearly all embodiments of the invention without substantial “‘time and effort’”.  Amicus curiae supporting Amgen’s position were filed on Dec. 22, 2021 by the Assoc. Univ. Tech. Managers (e.g., “the decision below cannot be reconciled with the language of the Patent Act and this Court’s precedent”), GSK (e.g., “Genus claims are critical to protect innovations of companies like GSK, as well as smaller entities and academic institutions, and to encourage investment and collaboration”), and Intellectual Property Professors (e.g., “The central feature of patent law in the life sciences industries is the genus claim.”)  Sanofi filed a brief in opposition on March 14, 2022.  In April, SCOTUS invited the Solicitor General (SG) of the United States to file a brief expressing its view, which was filed on Sept. 21, 2022.  Regarding Amgen’s first question, the SG argued that “[t]he lower courts’ finding of no enablement followed naturally from their conclusions as to the Wands factors, including that ‘no reasonable factfinder could conclude that there was adequate guidance beyond the narrow scope of the working examples’ or ‘that anything but ‘substantial time and effort’ would be required to reach the full scope of claimed embodiments”, and “Petitioners do not contend that they could prevail on enablement despite the individual Wands factors having been resolved against them.”  As to Amgen’s second question, the SG argued that SCOTUS’ previous “decisions confirm that the full scope of the claims must be considered in assessing enablement” (citing n Consolidated Electric Light Co. v. McKeesport Light Co., 159 U.S. 465 (1895); Holland Furniture Co. v. Perkins Glue Co., 277 U.S. 245 (1928)), Amgen’s “case-specific argument[s]” do “not warrant this Court’s review”, “disclosing how to produce some antibodies that perform a specified function is not equivalent to disclosing how to produce all such antibodies—and it is the latter that petitioners claim as their invention”, Amgen’s concern that “that the court of appeals’ standard is “‘impossible’ to satisfy any time a genus claim covers a ‘nontrivial’ number of embodiments’…is overstated”  (citing McRO, Inc. v. Bandai Namco Games Am. Inc., 959 F.3d 1091, 1099 (2020); Erfindergemeinschaft UroPep GbR v. Eli Lilly & Co., 276 F. Supp. 3d 629, 662-663 (E.D. Tex. 2017), aff’d, 739 Fed. Appx. 643 (Fed. Cir. 2018), cert. denied, 140 S. Ct. 449 (2019); and Wyeth & Cordis Corp. v. Abbott Labs., 720 F.3d 1380, 1386 (Fed. Cir. 2013) (“[e]ven ‘a considerable amount of experimentation is permissible”)), and the Federal Circuit does not “apply ‘a different,’ more stringent ‘enablement test for genus claims’ than for other types of claims” as its position here “simply reflect the fact that a disclosure must be ‘commensurate with the scope of the claims’” (citing National Recovery Techs., Inc. v. Magnetic Separation Sys., Inc., 166 F.3d 1190, 1196 (Fed. Cir. 1999)).  The SG therefore requested denial of Amgen’s require for a writ of certiorari.  As for the written description issues highlighted previously in our discussion of the Juno and Biogen cases, this case has been and will continue to be of great interest to those in the biotechnology and pharmaceutical industries.

Update (June 21, 2021):  Petition for rehearing en banc denied.  Judges Lourie, Prost and Hughes authored an opinion issued with the order.  In it, the judges explained that Amgen incorrectly argued that the FC has “created a new test for enablement” as “[g]enus claims, to any type of invention, when properly supported, are alive and well” (referring to “[c]hemical patent specifications”).  However, the opinion explained that “as with genus claims to chemical compounds, if” biological composition claims “encompass more subject matter than just a few species, they need to be enabled accordingly” (“Biological compositions not actually prepared need to be described constructively, if required to enable the full scope of the claims, with procedures and names of resultant compositions, as with chemical compositions…If the genus had been invented by the time of filing, it would have been fully enabled in the patent.”)  In this case, the judges wrote, “the narrow and limited guidance in the specification made far corners of the claimed landscape that were particularly inaccessible or uncertain to make unenabled” and given that “Amgen in fact has separate patent protection on the PCSK9 antibody” (U.S. 8,030,457), “the failure to obtain unsupported, unenabled claims has not deprived it of patent protection on the fruits of its investment.”  The opinion also states that the innovator can rely on the doctrine of equivalents to protect compounds “so close to species disclosed and claimed by a first entrant as to be an equivalent” and that the “second comer may encounter the expensive hurdle of having to meet its own regulatory requirements, if it does not qualify for ANDA or biosimilar status.”  Regarding functional claims generally, the opinion states that the analysis “is circular; enablement comes only with success, which depends upon enablement”, “one cannot claim everything that works”, “single means claims claim too much” (citing In re Hyatt, FC 1983), and “[m]ultiple means claims simply compound the problem.”  The opinion also refers to many earlier enablement decisions, noting that “[t]he much-cited Wands case is the signature authority on the issue” (In re Wands, FC 1988).

Brief Summary of Original FC Panel Opinion:  DC lack of enablement of Amgen’s anti-PCSK9 antibody claims affirmed. Summary:  Amgen appealed DC grant of JMOL for lack of enablement of claims 19 and 29 of US 8,829,165 and claim 7 of US 8,859,741 directed to antibodies against PCSK9.  In a prior appeal related to this suit, the FC remanded the DC decision with respect to “its evidentiary rulings and jury instructions regarding Sanofi’s defenses that the patents lack written description and enablement” and vacated the permanent injunction (Amgen, FC 2017).  Relevant to this appeal, “[t]he jury again found that Sanofi failed to prove that the asserted claims were invalid for lack of written description and enablement”, but the DC “granted Sanofi’s Motion for JMOL for lack of enablement and denied the motion for lack of written description.”  The FC panel explained that it reviewed enablement decision without deference and the underlying factual findings for clear error, and the requirements of an enablement determination (e.g., undue experimentation, Wands factors (Alcon, FC 2014; In re Wands, FC 1988 (“‘go to’ precedent for guidance on enablement”, “disclosure adequately taught using hybridoma technology to produce the needed claims antibodies”)).  It also explained that “[a]lthough a specification does not need to ‘describe how to make and use every possible variant of the claimed invention, when a range is claimed, there must be reasonable enablement of the scope of the range’” (McRO, FC 2020, citing AK Steel, FC 2003).  Amgen argued that “no undue experimentation is required to obtain antibodies fully within the scope of the claims” by, e.g., “following a roadmap using anchor antibodies and well-known screening techniques described in the specification or by making conservative amino acid substitutions in the twenty-six examples” (e.g., “binds to at least one of the following residues” on PCSK9, “an epitope on PCSK9 comprising at least one of residues 237 or 238 of SEQ ID NO:3, and…blocks the binding of PCSK9 to LDLR” (low-density lipoprotein receptor)).  Sanofi argued “that there are millions of antibody candidates within the scope of the claims” the specification lacks sufficient guidance, and “antibody generation is unpredictable”.  The FC panel reviewed the Wands decision as well as its Wyeth (FC 2013 (no enablement of “methods of preventing restenosis with compounds having certain functionality requirements”), Enzo (FC 2019 (claims requiring “particular structure and functionality” not enabled), and Identix (FC 2019 (no enablement due to “lack of guidance across…full scope”, “needle in a haystack”) decisions.  The FC panel also wrote that “functional claim limitations…pose high hurdles in fulfilling the enablement requirement for claims with broad functional language”.  And it concluded that “[t]he binding limitation is…require[s] undue experimentation” since, e.g., “the claims are far broader in functional diversity than the disclosed examples” (AbbVie, FC 2014), “this invention is in an unpredictable field of science”, and the “required experimentation ‘would take a substantial amount of time effort’”.  The FC panel therefore affirmed the DC decision.

Board IPR claim construction (even with harmless error) and obviousness determination affirmed

Bot M8 LLC v. Sony Interactive Entertainment LLC (USPTO as Intervenor)

Docket No. 2022-1291 (IPR2020-00922) (https://cafc.uscourts.gov/opinions-orders/22-1291.OPINION.5-9-2023_2123766.pdf)

DYK, BRYSON, PROST

May 9, 2023

Brief Summary:   Board IPR claim construction and obviousness determination affirmed; any error in claim construction found to be harmless.

Summary:  Bot M8 appealed Board IPR finding that all challenged claims of US 8,078,540 relating to a gaming machine that authenticates certain data and that has both a motherboard and a different board.  The claimed machines require “the ‘game program’ be written to the motherboard only after the game program has been authenticated” and “two different CPUs—one on the motherboard, one on a different board— for executing the ‘authentication program’ and ‘preliminary authentication program’ respectively.”  The Board’s final written decision found the independent claims unpatentable as obvious in view of two different combinations of prior art (Johnson and Martinek; and, Morrow ‘952, Morrow ‘771, and Diamant).  The FC panel review the Board’s “claim construction de novo and any subsidiary factfindings based on extrinsic evidence for substantial evidence” (Apple, FC 2022; Novartis AG, FC 2017; Intel, FC 2023).  Bot M8 argued that Board misconstrued the independent claims and determining the claims to be unpatentable.  It was undisputed that the claims “preclude[] writing the entire game program to the motherboard before authenticating the game program”, but Bot M8 argued that “writing any data—game program or not [or any portion of the game program]—to the motherboard before authenticating the game program.”  The FC panel agreed with the Board that this reading is inconsistent with the claim language.  It further explained that even “[a]ssuming (for argument’s sake) that Bot M8 is correct”, its “review under the APA is subject to a harmless-error rule… and the party challenging the Board’s decision must demonstrate the harmfulness of the alleged error” (Shinseki, US 2009; Vicor, FC 2017).  The FC panel explained that the Board “found that both Johnson and Morrow ’952 disclose writing only non-game-program data to the motherboard before authenticating the game program” and did not need to rely on Bot M8’s reading of the claim, and therefore any error by the Board was harmless.  Bot M8 also argued against a motivation to combine the cited art but the FC panel wrote that “Bot M8 fail[ed] to persuade us why no reasonable factfinder could have found as the Board did—that given Sony’s expert’s explanation and the references themselves, it nonetheless would have been obvious to a person of ordinary skill in the art to combine the references to yield the claimed invention” and therefore that substantial evidence supported the Board’s conclusion.  The Board decision was therefore affirmed.

DC findings that Vanda’s method of treatment claims are invalid for obviousness affirmed

Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. and Apotex, Inc. et al.

Docket No. 2023-1247 (https://cafc.uscourts.gov/opinions-orders/23-1247.OPINION.5-10-2023_2124577.pdf) (Non-Precedential)

DYK, BRYSON, PROST

May 10, 2023

Brief Summary:   DC obviousness findings regarding Vanda’s method of treatment claims affirmed. Summary:  Teva and Apotex (“Apotex”) appealed DC holding that its ANDA infringed four claims of four of Vanda’s patents relating to “a method of treating Non-24-Hour Sleep-Wake Disorder (“Non-24”) with tasimelteon” (Hetlioz^®). The disputed patents (RE46,604; US 10,149,829; 9,730,910; and 10,376,487) are four of many listed on the FDA’s Orange Book for this product.  The FC panel wrote that “[i]n a thorough opinion, the district court held that all four claims were invalid for obviousness” (over combinations of Hack, the ‘244 Publication, and Lankford or Hardeland).  Vanda argued the DC erred regarding RE604 claim 3 “in stating that a skilled artisan would look to Hack, a prior art reference that explains that melatonin can be used to entrain blind patients with Non-24, when considering whether there would have been a reasonable expectation that tasimelteon would entrain” (“tasimelteon and melatonin are not identical”, although “tasimelteon has high affinity for both the [melatonin] receptors”), but the FC panel found no error with the DC’s conclusion.  Vanda also argued that “none of the prior art references ‘would give a skilled artisan a reasonable expectation of success in using 20mg of tasimelteon . . . to entrain’”, but the FC panel disagreed, finding the evidence “sufficient to support” the DC’s finding.  Vanda also argued the DC “erred in its assessment of the objective indicia of non-obviousness” but the FC panel disagreed (e.g., Plant Genetic Sys., FC 2003 (“[t]he fact that the district court did not in its opinion recite every piece of evidence does not mean that the evidence was not considered”); Therasense (FC 2010) (“[O]bjective evidence of non-obviousness fails [when] it is not ‘commensurate in scope with the claims”)).  Regarding ‘487 patent claim 5, the FC panel agreed with the DC that “it would have been obvious to try administering tasimelteon without food”, citing KSR (US 2007 (“When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp.”) and Valeant (FC 2020 (“If one of these predictable solutions leads to the anticipated success, the combination was obvious to try.”) (e.g., here, “there was market pressure (regulatory advice) to determine if food would have an effect on the efficacy of a drug”)).  Regarding ’910 patent claim 4 (“(A) discontinuing the rifampicin treatment and then (B) treating the patient with tasimelteon”) and similar ‘829 patent claim 13, the FC panel agreed with the DC’s obviousness conclusion, finding no error in its conclusion that “a skilled artisan would have looked to the ramelteon art because ramelteon and tasimelteon bind to the same receptors, have similar half lives in the body, and are structurally similar” (Pfizer, FC 2007 (“Obviousness does not require certainty—it requires a reasonable expectation of success”)) and there was no teaching away.  The DC decision was therefore affirmed.

IPR obviousness decision reversed as prior art not shown to be analogous to Sanofi’s claimed invention

Sanofi-Aventis Deutschland GmbH v. Mylan Pharmaceuticals Inc.

Docket No. 2021-1981 (IPR2019-01657) (https://cafc.uscourts.gov/opinions-orders/21-1981.OPINION.5-9-2023_2123775.pdf)

REYNA, MAYER, CUNNINGHAM

May 9, 2023

Brief Summary:   IPR decision finding Sanofi’s claims obvious reversed as Mylan did not show art relied upon was analogous to Sanofi’s invention. Summary:  Sanofi appealed USPTO PTAB (“Board”) IPR decision finding all of the claims of US RE47,614 directed to “[a] drug delivery device comprising” including multiple components including “a spring washer” having “at least to fixing elements” unpatentable as obvious over the prior art (US 4,144,957 (“de Gennes”)).  Mylan brought the IPR and alleged obviousness in view of three prior art references including the Burren US patent publication, the Venenzia US patent, and deGennes. Mylan argued the ‘614 patents were obvious because “Burren with Venezia…teach the use of spring washers within drug-delivery devices and de Gennes to add ‘snap-fit engagement grips’ to secure the spring washer”.  “De Gennes”, Mylan and its expert argued, “while concerned with a clutch bearing [in automobiles], addresses a problem analogous to that addressed in Burren (axially [sic] fixation and support of two components relative to one another).”  “Sanofi argued that de Gennes is not analogous art to the ’614 patent” as it “relates to cars and not drug delivery devices or medical devices, such that a person of ordinary skill in the art “would not have considered a clutch bearing to be within the same field of endeavor” or “‘reasonably pertinent’ to the ’614 patent’s problem…which it asserted is ‘secur[ing] a cartridge against movement within a housing’”.  Mylan successfully argued to the Board that “Sanofi’s analogousness arguments relied on a ‘faulty understanding of controlling law’”, the Board finding de Gennes to be “analogous to the ’614 patent” because it “is reasonably pertinent to axially fixing two components relative towards each other, a problem addressed by the inventors of the ’614 patent.”  The FC panel explained that “[w]hether a reference is analogous art is an issue of fact” reviewed for substantial evidence.  In its appeal, Sanofi argued “the Board improperly shifted the burden of persuasion from Mylan—to prove the claims of the ’614 patent are unpatentable—to Sanofi—to defend the claims of the ’614 patent as patentable” (citing In re Magnum Oils, FC 2016) and “‘adopted Mylan’s problem statement derived from Burren and then worked backward to relate that problem to the ’614 patent,’ which led the Board to a ‘legally erroneous conclusion that lacks substantial evidence.’”  The FC panel agreed “with Sanofi that Mylan did not carry its burden to argue that de Gennes is analogous to the ’614 patent”, and that the Board relied on Mylan’s arguments regarding the problem of Burren (In re Bigio, FC 2004 (“same field of endeavor, regardless of the problem addressed”, “whether the reference still is reasonably pertinent to the particular problem”); Mandel, US 1948 (chemistry/cosmetics); In re Mariani, CCPA 1949 (“analogous to the claimed invention”)).  The Board decision was therefore reversed.

DC inventorship decision reversed as contribution “not significant when measured against the scope of the full invention”

Hip, Inc. v. Hormel Foods Corporation

Docket No. 2022-1696 (https://cafc.uscourts.gov/opinions-orders/22-1696.OPINION.5-2-2023_2120058.pdf)

LOURIE, CLEVENGER, TARANTO

May 2, 2023

Brief Summary:   DC decision finding party should have been name a joint inventor reversed as contribution “not significant when measured against the scope of the full invention”. Summary:  Hormel appealed DC holding that David Howard should be added as a joint inventor under section 256 to US 9,980,498 directed to methods of precooking bacon.  ‘498 claim 1 is directed to “[a] method of making precooked bacon pieces using a hybrid cooking system” using “a microwave oven” (claim 1) (or “a microwave oven, an infrared over, and hot air” (claim 5), “transferring the preheated bacon pieces to the cooking compartment of the oven”, and “cooking the preheated bacon pieces in the cooking compartment”.  The FC panel opinion explains that Hormel began this project in 2005 and met with David Howard of Unitherm Food Systems (now HIP) to discuss the project in 2007 and “entered into a joint agreement to develop an oven to be used in a two-step cooking process”.  Mr. Howard alleged “he disclosed the infrared preheating concept” in subsequent meeting with Hormel.  Hormel later made some adjustments to “solve[] the charred, off flavor of the bacon” and began “preheating the bacon with a microwave oven” to produce the “two-step cooking process”.  Hormel filed a provisional patent applications naming four inventors who assigned their rights to Hormel, but the inventors did not include Mr. Howard.  In April 2021, HIP sued Hormel to make Howard the sole inventor or add him as a joint inventor, arguing he “contributed to at least one of the following: (1) using superheated steam at a level of 90% or more in claims 3 and 12; (2) heating the internal surfaces of the oven to a temperature less than 375º F. in claim 1; (3) preheating by hot air in claim 5; and/or (4) preheating with an infrared oven in claim 5.”  The DC agreed, finding Howard to be a joint inventor.  In this appeal, Hormel argued Mr. Howard’s contribution of preheating with an infrared oven “was well known”, “part of the state of the art”, and “not significant when measured against the scope of the full invention” and that Mr. Howard’s “testimony was insufficiently corroborated.”  The FC panel explained that “an alleged inventor” must prove the claim “by ‘clear and convincing evidence’” (Hess, FC 1997; Pannu, FC 1998; Final Oil, FC 1997).  The FC panel agreed with Hormel that Howard was not a joint inventor because “[u]nder the second Pannu factor”, he did not “make a significant contribution…measured against the dimension of the full invention”, noting that “preheating with an infrared oven…is measured only once in the ‘498 patent specification as an alternative heating method” (and not in the examples) and “recited only once in a single claim”, not including independent claims 1 and 13.  The FC panel did not consider the other Pannu factors or address the corroboration issue.

TTAB decision affirming rejection of mark for likelihood of confusion affirmed by FC panel

In re Charger Ventures LLC

Docket No. 2022-1094 (https://cafc.uscourts.gov/opinions-orders/22-1094.OPINION.4-13-2023_2110336.pdf)

PROST, REYNA, STARK

April 13, 2023

Brief Summary:   TTAB affirmance of examiner’s refusal to register mark due to likelihood of confusion affirmed. Summary:  Charger appealed TTAB decision denying registration of its trademark SPARK LIVING “for leasing of real estate; real estate listing; real estate service, namely, rental property management” on grounds of likelihood of confusion with an earlier registered trademark SPARK for “[r]eal estate services, namely, rental brokerage, leasing and management of commercial property, offices and office space.”  After the examiner alleged a risk of confusion between the marks, Charger “amended its description of services to only cover residential real estate services” and argued “that the examining attorney failed to compare the marks in their entireties”.  The examiner then issued a new office action “requiring Charger to disclaim “LIVING” because “adding a term to a registered mark” or ‘[i]ncorporating the entirety of one mark within another does not obviate the similarity between the compared marks . . . nor does it overcome a likelihood of confusion’”.  “Thus,” the FC panel noted the examiner found “the marks had similar sound, appearance, connotation and commercial impression and similarity in just one element of a mark, alone, is sufficient to find likelihood of confusion.”  Charger then disclaimed “LIVING” and “amended the description to “specifically” exclude commercial property and office space”.  Charger appealed the subsequent rejection to the TTAB, which affirmed the examiner’s rejection.  The FC panel found the TTAB properly “addressed five of the Dupont factors: (1) similarity or dissimilarity of the marks, (2) similarity of dissimilarity of the nature of the goods or services, (3) the similarity or dissimilarity of established, likely-tocontinue trade channels, (4) the conditions under which and buyers to whom sales are made, and (5) strength of the mark (e.g., the number and nature of similar marks in use on similar goods)”, “the similarity or dissimilarity of the marks as well as the goods or services” being “key factors” (In re E.I. DuPont, CCPA 1973; Federated Foods, CCPA 1976; “the services need not be “identical or even competitive” but merely “related in some manner”).  The FC panel explained that the TTAB “concluded that, despite some commercial weakness in the term SPARK and sophistication of consumers, there was ‘insufficient evidence’… to overcome the ‘close similarity’ of the marks and relatedness of the services” (Coca-Cola, CCPA 1975).  The FC panel also explained that the TTAB “can focus its analysis on dispositive factors” depending on the circumstances (In re Dixie, FC 1997) and even “[a] single DuPont factor may…be dispositive of the likelihood of confusion analysis” (Kellogg, FC 1991).  The FC panel concluded the TTAB’s analysis was proper (e.g., it “compared the marks “in their entireties” and based its findings on the “overall commercial impression engendered by the marks as a whole”) and supported by substantial evidence (e.g., “companies are known to offer both residential and commercial services under the same mark”).  The TTAB decision was therefore affirmed.

DC ineligibility finding regarding “computer-readable” medium reversed, claim construction affirmed

Sequoia Technology, LLC v. Dell, Inc., et al. (Red Hat, IBM)

Docket No. 2021-2263-67 (https://cafc.uscourts.gov/opinions-orders/21-2263.OPINION.4-12-2023_2109603.pdf)

LOURIE, DYK, STOLL

April 12, 2023

Brief Summary:   DC patent ineligibility decision regarding “computer-readable” medium limitation reversed; claim construction affirmed.

Summary:  Sequoia appealed judgment of noninfringement and invalidity of US 6,718,436 based on adverse claim construction ruling regarding “computer-readable recording medium storing instructions for executing a method”, “disk partition”, and “logical volume” (e.g., “creating the logical volume by gathering disk partitions”).  Sequoia initially file complaints against certain Red Hat (and its parent company being IBM) customers “that make or sell products or services incorporating the accused products”.  Red Hat filed two IPRs during litigation that were denied (IPR2019-00465, -00467).  The magistrate judge adopted Red Hat’s construction of “construed “‘computer-readable recording medium’ to include transitory media (i.e., signals or waves)”, and “including” a list of items—none of which are transitory— and interpreted that language as leaving the door open for media that could be transitory” based on specification and expert testimony.  As “transitory media are ineligible statutory subject matter under 35 U.S.C. § 101” (In re Nuijten, FC 2007), the DC found claims 8-10 including “computer-readable recording medium” invalid.  The DC also found “‘used or not used” in the limitation “‘extent allocation table for indicating whether each extent in the disk partition is used or not used” “means that an extent ‘is or is not storing information.’”  The DC’s construction of “logical volume” and “disk partition” also contributed to its finding of non-infringement.  The FC panel first considered the patentability question regarding the “computer-readable recording medium storing instructions” limitation and found error with the DC’s analysis.  Beginning with the claim language (Pers. Media, FC 2020), it explained that “the claim language does not actually recite a ‘computer-readable medium’ or CRM” but the narrower “recording medium storing instructions” language, and that “[o]ther elements in the claim confirm that the claim is directed to hardware as opposed to transitory waves or signals.”  The specification was found to support the FC’s construction (Phillips, FC 2005; Trs. Columbia, FC 2016) as it “discloses only non-transitory media”.  Red Hat argued “that the specification states that CRM ‘includ[es]’ non-transitory media, and thus its definition is open-ended” but the FC panel found that not to “makes sense in the context of the disclosed invention” (Lucent, FC 2008; Netword, FC 2001; Phillips, FC 2005).  It based its decision “solely on the intrinsic evidence” and was “unpersuaded by Red Hat’s arguments…which rest on extrinsic evidence”, and found the DC improperly relied on expert testimony (e.g., not supported by Mentor Graphics, FC 2017 (“[a] patentee is free to be his own lexicographer”); Phillips (“a court should discount any expert testimony ‘that is clearly at odds with the claim construction mandated by . . . the written record of the patent.’”)).  The FC panel also disagreed that the USPTO Eligibility Guidelines suggest the claims should be presumed to “read[] on transitory media.”  The FC panel agreed with the DC’s construction of “disk partition” and “logical volume” based on the claim language, specification (Kraken, FC 2020 (“patent’s express purpose”); (Teleflex, FC 2002 and Kaufman, FC 2022 (cannot limit claims to preferred embodiments); Vitronics, FC 1996 (exclusion of preferred embodiment rarely correct)), and prosecution history (Phillips; Aylus, FC 2017 (“statements made by a patent owner during an IPR proceeding, whether before or after an institution decision, can be considered for claim construction”) and CUPP, FC 2022; Collins, FC 2000 (“when a patentee cites prior art, it may ‘have particular value as a guide to the proper construction of the term, because it may indicate . . . that the patentee intended to adopt that meaning’”) and Boehringer, FC 2003).  The DC decision was therefore reversed-in-part and affirmed-in-part.

FC panel affirms DC finding that Amgen’s Otezla® composition patents are not invalid, but also that method of treatment claims are invalid, for obviousness

Amgen Inc. v. Sandoz Inc. et al.

Docket No. 2020-1147, 1149-51 (https://cafc.uscourts.gov/opinions-orders/22-1147.OPINION.4-19-2023_2113208.pdf)

LOURIE, CUNNINGHAM, STARK

April 19, 2023

Brief Summary:   DC finding that two of Amgen’s Otezla^® composition patents not invalid for obviousness affirmed.  DC finding that another of Amgen’s Otezla^® method of treatment patents invalid for obviousness affirmed.

Summary:  Sandoz appealed DC holding claims 3 and 6 of Amgen’s US 7,427,638 and claims 1 and 15 of its US 7,893,101 not invalid for obviousness.  Amgen cross-appealed DC finding that claims 2, 19 and 21 of its US 10,092,541 invalid as obvious.  These Orange Book patents (three of 11 listed) relate to Amgen’s apremilast product for inhibiting phosphodiesterase-4 (PDE-4) for treating psoriasis and related conditions (stereomerically pure (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2- methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione; Otezla^®; NDA 205437).  Celgene assigned the patents to Amgen, and initially filed this Hatch-Waxman suit against Sandoz. 

Sandoz alleged ‘638 claims 3 and 6 were invalid as obvious over US 6,020,358 and a PCT application WO 01/034606 as the ‘358 patent as it describes “a racemic mixture containing apremilast” (a mixture including 50% of the (+) enantiomer) and “a genus of phosphodiesterase inhibitors, including a racemic mixture containing apremilast” with “seventeen example compounds that fall within the scope of the claimed genus”.  Both references were argued to teach “that racemates can be separated into individual enantiomers.”  The DC concluded Sandoz did not show a “reason or motivation to resolve the Example 12 racemic mixture into its enantiomers”, “that the desirable properties of Example 12 derived in whole or in part from the apremilast enantiomer”, “a reasonable expectation of success in resolving Example 12 into its individual enantiomeric components”, and a nexus between the claims and unexpected “substantial improvement over previously known” PDE inhibitors, “a long-felt need for a psoriasis treatment that was suitable for oral administration to a patient, without the risks and barriers to adherence that were common with other psoriasis treatments”, failure of others in development, skepticism in the industry, and “the commercial success of Otezla since it achieved FDA approval”.  The FC panel found no clear error with the DC’s conclusion (distinguishing it from PharmaStem, FC 2007 (“not unfair to hold the inventors to the consequences of their admissions because their characterization of the prior art references was not unreasonable”); and citing, e.g., Ortho-McNeil, FC 2008 and Ruiz, FC 2000 (objective indicia); stating there is no “line between a difference in degree insufficient to rebut a showing of obviousness and a difference in kind that may be sufficient to do so; each inquiry need be fact-specific” (Bristol-Myers, FC 2014).

Sandoz alleged the forms and compositions of the ‘101 claims, “directed to solid forms (e.g., crystalline polymorphic forms) of apremilast” (“Form B”), were not “explicitly nor inherently disclosed” in the priority provisional application (Yeda, FC 2016; Bettcher, FC 2011; In re Cruciferous, FC 2002; In re Olerich, CCPA 1981) and that Celgene “represented to the [EPO] that following Example 2 could result in crystalline Form C of apremilast as well as Form B.”  The DC disagreed based in part on Amgen’s expert testimony that Celgene’s representation was a mistake.  The FC panel agreed with the DC that ‘101 claims 1 and 15 are entitled to the priority date and did not address inherency as the evidence supported Form B was “actually disclosed”.  The FC panel also found no error with the DC’s finding the Celgene made a mistake in its statements to the EPO. Sandoz alleged the asserted claims of the ’541 patent, directed to dose titration methods of treatment, were obvious over three clinical trial-related prior art references, and the DC agreed as to claims 2, 19, and 21 (“a routine aspect of treating psoriasis with a drug like apremilast”, “obvious to try” (In re Cyclonezaprine, FC 2012 (“obvious-to-try theory must show that the possible options skilled artisans would have encountered were finite, small, or easily traversed”)).  The FC panel found no error with the DC’s conclusion of obviousness (e.g., “routine aspect of treating psoriasis”; Genentech, FC 2022 (“well-established, hence obvious, practice”; “as in Genentech, that varying a dose in response to the occurrence of side effects is well-known and obvious to the skilled artisan”)).

DC finding of UCB’s OB ‘589 patent invalid for anticipation and obviousness affirmed

UCB, Inc. et al. v. Actavis Laboratories UT, Inc. / Mylan Technologies, Inc.

Docket No. 2021-1924, -2336 (https://cafc.uscourts.gov/opinions-orders/21-1924.OPINION.4-12-2023_2109643.pdf)

MOORE, CHEN, STOLL

April 12, 2023

Brief Summary:   DC finding UCB’s ‘589 patent invalid for anticipation and obviousness affirmed.

Summary:  UCB appealed DC finding US 10,130,589 directed to transdermal rotigone patches (TTSs) for treating Parkinson’s disease (UCB’s product being Neupro^®) invalid for anticipation and obviousness.  The FC panel affirmed the DC’s decision as its “fact findings on overlapping ranges, teaching away, unexpected results, and commercial success are not clearly erroneous”.  The FC panel opinion explains that UCB’s “original” Neupro^® patch, covered by UCB’s US 6,884,434 and 7,413,747 (the Muller patents), “contains a dispersion of amorphous rotigotine and polyvinylpyrrolidone (PVP)” at a ratio of 9:2, where the “PVP stabilizes amorphous rotigotine by increasing the Tg and preventing hydrogen bonding between rotigotine molecules, which prevents a clumping of sorts that creates crystallization” (which “can reduce the amount of drug leaving the patch and hence reduce a patient’s dose”).  This opinion explains that “[t]he ’434 patent teaches a TTS having rotigotine in an amount effective for treating Parkinson’s disease, with PVP in the range of 1.5% to 5% (w/w)”, the ‘747 patent “teaches a TTS with a ratio of 9% rotigotine to 1.5% to 5% PVP by weight”, and “an exemplary process for making a TTS with a rotigotine to PVP weight ratio of 9:3 rotigotine to PVP.”  After finding storage of the original Neupro^® patches at room temperature led to the development of a Form II crystal, UCB recalled those, which was followed by FDA approval of a new version.  UCB sued Actavis in 2013 for infringement of the ‘434 patent and US 8,232,414 with its ANDA (UCB I), and the DC upheld the validity of the ‘434 patent, some of the ‘414 claims invalid, and granted UCB an injunction which expired with the ‘434 patent in 2021.  While UCB I was on appeal, the ‘589 patent issued, claiming priority to a 2009 provisional application, with claims to “[a] method for stabilizing rotigotine” using a “weight ratio of rotigotine free base to polyvinylpyrrolidone is in a range from about 9:4 to about 9:6.”  The FC panel explained that “the ranges of rotigotine to PVP ratios disclosed in the Muller patents and the ’589 patent overlap from about 9:4 to 9:5 and include the ratio in reformulated Neupro^®” which extends to “about 9.6”.  In 2019, UCB sued Actavis and Mylan (separately) for infringement of the ‘589 patent.  The DC made its ‘589 invalidity determination under the “‘at once envisage’ framework for anticipation articulated in Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381 (Fed. Cir. 2015)” (Nidec Motor, FC 2017) and obviousness “in view of multiple prior art references”.  UCB argued the DC “(1) impermissibly relied on hindsight in its analysis; and (2) improperly disregarded evidence of objective indicia of nonobviousness.”  The FC panel found no error with the DC’s analyses, citing, e.g., Ineos (FC 2015), Titanium Metals (FC 1985) (for anticipation, e.g., “no reasonable difference in how the invention operates over the ranges”, “claimed range is critical to the operability” (Genentech, FC 2020); for obviousness, Ormco, FC 2006 (“presumption of obviousness applies “[w]here a claimed range overlaps with a range disclosed in the prior art”), Almirall, FC 2022 (“absent a reason to conclude otherwise, a factfinder is justified in concluding that a disclosed range does just that—discloses the entire range”); “pre-Form II prior art” relevant; no teaching away (Galderma (FC 2013), DuPuy Spine (FC 2009) (“a reference does not teach away if it ‘merely expresses a general preference for an alternative invention but does not ‘criticize, discredit or otherwise discourage’ investigation into the invention claimed’”), no unexpected results (Bristol-Myers, FC 2014 (range must produce “a new property dissimilar to the known property”)), Hoffman-La Roche, FC 2014 (“evidence of superior efficacy does not undercut a reasonable expectation of success”); Fox Factory, FC 2019 (“evidence of commercial success must have a nexus to the claims to be given weight in an obviousness analysis”) (here, e.g., “Muller patents have operated as blocking patents dissuading competitors” (citing Merck (FC 2017) and Galderma)).  The DC decision was therefore affirmed.