• By Donald Zuhn

    World Health OrganizationLast week, World Health Organization Director-General Tedros Adhanom declared that the COVID-19 outbreak "can be characterized as a pandemic," cautioning that the WHO has "rung the alarm bell loud and clear."  At the time of the announcement, the WHO noted that there were 118,000 cases reported globally in 114 countries.  In its latest situation report, the WHO indicates that as of March 18, there have been 191,127 cases in 160 countries.  The Director-General also stated that "[t]his is not just a public health crisis, it is a crisis that will touch every sector – so every sector and every individual must be involved in the fight."  The WHO's declaration last week – and global developments since then – raise the question of how the pandemic is affecting the patent community.

    Since Sunday, we have reported (here and here and here) on the impact of the COVID-19 pandemic on the U.S. Patent and Trademark Office (USPTO), World Intellectual Property Organization (WIPO), European Patent Office (EPO), IP Australia, Intellectual Property Office of New Zealand (IPONZ), Brazilian Patent and Trademark Office (INPI), Canadian Intellectual Property Office (CIPO), and U.S. Federal courts, including, in particular, the Supreme Court and Federal Circuit.  Today we present recent developments in response to the COVID-19 pandemic in Mexico and at the Federal Circuit.

    Mexican Patent Office - Instituto Mexicano de la Propiedad IndustrialEarlier today, Mexican patent law firm Olivares notified the patent community regarding developments in its country.  Olivares advised that both federal and local jurisdictional authorities have suspended their activities from March 18 to April 19, 2020, and have decreed that no procedural terms will run during that period.  The suspension and interruption of procedural deadlines is being carried out by the Supreme Court of Justice, Collegiate Circuit Courts, Single-judge Circuit Courts, District Courts, Civil and Commercial Courts, and Federal Court of Administrative Affairs, including the Special Chamber for Intellectual Property Matters and the Special Chamber for Environmental and Regulatory Matters.

    However, Olivares also noted that the Mexican Institute of Industrial Property (IMPI), the Federal Copyright Office (INDAUTOR), the Federal Commission on Sanitary Risks (COFEPRIS), and the Consumer's Protection Bureau (PROFECO) continue to operate in a normal manner, and have not declared any suspension of their procedural terms and deadlines.

    Federal Circuit SealIn a notice posted on its website today, the Federal Circuit announced that all cases scheduled for argument during the April 2020 sitting will now be conducted by telephonic conference and no in-person hearings will be held.  Parties in all cases will receive an updated notice in their respective cases.

    Patent Docs will continue to monitor and report on patent-related developments related to the COVID-19 pandemic.  In addition, we encourage our readers to let us know about developments related to the COVID-19 pandemic at other patent offices.

  • By Kevin E. Noonan

    Supreme Court Building #1Recently, the Federal Circuit has taken up issues relating to infringement under the doctrine of equivalents (DOE) and a related doctrine, prosecution history estoppel (PHE), that limits the scope of equivalents that can be asserted under DOE.  See, e.g., Pharma Tech Solutions, Inc. v. Lifescan, Inc.; Amgen Inc. v. Coherus BioSciences Inc.; Indivior Inc. v. Dr. Reddy's Laboratories, S.A.; and UCB, Inc. v. Watson Laboratories IncIn three cases (stemming in one instance from a Federal Circuit opinion consolidated from two cases in the district court, by Eli Lilly & Co. against two ANDA defendants), the defendants found to be infringers under the DOE have filed petitions for certiorari challenging how the Federal Circuit adjudged the interplay between the DOE and PHE in affirming the infringement determinations (see Eli Lilly & Co. v. Hospira, Inc. and Ajinomoto Co. v. International Trade Commission).

    It will be recalled, by way of background, that the DOE arose in the modern era in Graver Tank & Mfg. Co. v. Linde Air Products Co., 339 U.S. 605 (1950), wherein the Supreme Court recognized that an "unscrupulous copyist" could practice a claimed invention without literal infringement in some circumstances, and as a consequence, the patent right could be turned into a "hollow and useless thing."  But the doctrine fell into disfavor at the Federal Circuit during the 1990s and arguably provided the first inkling to the Supreme Court that the Federal Circuit's patent jurisprudence would benefit from closer oversight.  In Warner-Jenkinson Co. v. Hilton Davis Chem. Co., and later in Festo v. Shoketsu Kinzoku Kogyo Kabushiki, the Supreme Court reiterated the vibrancy of the doctrine, Festo in particular setting forth the metes and bounds of the limitations PHE puts on the DOE.  Specifically, the Court held that while any amendment to a claim element during prosecution raised a presumption that the applicant had relinquished all equivalents to the element, this presumption could be rebutted in three instances:

    The equivalent may have been unforeseeable at the time of the application; the rationale underlying the amendment may bear no more than a tangential relation to the equivalent in question; or there may be some other reason suggesting that the patentee could not reasonably be expected to have described the insubstantial substitute in question.

    The question of proper application of the "tangential relationship" test was at issue in each of the cases underlying the certiorari petitions.  A brief background on the cases is set forth to provide the context for these petitions.

    Eli Lilly & Co. v. Hospira

    This decision arose in a consolidated appeal (Eli Lilly & Co. v. Hospira, Inc. and Eli Lilly & Co. v. Dr. Reddy's Laboratories, Ltd.) regarding infringement in ANDA litigation under the doctrine of equivalents of U.S. Patent No. 7,772,209, related to Lilly's anticancer drug Alimta® (pemetrexed disodium).  The accused generic competitor drugs comprised a different salt, pemetrexed ditromethamine.  During prosecution, Lilly had amended the claims to limit the pemetrexed salt species to the disodium salt itself.

    The District Court held and the Federal Circuit affirmed DOE infringement, on the basis that the narrowing amendment had only a tangential relationship to the differences in these salts, the amendment being made to distinguish different antifolate species and not different salt forms thereof.  Lilly did not dispute that its amendments satisfied the fundamental requirements of behavior that raises the estoppel:  that "the amendment in question was both narrowing and made for a substantial reason relating to patentability."  Lilly relied on the exception that the rationale for its amendments "[bore] no more than a tangential relation to the equivalent in question," citing Festo.  Hospira and Dr. Reddy's Laboratories colorfully argued that "the tangential exception is not a patentee's-buyer's-remorse exception" and that the tangential relationship exception should be construed narrowly (themes that would recur in Hospira's cert petition).  The Court agreed with the District Court's assessment that Lilly had narrowed the claims of the earlier, related application to overcome a rejection based on treatment with methotrexate, and that "the particular type of salt to which pemetrexed is complexed relates only tenuously to the reason for the narrowing amendment," which was to avoid prior art directed to methotrexate administration.  The Court further reasoned that the exception itself "only exists because applicants over-narrow their claims during prosecution" and that "the reason for an amendment, where the tangential exception is invoked, cannot be determined without reference to the context in which it was made, including the prior art that might have given rise to the amendment in the first place."  According to the panel, "[w]e do not demand perfection from patent prosecutors, and neither does the Supreme Court" (citing Festo).  Lilly's burden was to show that pemetrexed ditromethamine was 'peripheral, or not directly relevant, to its amendment . . . [a]nd as [the panel] concluded . . . , Lilly [had] done so."

    Ajinimoto v. ITC

    Ajinomoto petitioned the International Trade Commission (ITC) under Section 337 (19 U.S.C. § 1337) for an exclusion order against CJ Cheiljedang for importing animal feed-grade L-tryptophan amino acid products produced by several different strains of Escherichia coli that infringed Ajinomoto's U.S. Patent No. 7,666,655.  The claimed bacteria have been genetically engineered to increase L-aromatic amino acid production by fermentation, and in particular production of L-tryptophan.  The basis for this increased production depends on an E. coli gene, yddG, encoding an aromatic amino acid transporter that causes the bacteria to excrete these amino acids into the culture medium.  This is achieved in one of three ways:  either by introducing (via plasmid transduction) additional copies of the gene into the bacteria (denoted as [3a] in the opinion); integrating additional copies of this gene into the bacterial chromosome ([3b]); or using a transcriptionally "stronger" promoter to express the endogenous yddG gene ([3c]).  The full Commission reviewed and affirmed an ALJ's decision, of noninfringement of the imported products made by the earlier, [3a] strain, and reversed as to the ALJ's invalidity determination and noninfringement for products made using the later [3b] and [3c] strains under the doctrine of equivalents.

    The Federal Circuit agreed, on the grounds that prosecution history estoppel did not bar a determination of infringement under the doctrine of equivalents based on the "tangential relationship" test.  With regard to limitations introduced into the claims during prosecution regarding the second of the two later strains, the Commission had found that "the YddG protein encoded by the codon-randomized non-E. coli yddG gene of this strain [as practiced by the accused infringer] is an equivalent of SEQ ID NO:2" recited in claim 9.

    CJ challenged this ruling on two grounds:  that the amendments made during prosecution raised an estoppel against infringement under the doctrine of equivalents; and that the protein expressed in CJ's second strain failed to satisfy the "structure-way-result" rationale for infringement under the doctrine.  Citing Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 740 (2002), the majority recognized that the second of the three exceptions to PHE, that "the rationale underlying the amendment may bear no more than a tangential relation to the equivalent in question," was dispositive to the issue before the Court.  The basis for the majority's view was that during prosecution, patentees made an amendment to distinguish over prior art that narrowed the scope of the claim from alternatives to the protein having an amino acid sequence identified as SEQ ID NO: 2 that differed by "deletion, substitution, insertion, or addition of several amino acids."  The amendment changed the claim language to recite instead "a protein which comprises an amino acid sequence that is encoded by a nucleotide sequence that hybridizes with the [corresponding] nucleotide sequence of SEQ ID NO:1 under stringent conditions."  The standard the Federal Circuit majority applied to determine whether the "tangential relationship" test is adequate to rebut the estoppel "focuses on the patentee's objectively apparent reason for the narrowing amendment."  The majority held that Ajinomoto had satisfied this standard.

    Judge Dyk disagreed, on the ground that the amendments to the claims of the '655 patent had a direct relationship to the elements at issue (non-E. coli YddG protein of CJ's second later strain) and thus L-tryptophan produced by either of CJ's later two bacterial strains did not infringe under the doctrine of equivalents (a rationale relied upon by all three of the Petitioners for certiorari).

    Two of the certiorari petitions relate to whether the Federal Circuit properly applied the tangential relationship test to limit the effects of PHE on Lilly's claims reciting pemetrexed disodium.  Although the arguments were similar (that the Federal Circuit had erred, that this was an important issue having wide import on innovation that the Supreme Court should address, and that this case was a proper vehicle for Supreme Court correction of the Federal Circuit's error), there are some informative differences.

    Hospira's petition

    The question presented is:

    Whether a patentee may recapture subject matter via the doctrine of equivalents under the "tangential relation" exception by arguing that it surrendered more than it needed to during prosecution to avoid a prior art rejection, even if a claim could reasonably have been drafted that would literally have encompassed the alleged equivalent.

    Hospira minces no words regarding its position, asserting that "[t]he Federal Circuit's tangentiality jurisprudence has gone seriously awry" because "the Federal Circuit now holds that even when the patentee indisputably could 'reasonably be expected to have drafted a claim that would have literally encompassed the alleged equivalent' . . . the doctrine of prosecution history estoppel applies so long as the patentee can show that its purpose for an amendment is sufficiently disconnected from its theory of equivalence."  (The District Court based its opinion finding infringement under the DOE on the grounds that "the rationale underlying the amendment may bear no more than a tangential relation to the equivalent in question.")  This way of applying the Supreme Court's Festo jurisprudence "unfairly skews the patent playing field in favor of patentees, by artificially expanding the scope of patent monopolies and handcuffing the ability of competitors to design their products in a manner that avoids infringement," in Hospira's view.

    In this case, according to Hospira, Lilly's claims as filed encompassed all antifolates.  Lilly amended the claim to pemetrexed disodium, which were the claims at issue in the underlying ANDA litigation.  Hospira admits that its generic antifolate, pemetrexed ditromethamine, would have fallen within the scope of claims as filed directed to antifolates but not claims to pemetrexed disodium as granted.  The Federal Circuit's error was permitting Lilly to expand the scope of its claims reciting pemetrexed disodium to encompass its antifolate.  In Hospira's view "[t]his case should have been easy" because Lilly could have narrowed its claims to have literally encompassed Hospira's alleged equivalent (e.g., by amending to recite pemetrexed and its salts).  Hospira argues that the Federal Circuit's affirmance of the District Court's DOE infringement decision is contrary to the Supreme Court's rubric in Festo that equivalents should be found under circumstances where a patentee "lacked the words to describe the subject matter in question."  Rather, according to Hospira, the Federal Circuit used "Lilly's subjective goal in amending its claim . . . to distinguish pemetrexed compounds from other antifolates, not to distinguish one pemetrexed compound from another."

    Hospira contends that the general importance of the Federal Circuit's decision, and the reason for the Court to grant certiorari, is the harm it does to the public notice function of claims (a concern the Supreme Court has recognized in its DOE jurisprudence; see, e.g., Hilton-Davis) ("There can be no denying that the doctrine of equivalents, when applied broadly, conflicts with the definitional and public-notice functions of the statutory claiming requirement," Warner-Jenkinson v. Hilton Davis Chem. Co., 520 U.S. at 29 (1997)), nullifying the claim-limiting effects of decisions applicants make during prosecution in order, inter alia, to overcome rejection over prior art.  The Federal Circuit's decision permits applicants to play "bait-and-switch games" during prosecution, "making the strategic decision to narrow a claim during prosecution, then expanding the claim via the doctrine of equivalents by making post-hoc arguments about the reason for that narrowing" (emphasis in the petition), in Hospira's view.

    According to the petition, the question before the Court is "when the record makes clear that the patentee could reasonably have been expected to have drafted a claim that would have literally encompassed the alleged equivalent, can the patentee nonetheless take refuge in the 'tangential relation' exception?"  (The answer in Hospira's view is "no.")  The Federal Circuit erred in looking at the purpose of the amendment rather than its effect, that purpose being to exclude antifolates other than pemetrexed from the scope of the claim.  Lilly's amendment not only excluded other antifolates but excluded all antifolates other than pemetrexed disodium and thus Lilly should be estopped from asserting its claims against Hospira's pemetrexed ditromethamine.  This is the Federal Circuit's legal error in applying PHE under the Court's Festo precedent.  And the basis for this error was that the Federal Circuit put the patentee's interest over the public interest that PHE is intended to protect.

    Finally, the petition contends that the Court should grant certiorari because "[the] question presented recurs frequently and is important to the sound administration of American patent law."  The petition asserts (without citation) that "[i]t It is an unfortunate but routine tactic for patentees to narrow claims during prosecution in the Patent Office and then, after the patent is allowed, attempt to re-broaden them in the courts via the doctrine of equivalents" in support of its argument that the Court should grant its petition.  What the petition does support with citations (nine of them) is that disputes like the ones before the Court here arise with sufficient frequency to support the Court's review (one of which is Ajinimoto and Judge Dyk's dissent consistent with Hospira's position here).

    The petition completes its argument by identifying "internal inconsistencies" in Federal Circuit decisions involving the tangential relationship test (specifically citing Norian Corp. v. Stryker Corp., 432 F.3d 1356 (Fed. Cir. 2005)), as well as Felix v. American Honda Motor Co., 562 F.3d 1167 (Fed. Cir. 2009); Integrated Tech. Corp. v. Rudolph Techs., Inc., 734 F.3d 1352, 1358 (Fed. Cir. 2013); and Chimie v. PPG Indus. Inc., 402 F.3d 1371, 1383 (Fed. Cir. 2005).

    Finally, Hospira argues that this case is the "ideal vehicle" because "the facts are remarkably stark" and the issue clear-cut.

    Dr. Reddy's petition

    Not surprisingly, Dr. Reddy's certiorari petition tracks Hospira's closely.  The question presented by Dr. Reddy's is:

    [W]hether, under Festo's "tangential" exception to prosecution history estoppel, patent owners may recapture subject matter they could have claimed in prosecution but did not, by arguing that they surrendered more than they needed to during prosecution to address a rejection by the Patent Office.

    Slightly less aggressively than Hospira, Dr. Reddy's petition asserts that the Federal Circuit has "puzzled" over the proper application of the Festo tangential relationship test, and its cases have given two answers that are irreconcilable.  This case is an "ideal vehicle" (because, truthfully, there are few alternative ways to make this important point to the Court) because the outcome below depended on which of these two rationales was used.

    Like Hospira, Dr. Reddy's makes the case that Lilly made a strategic decision to narrow its claims to pemetrexed disodium (the active ingredient of its Alimta® drug product) rather than to alternative salts of the pemetrexed antifolate, illustrating these relationships with a helpful graphic:

    2020-03-19 Image

    Like Hospira, Dr. Reddy's declares that this should have been an "easy case" under Festo, because "Respondent could 'reasonably be expected to have drafted a claim that would have literally encompassed the alleged equivalent.'"  Instead, Lilly in this case limited the claims excessively, to literally encompass only its active pharmaceutical ingredient, or API.  This circumstance has arisen in other cases decided (reaching the opposite outcome) by the Federal Circuit, wherein the Court held that "a patent owner cannot invoke the tangential exception by arguing that, in hindsight, it surrendered more than it needed to address the Patent Office's invalidity rejection."  The other line of precedent, which the Federal Circuit followed in this case, has held the opposite:  that "[a] patent owner can invoke the tangential exception by arguing that, in hindsight, it surrendered more than it needed to address the Patent Office's invalidity rejection" (emphasis in petition).  Dr. Reddy's petition calls this a "prosecution remorse exception" (language also present in its arguments below).  And, Dr. Reddy's argues, the Federal Circuit's decision has the prejudicial effect on petitioners that they could not rely on the claim scope limiting amendments when developing their own drug with an antifolate that fell outside the literal scope of Lilly's claims.

    The petition cites copious Supreme Court precedent on the importance of PHE to cabin the scope of DOE and provide a reliance interest in competitors regarding non-infringement of their products based on PHE (including Schriber-Schroth Co. v. Cleveland Trust Co., 311 U.S. 211, 220-21 (1940); Exhibit Supply Co. v. Ace Patents Corp., 315 U.S. 126, 136-37 (1942); Smith v. Magic City Kennel Club, 282 U.S. 784, 790 (1931); Weber Elec. Co. v. E.H. Freeman Elec. Co., 256 U.S. 668, 677-78 (1921); Morgan Envelope Co. v. Albany Perforated Wrapping Paper Co., 152 U.S. 425, 429 (1894); and Shepard v. Carrigan, 116 U.S. 593, 598 (1886)).  As in Hospira's petition, Dr. Reddy also warns that failure to correct the Federal Circuit could lead to a situation where "the inventor might avoid the [Patent Office's] gatekeeping role and seek to recapture in an infringement action the very subject matter surrendered as a condition of receiving the patent," citing Festo.

    Dr. Reddy's petition asserts the "internal division" at the Federal Circuit as a reason why the Court should grant certiorari (an argument that may have persuasiveness due to being the Federal Circuit's equivalent to a "circuit split" amongst the remainder of the Federal Courts of Appeal).  The petition cites Federal Circuit cases illustrating the differences in various Federal Circuit judges' attitudes regarding the tangential relationship test starting with Festo and including Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 480 F.3d 1335, 1346-48 (Fed. Cir. 2007); Regents of Univ. of Cal. v. Dakocytomation Cal., Inc., 517 F.3d 1364, 1380-82 (Fed. Cir. 2008); Honeywell Int'l, Inc. v. Hamilton Sundstrand Corp., 523 F.3d (1304, 1321-22 (Fed. Cir. 2008); and Judge Dyk's dissent in the recent Ajinomoto case).

    The petition synthesizes these disparate decisions into two "irreconcilable" approaches:

    • Under one approach, the court asks why the patentee made the specific narrowing amendment it chose to makeSee, e.g, Felix v. Am. Honda Motor Co., 562 F.3d 1167, 1184 (Fed. Cir. 2009); Amgen Inc. v. Hoechst Marion Roussel, Inc., 457 F.3d 1293, 1315 (Fed. Cir. 2006).

    Under this approach, according to the petition, "the 'tangential exception' applies when an amendment adds multiple limitations to a claim at the same time, and not all relate to an examiner's rejection.  The limitations unrelated to the examiner's rejection may fit the tangential exception," the petition noting that this was the approach followed by Judge Dyk's dissent in Ajinimoto.  Relevant to the question presented here, the petition contends that "[w]here, as here, the patentee focused on a particular claim element, and responded to an examiner's rejection by narrowing in a way that excludes a defendant's allegedly equivalent product, the rationale for the narrowing amendment cannot be 'tangential' to the alleged equivalent," citing Honeywell Int'l, Inc. v. Hamilton Sundstrand Corp.

    • Under the other approach, "[s]ome panels accept precisely the type of buyer's-remorse arguments that other panels reject and base the tangential-exception inquiry on a post hoc assessment of what the patent applicant needed to surrender to avoid an examiner's rejection.  Those panels begin by phrasing the "reason" for the disputed narrowing amendment as surrendering only what was necessary to avoid a specific rejection—often to distinguish a particular piece of invalidating prior art," citing Insituform Techs., Inc. v. CAT Contracting, Inc., 385 F.3d 1360, 1370 (Fed. Cir. 2004) and Primos, Inc. v. Hunter's Specialties, Inc., 451 F.3d 841, 849 (Fed. Cir. 2006).

    In such cases, the "unnecessarily surrendered claim scope is 'tangential' to that reason—without regard to the applicant's choice of how far to go in avoiding the examiner's rejection," citing Ajinimoto, Regents, and Primos.  This was the approach taken in the case at bar.

    These two approaches are "fundamentally irreconcilable" according to the petition.  The petition is honest enough to admit that one approach (which it prefers) tends to result in PHE precluding a finding of infringement under DOE, while the approach taken by the District Court and Federal Circuit here tends to permit assertion of equivalents without prelusion by PHE.  Yet the petition also asserts that "[b]oth approaches cannot be right, and the approach applied here is plainly wrong."

    The petition also argues that the second approach (and necessarily the decision below) cannot be reconciled with Festo and other Supreme Court precedent.  And perhaps at least equally importantly:

    Under the approach the panel applied here, the public cannot objectively rely on narrowing amendments in prosecution to learn what a patent holder does not own.  Patent owners will be able to argue—as Lilly did here—that the "reason" for any narrowing amendment was to avoid a particular rejection, and that any surrender of scope that was not necessary to that reason is "tangential."  This invites precisely the sort of circumvention of the examination process that prosecution history estoppel is designed to prevent, where "the inventor might avoid the [Patent Office's] gatekeeping role and seek to recapture in an infringement action the very subject matter surrendered as a condition of receiving the patent," citing Festo.

    The petition concludes that "[o]nly this Court can explain what it meant when it announced the "tangential" exception in Festo (noting elsewhere in the petition that the tangential relationship standard arose solely from the Court without any explication in its Festo decision) and in the face of 18 years of Federal Circuit decisions that have not resolved the issue.  The petition emphasizes the importance of resolving the scope of the tangential relationship test by invoking the effects of uncertainty on "the ability of productive companies to determine their potential liability ex ante, before making substantial investments in competing products," including as examples that "[d]eveloping and securing FDA approval of a generic drug product, for example, typically costs millions of dollars"; "[a]nalogous costs for follow-on biologic manufacturers are hundreds of millions of dollars or more"; and "[a] new semiconductor plant costs billions of dollars."  Under these circumstances, "[t]oo much uncertainty in the scope of patents chills beneficial investments in legitimate products, as recognized by the Court in Festo and Merrill v. Yeomans, 94 U.S. 568 (1876).  And as has been noted in Hospira's petition, this case is "an ideal vehicle" for the Court to clarify the scope and application of the tangential relationship test because "the applicability of the tangential exception decides the entire case" and "this case cleanly exemplifies a recurring fact pattern in patent litigation:  a patent applicant surrenders more than necessary to avoid a rejection in prosecution, then tries to recapture some of that claim scope in litigation."

    CJ Cheiljedang's petition

    The question presented is:

    Whether, to avoid prosecution history estoppel under Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., "the rationale underlying the amendment" must be the rationale the patentee provided to the public at the time of the amendment.

    While the facts in this case differ substantially from the Hospira and Dr. Reddy's petitions, the issue as set forth in the petition are strikingly similar:  "the public's ability to rely on a patentee's representations to the Patent Office during prosecution (called the 'prosecution history') to determine the metes and bounds of a claim."  But here the petitioner asserts that the Federal Circuit adopted a new rule, wherein the tangential relationship exception to PHE applies "even where the patentee gave no contemporaneous explanation in the prosecution history for why it chose the particular amended claim language or how the amendment overcame the rejection."  This permits a patentee to expand the equivalent scope of amended claims "improperly" on a "post-hoc rationale" for any narrowing amendment, in light of the accused product, to enable the patentee to recapture scope voluntarily surrendered during prosecution.  The result "creates perverse incentives at odds with the Patent Act's and this Court's focus on public notice" because it does not encourage transparency in patent prosecution but rather encourage an applicant to withhold any explanation for patent prosecution decisions in order to "craft with hindsight a rationale designed to be "tangential" to the alleged equivalent."  The results, according to petitioner, will be "devastating" because "[t]he public will be denied notice of the actual scope of the surrender or what is subject to subsequent recapture as an "equivalent" until the end of infringement litigation, with the prospect of millions of dollars in damages and potential injunctions," analogous to indefiniteness in claims considered by the Court in Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898 (2014).

    Petitioner here analyzes the Federal Circuit's cases involving the tangential relationship test for PHE to have "specifically looked to the patentee's explicit explanation in the prosecution history of how its amendment overcame the rejection," citing Insituform Techs., Inc. v. CAT Contracting, Inc., 385 F.3d 1360 (2004); Regents of Univ. of Cal. v. Dakocytomation Cal., Inc., 517 F.3d 1364 (2008); and Intervet Inc. v. Merial Ltd., 617 F.3d 1282 (2010).  In petitioner's view, the Federal Circuit "made a dramatic departure from [its] historical precedent" in its decision in Hospira and in this case.  These decisions "significantly frustrate the public notice function of the prosecution history" and "allow a patentee to recapture claim scope it voluntarily surrendered during prosecution in order to secure allowance of its patent, despite the patentee's having provided no notice to the public that it intended to surrender any less than the entire territory between the original and amended claims."  This creates uncertainty that Petitioner asserts will "stifle the progress of science and the useful arts" because "[p]otential innovators, who would otherwise be able to design around a patent, may instead decline to do so, unwilling to run the risk of being found to infringe under a doctrine of equivalents theory that recaptures what a patentee appears on the face of the patent and the prosecution history to 'have surrendered,'" particularly in the pharmaceutical industry due to high development costs, according to the petition.

    The petition also emphasizes the important role PHE plays in the public notice function of patents, by striking a balance that "seeks to guard against [both] unreasonable advantages to the patentee and disadvantages to others arising from uncertainty as to their rights" citing General Elec. Co. v. Wabash Appliance Corp., 304 U.S. 364, 369 (1938).  The apprehension PHE addresses is of early provenance in U.S. patent law, with the brief citing Evans v. Eaton, 20 U.S. 356, 434 (1822), for the proposition that a patentee cannot be permitted to "practi[ce] upon the credulity or the fears of other persons, by pretending that his invention is more than what it really is."  The Court's jurisprudence regarding DOE is limited to particular circumstances where language is insufficient to "capture the essence" of the invention, according to petitioners.  And because "the Court has always recognized that . . . the doctrine of equivalents 'conflicts with the definitional and public-notice functions of the statutory claiming requirement,' Warner-Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17, 29 (1997), [the DOE] must be applied with restraint, so as not to stifle innovation."  The petition applies these considerations to its argument for Supreme Court review, arguing that the Federal Circuit's decisions, in its case and in the Hospira case, has upset this balance by permitting patentees to supply post-hoc rationales in support of equivalents arguments, harming the public notice function of patents as cabined by PHE.

    As in the other two certiorari petitions, this one maintains that the Federal Circuit's decision is an "ideal vehicle" for Supreme Court review, because the prosecution history is devoid of any argument or explanation as to "how its narrowing amendment overcame the prior art rejection, why it chose the amended claim language that it did, or whether it intended to surrender any less than the full territory between its original and amended claims," as Judge Dyk noted in his dissent (emphasis in petition).  There is thus no need for the Court to weigh evidence or argument — the issue is whether the Federal Circuit should have considered "post-hoc" rationales for the amendments at all, or found that the patentee could not bear its proper burden of overcoming the presumption that the narrowing amendment precluded a finding of infringement under the DOE.

    Patentees in each case will have the opportunity to respond (if they so choose) and the Court will consider the petitions in due course over the next month or so, with argument in the Fall Term should the Court grant certiorari in any or all of them.

  • By Donald Zuhn

    World Health OrganizationLast week, World Health Organization Director-General Tedros Adhanom declared that the COVID-19 outbreak "can be characterized as a pandemic," cautioning that the WHO has "rung the alarm bell loud and clear."  At the time of the announcement, the WHO noted that there were 118,000 cases reported globally in 114 countries.  In its latest situation report, the WHO indicates that as of March 17, there have been 179,112 cases in 159 countries.  The Director-General also stated that "[t]his is not just a public health crisis, it is a crisis that will touch every sector – so every sector and every individual must be involved in the fight."  The WHO's declaration last week – and global developments since then – raise the question of how the pandemic is affecting the patent community.

    On Sunday and Monday, we reported (here and here) on the impact of the COVID-19 pandemic on the U.S. Patent and Trademark Office, World Intellectual Property Organization, European Patent Office, and Federal courts, including, in particular, the Supreme Court and Federal Circuit.  Today we present responses from IP Australia, Intellectual Property Office of New Zealand (IPONZ), Brazilian Patent and Trademark Office (INPI), and Canadian Intellectual Property Office (CIPO) to the COVID-19 pandemic.

    IP AustraliaAustralian patent law firm Griffith Hack noted on its website that:

    • We are in contact with IP Australia and IPONZ and at this stage we have not been advised of any changes to processes or deadlines.  We note that Australian legislation includes relatively generous provisions for obtaining extensions of time when a deadline is missed and we have extensive experience in obtaining such extensions.  Please contact us if you have a case where an extension is necessary.

    • From today (March 18th) the Federal Court of Australia (where the majority of IP legal matters are heard) has suspended face-to-face hearings listed up to 30 June 2020.

    INPI_1Brazilian patent law firm Dannemann Siemsen notified the patent community regarding developments at INPI.  While noting that INPI continues to operate normally and has its staff and examiners working either from home or in the Office, in view of the Covid-19 outbreak, INPI issued a regulation on Monday, March 16, 2020, concerning the prosecution of cases.  In particular, INPI has cancelled all in-person meetings until further notice.  Also, while recommending that applicants should meet deadlines where possible, INPI announced that deadlines would be postponed until April 14, 2020.

    Dannemann Siemsen also recommended that to the extent possible, applicants should try to respond to pending office actions and pay applicable fees within the original deadlines.  The firm noted that this will reduce accumulation of workload, which would otherwise create a serious risk of congestion of INPI's online system, leading to the possible missing of deadlines in April.

    CIPOEarlier today, Canadian patent law firms MBM Intellectual Property Law, Gowling WLG, and Bereskin & Parr LLP notified the patent community regarding recent developments at CIPO.  In particular, CIPO posted a notice on its website today concerning service and website interruptions as a result of the pandemic.  In that notice, CIPO indicated that it "remains open and in operation at this time; however, clients should expect significant delays in all CIPO services."  CIPO also stated that:

    On account of the unforeseen disruption caused by the COVID-19 outbreak, and being satisfied that it is in the public interest to do so, the Commissioner of Patents, under subsection 78(2) of the Patent Act, the Registrar of Trademarks under subsection 66(2) of the Trademarks Act, and the Minister under subsection 21(2) of the Industrial Design Act have designated for the purposes of subsection 78(1) of the Patent Act, subsection 66(1) of the Trademarks Act, and subsection 21(1) of the Industrial Design Act all days in the period of time beginning on March 16, 2020 and ending on March 31, 2020.  The result of designating these days is that if a time period fixed under the Patent Act, Trademarks Act and Industrial Design Act in respect of any business before the Canadian Intellectual Property Office for doing anything ends on any of these designated days, that time period is extended to the next day that is not either a designated day or a day that has been prescribed under section 5 of the Patent Rules, section 15 of the Trademarks Regulations and section 36 of the Industrial Design Regulations. It should be noted that if the circumstances that led to the designation of these days continues, the Commissioner, Registrar and Minister may decide to extend the period of time for which days are designated.

    CIPO reminded the patent community that its "online solutions are available to you 24/7 and anywhere," and encouraged applicants and representatives to use its online services for all transactions with CIPO.

    As Gowling noted on its website, the announcement by CIPO earlier today means that "[a]ll deadlines falling between March 16 and March 31 have been automatically extended to April 1."  Gowling also noted that hearings of the Patent Appeal Board and the Trademarks Opposition Board will take place by telephone and/or teleconference until at least April 30, 2020, or will be postponed.

    On Monday, CIPO announced that its regional offices in Toronto, Vancouver, Edmonton, and Montréal would not be receiving CIPO correspondence until further notice.

    Patent Docs will continue to monitor and report on patent-related developments related to the COVID-19 pandemic.  In addition, we encourage our readers to let us know about developments at other patent offices for responding to the COVID-19 pandemic.

  • By Kevin E. Noonan

    Federal Circuit SealThe latest Federal Circuit decision on subject matter eligibility in the life sciences came down (by a divided court) in favor of eligibility, in Illumina, Inc. v. Ariosa Diagnostics, Inc.  The claims at issue fell into the third "bucket" of eligibility, being neither diagnostic method claims (always ineligible at the Federal Circuit) nor method of treatment claims (eligible, at least until the Supreme Court grants certiorari in the next iteration of Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals), but rather (as denoted in the majority opinion), method of preparation claims, a philosophical cousin to the claims in Rapid Litig. Mgmt. Ltd. v. CellzDirect, IncAnd as an added bonus, Judge Reyna dissented in a manner that illustrates his thinking on patent eligibility of inventions involving natural phenomena (and natural products).

    The case arose over U.S. Patent No. 9,580,751 (the '751 patent) and U.S. Patent No. 9,738,931 (the '931 patent), directed to the solution of an unexpected difficulty in detecting cell-free fetal DNA (cffDNA):

    [T]he major proportion (generally >90%) of the extracellular DNA in the maternal circulation is derived from the mother.  This vast bulk of maternal circulatory extracellular DNA renders it difficult, if not impossible, to determine fetal genetic alternations [sic] . . . from the small amount of circulatory extracellular fetal DNA.

    The inventors found that cffDNA was significantly smaller (300-500 bp) than the "interfering" maternal DNA, and thus using admittedly conventional techniques of size separation the cffDNA could be isolated and rendered detectable.

    Illumina and Sequenom asserted claims 1, 2, 4, 5, 9, and 10 of the '751 patent and claims 1, 2, and 10–14 the '931 patent against Ariosa and Roche Diagnostics; the Court considered claim 1 from each patent to be representative:

    '751 patent:

    1.  A method for preparing a deoxyribonucleic acid (DNA) fraction from a pregnant human female useful for analyzing a genetic locus involved in a fetal chromosomal aberration, comprising:
        (a) extracting DNA from a substantially cell-free sample of blood plasma or blood serum of a pregnant human female to obtain extracellular circulatory fetal and maternal DNA fragments;
        (b) producing a fraction of the DNA extracted in (a) by:
            (i) size discrimination of
            (ii) selectively removing the DNA fragments greater than approximately 500 base pairs,
            wherein the DNA fraction after (b) comprises a plurality of genetic loci of the extracellular circulatory fetal and maternal DNA; and
        (c) analyzing a genetic locus in the fraction of DNA produced in (b).

    '931 patent:

    1.  A method, comprising:
        (a) extracting DNA comprising maternal and fetal DNA fragments from a substantially cell-free sample of blood plasma or blood serum of a pregnant human female;
        (b) producing a fraction of the DNA extracted in (a) by:
            (i) size discrimination of extracellular circulatory fetal and maternal DNA fragments, and
            (ii) selectively removing the DNA fragments greater than approximately 300 base pairs,
        wherein the DNA fraction after (b) comprises extracellular circulatory fetal and maternal DNA fragments of approximately 300 base pairs and less and a plurality of genetic loci of the extracellular circulatory fetal and maternal DNA fragments; and
        (c) analyzing DNA fragments in the fraction of DNA produced in (b).

    The District Court on summary judgment held these claims and all asserted claims to be ineligible under 35 U.S.C. § 101 and the Supreme Court's Alice/Mayo test (see "Illumina, Inc. v. Ariosa Diagnostics, Inc. (N.D. Cal. 2018)"), and this appeal followed.

    The Federal Circuit reversed, in an opinion by Judge Lourie joined by Judge Moore; Judge Reyna (the author of the Court's Ariosa Diagnostics Inc. v. Sequenom, Inc. decision) dissented.  Judge Lourie got right to the point, stating "[t]his is not a diagnostic case.  And it is not a method of treatment case.  It is a method of preparation case."  The opinion acknowledged the consistent precedent post-Mayo that diagnostic method claims are ineligible, and method of treatment claims are eligible, citing Judge Moore's dissent from denial of rehearing en banc in Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC ("Since Mayo, we have held every single diagnostic claim in every case before us ineligible."); the panel decision in Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC; Cleveland Clinic Found. v. True Health Diagnostics LLC, 859 F.3d 1352 (Fed. Cir. 2017); and Cleveland Clinic Found. v. True Health Diagnostics LLC.  The panel majority also recognized that the Court had consistently held method of treatment claims to be patent-eligible, citing Endo Pharm. Inc. v. Teva Pharm. USA, Inc.; Natural Alternatives Int'l, Inc. v. Creative Compounds, LLC; and, of course, Vanda Pharm. Inc.

    The majority appreciated a distinction lost on the dissent:  "[h]ere, it is undisputed that the inventors of the '751 and '931 patents discovered a natural phenomenon.  But at step one of the Alice/Mayo test, 'it is not enough to merely identify a patent-ineligible concept underlying the claim; we must determine whether that patent-ineligible concept is what the claim is 'directed to," citing Rapid Litig. Mgmt. Ltd. v. CellzDirect, Inc.

    The majority understood the natural phenomenon underlying the claimed invention to be "that cell-free fetal DNA tends to be shorter than cell-free maternal DNA in a mother's bloodstream" despite some apparent inconsistencies in how at least Roche enunciated its interpretation.  The critical question as understood by the majority was "whether the claims are 'directed to' that natural phenomenon."  The majority held that the claims were not directed to the natural phenomenon but rather were directed to "a patent-eligible method that utilizes it."  In support of this conclusion, Judge Lourie wrote regarding the specificities of the claims (albeit not the five specificities he identified in his Vanda opinion).  These include "specific process steps—size discriminating and selectively removing DNA fragments that are above a specified size threshold" that increased the relative amount of cffDNA in the processed sample compared to maternal DNA.  The claimed method "change[d] the composition of the mixture" and produced a DNA-containing fraction that was different from what naturally occurs in maternal blood.  This was what distinguished, for the majority, what was claimed from merely "observing that fetal DNA is shorter than maternal DNA or detecting the presence of that phenomenon."

    The written description of the invention (upon which the dissent extensively relied to draw the opposite conclusion) supported this view, according to the opinion:

    As described by the specification, the inventors used these concrete process steps, not merely to observe the presence of the phenomenon that fetal DNA is shorter than maternal DNA, but rather to exploit that discovery in a method for preparation of a mixture enriched in fetal DNA.

    The panel majority distinguished the decision in Ariosa, where the claims were directed to a method "for detecting a paternally inherited nucleic acid" (claims 1 and 24) or a method "for performing a prenatal diagnosis" (claim 25).  The only steps recited in those claims were related to making more of the cffDNA by amplification, followed by a detecting or sequencing step.  As in Mayo, Athena, and Cleveland Clinic, the Sequenom claims were directed to detecting a natural phenomenon:  the Sequenom inventors "discovered that cell-free fetal DNA exists, and then obtained patent claims that covered only the knowledge that it exists and a method to see that it exists.  Those claims were thus ineligible."  In contrast, the claims at issue here were not directed to the correlation between cffDNA size and its "tendency" to be maternal or fetal in origin.  The claims at issue here is produced a fraction enriched in fetal DNA, which distinguished them from the invalid claims in Ariosa for the panel majority.

    And regarding the effect the Supreme Court's AMP v. Myriad Genetics decision has on these claims, the majority states:

    Thus, in Myriad, the claims were ineligible because they covered a gene rather than a process for isolating it.  Here, we encounter the opposite situation, i.e., the claims do not cover cell-free fetal DNA itself but rather a process for selective removal of non-fetal DNA to enrich a mixture in fetal DNA.  Thus, the Supreme Court's decision in Myriad is not on point.

    With regard to the Cellzdirect precedent, the panel majority analogized by noting that those inventors did not "invent" hepatocytes, but rather invented a method for making preparations of them that relied on the hepatocytes natural ability to be subjected to multiple rounds of freezing and thawing unappreciated in the prior art.  For the majority, the '751 and '931 patents similarly do not claim (and the inventors do not assert they had invented) cffDNA or even the differential size distribution between maternal and fetal DNA in maternal blood.  The panel majority recognized that the inventors here relied on this natural phenomenon to invent a method of separating cffDNA into an enriched fraction by "physical process steps" that "selectively remove some maternal DNA in blood to produce a mixture enriched in fetal DNA."

    The majority summarized its opinion as follows:

    The inventors here patented methods of preparing a DNA fraction.  The claimed methods utilize the natural phenomenon that the inventors discovered by employing physical process steps to selectively remove larger fragments of cell-free DNA and thus enrich a mixture in cell-free fetal DNA.

    Judge Reyna dissented, his dissent nicely setting forth the philosophical differences between the members of this Court (as well as the Supreme Court) for whom the eligibility/ineligibility dichotomy is categorical:  once a "natural phenomenon" is identified, the invention cannot be patented (despite Judge Reyna's protestations at the end of his dissent that "process claims that involve naturally occurring phenomena from beginning to end could be directed to patent eligible subject matter, but this is not such a case" — there will never be such a case).

    The dissent recites the conventional view that applying routine, well-understood, and conventional methods to a newly discovered natural phenomenon is enough, per se, to preclude patent eligibility.  What Judge Reyna continues to refuse to acknowledge (and he is not alone in this particular brand of short-sightedness) is that there is nothing routine, well understood, and conventional (and cannot be) in using old techniques in new ways.  Indeed, there would be very little patenting if the use of older technology could not be a part of innovation; after all, the goal of building a better mousetrap would be considerably more difficult if the existence of a mousetrap itself preluded patenting a better one.

    Judge Reyna states that "the claims are directed to a natural phenomenon [because the] patents' only claimed advance is the discovery of that natural phenomenon," which for him categorically precludes patent eligibility.  Ignoring the fact that the claimed methods permit cffDNA to be detected, in his view "[t]he inventors discovered a natural phenomenon: that cffDNA tends to be shorter than cell-free maternal DNA in a mother's blood.  Other than the surprising discovery, nothing else in the specification or the record before us indicates there was anything new or useful about the claimed invention."  And he disregards the distinction drawn by the majority between "method of preparation" claims and method of treatment or diagnostic claims, stating that "[a] 'method of preparation case' is treated no differently than any other process claim under our law," not considering the differential treatment (even by Justice Breyer in Mayo) between cases like Parker v Flook and Diamond v Diehr.

    Regarding the significance of the written description to the question of whether the claims are "directed to" a natural phenomenon, the dissent appears to assert that if the invention identifies or recites a natural phenomenon, it is per se directed to the natural phenomenon, wherein the written description supports ineligibility merely by identifying the natural phenomenon (and seemingly equating an invention "based on" a natural phenomenon with one that is directed to it):

    If a written description highlights the discovery of a natural phenomenon—e.g., by describing the natural phenomenon as the only "surprising" or "unexpected" aspect of the invention or that the invention is "based on the discovery" of a natural law—the natural phenomenon likely constitutes the claimed advance" [citing Ariosa, Athena, and Cleveland Clinic].

    (Somewhat annoyingly, the dissent consistently brackets the term "surprising" with quotation marks; a jurist doesn't need to agree that "surprisingness" is enough to confer patent eligibility, but there is nothing in the record to refute that the results were surprising to one of ordinary skill in the art, the only actor whose "surprise" at the discovery is legally relevant).

    Touching sub silentio on how the Court has interpreted claims involving natural products after Myriad, the dissent further states that ineligibility is supported by "[t]he fact that the claimed method steps begin and end with a naturally occurring substance, as in Ariosa" and that "[t]he inventors did not create or alter any of the genetic information encoded in the cff-DNA in the claimed method steps," which seems on its face to be contrary to the Supreme Court's Diamond v Chakrabarty decision.  Nevertheless, Judge Reyna states:

    Likewise, the claimed method here begins and ends with a naturally occurring substance.  The claimed method begins with extracting a sample of blood plasma or serum from a pregnant mother that consists wholly of various naturally occurring substances, including cff-DNA.  The claimed method separates those naturally occurring substances by size, leaving a "fraction" of the original sample that is predominantly cff-DNA.  The claimed method ends with analyzing the components of the "fraction," which contains cff-DNA.  The substances present throughout the process are naturally occurring substances, and the claimed method steps do not alter those substances [except, of course, by enriching them in the resulting fraction].  The claimed method is therefore directed to a natural phenomenon.

    The dissent is also focused on whether the claims constitute an "advance" in the art (ignoring the "advance" that the invention permits cffDNA to be analyzed):

    Where a written description identifies a technology as well-known or performed using commercially available tools or kits, that technology cannot logically constitute a claimed advance" [citing Ariosa, Athena  (identifying the claimed "immunological assay techniques [as] known per se in the art" and therefore not the claimed advance); and Cleveland Clinic (relying on the patent's disclosure of "commercially available testing kits" for detecting the natural law)].

    There is an apparent difference between how the majority and the dissent consider the Court's CellzDirect precedent.  Judge Reyna appreciates as a distinction that, in Cellzdirect, "the inventors created a new and useful cryopreservation technique comprising multiple freeze-thaw cycles" that went beyond applying a known laboratory technique to a newly discovered natural phenomenon and, instead, created an entirely new laboratory technique."  The claim in the Cellzdirect case does not support this interpretation:

    1.  A method of producing a desired preparation of multi-cryopreserved hepatocytes, said hepatocytes being capable of being frozen and thawed at least two times, and in which greater than 70% of the hepatocytes of said preparation are viable after the final thaw, said method comprising:
        (A) subjecting hepatocytes that have been frozen and thawed to density gradient fractionation to separate viable hepatocytes from non- viable hepatocytes,
        (B) recovering the separated viable hepatocytes, and
        (C) cryopreserving the recovered viable hepatocytes to thereby form said desired preparation of hepatocytes without requiring a density gradient step after thawing the hepatocytes for the second time, wherein the hepatocytes are not plated between the first and second cryopreservations, and wherein greater than 70% of the hepatocytes of said preparation are viable after the final thaw.

    The only difference between conventional method of cryopreservation and the claimed invention was that the claims direct that conventional methods be performed twice.  It is ironic that this repetition is sufficient to distinguish the claims here under these circumstances.

    The biggest risk of the philosophy enunciated in this dissent is this:

    The Majority's reasoning is shortsighted.  A process that merely changes the composition of a sample of naturally occurring substances, without altering the naturally occurring substances themselves, is not patent eligible" [citing Genetic Techs. and Ariosa, both of which involved claims reciting PCR amplification of specific DNA sequences].

    If this was ever to be the law it would preclude on patent eligibility grounds claims to any natural product that differed solely by its isolation and concentration, again seemingly contrary to Supreme Court precedent.

    Illumina, Inc. v. Ariosa Diagnostics, Inc. (Fed. Cir. 2020)
    Panel: Circuit Judges Lourie, Moore, and Reyna
    Opinion by Circuit Judge Lourie; dissenting opinion by Circuit Judge Reyna

  • By Donald Zuhn

    World Health OrganizationOn Wednesday, World Health Organization Director-General Tedros Adhanom declared that the COVID-19 outbreak "can be characterized as a pandemic," cautioning that the WHO has "rung the alarm bell loud and clear."  At the time of the announcement, the WHO noted that there were 118,000 cases reported globally in 114 countries.  In its latest situation report, the WHO indicates that as of March 16, there have been 167,511 cases in 151 countries.  The Director-General also stated that "[t]his is not just a public health crisis, it is a crisis that will touch every sector – so every sector and every individual must be involved in the fight."  The WHO's declaration on Wednesday – and global developments since then – raise the question of how the pandemic is affecting the patent community.

    Yesterday, we reported on the impact of the COVID-19 pandemic on the U.S. Patent and Trademark Office, World Intellectual Property Organization, European Patent Office, and Federal courts, including, in particular, the Federal Circuit.  Today we present the latest Patent Office and Federal Court responses to the COVID-19 pandemic.

    USPTO SealIn a USPTO Alert e-mail distributed earlier today, the U.S. Patent and Trademark Office announced some relief for customers affected by COVID-19.  In particular, the Office declared that it "considered the effects of coronavirus to be an 'extraordinary situation' within the meaning of 37 CFR 1.183 and 37 CFR 2.146 for affected patent and trademark applicants, patentees, reexamination parties, and trademark owners," and thus, would be waiving petition fees in certain situations for customers impacted by the coronavirus.  More specifically, the Office explained in an official notice posted on its website that:

    For patent applicants or patent owners who were unable to timely reply to an Office communication due to the effects of the coronavirus outbreak, which resulted in the application being held abandoned or the reexamination prosecution terminated or limited, the USPTO will waive the petition fee in 37 CFR 1.17(m) when the patent applicant or patent owner files the reply with a petition under 37 CFR 1.137(a).  See 35 U.S.C. § 41(a)(7).  The inclusion of a copy of this notice with the reply required to the outstanding Office communication will be treated as a representation that the delay in filing the reply was due to the effects of the Coronavirus outbreak, and as a request for sua sponte waiver of the petition fee under 37 CFR 1.17(m).  In addition, the petition under 37 CFR 1.137(a) must include a statement that the delay in filing the reply required to the outstanding Office communication was because the practitioner, applicant, or at least one inventor, was personally affected by the Coronavirus outbreak such that they were unable to file a timely reply.

    The Office recommended that patent applicants and owners taking advantage of the fee waiver should "promptly file the petition under 37 CFR 1.137(a)," and in particular, "not later than two months of the issue date of the notice of abandonment or the notification that reexamination prosecution has been terminated" or "not later than six months after the date the application became abandoned or the reexamination prosecution was terminated or limited" (in the event that the patent applicant or owner did not receive a notice of abandonment or notification that reexamination prosecution has been terminated), in order to be entitled to a waiver of the petition fee.

    The Office also makes it clear that "[t]his notice does not grant waivers or extensions of dates or requirements set by statute," reminding stakeholders that:

    [T]he following patent-related time periods are not extendable by petition: (1) the period set forth in 35 U.S.C. § 119(a)-(d) to file a nonprovisional patent application claiming the benefit of a prior­-filed foreign application; (2) the period set forth in 35 U.S.C. § 119(e) during which a nonprovisional application claiming the benefit of a prior filed provisional application must be filed in order to obtain benefit of the provisional application's filing date; (3) the copendency requirement of 35 U.S.C. § 120 between a parent application which issues as a patent and a later filed child application, which requires that the child application be filed prior to issuance of the parent application; (4) the three-month time period to pay the issue fee set forth in 35 U.S.C. § 151; and (5) the 35 U.S.C. § 304 two-month time period from the date of patentee service, for a requester to file, in an ex parte reexamination, a reply to a statement filed by the patentee.

    WIPOLike the USPTO, the World Intellectual Property Organization issued an update on COVID-19 today, announcing that it was "reserving access to its Geneva, Switzerland, headquarters for personnel essential to the delivery of the Organization's business continuity protocol, while reassuring that processing of applications filed via WIPO’s Global IP Services has not been affected by the Covid-19 outbreak."  WIPO noted that via the implementation of its business continuity plans, it has been able to continue to process applications filed through the Patent Cooperation Treaty (PCT), the Madrid System for the International Registration of Marks, the Hague System for the International Registration of Industrial Designs, as well as administer other IP and related systems.

    EPOOn Sunday, the European Patent Office provided a notice concerning the disruptions due to the COVID-19 outbreak.  In particular, the EPO announced that:

    As a state in which the European Patent Office is located the Federal Republic of Germany, like many other Contracting States, is experiencing restrictions on the movement and circulation of persons as well as on certain services, exchanges and public life in general, which can be qualified as a general dislocation within the meaning of Rule 134(2) EPC.  Periods expiring on or after the date of the publication of this notice are thus extended for all parties and their representatives to 17 April 2020.  In accordance with Article 150(2) EPC this applies also for international applications under the PCT.  The above period may be further extended by the publication of another Notice in case the dislocation extends beyond the aforementioned date.

    Thus, periods expiring on or after the March 15, 2020 will be extended for all parties and their representatives to April 17, 2020.  The EPO also reminded applicants, parties, and their representatives that:

    Rule 134(5) EPC offers a safeguard in the case of non-observance of a time limit as a result of a dislocation in the delivery or transmission of mail caused by an exceptional occurrence affecting the locality where an applicant, a party or their representative resides or has his place of business.  This provision applies to cases where the failure to observe time limits is the result of exceptional circumstances beyond the applicant's control and may therefore be invoked by any applicants, parties to proceedings or their representatives affected by the disruption in the areas affected by the outbreak.

    The EPO's notice suggested that this safeguard would be available to applicants, parties, and their representatives residing in "high risk areas," which currently are defined by the EPO as China, South Korea, Iran, Italy, the German Landkreis Heinsberg in Nordrhein-Westfalen, and the French region Grand Est.  The EPO notes that under Rule 134(5) EPC:

    [A]ny document received late will be deemed to have been received in due time if the person concerned offers evidence that on any of the ten days preceding the day of expiry of a period, it was not possible to observe the time limit due to this exceptional occurrence and that the mailing or the transmission was effected at the latest on the fifth day after the end of the disruption.

    Finally, the EPO notice states that:

    [W]here the interested party offers satisfactory evidence that a time limit under the PCT was not met due to natural calamity or other like reason in the locality where the interested party resides, has his place of business or is staying, and that the relevant action was taken as soon as reasonably possible (and no later than six months after expiry of the time limit in question), the delay in meeting the time limit is excused.  This provision applies to international applications pending in the international phase, but not to the priority period.

    Federal Circuit SealThe Federal Circuit also provided additional information earlier today regarding its response to the COVID-19 pandemic, declaring that it would be restricting public access to the National Courts Building complex as of noon today "[b]ased on declared public health emergencies impacting Washington, D.C. and the National Capital Region and ongoing efforts to mitigate community transmission and the impact of COVID-19."  The Federal Circuit's order can be found here, and its advisory can be found here.  In its advisory, the Federal Circuit notes that on scheduled argument and hearing days, only (a) arguing counsel and parties with a scheduled in-person hearing and (b) credentialed members of the press will be permitted in the National Courts Building, and that no other members of the public will be permitted to attend argument.  The advisory also notes that individuals who have been diagnosed with the COVID-19 virus, who have had known contact with a person with the COVID-19 virus, who have been asked to self-quarantine, or who are experiencing flu-like symptoms (e.g., fever, shortness of breath, or cough) may not enter the courthouse.

    Supreme Court SealFinally, the U.S. Supreme Court announced today that it "is postponing the oral arguments currently scheduled for the March session (March 23-25 and March 30-April 1)," and "will examine the options for rescheduling those cases in due course in light of the developing circumstances."  The Court plans to hold its regularly scheduled Conference on March 20, although some Justices may be participating in the Conference by phone, and issue its regularly scheduled Order List on March 23.  The Court indicated that "filing deadlines are not extended under Rule 30.1."  Although the Supreme Court Building will continue to be open for official business, the Building will remain closed to the public until further notice.

    The Court also noted that its postponement of argument sessions in light of public health concerns is not unprecedented, and that the Court postponed scheduled arguments for October 1918 in response to the Spanish flu epidemic, and shortened its argument calendars in August 1793 and August 1798 in response to yellow fever outbreaks.

    Patent Docs will continue to monitor and report on patent-related developments related to the COVID-19 pandemic.

  • By Donald Zuhn

    World Health OrganizationOn Wednesday, World Health Organization Director-General Tedros Adhanom declared that the COVID-19 outbreak "can be characterized as a pandemic," cautioning that the WHO has "rung the alarm bell loud and clear."  At the time of the announcement, the WHO noted that there were 118,000 cases reported globally in 114 countries.  In its latest situation report, the WHO indicates that as of March 15, there have been 153,517 cases in 143 countries.  The Director-General also stated on Wednesday that "[t]his is not just a public health crisis, it is a crisis that will touch every sector – so every sector and every individual must be involved in the fight."  The WHO's declaration on Wednesday – and global developments concerning the COVID-19 pandemic since then – raises the question of how the pandemic has been affecting patent offices and the courts.

    USPTO SealOn Friday, the U.S. Patent and Trademark Office announced that examiner and examining attorney interviews, Patent Trial and Appeal Board (PTAB) and Trademark Trial and Appeal Board (TTAB) oral hearings, and other similar in-person meetings with parties and stakeholders scheduled to take place at the USPTO's offices on that day would be conducted remotely by video or telephone.  At about the same time that the Centers for Disease Control and Prevention (CDC) issued a recommendation this evening that "for the next 8 weeks, organizers (whether groups or individuals) cancel or postpone in-person events that consist of 50 people or more throughout the United States," the USPTO distributed a USPTO Alert e-mail to stakeholders that announced the closure of USPTO facilities to the public.  In particular, the USPTO announced that:

    Out of an abundance of caution for the health and safety of the public and USPTO employees, all USPTO offices will be closed to the public beginning Monday, March 16, 2020 until further notice.  USPTO offices will remain open for employees, contractors, and those with access badges.  Unless otherwise notified, USPTO operations will continue without interruption.  Patent and trademark application deadlines and other deadlines are not extended.  Those with official business with the USPTO should reach out to their points of contact with any questions or through the CONTACT US link.  Thank you for your cooperation.  We regret any inconvenience.  For more information on coronavirus please visit: cdc.gov/covid19.

    WIPOEarlier this month, the World Intellectual Property Organization issued an update on COVID-19, stating that as of March 6, WIPO "remain[ed] operational and the Organization continues to liaise with the World Health Organization (WHO) and the Swiss authorities and take measures, in line with their guidelines, to mitigate the effects of this situation."  WIPO noted that such measures include:

    • Postponement (cancellation if postponement is not possible) of all events and meetings organized or co-organized by WIPO, either in Geneva or elsewhere, during the months of March and April;
    • Suspension of group visits to WIPO, until further notice;
    • Limiting duty travel to essential trips, until further notice.

    WIPO also released an informational notice for meeting participants.

    EPOOn Thursday, the European Patent Office provided an update on COVID-19 on its website.  The EPO announced that oral proceedings before examining and opposition divisions would "in principle take place as scheduled," but that oral proceedings involving parties or representatives who have recently visited "high risk areas" (defined by the EPO as China, South Korea, Iran, Italy, the German Landkreis Heinsberg in Nordrhein-Westfalen, and the French region Grand Est) would be held by videoconference or postponed, upon request.  The EPO also indicated that:

    In other cases where the general spread of Coronavirus prevents a party or representative from attending oral proceedings, for instance in case of travel restrictions in companies or patent attorney firms, the EPO will do everything feasible to remove the need for the party or representative to travel to oral proceedings.  In particular, oral proceedings by videoconference will be offered in examination and, to the extent possible, in opposition proceedings.  The relevant party or representative should indicate in each particular case which alternative measures they request.

    The EPO further announced that:

    We are postponing all EPO organised events that involve more than 50 participants in March and April.  Organisers will contact participants on an individual basis and, where possible, inform them of the new dates.
    – We are requesting external partners to abstain from visiting the EPO if they have recently visited a high risk area.
    – We are cancelling all duty travel scheduled for March and April as of 5 March 2020.  This includes any travel between EPO sites (except for movements between our local offices in Munich).  All staff who are currently on duty travel are recommended to return to their usual place of work as soon as reasonably possible.

    Administratove Office of US CourtsOn Thursday, the United States Courts website, which is maintained by the Administrative Office of the U.S. Courts on behalf of the Federal Judiciary, released a statement on the "Judiciary Preparedness for Coronavirus (COVID-19)."  That statement indicated that "Federal courts are individually coordinating with state and local health officials to obtain local information about the coronavirus (COVID-19), and some have issued orders relating to court business, and public and employee safety," and recommended that site visitors use the Federal Court Finder to navigate to a court's website for court specific information.

    Federal Circuit SealThe Federal Circuit earlier announced that "[c]urrently, there has been no adjustment in court operations," and that "[t]he court will provide additional information to litigants and the public should there be a change to that status."  On Thursday, the Federal Circuit announced that:

    As part of the Federal Circuit's response to public health guidance to minimize the risk of community transmission of COVID-19 in the United States, the court is proceeding with arguments scheduled for the April 2020 sitting as follows.  Some of the cases are being removed from the argument calendar and will be submitted on the briefs.  In cases remaining on the argument calendar, if counsel for either party is located outside the National Capital area, the argument will be conducted by telephonic conference at the date and time previously scheduled.  In cases scheduled for argument where counsel for both parties are local, as of now, the court plans to proceed with in-person argument as previously scheduled.  Parties in all cases will be notified individually as to how we plan to proceed in their case.

    According to established practice, the court will release same-day audio for all arguments on its website (available at http://www.cafc.uscourts.gov/oral-argument-recordings).  The court will continue to provide updated information to litigants and the public as the situation develops.

    Patent Docs will continue to monitor and report on patent-related developments related to the COVID-19 pandemic.

  • CalendarMarch 19, 2020 – "Navigating the Coronavirus Pandemic: How Firms Are Aiding Clients and Running Their Own Operations" (Law.com) – 11:00 am to 12:00 pm (EDT)

    March 19, 2020 – "Linking an Invention to the Evidence: Strategic Considerations from Prosecution to Litigation" (Fitch Even) – 12:00 to 1:00 pm (EDT)

    April 27-28, 2020 – Paragraph IV Disputes Master Symposium (American Conference Institute) – New York, NY

    May 20-21, 2020 – Advanced Summit on Life Sciences Patents (American Conference Institute) – New York, NY

  • Law.comLaw.com will be offering a webinar entitled "Navigating the Coronavirus Pandemic: How Firms Are Aiding Clients and Running Their Own Operations" on March 19, 2020 from 11:00 am to 12:00 pm (EDT).  Gina Passarella of Global Legal Brands, Patrick Fuller of Legal Intelligence, Heather Nevitt of GLL, and Richard Caruso Legal Media will detail explore what clients are asking of their firms as a result of the coronavirus pandemic, the needs of clients by industry and geography, how clients may adjust their outside legal spend, what law firms are doing to respond to the crisis for clients and themselves, and what this will all mean for law firm business in the near and far terms.  The panel will discuss the following:

    • COVID-19 Disruption: How are clients' businesses being impacted? How are they adjusting investments, growth, supply chains, etc.? How long do they expect to feel the impacts?
    • How are law firms making decisions on firm operations, client meetings, remote work?
    • The legal issues clients are grappling with due to the coronavirus.
    • How might clients change their use of outside counsel as a result? What legal expertise will be needed? Where might they scale back?  How will outside legal spend be impacted, if at all?
    • What has been the most helpful type of advice they’ve received so far? And where are they turning to get advice?

    While there is no cost to participate in the webinar, advance registration is required.  Those interested in attending the webinar can register here.

  • By Donald Zuhn

    Federal Circuit SealLast month, in Serta Simmons Bedding, LLC v. Casper Sleep Inc., the Federal Circuit vacated a decision by the U.S. District Court for the Southern District of New York granting summary judgment of non-infringement to Defendant-Cross-Appellant Casper Sleep Inc. and remanded with instructions to enforce a settlement agreement between Casper and Plaintiffs-Appellants Serta Simmons Bedding, LLC and Dreamwell, Ltd.  The Federal Circuit also affirmed the District Court's denial of Casper's motion for fees and costs.

    Serta, which owns U.S. Patent Nos. 7,036,173; 7,424,763; and 8,918,935, filed suit against Casper for infringement of certain claims of those patents.  In response, Casper filed three motions for summary judgment of non-infringement.  While those motions were pending, Serta and Casper executed a settlement agreement, which required Casper to pay $300,000 within ten days of the agreement, cease the manufacture of certain products within 27 days of the agreement, and substantially discontinue marketing of those products with 58 days of the agreement.  The agreement also required the parties to dismiss all claims and counterclaims and release each other from all liabilities within five days of Casper's payment, and file a joint motion to stay the case pending final settlement (which the parties filed on the same day the settlement agreement was executed).

    Two days after the settlement agreement was executed and the joint motion to stay was filed, the District Court issued an order granting Casper's summary judgment motions.  Following the District Court's grant of summary judgment of non-infringement, Casper informed Serta that it would not make the payment under the settlement agreement because the agreement was "null and void" in view of the summary judgment order.  Serta filed motions to enforce the settlement agreement and vacate the summary judgment order, which the District Court denied, contending that it lacked jurisdiction to enforce the settlement agreement once the summary judgment order was issued.  Casper also filed a motion for fees and costs, which the District Court denied.  Serta appealed to the Federal Circuit and Casper cross-appealed.

    In an opinion by Judge Dyk, joined by Judges Plager and Stoll, the Federal Circuit noted that "[g]enerally, a '[s]ettlement moots an action' because there is no longer a case or controversy with respect to the settled issues," citing Gould v. Control Laser Corp., 866 F.2d 1391, 1392 (Fed. Cir. 1989).  Casper argued that the settlement agreement did not moot the action because it called for future performance.  However, the opinion cites Exigent Technology, Inc. v. Atrana Solutions, Inc., 442 F.3d 1301 (Fed. Cir. 2006), for the proposition that "an enforceable settlement generally renders a case moot even though the parties have not yet performed the terms."

    In Exigent Technology, the Federal Circuit encountered circumstances that were similar to those in the instant appeal — the district court in that case granted defendant's motion for summary judgment of non-infringement and ordered the case dismissed without first determining whether the parties entered into an enforceable agreement, which would have rendered the entry of final judgment moot.  As a result, the Federal Circuit in Exigent Technology "recognized that a binding settlement generally moots an action despite the fact that the settlement agreement requires further implementing steps to be taken."  The opinion also cites four decisions from other circuits in support of this proposition.

    Casper countered with two Seventh Circuit decisions that supported its argument that the case was not mooted by the settlement agreement.  However, the Federal Circuit responded by stating that "[t]hose cases are not binding on us, are questionable on the merits, and in any event, are distinguishable since one involved a settlement agreement that was not yet binding, and the other potentially required further action by the court" (citations omitted).  The panel therefore concluded "that a binding settlement agreement generally moots the action even if the agreement requires future performance," and vacated the District Court's entry of judgment and summary judgment order because the settlement agreement rendered moot the underlying infringement case.

    With respect to the District Court's denial of Serta's motion to enforce the settlement agreement for lack of jurisdiction, the panel indicated that "[w]hile not binding, we find persuasive several Second Circuit cases holding that a district court has jurisdiction to enforce a settlement agreement when the proceedings are ongoing."  The panel concluded that "under Federal Circuit law a district court has jurisdiction to enforce a settlement agreement that resolves patent infringement claims if the motion to enforce is filed before the case is dismissed and the proceedings are ongoing," adding that in view of the panel's decision on appeal "there will be no final judgment dismissing the parties' claims until the remand proceedings are concluded," and therefore finding that the District Court will have jurisdiction to enforce the settlement agreement.  Thus, the panel directed the District Court to enforce the settlement agreement during remand proceedings.

    Finally, with respect to Casper's motion for fees and costs, which the District Court denied, the panel noted that because it had vacated the summary judgment order, Casper was not a prevailing party, and Casper's request for fees under § 285 was moot.  The panel also rejected Casper's request for fees and costs relating to pre-settlement litigation under 28 U.S.C. § 1927 and the District Court's inherent power because the settlement agreement precluded an award of fees and costs pertaining to proceedings that occurred prior to the execution of the settlement agreement.

    Serta Simmons Bedding, LLC v. Casper Sleep Inc. (Fed. Cir. 2020)
    Panel: Circuit Judges Dyk, Plager, and Stoll
    Opinion by Circuit Judge Dyk

  • By Donald Zuhn

    USPTO SealLast week, the U.S. Patent and Trademark Office issued a notice in the Federal Register (85 Fed. Reg. 12222), in which the Office clarified its practice with respect to those situations where the Office will require additional information about whether a delay in seeking the revival of an abandoned application, acceptance of a delayed maintenance fee payment, or acceptance of a delayed priority or benefit claim was unintentional.  In particular, for petitions decided on or after March 2, 2020, the Office will require additional information when a petition to revive an abandoned application is filed more than two years after the date the application became abandoned, a petition to accept a delayed maintenance fee payment is filed more than two years after the date the patent expired for nonpayment, or a petition to accept a delayed priority or benefit claim is filed more than two years after the date the priority or benefit claim was due.

    The notice indicates that the provisions for the revival of an abandoned application, for the acceptance of a delayed maintenance fee payment, and for the acceptance of a delayed priority or benefit claim all provide that "[t]he Director may require additional information where there is a question whether the delay was unintentional" (37 C.F.R. §§ 1.137(b)(4), 1.378(b)(3), 1.55(e)(4), 1.78(c)(3) and (e)(3)).  The notice also indicates that the reason for requiring additional information when a petition in the above instances is filed more than two years from the date an application became abandoned, a patent expired, or a priority or benefit claim was due "is to ensure that . . . the USPTO is provided with sufficient information of the facts and circumstances surrounding the entire delay to support a conclusion that the entire delay was 'unintentional,'" adding that "[a]n extended period of delay (i.e., more than two years from the date the application became abandoned, the patent expired, or a priority or benefit claim was due) in filing a petition to revive an application, accept a delayed maintenance fee payment, or accept a delayed priority or benefit claim . . . raises a question as to whether the entire delay was unintentional."

    Practitioners or applicants who have had to revive an unintentionally abandoned application may be familiar with M.P.E.P. § 711.03(c)(II)(D), which states:

    The Office does not generally question whether there has been an intentional or otherwise impermissible delay in filing an initial petition pursuant to 37 CFR 1.137(a) or (b), when such petition is filed: (A) within 3 months of the date the applicant is first notified that the application is abandoned; and (2) within 1 year of the date of abandonment of the application.  Thus, an applicant seeking revival of an abandoned application is advised to file a petition pursuant to 37 CFR 1.137 within 3 months of the first notification that the application is abandoned to avoid the question of intentional delay being raised by the Office (or by third parties seeking to challenge any patent issuing from the application).

    In view of the above, the Office's clarification may appear to be a little more permissive for revival of unintentionally abandoned applications.  However, the Office indicates in the notice that:

    The USPTO may revisit the two-year time period established in this notice for requiring an additional explanation as to whether a delay is unintentional at a future point and may adjust the time period based on an evaluation of whether a two-year time period is appropriate for requesting additional information when determining whether a period of delay is unintentional.

    The notice also concludes by stating that "[n]othing in this notice should be taken as an indication that the USPTO will only require additional information in consideration of a petition . . . filed more than two years after [the date an application became abandoned, the date a patent expired, or the due date of the priority or benefit claim]."  Instead, "[t]he USPTO may require additional information whenever there is a question as to whether the delay was unintentional."