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  • The USPTO’s Guidance on Use of AI-based Tools in Practice

    By Joshua Rich and Michael Borella —

    USPTO SealSince President Biden issued his Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence, the U.S. Patent and Trademark Office has been investigating the potential pitfalls of practitioners' use of AI in patent and trademark practice.  On April 11, the Office issued its "Guidance on Use of Artificial Intelligence-Based Tools in Practice Before the United States Patent and Trademark Office."[1]  And while the Guidance does not include or propose any new rules, it provides useful reminders of how to ensure compliance with the rules (along with a dash of advocacy for the USPTO's positions on prosecution strategy).

    The starting point for the USPTO's analysis of the effects of AI is the potential efficiencies and cost savings that use of AI-based tools can provide.  After all, the USPTO is already using such tools itself:

    For example, patent examiners are performing AI-enabled prior art searches using features like More Like This Document (MLTD) and Similarity Search in the Office's Patents End-to-End (PE2E) Search tool.

    The Office recognizes that practitioners are already (and increasingly) using tools to locate prior art, review patent applications, and monitor examiner behavior.  But along with the benefits of using AI-tools come risks:  hallucination, disclosure of confidential client information, and violation of export control laws and rules.  The Guidance attempts to show practitioners how they should — and (in some cases) must — mitigate those risks based on the existing rules and regulations.

    The USPTO's guidelines rely on six different sets of rules and policies as sources for the obligations for practitioners.

    • The duty of candor: "Each individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability as defined in this section."[2]

    • The signature requirement for nearly all submissions to the USPTO, which carries with it the implied certification that the person signing or submitting the paper was the one actually signing it and vouching under penalty of perjury that ""[a]ll statements made therein of the party's own knowledge are true, all statements made therein on information and belief are believed to be true"[3] and an obligation to make a reasonable inquiry to ensure the accuracy of those statements.[4]

    • The obligation of confidentiality: "A practitioner shall not reveal information relating to the representation of a client unless the client gives informed consent, the disclosure is impliedly authorized in order to carry out the representation, the disclosure is permitted by paragraph (b) of this section, or the disclosure is required by paragraph (c) of this section."[5]

    • The foreign filing license requirement and regulations governing export of technology, including ITAR (International Traffic in Arms Regulations), EAR (Export Administration Regulations), and AFAEAR (Assistance to Foreign Atomic Energy Activities Regulations).  Notably, the USPTO has previously said that "[a] foreign filing license from the USPTO does not authorize the exporting of subject matter abroad for the preparation of patent applications to be filed in the United States."[6]  Further, ITAR, EAR, and AFAEAR prohibit not only exporting certain technical data in the traditional sense — that is, sending the information overseas — they also prohibit allowing nationals of certain foreign countries to have access to that information, even within the United States.

    • Policies regarding access to the USPTO's electronic systems, including Patent Center, P-TACTS, ESTTA, and USPTO.gov. Among other things, only individuals may have USPTO.gov accounts and must not share the account with others (including AI-based tools).

    • Professional responsibility duties to clients, including the duty of competence (which includes a duty to be competent with technology used to handle client matters before the USPTO)[7] and the duty to "reasonably consult with the client about the means by which the client's objectives are to be accomplished" and "explain a matter to the extent reasonably necessary to permit the client to make informed decisions regarding the representation."[8]

    Those rules and regulations apply to the use of AI in at least four different contexts of USPTO patent and trademark practice.[9]  Those contexts can involve different AI tools and considerations, but there in one unifying theme:  use of an AI tool does not relieve a practitioner of compliance with existing duties.  Indeed, the USPTO does not expect any more out of practitioners who use AI tools than it does from practitioners who use assistance of junior attorneys or paralegals — the practitioner is responsible for reviewing work product and ensuring that it is technically and legally correct.  Notably, however, the USPTO seeks to put a thumb on the scales balancing certain duties owed by practitioners.

    First, AI tools are increasingly being used in the drafting of prosecution (and PTAB-related) documents.  Even word processing software such as Microsoft Word are beginning to incorporate AI tools.  But specialized AI tools are also being rolled out that can assist in patent and claim drafting, responding to office actions, and preparing forms (such as IDSs).  While such tools are growing more and more robust and useful, they still have deficiencies that must be double-checked.  Double-checking is not only good practice, the Guidelines make it clear that it is a requirement of both the duty of candor and the signature requirement.  "Therefore, if an AI tool is used in drafting or editing a document, the party must still review its contents and ensure the paper is in accordance with the certifications being made."  A practitioner should also reasonably consult with the client to ensure that the client agrees to the means for accomplishing its goals.

    Given the requirement for an attorney or agent to double-check the entirety of a submission, the Guidance does not suggest a general obligation to disclose the use of AI tools in preparing papers.  There are potential exceptions, however.  For example, practitioners often include language to broaden the disclosure of an invention using alternative embodiments and potential substitutions known in the art.  While there may be a question whether this makes the patent attorney a joint inventor, the issue is more concerning if an AI tool has come up with the alternatives.  Not only may it throw inventorship in question (and require disclosure of the AI drafting tool), it may exceed the true scope of the invention.

    The Office also counsels that "Practitioners are also under a duty to refrain from filing or prosecuting patent claims that are known to be unpatentable.  Therefore, in situations where an AI tool is used to draft patent claims, the practitioner is under a duty to modify those claims as needed to present them in patentable form before submitting them to the USPTO."  The first sentence is uncontroversial:  it is improper to seek claims that you know — not suspect, know — to which the client is not entitled.  But the second sentence is much more opaque.  Whether an AI tool is used or not, if "patentable form" is intended to mean something more than the opposite of "known to be unpatentable" is seems to be placing a higher obligation on the review of AI-drafted claims than that imposed on the review of human-drafted claims.  That would appear to be more an Office request than an obligation.

    Similarly, the Guidance points out that the obligation to review an IDS requires more than checking to see that it is in proper format.  Rather, it requires "reviewing each piece of prior art listed in the form."  But the Guidance then asserts that the review requires a practitioner to cull not only those references that are irrelevant but also those that include "marginally pertinent cumulative information."  Of course, the duty of disclosure requires the citation of material prior art and what may be "marginally pertinent" in the eyes of one may be "material" to another.  Practitioners and Examiners often disagree vehemently over the relevance of cited art.  By emphasizing the obligation to eliminate irrelevant art and extending it to "marginally pertinent" art, the Guidance seem to be trying to tip the scales away from citing all potentially relevant art.  That is, the Office seems to be trying to use the vehicle of the Guidance ease the Examiner's burden of reviewing submitted art at the cost of greater risk of violation of the duty of disclosure.  Whether an AI tool is used or not should not affect that calculus.

    The issue is that, on one hand, the USPTO has set forth the duty of candor in Rule 56 and elsewhere.  But, on the other hand, the Guidance implicitly incentivizes practitioners to NOT strictly follow Rule 56.  The notion of what a "reasonable Examiner" might consider to be relevant art varies dramatically between Examiners and art units.  Further, there is no practically useful test for what constitutes cumulative art.  Given this, the burden of determining whether to disclose art that falls into either of these gray areas should not fall on practitioners.  Instead, practitioners should be encouraged to err on the side of disclosure when in doubt.

    With regard to trademark filings, many of the concerns related to document preparation are the same.  The Guidance brings up one additional example of the perils of AI hallucination, specifically, submission of an AI-generated specimen of use.  Again, the AI tool must be double-checked to make sure it has provided accurate information.

    Second, AI tools may be useful in the mechanical process of filing documents with the USPTO.  But the rules seem to throw a wrench into that prospect, at least as far as they currently are written.  Almost all submissions require a person's signature; the Guidance unequivocally states, "It would not be acceptable for the correspondence to have the signature of an AI tool or other non-natural person."  Thus, even if a person has prepared a document, it would be a violation of rules to have an AI tool affix a signature and submit the document.  That is especially true because a non-natural person cannot have a USPTO.gov account.  Thus, for now, AI tools cannot be used to file USPTO documents.

    Third, AI tools could be used to access USPTO systems, for example, to scrape filings to include in a large language model.  Again, however, an AI tool cannot have a USPTO.gov account and certain actions violate the terms of service of USPTO websites.  As the Guidance warns, "Users should also be extremely careful when attempting to data mine information from USPTO databases.  Using computer tools, including AI systems, in a manner that generates unusually high numbers of database accesses violates the Terms of Use for USPTO websites, and users using tools in this way will be denied access to USPTO servers without notice and could be subject to applicable state criminal and civil laws."  As the Guidance points out, however, the USPTO does offer bulk access to its data for purposes of mass downloading, and those interfaces should be used instead.

    Fourth, the Guidance raises the concern of potential unintended disclosure of client confidential information when using an AI tool.  As the Guidance cautions:

    This can happen, for example, when aspects of an invention are input into AI systems to perform prior art searches or generate drafts of specification, claims, or responses to Office actions.  AI systems may retain the information that is entered by users.  This information can be used in a variety of ways by the owner of the AI system including using the data to further train its AI models or providing the data to third parties in breach of practitioners' confidentiality obligations to their clients under, inter alia, 37 CFR 11.106.  If confidential information is used to train AI, that confidential information or some parts of it may filter into outputs from the AI system provided to others.

    This is an especially acute concern because current large language models are "black boxes" with terms of service that may change without much notice.  But the use of a tool with terms of service that prohibit use of inputs to teach the model may not be sufficient if the owner of the tool is not especially trustworthy.  The Guidance suggests that "practitioners must be especially vigilant to ensure that confidentiality of client data is maintained" when client data is used with an AI tool (but also when client data is stored on third-party storage).  The concern may extend to knowing where the model's servers are based, since disclosure to the model may violate the foreign filing license rules or export control regulations.  In short, the Guidance suggests extreme caution in maintaining the confidentiality of client data.

    All in all, the Guidance is intended to reinforce that the use of AI tools does not relieve practitioners of their obligations to comply with existing rules and regulations, even if it may simplify or quicken prosecution tasks.  There are clear risks and pitfalls, and the Guidance helps highlight them without placing additional obligations on practitioners.

    [1] 89 Fed. Reg. 25,609 (Apr. 11, 2024).
    [2] 37 C.F.R. § 1.56.  There are analogous duties of candor and good faith in 37 C.F.R. § 1.555(a) and 37 C.F.R. § 42.11.
    [3] 37 C.F.R. § 11.18(b)(1).
    [4] 37 C.F.R. § 11.18(b)(2).
    [5] 37 C.F.R. § 11.106(a).
    [6] Scope of Foreign Filing Licenses, 73 Fed. Reg. 42,781 (July 23, 2008).
    [7] 37 C.F.R. § 11.101.
    [8] 37 C.F.R. § 11.104.
    [9] In the Guidance, the Office included a fifth context, "Fraud and Intentional Misconduct."  But the Guidance does nothing more than reiterate the previously-stated concerns with the submission (or omission) of materials in violation of the duty of candor and use of AI tools to violate the terms of service of USPTO websites.

  • Janssen Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2024)

    By Kevin E. Noonan –

    Federal Circuit SealIn its recent decision in Janssen Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc. the Federal Circuit reminds us that most verities in patent law are not eternal and are frequently subject to case-by-case interpretation, in this case the purported verity being that reciting the indefinite article ("a") in a patent claim is construed to mean "one or more."  Besides showing that "it ain't necessary so" the case is beneficial for motivating a review of when and under what circumstances "a" means "one or more" and when it means "one," but it also illustrates how this perhaps necessary flexibility in claim construction can also lead to what can appear to be outcome-oriented decisions producing more head scratching than enlightenment.

    The issue arose in ANDA litigation over Janssen's Invega Sustenna drug, an "extended-release intramuscular injectable of paliperidone palmitate, which is indicated for the treatment of schizophrenia in adults," according to the opinion.  Janssen asserted several claims of U.S. Patent No. 9,439,906; dependent claim 2 was considered representative by the Court:

    2.  A dosing regimen for administering paliperidone palmitate to a psychiatric patient in need of treatment for schizophrenia, schizoaffective disorder, or schizophreniform disorder comprising
        (1) administering intramuscularly in the deltoid of a patient in need of treatment a first loading dose of about 150 mg-eq. of paliperidone as paliperidone palmitate formulated in a sustained release formulation on the first day of treatment;
        (2) administering intramuscularly in the deltoid muscle of the patient in need of treatment a second loading dose of about 100 mg-eq. of paliperidone as paliperidone palmitate formulated in a sustained re-lease formulation on the 6th to about 10th day of treatment; and
        (3) administering intramuscularly in the deltoid or gluteal muscle of the patient in need of treatment a first maintenance dose of about 25 mg-eq. to about 150 mg-eq. of paliperidone as paliperidone palmitate in a sustained release formulation a month (±7 days) after the second loading dose,
    [The dosing regimen of claim 1] wherein after administration of the first maintenance dose, subsequent maintenance doses of from about 25 mg-eq. to 150 mg-eq. are administered in the deltoid or gluteal muscle of the psychiatric patient in need of treatment at monthly (±7 days) intervals.

    (where the italicized portion is the language of independent claim 1).

    as was dependent claim 10:

    10.  A dosing regimen for administering paliperidone palmitate to a renally impaired psychiatric patient in need of treatment for schizophrenia, schizoaffective disorder, or schizophreniform disorder comprising
        (a) administering intramuscularly in the deltoid of a renally impaired psychiatric patient in need of treatment a first loading dose of from about 75 mg-eq. of paliperidone as paliperidone palmitate formulated in a sustained release formulation on the first day of treatment;
        (b) administering intramuscularly in the deltoid muscle of the patient in need of treatment a second loading dose of from about 75 mg-eq. of paliperidone as paliperidone palmitate formulated in a sustained release formulation on the 6th to about 10th day of treatment; and
        (c) administering intramuscularly in the deltoid or gluteal muscle of the patient in need of treatment a first maintenance dose of about 25 mg-eq. to about 75 mg-eq. of paliperidone as paliperidone palmitate in a sustained release formulation a month (±7 days) after the second loading dose,
    [The dosing regimen of claim 8] wherein the sustained release formulation is an aqueous nanoparticle suspension.

    (where the italicized portion is the language of independent claim 8).

    Dependent claim 13 was also asserted, which limited the patient population to schizophrenics and included the limitation that the dose range was 25 mg-eq. to about 50 mg-eq. for the "maintenance dose"; and finally dependent claims 20 and 21 directed to the particle size of the dosage, the opinion setting forth claim 19, from which claims 20 and 21 depend as reciting the "most pertinent" particle size:

    19.  The dosing regimen of claims 1, 4, 8 or 11 wherein the sustained release depot formulation is an aqueous nanoparticle suspension consists essentially of
        (a) 156 mg/ml of the paliperidone palmitate having an average particle size (d50) of from about 1600 nm to about 900 nm;
        (b) 12 mg/ml of polysorbate 20;
        (c) one or more buffering agents sufficient to render the composition neutral to very slightly basic (pH 8.5);
        (d) 30 mg/ml of a suspending agent wherein the suspending agent is polyethylene glycol 4000; and
        (e) water q.s. ad 100%.

    (wherein here italics identify the relevant limitations):

    The opinion recites that paliperidone itself is the "major active metabolite" of an earlier (1990's) antipsychotic drug, risperidone.  Paliperidone esters such as the palmitate were known in the prior art to have the beneficial property of slow dissolution after intramuscular injection, and the opinion notes that the skilled worker could "easily determine the effective amount of paliperidone to administer."  Although the drug has been on the market for some time in tablet form patient compliance has been an issue.  There were earlier patents directed to methods for administering the drug by injection monthly (U.S. Patent Nos. 6,577,545 and 6,555,544).  In addition to treatment regimens, the '906 patent discloses optimal particle sizes for the formulation, as well as injection in the deltoid muscle for rapid initial plasma concentrations and thereafter administering to the deltoid or gluteal muscles.

    Teva stipulated to infringement but challenged the validity of the asserted claims on obviousness and indefiniteness grounds.  The opinion notes that the "safety of paliperidone, its efficacy for treating schizophrenia, and its recommended dosing were all well established as of the '906 patent's priority date" and that "long acting injectables (LAIs)—administered intramuscularly—of other antipsychotics were [also] on the market" at that time.  For its obviousness challenge under these prior art circumstances Teva asserted three references:  "(1) clinical study protocol NCT00210548 ("the '548 protocol"); (2) the '544 patent; and (3) International Publication No. WO 2006/114384 ("WO'384")."  The '548 protocol described a Phase III clinical trial intending to show that three fixed doses (50, 100, or 150 milligrams equivalent) of paliperidone administered to the buttocks were more efficacious than placebo in treating schizophrenia (both party's experts agreed that this protocol was expected to be safe and effective, although there were no results reported therein).  Even though not available in the art at the '906 patent's earliest priority date, the opinion notes that the 50 mg dose was not more effective than placebo, while both the 100 and 150 mg doses had defects that precluded Janssen from using these results to support FDA approval.

    The '544 patent (owned by Janssen) claimed "'[a] pharmaceutical composition [of paliperidone palmitate] suitable as a depot formulation for administration by intramuscular or subcutaneous injection, comprising,' among other things, a 'therapeutically effective amount' of paliperidone palmitate," as well as methods of using this pharmaceutical composition to treat schizophrenia.  The specification of the '544 patent discloses ("emphasizes," according to the opinion) the ability to "space out" paliperidone palmitate administration by "three weeks to a month" while maintaining a blood plasma concentration of "above 10 ng/ml and below 100 ng/ml."  "Most pertinent for our purposes on appeal," the opinion states, is disclosure of optimal particle size and "details related to applying 'mechanical means' to reduce the effective average particle size," specifically providing this table:

    Table
    Finally, the PCT application (WO'384, also owned by Janssen) discloses both the Invega Sustenna formulation and particle sizes at drug concentrations of 25-150 mg-eq.

    The District Court held that Teva had not established that any of the claims of the '906 patent were invalid for obviousness or indefiniteness, and this appeal followed.

    The Federal Circuit affirmed the trial court's finding regarding indefiniteness of claims 19-21 but vacated and remanded its non-obviousness determination as to all claims, in an opinion by Judge Prost joined by Judges Dyk and Hughes.  The Court agreed with Teva that the District Court erred in requiring Teva to show that:

    [I]t would have been obvious to use the recited dosing regimens for the general population of patients—i.e., a generalized dosing regimen.  The court found that the prior art did not demonstrate population-wide safety and efficacy and thus did not teach a generalized dosing regimen.  Teva contends that the claims were not directed to a generalized dosing regimen and therefore the district court asked for a showing of obviousness that went beyond what was claimed.

    The opinion specifically asserts that the claims were directed to "a psychiatric patient in need of treatment for schizophrenia" using certain dosage amounts and administration times (emphasis in opinion).  In the Court's opinion:

    Nothing in the claims requires that the regimen be used for—let alone be ideal for—the patient population generally or a certain percentage of the patient population.  On their face, the claims only recite a dosing regimen for a psychiatric patient.  Because "[w]hat matters is the objective reach of the claim," KSR[ v. Teleflex], 550 U.S. at 419, the district court erred to the extent it effectively defined its obviousness inquiry as one concerning the "generalized" suitability of the dosing regimens [emphasis in opinion].

    This sentiment raises at least two questions:  first, the proper scope of claims reciting "a" member of a patient population (and how it Is to be determined) and second whether disclosure of clinical trial results can be interpreted as being insufficient to satisfy patentability standards for patient populations for such claims.  The jurisprudential history of construction of the indefinite article "a" is not completely straightforward; although treatises somewhat blithely assert that using "a" indicates the proper construction to be "one or more" (see Robert C. Faber, Landis on Mechanics of Patent Claim Drafting 531 (3d ed. 1990)), in fact the case law is more nuanced.  The Federal Circuit in  KCJ Corp. v. Kinetic Concepts, Inc. 223 F.3d 1351 (Fed. Cir. 2000), opined that "[t]his court has repeatedly emphasized that an indefinite article 'a' or 'an' in patent parlance carries the meaning of 'one or more' in open-ended claims containing the transitional phrase 'comprising,'" citing Elkay Mfg. Co. v. Ebco Mfg. Co., 192 F.3d 973, 977, 52 USPQ2d 1109, 1112 (Fed. Cir. 1999); AbTox, Inc. v. Exitron Corp., 122 F.3d 1019, 1023, 43 USPQ2d 1545, 1548 (Fed. Cir. 1997); and North Am. Vaccine, Inc. v. American Cyanamid Co., 7 F.3d 1571, 1575-76, 28 USPQ2d 1333, 1336 (Fed. Cir. 1993).  And "[m]oreover, standing alone, a disclosure of a preferred or exemplary embodiment encompassing a singular element does not disclaim a plural embodiment."  The opinion also states that "although the specifications may well indicate that certain embodiments are preferred, particular embodiments appearing in a specification will not be read into the claims when the claim language is broader than such embodiments," citing Electro Med. Sys., S.A. v. Cooper Life Sciences, Inc., 34 F.3d 1048, 1054, 32 USPQ2d 1017, 1021 (Fed. Cir. 1994).

    But some of this cited case law embodies the exceptions to this general rule (to the extent it is general); for example, Abtox, wherein "a" gas chamber was construed as limiting the claims to a single gas-containing chamber based on intrinsic evidence, including the specification (and drawings) as well as the prosecution history that were consistent with construing the claim language to be limited to a single chamber and North Am. Vaccine, Inc. where in the absence of use of "a" in the specification to mean "one or more" (by example) construing the claim to encompass more than one would create a written description deficiency, the Court stating that "[a] patent applicant cannot disclose and claim an invention narrowly and then, in the course of an infringement suit, argue effectively that the claims should be construed to cover that which is neither described nor enabled in the patent."  It is fair to say that "construction of the indefinite article does not conform to uniform treatment or 'black letter law' but rather is interpreted based on how it is used in the intrinsic evidence (claims, specification, and prosecution history)," Insituform Technologies v. Cat Contracting, 99 F.3d 1098 (Fed Cir 1996).

    Here, the claim recites "a" dosing regimen for treating "a" psychiatric patient (this of course is done individually to a population of individuals not to a population per se) comprising the details of the regimen.  The Court held that the District Court used evidence adduced by Janssen of clinical trial results improperly to read a limitation regarding patient populations into the claim that recited the dosing regimen for treating "a" psychiatric patient. (In a footnote the panel states "it is unclear whether that [dosing] requirement would indicate that physicians typically (or always) dose that way or that some (or all) patients achieve a certain level of a particular unnamed result").  This principle brings to mind recent precedent on enablement, and whether claims to therapeutic treatments and regimens for administering them will be subject to similar requirements for a showing of how many psychiatric patients would be enough for these claims to be non-obvious under similar circumstances as in this case (contrary, for example, to distinctions by the Court between patentability requirements and regulatory requirements; see, In re Brana, 51 F.3d 1560 (Fed. Cir. 1995)).

    The District Court's "misunderstanding" the Court apprehends based on these distinctions made it clear to the panel that they "impacted the district court's overall obviousness analysis," citing statements in the district court decision related to injection site (deltoid, thigh, or gluteal) and dosing amounts.  The opinion asserts that the District Court erred for not considering evidence that the prior art taught making these choices on an individualized rather than patient population basis, based on the Court's construction that such individualized evidence was indicated if not mandated by claim limitations to "a" psychiatric patient being treated by "a" dosage regimen.  And with regard to the District Court's assessment of there not having been a reasonable expectation of success in combining the asserted prior art the panel states that "there too [the District Court] seemed to require an expectation of success not for administering paliperidone palmitate to a patient according to the dosing regimen claimed, but rather success in achieving the goals a POSA would have across an (undefined) average population of patients, such that a POSA would expect to use the regimen as a 'generalized multi-dose regimen.'"  This error, according to the opinion was the result of "conflat[ing] the invention of the claims with Janssen's approval process when it referred to the difficulties Janssen encountered with the . . . clinical trial as an indication of unpredictability in the 'invention process.'"  "In sum," according to the opinion, " . . . the court's framing led it to ask the wrong questions about important aspects of the obviousness inquiry.  This error requires a remand as to all claims because as it currently stands, the record does not contain underlying obviousness factfindings that are cued to the 'a psychiatric patient' claims at issue here."

    The opinion also faults the District Court for assessing obviousness of claims regarding administration to patients having renal impairment to those patients wherein the impairment was "mild," there being no such limitation recited in the claims.

    More generally, the Court gave credence to Teva's argument that the District Court had contravened the dictates in KSR regarding "impermissibly rigid" assessment of obviousness, based on the District Court not giving the proper weight to the ability of the skilled worker to deduce what the references "fairly suggest[ed]" or employ "ordinary creativity," inter alia by purportedly applying these references to the claims in a "one-by-one" manner (a criticism countless patent prosecutors have heard from PTO examiners), calling it a "seemingly siloed and inflexible approach."  Consequently, the panel believed that the District Court did not consider "how background knowledge in the art would have impacted a POSA's understanding of, or motivation to modify, the primary references at issue, thereby inflating the significance of minor variations between the prior art and the claims."  The opinion also criticizes how the District Court relied on the '548 protocol with regard to the skilled worker's motivation to combine, insofar as the District Court "concluded that in the pharmaceutical context, if a prior art reference does not contain safety and efficacy data, there is no reason to combine it with other prior art references."  The Federal Circuit rejected this approach, stating that the lack of safety and efficacy data in a prior art reference to a clinical trial did not justify the lower court "discarding" that prior art (echoing recent Federal Circuit precedent that claims directed to pharmaceutical compositions and methods of treatment require affirmative recitation of safety and efficacy requirements; see United Therapeutics Corp. v. Liquidia Technologies, Inc., cited in the opinion).  The opinion faults the District Court for not considering what the results of the '548 protocol would have suggested to the skilled worker, or the relevance of the Phase III status of the clinical trial, or that "paliperidone was already on the market and prescribed to patients in need of treatment for schizophrenia" (which might be an important motivation for the Court's opinion).  According to the opinion, what was "more important" was that the '906 claims "do not recite any particular result or outcome, nor do they recite a need for population-wide statistically significant data" (ignoring the implicit meaning of claims to a therapeutic treatment regimen as being safe and effective, or the formalistic futility of requiring such claims (or all such claims) to affirmatively make such representations, with the opinion once again making a distinction between "a psychiatric patient" and a population of such patients).  The status of the clinical trial as having failed was not public knowledge and thus, the panel reasonably contends the skilled worker might have had a different motivation towards combining this reference with other prior art in the absence of such knowledge.  Finally, the Court found error in the District Court's analysis of modifications of unequal loading doses and injections sites, based on its erroneous consideration of the '548 protocol, as well as asserting particular error regarding claims to treatment of renally impaired psychiatric patients (such as not giving sufficient weight to prior art dosage information from orally administered paliperidone palmitate for claims to the drug administered by injection).

    Turning to the District Court's nonobviousness determination for claims directed to particle size, the panel found error over the standard applied for teaching away from the '544 patent, based on lack of specific disclosure regarding this parameter ("[S]ilence does not imply teaching away," Allergan, Inc. v. Apotex Inc., 754 F.3d 952, 964 (Fed. Cir. 2014)).

    The opinion also provides a thorough discussion of the remedial requirements on remand for the District Court regarding secondary considerations (objective indicia) of non-obviousness, including unexpected results (involving comparisons to psychiatric drugs other than paliperidone palmitate and reliance on the unknown bases for clinical failure in the '548 protocol).  The opinion criticizes the District Court's lack of proper nexus evidence regarding industry praise, and disregard for the effect of blocking patents to the long-felt need and commercial success considerations, citing Acorda Therapeutics, Inc. v. Roxane Labs., Inc., 903 F.3d 1310, 1339 (Fed. Cir. 2018).

    Regarding the indefiniteness decision for claims 19-21 directed to particular particle sizes, the Court affirmed the District Court based on that decision being supported by "factual findings that Teva has not shown to be clearly erroneous."  Teva argued that various means for determining particle sizes could lead to "meaningfully different results, creating a situation where the same physical samples of paliperidone palmitate would simultaneously fall inside and outside the claim depending only on how its particle-size measurement is taken," and in particular on particle size deviations that the District Court found were "an outlier measurement taken with a defective device."  The Federal Circuit held that Teva had not established that this District Court determination was clearly erroneous, citing Takeda Pharm. Co. v. Zydus Pharms. USA, 743 F.3d 1359, 1366–67 (Fed. Cir. 2014), for the principle that "the 'mere possibility of different results' is insufficient for indefiniteness."

    The panel opinion is sufficiently thorough that the District Court should have ample direction regarding how it should fashion its considerations of the facts, claims, and prior art references to satisfy the Federal Circuit's criticisms of its non-obviousness determinations.  More concerning is the extent to which a court created to harmonize U.S. patent law has apparently endeavored to decide the specific case before it without due considerations on how "black letter" law will be properly applied to the next case it reviews, with regard to claims reciting "a" limitations and the inherent limitations of safety and efficacy for therapeutic treatments and methods of use thereof otherwise not challenged on written description or enablement grounds.  The decision (and United Therapeutics before it) suggests that it would be prudent in future to include affirmative disclosure regarding these inherencies in specifications supporting claims to therapeutic treatments and administration regimens therefor.

    Janssen Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2024)
    Panel: Circuit Judges Dyk, Prost, and Hughes
    Opinion by Circuit Judge Prost

  • Biomedical Device Consultants and Laboratories of Colorado, LLC  v. Vivitro Labs, Inc. (Fed. Cir. 2024)

    By Kevin E. Noonan –

    Federal Circuit SealA preliminary injunction is one of the most potent weapons in a patent plaintiff's arsenal, being capable of shutting down an accused infringer's continued infringement, prohibiting the infringing product from the stream of commerce, and forcing (or at least strongly motivating) a defendant to settlement.  Being so powerful, such injunctions are not easily obtained and are cabined by several requirements, the most potent being the need to show a likelihood of success on the merits at trial.  In Biomedical Device Consultants and Laboratories of Colorado, LLC  v. Vivitro Labs, Inc., the Federal Circuit illustrated the importance of such a showing in affirming a District Court denial based on plaintiff's failure to satisfy this prong of the eligibility test.

    The case arose in litigation over U.S. Patent No. 9,237,935, directed to Biomedical Device Consultants (BDC) devices for testing heart valve durability based on accelerated fatigue rates.  Claim 1 was considered representative by the Federal Circuit in its opinion (wherein only the relevant limitation was reproduced therein):*

    1.  A device for accelerated cyclic testing of a valved prosthetic device comprising . . .
        an excess volume area capable of operating at the accelerated pulsed rate, wherein the excess volume area is in fluid communication with the fluid return chamber providing a volume for storing a volume of a test system fluid when the test system fluid is under compression.

    The opinion identified three limitations in dispute: (1) that the claimed device is "capable of operating at the accelerated pulsed rate," (2) that it is "in fluid communication with the fluid return chamber," and (3) that it "provid[es] a volume for storing a volume of a test system fluid when the test system fluid is under compression," supported by specific disclosure in the specification:

    The compliance chambers 135 provide excess volume area for fluid to move into when the piston 114 performs a compression stroke. As the pressure of the gas in the compliance chamber 135 increases, the volume occupied by the gas decreases to provide additional volume for displacement of the liquid working fluid within the test chamber 106.

    And illustrated by a detailed figure exemplifying the return chamber 136, the compliance chamber 135, test valve sample 130, and the fluid flow path of  the claimed device:

    Figure 3Fig. 3

    The term "compliance," while being a recognized term of art was expressly defined in the specification wherein "'compliance' refers to the ability of the cavities forming the compliance chambers 135 to absorb some of the pressure placed upon the fluid in the test chamber 106 and further to control recoil toward the original volume dimensions upon removal of the compressive force"; this definition was not disputed.

    The basis for the District Court's denial of a preliminary injunction to BDC for failure to establish a likelihood of success on the merits was that the Disrtrict Court considered there to be a "substantial question" regarding infringement.  This determination arose due to the "preliminary construction" of the term "excess volume area" to mean that the compliance chamber of the device was "separate and needs to be fluidly connected" to the remainder of the device (emphasis in opinion) (although there was some inconsistency regarding whether this construction was based on the plain meaning of the claim or on BDC's construction in an inter partes review of a related patent).  Based on this construction the District Court held that the accused infringing article did not comprise an excess volume area.  Moreover, Vivitro (according to the District Court) had asserted grounds for validity not rebutted by BDC (at least not sufficient to show that those assertions "lacked substantial merit").  These included assertions of an operating manual from a competitor (Dynatek) that anticipated (for claims 1, 2, 8 and 13), or in combination with a Chinese patent to Xi rendered obvious the entirety of BDC's asserted claims; these assertions were supported by an expert declaration and the disclosures of the art illustrated in the opinion:

    Dynatek prior art:

    Fogure IAFIGURE lA

    The Federal Circuit affirmed, in an opinion by Judge Lourie joined by Judges Dyk and Stark.  The opinion expressly sets forth the requirements for a plaintiff to obtain a preliminary injunction (and for which the plaintiff bears the burden to establish):

    "(1) it is 'likely to succeed on the merits,' (2) it is 'likely to suffer irreparable harm in the absence of preliminary relief,' (3) the 'balance of equities tips in [its] favor,' and (4) 'an injunction is in the public interest,'" citing BlephEx, LLC v. Myco Indus., Inc., 24 F.4th 1391, 1398 (Fed. Cir. 2022) (quoting Winter v. Nat. Res. Def. Council, Inc., 555 U.S. 7, 20 (2008).

    Although other than the first prong, these requirements were not discussed in the opinion.  Failure to rebut a substantial question of non-infringement or invalidity precludes a plaintiff from obtaining an injunction under, inter alia, Genentech, Inc. v. Novo Nordisk, A/S, 108 F.3d 1361, 1364 (Fed. Cir. 1997).  The standard on appeal is a showing by a rebuffed plaintiff that the district court had abused its discretion, a standard the panel opines BDC did not satisfy here.  The panel rendered its decision on the invalidity issue and did not consider the District Court's non-infringement grounds for denying BDC its injunction.

    Regarding invalidity, the opinion notes that the burden on the defendant is not to establish these grounds by clear and convincing evidence (and further noting that to prevail at trial the defendant would need to satisfy that standard).  Rather to avoid a preliminary injunction a defendant must merely raise a question of "vulnerability" having a lower standard (albeit not expressly defined in the opinion).  A district court's refusal to grant a preliminary injunction on this basis is reviewed by the Federal Circuit deferentially for clear error Rule 52(a) of the Federal Rules Civil Procedure.

    On the merits of BDC's arguments on appeal, the Federal Circuit rejected the argument that the Dynatek reference did not anticipate claims 1, 2, 8 and 13 because "(1) its capacitance tank is in fluid communication with the distribution chamber, not the return chamber, (2) its capacitance tank cannot store test fluid when 'the test system fluid is under compression' because the test system as a whole is not under compression, and (3) its capacitance tank is not physically capable of 'operating at the accelerated pulsed rate.'"  The panel distinguished BDC's arguments based on Vivitro's expert testimony to the contrary and the panel's appreciation of deficiencies in those arguments, such as questions regarding positioning of the test valve between the capacitance tank and the return chamber and BDC's failure to show how the District Court's assessment was erroneous (this interpretation being supported by the '935 specification itself).  The Court also rejected BDC's arguments regarding Dynatek's failure to disclose that its test system was under pressure, on the grounds that BDC's claims required that the test system fluid, not the test system itself be under such pressure.  Similarly, the panel rejected BDC's distinction that the Dynatek system could not "operate at the accelerated pulsed rate" wherein "the capacitance tank is designed to address only small variations in volume over longer periods of time and that the tube connecting the capacitance tank to the test system is, 'as a matter of ordinary physics,' too narrow to allow fluid to transfer back and forth at an accelerated rate" because these properties are not required by the plain language of the asserted claims.

    Turning to the obviousness grounds for the District Court's decision, the Federal Circuit rejected BDC's assertions that the error was that "further briefing" was requested to support an obviousness determination based on the combination of the Dynatek and Xi references with a third reference BDC argued should have been included, because in the panel's opinion the evidence from the combination of Dynatek and Xi was sufficient.  The Court further rejected BDC's arguments that it was an abuse of discretion for the District Court to find a sufficient question of obviousness had been raised by the combination of Dynatek and Xi alone, based on the same logic applied to BDC's arguments distinguishing its device from those disclosed in Dynatek and Xi.  The Court also rejected BDC's arguments that the District Court had not established a motivation to combine the Dynatek and Xi teachings, stating that "simple substitution [of certain components] would result in a tester with fewer parts that would be easier for an end user to assemble, setup, and transport."  Nor were BDCs "teaching away" arguments persuasive because those allegations did not "'criticize, discredit, or otherwise discourage' investigation into the invention claimed," citing for this standard DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1327 (Fed. Cir. 2009).  Finally, regarding the "secondary considerations" of non-obviousness the opinion states that this argument was first raised in BDC's Reply brief, leaving Vivitro to argue at the oral hearing for the first time against these grounds of non-obviousness.

    The opinion recognizes that neither claim construction nor validity (nor infringement) has been definitively decided yet and that the Court's decision here is expressly limited to BDC not being entitled to a preliminary injunction.  Those remaining questions await trial.

    * Claim 1 in its entirety reads:

    1.  A device for accelerated cyclic testing of a valved prosthetic device comprising
        a pressure source configured to drive a test system fluid cyclically within the device above a normal physiological rate, at an accelerated pulsed rate of greater than 200 beats per minute within the device; and
        a pressurizable test chamber for containing the test system fluid and further comprising
        a fluid distribution chamber positioned on a first side of the valved prosthetic device and in fluid communication with the pressure source;
        a fluid return chamber positioned on a second side of the valved prosthetic device;
        a fluid return conduit both structurally and fluidly connecting the fluid distribution chamber to the fluid return chamber; and
        an excess volume area capable of operating at the accelerated pulsed rate, wherein the excess volume area is in fluid communication with the fluid return chamber providing a volume for storing a volume of a test system fluid when the test system fluid is under compression.

    Biomedical Device Consultants and Laboratories of Colorado, LLC  v. Vivitro Labs, Inc. (Fed. Cir. 2024)
    Nonprecedential disposition
    Panel: Circuit Judges Lourie, Dyk, and Stark
    Opinion by Circuit Judge Lourie

  • ACI Summit for Women Leaders in IP Law

    ACIThe American Conference Institute will be holding its 4th Annual Summit for Women Leaders in IP Law on June 25-26, 2024 at the National Union Building in Washington D.C.  The Summit will enable women in Intellectual Property roles to come together to explore industry trends and important factors impacting today's women IP leaders and practitioners.  This year's co-chairs are Vanessa Bailey, Head of Patent Policy at Amazon and Adrianna S. Luedke, Director and Associate General Counsel at Lockheed Martin Corp.

    In past conferences, attendees have been able to learn to advance and thrive in the intellectual property field, to benefit professionally and personally from the advice and storytelling of other women in the industry, and meet with industry counterparts and expand their network with a focus on camaraderie.

    This year's program highlights include battling with DEI backlash, tackling the AI-IP conundrum, IP litigation spotlight, secrets from the boardroom and key strategies for safeguarding.  Here will also be concurrent "Bids of Feather" roundtables on mentoring, personal branding, and the CHIPS Act.

    Valencia Martin-Wallace, Deputy Commissioner for Patents, U.S. PTO and Jennifer Dixon, Assistant Chief, Special Counsel for Policy and Intellectual Property, Antitrust Division, U.S. Department of Justice will be the Keynote Speakers.

    The brochure, agenda, and registration information can be found here.  The fee for the conference is $2,095.  ACI can be contacted by e-mail at customerservice@americanconference.com and by telephone at 1-888-224-2480.

    Patent Docs readers can save 10% by using promo code: D10-999-PD24.

  • ACI Summit on Biosimilars

    ACIAmerican Conference Institute (ACI) will be holding is 15th Annual Summit on Biosimilars & Innovator Biologics: Legal, Regulatory, and Commercial Strategies for the Innovator and Biosimilars Marketplace on June 20-21, 2024 at the New York City Bar Association.  Conference Co-Chairs are Deidre Parsons, Senior Director, Public Policy & Governmental Relations, Alnylam Therapeutics; Harshika Sarbajna, Vice President Commercial and Head Global, Alvotech; and Paki Banky, Director, Senior IP Counsel, IP Lead Cell and Gene at Novartis.

    Conference attendees will hear from Administrative Patent Judges the Honorable Jacqueline Bonilla, Deputy Chief; the Honorable Linda Horner; and the Honorable Grace Obermann, as well as Supervisory Patent Examiner Vanessa Ford and Laurel Goldberg, Regulatory Counsel, CDER, Food and Drug Administration.

    ACI faculty will offer presentations on the Biden Administration's initiatives on drugs and pricing strategies; an investors' roundtable on biosimilar valuation; the impact and insights for the future from Humira biosimilar launches; IPRs and policies and practices before the PTAB; and diversity, equity and inclusion in this industry, among others.

    An agenda for the conference can be found here, including a complete brochure for this conference, detailed descriptions of conference sessions, list of speakers, and registration form.  The registration fee is $2,395 for registration and payment by Mary 24, 2024; and $2,595 for payment by June 20th.  Patent Docs readers are entitled to a 10% discount off registration using discount code D10-999-PD24.  Those interested in registering for the conference can do so here, by emailing CustomerService@AmericanConference.com, or by calling 1-888-224-2480.

    Patent Docs is a media partner of ACI's 15th Annual Summit on Biosimilars.

  • ACI Advanced Summit on Life Sciences Patents

    ACIAmerican Conference Institute (ACI) will be holding its 22nd Advanced Summit on Life Sciences May 29-30, 2024 at the Fairfield Inn & Suites Manhattan Times Square South, New York, NY.

    This year's conference co-chairs include MJ Edwards (Senior Associate General Counsel, Patent Prosecution Team Lead, Gilead Sciences Inc.), Nicole Woods (Vice President, Assistant General Patent Counsel, Eli Lilly and Company), and Mercedes Meyer (Partner, Banner Witcoff LLP).

    This year's event highlights deep dives into the best regulatory and IP strategies for protecting digital health therapies and inventions created with the assistance of AI and machine learning, establishing sound and successful protocols to procure and enforce life sciences patents in the U.S. and internationally and much more.

    An agenda for the conference can be found here, including a complete brochure for this conference, detailed descriptions of conference sessions, list of speakers, and registration form.  The registration fee for the conference is $2,595.  Patent Docs readers are entitled to a 10% discount off of registration using discount code D10-999-PD24.  Those interested in registering for the conference can do so here, by e-mailing CustomerService@AmericanConference.com, or by calling 1-888-224-2480.

    Patent Docs is a media partner of ACI's 22nd Advanced Summit on Life Sciences.

  • ACI Paragraph IV Disputes Conference

    ACIThe American Conference Institute (ACI) will be presenting its 20th Annual Paragraph IV Disputes Conference on April 25-26, 2024 in New York City.  As in the past, this curated program will not only address "hot" topics but also will put the issues within the context of pre-suit considerations, case filings, final adjudication, and every step in between.

    This year's conference co-chairs include Andrei Iancu (Partner, Sullivan & Cromwell LLP and former Director of the USPTO), Brian Malkin (Associate General Counsel, Teva Pharmaceuticals), and Mira Mulvaney (Assistant General Patent Counsel, IP Litigation, Eli Lilly & Company).

    The conference will be honored by the presence of the Honorable Pauline Newman and former Chief Judge the Honorable Randall Rader from the Federal Circuit, as well as the Honorable Judge Stanley R. Chester from the District Court of New Jersey and Magistrate judge the Honorable Tonianne J. Bongiovanni and the Honorable Sherry R. Fallon.

    Joining participants will be Hatch-Waxman litigators, in-house advisers, Chief IP and senior IP/Patent counsel from leading brand name and generic pharmaceutical companies, who will discuss, debate, and analyze the latest trends, decisions, legislative and regulatory advancements affecting Hatch-Waxman litigation.

    The brochure, agenda, and registration information can be found here.  ACI can be contacted by e-mail at  customerservice@americanconference.com and by telephone at 1-888-224-2480.

    Patent Docs readers can save 10% by using promo code: D10-999-PD24.

  • Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. (Fed. Cir. 2024)

    By Kevin E. Noonan –

    Federal Circuit SealA fractured affirmance of a district court decision to dismiss an infringement action under 35 U.S.C. § 271(e)(1) was the occasion for the Federal Circuit to illustrate the continued debate over the scope of the safe harbor enacted as part of the Hatch-Waxman Act in Edwards Lifesciences Corp. v. Meril Life Sciences Pvt.

    The case arose over a brief (one week) importation of two transcatheter heart valve systems (Class III medical devices, subject to regulatory approval by FDA) by Meril in conjunction with attendance by their representatives at a medical conference.  These representatives were instructed not to engage in any sales activities for U.S sales (and indeed their activities did not include any ex-U.S. sales either) nor did the infringing article ever leave the bag in which they were carried.  The purported purpose of Meril's attendance at the medical conference was to attract interest from doctors who would be willing to be involved in clinical trials required by the FDA for regulatory approval of the devices, which involved displays and presentations regarding those devices.  The opinion notes that Meril had performed clinical trials in India and obtained approval for its devices in that country as well as obtained CE certification for marketing in Europe.  Further evidence before the District Court showed that Meril had begun work on a premarket submission and planning for a three-arm clinical trial that could be part of future submissions to FDA, had contacted FDA regarding such trials, and had worked with a medical device consulting company (CardioMed LLC) to assist in preparing its premarket submission documents.

    Based on these activities, Edwards filed suit against Meril for patent infringement, i.e., importing the devices into the U.S. without a license.  The District Court granted summary judgment in favor of Meril based on their activities falling within the scope of the § 271(e)(1) safe harbor, and this appeal followed.

    The Federal Circuit affirmed, in an opinion by Judge Stoll joined by Judge Cunningham; Judge Lourie dissented.  The majority opinion was based on the broad scope of the safe harbor tailored by the Supreme Court in Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 670–71, 674 (1990) (which expanded the safe harbor to include medical devices like the ones Meril imported into the U.S.), and Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193, 202 (2005) (which held that it "provides a wide berth for the use of patented [inventions] in activities related to the federal regulatory process"), as it has been further developed by several Federal Circuit cases (which Judge Lourie maintained in his dissent had been, at least in part, wrongly decided).  The majority emphasized the scope of the application of the statute, to include "all uses of patented inventions that are reasonably related to the development and submission of any information under the [FDA]," that this scope was not limited in when the activities occurred, and that it applied "even if the information is never ultimately submitted to the FDA" under Merck.  The majority opinion sets forth the Federal Circuit's explication of the evolution of the doctrine at its hands, illustrated by three cases:  AbTox, Inc. v. Exitron Corp., 122 F.3d 1019, 1027 (Fed. Cir. 1997); Momenta Pharm., Inc. v. Teva Pharm. USA Inc., 809 F.3d 610, 619 (Fed. Cir. 2015); and Amgen Inc. v. Hospira, Inc., 944 F.3d 1327, 1338 (Fed. Cir. 2019), which merit brief consideration here as characterized by the majority.

    "Starting with Abtox," the opinion asserts that the statute "does not look to the underlying purposes or attendant consequences of the activity . . . as long as the use is reasonably related to FDA approval."  This statutory construction is supported, according to the majority, because the language therein is that otherwise infringing acts were in the safe harbor provided they were performed "'solely for uses reasonably related to' FDA approval" (emphasis in opinion; this emphasis on uses rather than the solely requirement is the major philosophical distinction between the majority and Judge Lourie in dissent).  The rationale asserted by the Court in Abtox was that "intent or alternative uses" were "irrelevant" to the invocation of § 271(e)(1) because "the statutory language allows [defendant] to use its data from the tests for more than FDA approval," citing Telectronics Pacing Sys., Inc. v. Ventritex, Inc., 982 F.2d 1520, 1524–25 (Fed. Cir. 1992).  Turning to Momenta, the majority asserts that activities such as "routine record retention" associated with "post-approval, commercial production" was not protected under § 271(e)(1).  Finally, in Amgen the Court affirmed jury instructions to the effect that "additional underlying purposes [for alleged safe harbor activity] do not matter as long as [defendant] proved that the manufacture of any given batch of drug substance was reasonably related to developing information for FDA submission" under circumstances where 7 of 21 otherwise infringing batches were found to fall under the safe harbor because they were used for "pre-approval inspection" while the others, used for "various types of [commercial] testing" did not.

    With regard to the term "solely" in the statute, the majority states that it modifies the phrase "for uses," and thus that "the safe harbor is available only for acts or uses that bear a reasonable relation to the development and submission of information to the FDA," relying on Merck.  Importantly, the majority went on to say that the statute does not require "that the use must only be reasonably related to the development and submission of information to the FDA" (emphasis in opinion, and somewhat ironic insofar as "solely" and "only" are synonymous).

    Using this explication as prelude, the majority determined that "the relevant inquiry is not why Meril imported the two transcatheter heart valve systems, or how Meril used the imported transcatheter heart valve systems, but whether the act of importation was for a use reasonably related to submitting information to the FDA" (emphases again in the opinion).  Accordingly, the majority affirmed the District Court grant of summary judgment in view of the undisputed facts (set forth above).

    The majority rejected Edwards's three arguments on appeal.  First, Edwards argued that there were genuine issues of material fact disregarded by the District Court, that the actions of Meril's representatives were commercially driven.  The majority rejected this contention in light of the evidence that the representatives were expressly told not to pursue commercial goals for U.S. sales and while they were under no such strictures regarding non-U.S. sales no such sales-directed activity occurred.  That the representatives did not bring their devices with them to dinners and other activities with clinical scientists to be recruited to direct clinical trials was also not probative to the majority of intent outside the scope of the safe harbor.  The majority also rejected Edwards's contention that Meril's disregard of some of the advice given by its FDA consultant and guidance from FDA was evidence that Meril did not intend to enter clinical trials for FDA submission, finding no basis in the undisputed evidence before the District Court.  In an interesting twist of emphasis, the majority rejected Edwards's arguments because, in their view, "no reasonably minded juror" would have inferred that "Meril's sole purpose for importing [its devices] was to support its commercial sales efforts, and the importation was wholly unrelated to recruiting clinical investigators and wholly unrelated to any FDA submission," turning the question of "sole" purpose on its rhetorical head (emphasis in opinion).

    The majority also rejected Edwards's second argument, that Meril's failure to use the imported devices stripped them from the protection of the safe harbor as a matter of law because the District Court "deem[ed] Meril's intent irrelevant in the absence of evidence of a protected use."  This argument failed for two reasons, according to the majority:  first, that there was nothing in the statute that required such a use to provide safe harbor protection and that importation itself was so eligible (as the District Court held).  Second, and relevant to the dissent's position, the majority asserted that:

    [O]ur interpretation of § 271(e)(1) applies the safe harbor regardless of the defendant's intent or purpose behind the otherwise infringing act (citing Amgen, 944 F.3d at 1338–39; and AbTox, 122 F.3d at 1030).  Nothing in our jurisprudence suggests that the availability of the safe harbor turns on the party's subjective intent behind an act.  And that remains true regardless of whether there are additional uses by defendant.

    Finally, Edwards argued that the District Court had improperly relied on declaration evidence from one of Meril's representatives, which argument the majority rejected because the District Court relied on other evidentiary bases for its decision.

    Judge Lourie's dissent went straight to the point:

    I [dissent] because the majority perpetuates the failure of this court and others to recognize the meaning of the word "solely" in interpreting § 271(e)(1).  The majority also errs in following the error of AbTox, Inc. v. Exitron Corp., 122 F.3d 1019 (Fed. Cir.), opinion amended on reh'g, 131 F.3d 1009 (Fed. Cir. 1997), and its progeny that the purposes of the infringing act do not matter in evaluating the safe harbor.

    I believe that "solely" creates a safe harbor only for uses, sales, and importations that solely are for, as the statute says, development of information for the FDA.  The purpose of the infringing act is meaningful and important to determining the safe harbor.  And attempts to tie the word "solely" to be modifying one or another subsequent term does not change that meaning.

    Judge Lourie recognized that the District Court "reasonably followed" these earlier decisions and that the error was in the Court's earlier safe harbor precedent, due to their decisions having given "short shrift" to the word "solely" in the statute.  Using the proper interpretation of that statute, Meril's activities would have raised a genuine issue of material fact (precluding summary judgment) regarding whether importing the devices was "solely for uses reasonably related to the development and submission of information" (emphasis in dissent).  In view of the legislative history and intent of the Hatch-Waxman Act (wherein the safe harbor abrogated the Court's decision in Roche Prods., Inc. v. Bolar Pharm. Co., 733 F.2d 858, 861 (Fed. Cir. 1984), rendering infringing any activity prior to patent expiry), Judge Lourie opines that "[t]he word 'solely' was included in the statute to ensure that infringing activity that was performed for purposes other than the development and submission of information under a federal law regulating drugs would not be exempt" (citing portions of that legislative history).  Relying on the Oxford English Dictionary, Judge Lourie distinguished the meaning of "solely" ("a single person (or thing); without any other as an associate, partner, sharer, etc.; alone; occasionally, without aid or assistance" or "[a]part from or unaccompanied by others; solitary") from "partially," "slightly," "jointly," or have "any other ambiguous meaning."  Judge Lourie also noted that it was well recognized by commentators at the time that the legislative history precluded the safe harbor from "permit[ting] the commercial sale of a patented drug by the party using the drug to develop [federal regulatory] information," i.e., commercial sales were not exempt even if they resulted in such information (the Judge further stating that importation was similar prohibited unless the exemption applied).

    The consequence of the Federal Circuit's improper interpretation of the statute, according to the dissent, was that by following it "the district court here wholly ignored the presence of the word 'solely' in the statute," noting that the word was completely absent from the District Court's analysis and holding, something that "was not merely a harmless omission."  Judge Lourie called out in particular the statement, relegated to a footnote in the District Court's opinion, that "[b]ecause intent and alternative uses are not relevant to the application of the safe harbor once it is determined that the allegedly infringing acts were reasonably related to FDA approval, the Court need not reach the issue of Meril's alleged commercial intent," which cited AbTox and Amgen for support of this principle.  Judge Lourie sets forth in this regard his own explication of Abtox, Momenta, and Amgen (as well as Telectronics Pacing Systems) in assessing the responsibility for this error to properly be placed at the Federal Circuit's doorstep.  In this analysis, he noted instances where the word "solely" did not appear in the Court's reasoning (Telectronics), where intent was specifically disregarded (Abtox, which stated that the safe harbor "does not look to the underlying purposes or attendant consequences of the activity . . . , as long as the use is reasonably related to FDA approval"), Momenta (which expanded the scope of the safe harbor), and Amgen.  To be sure, Judge Lourie found at least the impetus for this trend in the Supreme Court's expansive interpretation of the statute in Merck (wherein the Court included activities resulting in experimental evidence that was not for whatever reason submitted to FDA), but asserts that the Court's decision did not mandate the disregard of the statutory restrictions imposed by the word "solely" that the Federal Circuit's case law had sanctioned.  In particular, Judge Lourie finds support in the Merck decision for his thesis regarding the error in Federal Circuit's interpretation, wherein the Court stated that "[b]asic scientific research on a particular compound, performed without the intent to develop a particular drug or a reasonable belief that the compound will cause the [desired physiological effect], is surely not 'reasonably related to the development and submission of information' to the FDA."

    Judge Lourie's remedy is en banc review, to permit the full Federal Circuit to reconsider its precedent.  While it is somewhat remarkable that such a fundamental interpretation of the statute is necessary forty years after enactment it is consistent with a judicial philosophy generally in favor of interpreting narrowly exemptions to patent law protections for innovators.  Whether Judge's Lourie's brethren recognize the distinctions he has drawn shall be seen.

    Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd. (Fed. Cir. 2024)
    Panel: Circuit Judges Lourie, Stoll, and Cunningham
    Opinion by Circuit Judge Stoll; dissenting opinion by Circuit Judge Lourie

  • USPTO Updates Service Methods for Notices of Appeal and Related Documents

    By Joshua Rich —

    USPTO SealIn a Federal Register notice dated March 29, 2024, the U.S. Patent and Trademark Office is updating the required method for serving it with a notice of appeal to the U.S. Court of Appeals for the Federal Circuit, a notice of election to proceed by civil action in district court, or a request for extension of time to file a notice of appeal or commence a civil action.  Previously, all such notices or requests had to be served by mail.  Under the new rule, the notices and requests are to be served by email (with Priority Mail as a failsafe if email is not feasible.

    The new rule requires a party to serve an email address in the Office of the General Counsel to be posted on the USPTO website.  If that cannot be done, the party can serve the Office of the Solicitor.

    While this seems like a small change (and it is), it has some clear benefits for practitioners.  First, it modernizes practice to bring it more in line with the more streamlined process used in litigation.  That is, litigators are accustomed to serving opposing parties by email rather than snail mail.  Second, the USPTO will accord the service copy with a time-stamped receipt date which serves as proof of receipt of service of the notice.  This prevents any potential concern that the service copy "got lost in the mail."  But potentially most importantly, this procedure is just easier — no printing copies, trips to the Post Office, or other hassle.

  • Cardiovalve Ltd. v. Edwards Lifesciences Corp. (Fed. Cir. 2024)

    By Kevin E. Noonan –

    Federal Circuit SealLast week, the Federal Circuit handed down a pair of non-precedential decisions affirming the Patent Trial and Appeal Board (PTAB) in inter partes review (IPR) proceedings.  This post concerns the decision in Cardiovalve Ltd. v. Edwards Lifesciences Corp., which has as its most significant aspect an unnecessary untethering of obviousness with evidence regarding the skill and inventiveness of the person of ordinary skill in the art under KSR International Co. v. Teleflex Inc.

    The case arose with Edwards's challenge of claims 1-3, 5, 6, and 8-11 of Cardiovalve's U.S. Patent No. 10,226,341 directed to an apparatus for implanting a prosthetic heart valve in a patient in need thereof. Claim 1 was considered representative by the panel:

    1.  Apparatus for use at a native valve of a subject, the native valve including at least a first native leaflet and a second native leaflet, the apparatus comprising:
        an implant, comprising:
        an annular portion, being configured to be placed against an upstream side of the native valve, and having an inner perimeter that defines an opening, and
        at least one leaflet clip:
                (i) coupled to the annular portion,
            (ii) comprising:
                at least two clip arms, movable with respect to each other to open and close the clip; and a clip-controller interface, the clip-controller interface being coupled to at least one of the clip arms, and
            (iii) configured:
                to be coupled to a portion of the first native leaflet by the clip arms being brought together to close around the first native leaflet,
                to be coupled to a portion of the second native leaflet by the clip arms being brought together to close around the second native leaflet, and
                to hold together the portion of the first leaflet and the portion of the second leaflet; and
            a delivery apparatus, configured to deliver the implant to the native valve, and comprising at least one clip controller, the at least one clip controller being reversibly couplable to the clip-controller interface, and configured to facilitate opening and closing of the clip, and the delivery apparatus being intracorporeally decouplable from the implant.
        wherein the bold, italicized language is relevant to the issues before the Court.

    The prior art cited in the IPR petition, U.S. Patent No. 7,635,329, in support of Edwards's obviousness contentions, disclosed a device for stabilizing valve leaflets illustrated in Figure 9B of this patent:

    Image
    where the "device, 14, [that] includes two proximal elements, 16, and two distal elements, 18, [is] configured such that a proximal and distal element pair, when brought together, form a clip that grasps a heart valve leaflet, LF, from the top and bottom [and wherein the] fixation device also includes flaps, 104, which restrict upward motion of the leaflets to better enable the proximal and distal elements to grasp the leaflets."  Also noted in the opinion is that "[o]nce the leaflets have been grasped, the flaps . . . may be removed . . . or may be left behind to assist in holding the leaflets" (emphasis in opinion).  Before the Board, Cardiovalve conceded that all the limitations recited in its claims were disclosed in the '329 patent except that the device comprise "at least one leaflet clip" "coupled to the annular portion" of the device.  The Board found that the pairs of proximal and distal elements disclosed in the '329 patent together constitute a "leaflet clip" as disclosed and claimed in the '341 patent, that the flaps "constitute or contain" an "annular portion, and further that any direct or indirect attachment is a "coupling."  Based on these conclusions, the Board found the challenged claims of the '341 to be obvious, and this appeal followed.

    The Federal Circuit affirmed in a decision by Judge Taranto joined by Judges Chen and Stoll.  Cardiovalve's sole argument on appeal was that the Board erred in concluding that it would have been obvious to attach, "either directly or indirectly, [the flaps] disclosed in the '329 patent" to its proximal and distal elements."  The opinion notes that the Board applied the seminal teaching from KSR that:

    When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a [relevant artisan] has good reason to pursue the known options within his or her technical grasp.  If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.  In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.

    The panel held that the Board had substantial evidence for its conclusion that Edwards satisfied these requirements.  The panel's reasoning was that the disclosure in the '329 patent that the flaps could be "left behind" necessitated that they be attached to something fixed either to the device disclosed therein or to heart tissue, which provided a "finite number of predictable options."  The Board also relied on Edwards's expert witness regarding why the skilled artisan would know to attach the flaps to the device and why such an attachment would be expected to succeed, thus providing the reasonable expectation of success required by KSR (something Cardiovalve did not challenge).  And the fact that there might have been a small number of other alternatives, as argued by Cardiovalve, did not rebut the Board's determination that the one consistent with the invention claimed in the '341 patent was obvious.

    The one interesting aspect of the decision, and one that has garnered comment, was the panel's rejection of Cardiovalve's argument that recitation of the "known options" in the cited passage of the KSR opinion should be limited to what was actually known in the prior art.  (Indeed, it was the genius of Giles Rich and PJ Federico to tether obviousness under Section 103 to the prior art in ways that a century of Supreme Court precedent never did, leaving a determination of invalidity under what philosophically was obvious to the "flash of genius" and other inchoate and unpredictable standards.)  The Federal Circuit's basis for negating this requirement on the prior art was that the requirement was "nowhere articulated in KSR, and adopting it would be inconsistent with the Supreme Court's rejection in KSR of a rigid demand for the steps in an obviousness analysis to be proved by prior-art documents, to the exclusion of the knowledge and skill of the relevant artisan."  And the Court refused to recognize such a requirement in its own precedent, abjuring such existing precedent cited by Cardiovalve (specifically, Uber Technologies, Inc. v. X One, Inc., 957 F.3d 1334, 1339–40 (Fed. Cir. 2020); and Bayer Schering Pharma AG v. Barr Laboratories, Inc., 575 F.3d 1341, 1350 (Fed. Cir. 2009); indeed, this reasoning smacks not a little of being equivalent to stating that just because the Court had reasoned correctly in the past did not necessitate continuing to do so).  Of course there is nothing in KSR's averments regarding the basis for making an obviousness determination based on the knowledge and skill of the prior art artisan that does away with the requirement for evidence that the alternatives relied upon to make that determination would have been understood by the worker of ordinary skill at the time the invention was made and not simply presumed to have existed (being the epitome of hindsight, which KSR also warns against).

    The remainder of the panel's reasoning for its decision merely begs the question, i.e., assumes the conclusion, based on Edwards's argument that "a relevant artisan would have found it obvious to attach Goldfarb's flaps to its fixation device (and therefore indirectly to its proximal and distal elements), because the flaps, if left behind, had to be attached somewhere and this was an obvious location."  In the Court's application of the cited portion of the KSR decision the opinion states that "when a relevant artisan would have recognized a problem, a consideration of whether only a small number of solutions existed is a natural part of an evaluation of whether a patent-claimed solution would have been obvious.  The Board's undertaking such consideration here was therefore a legitimate exercise of its duty to evaluate whether Edwards was right or wrong about the position Edwards consistently maintained—that attachment to the implant would have been obvious" (the relevance of the italicized language being itself questionable).  The questionable nature of this basis for affirming the Board's decision is even more unfortunate because the opinion contains an ample basis for affirmance, whereby "the Board actually found reasons for a relevant artisan to choose the Edwards-urged solution over the alternative(s)—at the least, greater simplicity," reliance on which would have avoided disturbing dicta in what was otherwise (and fortunately) just another non-precedential opinion by the Court.

    Cardiovalve Ltd. v. Edwards Lifesciences Corp. (Fed. Cir. 2024)
    Nonprecedential disposition
    Panel: Circuit Judges Taranto, Chen, and Stoll
    Opinion by Circuit Judge Taranto