Patent Docs

USPTO Drops Proposal to Change Terminal Disclaimer Practice

By Joshua Rich and Andrew Velzen --

On May 10, 2024, the U.S. Patent and Trademark Office published a Notice of Proposed Rulemaking (NPRM) regarding terminal disclaimer practice.  The proposed rule would have required any terminal disclaimer filed to obviate nonstatutory (obviousness-type) double patenting to include provisions tying the validity and enforceability of the claims of that patent to the validity and unenforceability of each of the claims in the other patent.  The NPRM drew over 300 comments, including a highly critical open letter from former USPTO Directors and others.  Now, in light of the vociferous criticism, much like Drake[1] or Nirvana[2] (or for an older audience, Gilda Radner[3]), the USPTO has said "Nevermind."[4]

The NPRM announced a proposed change to 37 C.F.R. § 1.321 that would have added an additional requirement for a terminal disclaimer to be used to overcome nonstatutory double patenting rejections (in addition to the common ownership requirement).  Namely, under the proposed rule, the terminal disclaimer would also have needed to:

[I]nclude an agreement . . . that the patent in which the terminal disclaimer is filed, or any patent granted on an application in which a terminal disclaimer is filed, will be enforceable only if the patent is not tied and has never been tied directly or indirectly to a patent by one or more terminal disclaimers filed to obviate nonstatutory double patenting rejections in which:

any claim has been finally held unpatentable or invalid as anticipated or obvious by a Federal court in a civil action or by the USPTO . . . or

a statutory disclaimer of a claim is filed after any challenge based on anticipation or obviousness to that claim has been made."[5]

The proposed rule would purportedly "promote innovation and competition by allowing a competitor to avoid enforcement of patents tied by one or more terminal disclaimers to another patent having a claim . . . held unpatentable."[6]

There were a raft of potential problems with the proposed rule, ranging from conflicts with codified law and precedent to policy concerns, as we noted in previous posts.[7]  Following in our footsteps, several former high-ranking USPTO officials (including former Directors) signed onto an open letter to Director Vidal.[8],[9]  In fact, the Directors found the NPRM so inflammatory, that they called for not only a non-enactment of the proposed rule, but also an immediate withdrawal of the NPRM, itself.

The letter argued that the proposed rule was an improper -- indeed, illegal -- exercise of rulemaking authority on two basic grounds.

First, it argued that the proposed rule would constitute a "substantive" rule and, therefore, was beyond the USPTO's statutory authority to implement (i.e., illegal).  Under 35 U.S.C. § 2(b)(2)(A), the USPTO "may establish regulations, not inconsistent with law, which . . . shall govern the conduct of proceedings in the Office."[10]  This is frequently interpreted as giving the USPTO the authority to make procedural rules, but not substantive ones.[11]  Notably, both the proposed rule and former Directors' letter preceded the overturning of Chevron deference by the Supreme Court in Loper Bright Enterprises v. Raimondo.[12]  That decision shifted the ground beneath the USPTO's feet, robbing it of deference in rulemaking, and arguably making the proposed rule even further outside the USPTO's purview.

Second, the Directors' letter argued as we had before that the proposed rule conflicted with the Patent Act because it would render entire families of patents invalid or unenforceable whenever a single claim in an entirely different patent tied to it by a terminal disclaimer was found invalid or unenforceable.  It did not seem like a close question, since 35 U.S.C. § 282(a) requires that:

A patent shall be presumed valid.  Each claim of a patent (whether in independent, dependent, or multiple dependent form) shall be presumed valid independently of the validity of other claims; dependent or multiple dependent claims shall be presumed valid even though dependent upon an invalid claim.  The burden of establishing invalidity of a patent or any claim thereof shall rest on the party asserting such invalidity [emphasis added].

The proposed rule would have turned that presumption on its head and linked the validity of all members of a terminal disclaimer family together.  If one claim had fallen, it would have been an anchor around the neck of all the others, sinking them with it.

The Directors' letter also attacked the proposed rule on policy grounds.  It argued the NPRM relied on an insufficient investigation of the need for the proposed rule and that the proposed rule "seeks to solve a problem that does not exist."  Indeed, even the data presented in the NPRM, itself, seemed to undercut the necessity of the proposed rule.  Furthermore, the letter set forth a parade of horribles that could result as unintended consequences of the proposed rule.

In light of the former Directors' letter (and many other negative comments), the USPTO has now announced that it "has decided not to move forward with the proposed rule at this time and to withdraw the proposed rule," citing "resource constraints."[13]  In a note of grace in withdrawing the proposed rule, the USPTO noted that:

Despite the decision not to move forward with the proposed rule at this time, the USPTO appreciates and takes seriously the thoughtful perspectives raised by commenters.  The USPTO will continue engaging with its stakeholders as it works to foster a balanced, robust, and reliable intellectual property system.

Regardless, the final result is the one suggested by the authors and the former Directors alike:  the withdrawal of the proposed rule requiring changes to terminal disclaimer practice to obviate nonstatutory double patenting.

[1] https://en.wikipedia.org/wiki/Honestly,_Nevermind
[2] https://en.wikipedia.org/wiki/Nevermind
[3] https://www.youtube.com/watch?v=fZLeaSWY37I
[4] https://public-inspection.federalregister.gov/2024-28263.pdf
[5] https://www.federalregister.gov/documents/2024/05/10/2024-10166/terminal-disclaimer-practice-to-obviate-nonstatutory-double-patenting.
[6] https://www.federalregister.gov/documents/2024/05/10/2024-10166/terminal-disclaimer-practice-to-obviate-nonstatutory-double-patenting
[7] For in-depth discussions of the problems with the proposed rule, see https://www.patentdocs.org/2024/05/uspto-proposed-rule-change-to-terminal-disclaimer-practice.html, https://www.patentdocs.org/2024/05/the-usptos-proposed-terminal-disclaimer-rule-a-litigators-perspective.html
[8] The letter was signed by former directors Andrei Iancu, David Kappos, and Drew Hirshfeld and former deputy directors Laura Peter and Russell Slifer. A copy of the letter can be found here: https://patentdocs.typepad.com/files/2024-05-28-letter.pdf
[9] For an extensive discussion of the letter, please see https://www.patentdocs.org/2024/06/former-directors-request-rescission-of-proposed-rule-change.html.
[10] https://www.law.cornell.edu/uscode/text/35/2.
[11] See also Merck & Co. v. Kessler, 80 F.3d 1543 (Fed. Cir. 1996); Animal Legal Def. Fund v. Quigg, 932 F.2d 920 (Fed. Cir. 1991).
[12] No. 22–451, 603 U.S. __, 144 S. Ct. 2244 (2024).
[13] https://public-inspection.federalregister.gov/2024-28263.pdf

USPTO Institutes Additional Fees for Large Information Disclosure Statement Filings

By Michael Borella and Joshua Rich --

The advice to practitioners faced with marginally relevant prior art has long been "when in doubt, cite it."  There was a small cost for the applicant (or practitioner) to cite such art by filing an information disclosure statement (IDS), but substantial potential risks that could arise if the art was not cited.  On the other hand, examiners had to consider tangentially-related art along with the most relevant art.  The USPTO has now decided to institute a fee for filing large IDSs, which may very well have unintended, adverse consequences for the patent system as a whole.  It will create greater ethical challenges for practitioners and may degrade patent quality.  That is, the USPTO's cure may be worse for everyone involved than the problem has been for examiners.

The duty to disclose prior art on an IDS is unique to U.S. patent law practice.  While some other jurisdictions have prior art disclosure procedures (for example, in Canada, applicants can identify prior art voluntarily or do so in response to an examiner's request) or require identification of co-pending applications in other jurisdictions (such as in India, where the art cited in these applications may be used for evaluation of patentability), the U.S. requirements are both obligatory and more extensive.  As set forth in 37 C.F.R. § 56(a), the duty of disclosure requires that:

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 [emphasis added].

§ 56(b) adds some clarity on whether art is "material", stating that "information is material to patentability when it is not cumulative to information already of record or being made of record in the application."

The duty applies to a surprisingly large number of individuals -- all patent practitioners (whether in house or outside counsel) working on the application, all inventors, and any other individuals "associated with the filing and prosecution of a patent application."

A failure to discharge the duty of disclosure can have severe consequences for both the patentee (a finding of inequitable conduct can render the patent unenforceable) and practitioners (who can face professional discipline).  That is, the cost of failing to disclose a material, non-cumulative reference is potentially devastating.  Accordingly, it is critical for an applicant to thoroughly disclose all such references.

But the rub with the duty to disclose is that there is no clear definition of what is material to patentability or cumulative.  Both of these terms have a degree of subjectivity, and will be fiercely litigated based on facts unique to each case.  Given that, the aforementioned individuals are incentivized to disclose all known art when filling out IDSs because the cost of an incremental disclosure is far lower than that of even just being accused of inequitable conduct.

The USPTO contends, however, that "[in] many instances, these large IDS submissions contain clearly irrelevant, marginally relevant, or cumulative information."  To battle this perceived problem, on November 20, 2024, the USPTO published its final rule for "Setting and Adjusting Patent Fees During Fiscal Year 2025" in the Federal Register.  While the final rule includes a number of fee increases and new fees, the IDS-specific fees are set forth in Table 10 and excerpted below.

Notably, while Table 10 provides the large entity (undiscounted) fees, the final rule makes no mention of small or micro entity discounts for these fees.  Thus, it appears that the new IDS payment rules are as follows for all applicants:

a first amount ($200) in § 1.17(v)(1) for a cumulative number of applicant-provided or patent owner-provided items of information in excess of 50;

a second amount ($500) in § 1.17(v)(2) for a cumulative number of applicant-provided or patent-owner-provided items of information in excess of 100 but not exceeding 200, less any amount previously paid under § 1.17(v)(1); and

a third amount ($800) in § 1.17(v)(3) for a cumulative number of applicant-provided or patent owner-provided items of information in excess of 200, less any amounts previously paid under § 1.17(v)(1) and/or (v)(2).

The USPTO justifies these fees by noting that "[a]bout 5% of applications contain 51 to 100 applicant-provided items of information, about 4% of applications contain 101 to 200 applicant-provided items of information, and only 4% of applications contain more than 200 applicant-provided items of information."  While this means that the new IDS fees are expected to only impact about one of every eight applications, the USPTO states that it has provided examiners with "approximately 80,000 additional hours each year to consider large IDS submissions in applications, costing the agency $10 million annually."  The USPTO further asserts that "this cost is subsidized generally by patent fees, primarily maintenance fees collected for patents that resulted from applications that did not contain large IDS submissions."

At first blush, this seems to be a reasonable justification for the fees.  However, upon deeper reflection it is not clear how the USPTO has calculated these numbers and whether they reflect actual costs in practice.  For example, it is common practice for applicants to file continuation applications with an IDS citing all art from all parent applications.  This can easily break the new 50-reference limit on free IDSs, especially if the application family has foreign counterparts where art has been cited or is perhaps the 3rd or 4th continuation (or more).

This is less of a burden than meets the eye because the USPTO typically assigns the same examiner to all U.S. applications in a family.  So the majority of references in an IDS for a continuation may have already been considered by the examiner, and the examiner can proceed through the cited references much more quickly than references that are actually new.  If the USPTO's analysis does not take this factor into account, it is misleading and could dramatically overestimate the actual cost of handling large IDSs.

Regarding continuations and the like, the USPTO writes:

The cumulative count is determined for each application or patent separately.  That is, the count from an application does not carry over to any continuing applications, CPAs, reissue applications, or any post-issuance proceedings such as supplemental examinations or reexamination proceedings.  Instead, continuing, CPA, and reissue applications and post-issuance proceedings will start with a count of zero.[1]

This means that references cited in a parent application do not count against any of its child applications unless those references are re-cited in the children.  But the USPTO reiterates its policy that examiners must "consider items of information that were considered in a parent application when examining a child application (e.g., a continuation, continuation-in-part, or divisional application) without any action required on the applicant's part."  It continues by clarifying that "applicants who wish to avoid paying the IDS size fees in a child application for items of information considered in a parent application may do so by not resubmitting the items."  That is, for the examiner, an applicant citing the same references makes essentially no difference in the scope of art that must be considered, but the applicant may face substantial fees for re-citation of those references.

The USPTO's statements suggest a fee-reducing solution for applicants -- do not cite any references in child application if those references were cited and considered in any of its parents.  The applicant will still need to cite any references that were not cited in the parent applications, but that number is likely to be significantly smaller.  The downside to this strategy is that the uncited references from the parent application will not appear on the face of the any patent that issues from the child application.

The value of the cited references being so clearly set forth in the patent is debatable, but it is clear that it provides some benefit.  On one hand, whether references are printed on its face has no material impact on the validity of a patent.  On the other hand, it may be helpful to show a jury (and perhaps certain judges) this crystal clear evidence that the examiner found the issued claims patentable over the references.  And for the public, it provides immediate notice that the cited art was considered by the examiner without requiring a dive into the prosecution history.

To simplify its enforcement of the IDS fee plan, the USPTO is also requiring that "an IDS contain a clear written assertion by the applicant and patent owner that the IDS is accompanied by the appropriate IDS size fee or that no IDS size fee is required."  While "[t]here is no specific language required for the written assertion, . . . it should be readily identifiable on the IDS and clearly convey the applicable IDS size fee by specifying the particular paragraph in § 1.17(v) that applies (e.g., ''the fee due under 1.17(v)(2)''), if any."

The USPTO will update its standard IDS form to incorporate this language, but there is a trap for the applicant.  Unlike other fees, the applicant cannot generally authorize the office to charge the appropriate IDS fee to a deposit account.  Instead, "authorization to charge fees to a deposit account is not a compliant written assertion under the new § 1.98(a) requirement, unless the authorization clearly identifies the particular IDS size fee that should be charged for submission of a particular IDS."

This means that the applicant needs to maintain an accurate count of applicant-submitted references per application.  Doing so is an onerous task that the USPTO is pushing on to applicants.  While there may be software tools to help an applicant do this bookkeeping, these tools are not free and the labor cost of using them is not cheap.  So, for the privilege of paying the USPTO more fees, applicants have do more work.  And the burden will fall most heavily on small and micro entities and lower-cost practitioners who have less ability to spread the cost of calculation over numerous applications.

The USPTO states, to the contrary, that "the fee should not disproportionately impact small and micro entities."  We disagree.  All USPTO fees disproportionately impact small and micro entities.  The largest entities are multi-billion and trillion dollar companies.  While their patent budgets are finite, they are often quite large and can be adjusted for inflation and fee increases.  On the other hand, small and micro entities are often startups, small businesses, or individual inventors.  These entities are self-funded or funded through loans, angel investors, and/or venture capital, and every dollar counts.  Patent filing and prosecution (not to mention inter partes reviews) are significant costs that are harder to absorb than for larger entities.  As a general premise, bureaucracy favors the powerful.  Here, the USPTO's increase in the bureaucratic process required to comply with the duty to disclose will disproportionately impact those with fewer resources.

In any event, what is an applicant to do in light of the final rule and its new IDS fees?  Here are a few concrete suggestions to reduce the impact of these fees and the time-cost of associated labor.

• As noted above, refrain from filing previously-cited art in IDSs in continuations and other forms of child applications.  While doing so results in the references not appearing on the issued patent, they are still of record in the file wrapper of the parent(s).

• The new fees are based on the number of applicant-cited references per application, but not the size of these references.  To the extent that the applicant can cite to longer, more comprehensive references in lieu of multiple shorter references containing the same content, the applicant should do so.[2]  For example, a product manual (if it qualifies as prior art) is often one of the most detailed and relevant references available to applicants and could (in principle) replace several other references that are cumulative.

• Many applicants use third-party prior art search firms.  Applicants may wish to instruct these firms to provide search results for no more than the very most relevant references found.  Applicants have no duty to disclose references of which they are not aware and do not have in their possession.  Of course, this may make the examiner's job more difficult and decrease patent quality, but it is a problem the USPTO is buying for itself.

• Applications with corresponding academic publications may be the type that most easily run afoul of the new fees.  Modern academic papers routinely cite dozens or even hundreds of non-patent literature references.  Some of these are quite lengthy (e.g., book chapters or entire books).  Moreover, it may be difficult for patent practitioners to reasonably determine the relevance or cumulative nature of such references in highly sophisticated, complex sciences and technologies.  Current practice is to cite all references in a corresponding paper in an IDS, and there may not be a way to avoid doing so without incurring more actual cost than the USPTO fees themselves.

• While applicants should avoid citing references of marginal relevance, they need to remember the subjective nature of such an analysis.  When push comes to shove, it is better for both the applicant and practitioner to pay the USPTO a few hundred dollars than risk any eventual patent being found unenforceable due to a known but uncited reference.

In short, there may be steps that applicants can take to minimize the effect of the new fee rules.  But we are going to see prosecution practices change in unpredictable ways that may not benefit applicants, practitioners, examiners, or the public.

[1] Given that the cost of Requests for Continuing Examination (RCEs) are going up significantly, the cost of an IDS citing additional references may factor heavily into whether an applicant files a continuation application or an RCE.  This is another unintended consequence of the USPTO’s fee changes, but it is unclear how it will change prosecution practice.

[2] It should go without saying that the applicant must never engage in gamesmanship, such as combining multiple references into one file and submitting it as a single reference or citing a later-dated, more comprehensive document instead of an earlier publication.

USPTO Director Announces Resignation

By Kevin E. Noonan --

As has been expected, the Director of the U.S. Patent and Trademark Office, the Honorable Kathi Vidal, has announced her resignation.  Deputy Director Derrick Brent will assume her position (at least temporarily) starting in the second week of December.

As Director, Ms. Vidal (at right) has been involved in a variety of efforts unlikely to survive the change in administration and her letter exhibits her awareness of these changing tides.  Her announcement relates her intentions to go back to the private sector.

Regarding her tenure, Ms. Vidal provides praise for the PTO workforce and called the Office during her tenure an "agency of opportunity."  While citing a number of the Office's accomplishments while she was Director she expressly calls out the agency's Strategic Plan Accomplishments Page, the National Strategy for Inclusive Innovation, and National Entrepreneurship Strategy and creation of "the new Office of Public Engagement."  The Office's continuing mission, she states, is "to drive U.S. innovation, inclusive capitalism, and global competitiveness for the benefit of all Americans," and calls for a peaceful and orderly transition" of administrations.

The message itself is set forth below, including her personal e-mail address.

Message to my USPTO friends and colleagues:

It has been an honor and a true joy to be with you on our collective journey these last few years.  Together we have transformed the USPTO.  We have executed on our mission to proactively defend and promote strong intellectual property to lift communities, create better jobs, and foster the American innovative spirit in everyone.  And we have been successful because of our commitment to putting employees first.

Though our work is not done, it is time for me to turn the reins over to Deputy Director Derrick Brent, who has worked alongside me every step of the way.  My last day at the USPTO will be in the second week of December.  I will be moving back into the private sector and working with individuals and companies directly, committed to our same mission.

Know that the work we have done—from weaving employee experience and inclusion into the fabric of our operations, to focusing on the USPTO as not only America's Innovation Agency but as an agency of opportunity—will persist.

Thank you for your dedication, service, and support of one another.  You have challenged me, and each other, to be better.  And you have showed up every day with ingenuity and thoughtfulness to meet that challenge!  You are not only some of the most skilled and innovative people I've ever worked with, you are my friends and treasured colleagues, and I will be forever grateful for your work, which powers our communities and country.

Our record of accomplishments during the Biden-Harris Administration is unprecedented (Strategic Plan Accomplishments Page).  Together we pointed the USPTO in a new direction focused on employees and customers.  We united under the mission to drive U.S. innovation, inclusive capitalism, and global competitiveness for the benefit of all Americans.  We sat at the table with our union representatives to enshrine our people-first approach into updated collective bargaining agreements for Patents and Trademarks employees, and for support staff to come.  And we created the new Office of Public Engagement to expand and strengthen our outreach.  I am very proud of the amazing progress we've made together.

We would not have gotten this far without the strength of our people at the USPTO.  We have developed processes, procedures, and policies to improve the employee experience and inclusion.  Thousands of you contributed to those changes through my small listening sessions, with questions and ideas in the employee portal, and in conversations at events.  And as a result, we were named one of the most inspiring places to work in government this year.  That is an accolade I know I am very proud of and that agency leadership is committed to maintaining.

As we approach the end of the Biden-Harris Administration, please keep up the good work and continue to execute on our mission for innovators and creators.  And please stand ready to work with the incoming administration's team.  As President Biden said last week, the American people deserve a peaceful and orderly transition.

Even though I will be moving on in the next few weeks, I am committed to finding new ways to work alongside and support you, including founding a new ChIPs USPTO chapter, working to foster our alumni network that we launched here together, supporting you through the Patent and Trademark Office Society and the American Association of Patent Judges, advancing our National Strategy for Inclusive Innovation and National Entrepreneurship Strategy, and so much more!

I will remain a click away at [email protected] and will see you on socials.

With gratitude,

Kathi

Teva v. Amneal -- Amneal's Responsive Brief

By Kevin E. Noonan --

The Federal Circuit has been petitioned by plaintiff Teva Branded Pharmaceutical Products R&D, Inc. to reverse a decision in favor of Defendant Amneal Pharmaceuticals, wherein the District Court entered an injunction ordering Teva to delist five Orange Book-listed patents, in Teva Pharms. Inc. v. Amneal Pharms. LLC.  This post concerns Amneal's response to Teva's arguments in its Opening Brief.

To recap, the issues arose in litigation over Amneal's ANDA directed to its generic version of Teva's ProAir® HFA (albuterol sulfate) Inhalation Aerosol product.  In this litigation, Teva asserted five Orange Book-listed patents:  U.S. Patent Nos. 8,132,712 ("the '712 patent"), 9,463,289 ("the '289 patent"), 9,808,587 ("the '587 patent"), 10,561,808 ("the '808 patent"), and 11,395,889 ("the '889 patent") having these representative claims:

8,132,712:

1.  A dose counter for a metered-dose inhaler, the counter comprising: an actuator; a rotary gear; a driver for driving the rotary gear in a step-wise fashion in response to displacement of the actuator, the rotary gear comprising a wheel mounted on a spindle which wheel having a plurality of ratchet teeth around its periphery; a pawl to prevent reverse rotation of the rotary gear; and a display coupled to the rotary gear, the display having a visible array of incrementing integers on a surface thereof indexable by a single integer in response to each step of the step-wise rotary motion of the rotary gear; wherein the pawl comprises at least two ratchet teeth each for engaging with the ratchet teeth of the wheel to prevent reverse rotation of the rotary gear, the at least two ratchet teeth being radially spaced such that one of the at least two ratchet teeth of the pawl engages with the ratchet teeth of the wheel following each step of the step-wise rotary motion of the rotary gear.

18.  The use of a dose counter for preventing miscounting in a metered dose inhaler, the dose counter comprising: an actuator; a rotary gear; a driver for driving the rotary gear in a step-wise fashion in response to displacement of the actuator, the rotary gear comprising a wheel mounted on a spindle which wheel having a plurality of ratchet teeth around its periphery; a pawl to prevent reverse rotation of the rotary gear; and a display coupled to the rotary gear, the display having a visible array of incrementing integers on a surface thereof indexable by a single integer in response to each step of the step-wise rotary motion of the rotary gear; wherein the pawl comprises at least two ratchet teeth each for engaging with the ratchet teeth of the wheel to prevent reverse rotation of the rotary gear, the at least two ratchet teeth being radially spaced such that one of the at least two ratchet teeth of the pawl engages with the ratchet teeth of the wheel following each step of the step-wise rotary motion of the rotary gear.

9,463,289:

1.  An inhaler for metered dose inhalation, the inhaler comprising:
    a main body having a canister housing,
    a medicament canister, which is moveable relative to the canister housing and retained in a central outlet port of the canister housing arranged to mate with a canister fire stem of the medicament canister, and
    a dose counter having an actuation member having at least a portion thereof located in the canister housing for operation by movement of the medicament canister,
    wherein the canister housing has an inner wall, and a first inner wall canister support formation extending inwardly from a main surface of the inner wall, and
    wherein the canister housing has a longitudinal axis X which passes through the center of the central outlet port,
    the inner wall canister support formation, the actuation member, and the central outlet port lying in a common plane coincident with the longitudinal axis X.

9,808,587:

1.  An inhaler for metered dose inhalation, the inhaler comprising:
    a main body having a canister housing,
    a medicament canister, which is moveable relative to the canister housing and retained in a central outlet port of the canister housing arranged to mate with a canister fire stem of the medicament canister, and
    a dose counter having an actuation member having at least a portion thereof located in the canister housing for operation by movement of the medicament canister,
    wherein the canister housing has an inner wall, and a first inner wall canister support formation extending inwardly from a main surface of the inner wall,
    wherein the canister housing has a longitudinal axis X which passes through the center of the central outlet port, and
    wherein the first inner wall canister support formation, the actuation member, and the central outlet port lie in a common plane coincident with the longitudinal axis X such that the first inner wall canister support formation protects against unwanted actuation of the dose counter by reducing rocking of the medicament canister relative to the main body of the inhaler.

10,561,808:

1.  A dose counter for an inhaler, the dose counter having a counter display arranged to indicate dosage information, a drive system arranged to move the counter display incrementally in a first direction from a first station to a second station in response to actuation input, wherein a regulator is provided which is arranged to act upon the counter display at the first station to regulate motion of the counter display at the first station to incremental movements.

11,395,889:

1.  An incremental dose counter for a metered dose inhaler having a body arranged to retain a canister for movement of the canister relative thereto, the incremental dose counter having a main body, an actuator arranged to be driven and to drive an incremental output member in a count direction in response to canister motion, the actuator being configured to restrict motion of the output member in a direction opposite to the count direction, such that the actuator acts as an anti-back drive member when the actuator is in a non-depressed position, and wherein the incremental dose counter further comprises a second anti-back member configured to restrict motion of the output member in a direction opposite to the count direction when the actuator is disengaged from the output member by a bump surface.

The District Court granted Amneal's motion on the pleadings (asserted in its counterclaims as required by statute) that these patents were improperly listed in the Orange Book as not being directed to an FDA-approved drug nor method of using such a drug for treating a disease or disorder, and granted an injunction compelling Teva to delist these patents.  Teva appealed, the Federal Circuit entering a stay on the order to delist during pendency of the appeal.

On appeal, Teva made two arguments:  the first is based on a legal and technical definition of how the term "drug product" is defined in the statute, and the second is whether the District Court erred procedurally, including whether claim construction was required to properly determine the first question.

Amneal's Responsive Brief

In its responsive brief, Amneal (unsurprisingly) argues that the District Court made the right decision (and to be fair also has the easier argument, in view of the intrinsic tug of the argument that Orange Book-listed patents should, at a minimum, recite the drug product itself, in this case albuterol sulfate).  In its argument, Amneal emphasizes (literally) that FDA's definition of a "drug product" recites "a finished dosage form…that contains a drug substance, generally, but not necessarily, in association with one or more other ingredients," citing 21 C.F.R. § 314.3 (emphasis added) (in contrast to Teva, Amneal cites the FDA rules rather than the statutory language).  Amneal contends that "the drug substance" is albuterol sulfate per se and not the combination of the drug and the inhaler that is the subject matter of the claims destined to be delisted if the District Court decision is affirmed.  As Amneal states in its argument, "[i]t is undisputed, however, that the Asserted Patent claims do not recite, identify or refer to the drug substance—albuterol sulfate—as a part of the claimed inventions" (at least not expressly).  Amneal argues that, to overcome these infirmities Teva and its amici (actually only two of seven amicus briefs filed) "seek in effect to rewrite the Listing Statute" by changing the plain meaning of the term "claims" therein to mean "reads on any part of" (which is an abbreviated but not entirely unfair characterization).  Teva does indeed argue in its opening brief that the claims of its asserted patents read on its ProAir inhalation device, but that this is analogous to claims for excipients or generic claims that do not recite the species identified as the active pharmaceutical ingredient.  Where Amneal identifies the principle distinction between the parties' positions is in the definition of the term "drug product," as will be set forth herein.  Further, Amneal disputes the need for claim construction because "even if the claims were construed as Teva proposes, the Asserted Patents still would not qualify for listing in the Orange Book" as they do not recite albuterol sulfate as an affirmative limitation therein.

Amneal's brief identifies the legal issue in the appeal as being the proper construction of that portion of the statute that sets forth what must be disclosed in any patent listed in the Orange Book (21 U.S.C. § 355(b)(1)(A)(viii)):

(viii) the patent number and expiration date of each patent for which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or sale of the drug, and that—

(I) claims the drug for which the applicant submitted the application and is a drug substance (active ingredient) patent or a drug product (formulation or composition) patent; or

(II) claims a method of using such drug for which approval is sought or has been granted in the application.

Amneal's interpretation of this portion of the statute is that it requires any patent listed to be one wherein "there [would] be a reasonable basis to assert that the patent would be infringed by the unauthorized manufacture, use, or sale of the NDA drug" (emphasis added).  The brief sets forth the history of this portion of the statute insofar as it was changed in 2021, purportedly due to an appreciation (evinced by a House committee report) of "the proliferation of device patents submitted under the auspices of the Listing Statute for drug device combination products, including, most commonly, inhalers," which delayed generic entry by an average of 3.4 years.  Relevant to the issue before the Court, Amneal cites the definition of "drug product" in FDA regulations (but not the statute) to require the presence of the drug substance, citing 21 C.F.R. § 314.3:  "Drug product is a finished dosage form, e.g., tablet, capsule, or solution, that contains a drug substance, generally, but not necessarily, in association with one or more other ingredients (emphasis in brief)."  The statute, on the other hand, defines the term "drug" broadly (according to Amneal) at 21 U.S.C. § 321(g)(1):

(A) articles recognized in [certain compendia]; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C).

and defines "device" at 21 U.S.C. § 321(h)(1) as:

[A]n instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is — (A) recognized in [certain compendia], (B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (C) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

As interpreted by the D.C. Circuit, "FDCA prohibits the FDA from treating a device as if it were a 'drug,'" citing Genus Medical Techs. LLC v. United States, 994 F.3d 631, 644 (D.C. Cir. 2021), "even though [Amneal concedes] the term 'drug' is so broadly defined that it linguistically could include a device."  Amneal points out that the District Court held, consistent with the decision by the Second Circuit's decision in United Food v. Takeda Pharm. Co. Ltd., 11 F.4th 118, 134 (2d Cir. 2021), that "the Listing Statute required a drug product patent to claim not just any 'drug,' but specifically 'the drug for which the applicant submitted the application,'" nor did any of the asserted claims to inhaler devices qualify under the statute as a "finished dosage form."

Regarding the requirements for qualifying as a drug product Amneal's brief identifies three:

• "First, it must be a 'patent for which a claim of infringement could reasonably be asserted [against unauthorized] manufacture, use or sale' of the NDA product. 21 U.S.C. § 355(b)(1)(A)(viii).  In other words, it must be infringed by the NDA product.

• "Second, the patent must be a 'drug product' patent, which simply means that it must claim a drug product. 21 U.S.C. § 355(b)(1)(A)(viii)(I) [although this seems to beg the question here].

• "Third, the patent must 'claim[] the drug for which the applicant submitted the application.""

Amneal argues that the second and third requirements act in tandem to require that the patents claim not just any drug product but the approved drug product itself.  Under this interpretation, the Orange Book-listed claims must recite the drug product (here, albuterol sulfate) and as they undisputedly do not the Court should affirm the judgment of the District Court and lift the stay of the injunction compelling Teva to delist these patents.

Amneal argues that Teva's interpretation of these statutory provisions is erroneous, by being contrary to how the term "claims" is interpreted, inter alia, in Hoechst-Roussel Pharms., Inc. v. Lehman, 109 F.3d 756, 758-59 (Fed. Cir. 1997), and Graver Tank & Mfg. Co., Inc. v. Linde Air Prods. Co., 339 U.S. 605 (1950).  Further, Amneal argues that this interpretation would render superfluous the requirement that the patent "claims the drug," contrary to statutory interpretation precedent citing Facebook, Inc. v. Windy City Innovations, LLC, 973 F.3d 1321, 1336 (Fed. Cir. 2020), and Arlington Cent. Sch. Dist. Bd. of Educ. v. Murphy, 548 U.S. 291, 299 n.1 (2006) in support for this argument.  Also, Amneal argues, this overbroad reading of the statute would permit listing of patents for "any type of component, regardless of its nature."  While conceding that "adjacent" provisions of the NDA statute permits "NDA applicants to submit information and samples of all components of the NDA drug" in Amneal's view what is permitted to be listed in the Orange Book is more narrow (it "does not broadly permit listing of any kind component patents" (emphasis in brief)).  What is permitted is listing patents of only one kind, those that claim "a drug substance (active ingredient)" under 21 U.S.C. §355(b)(1)(A)(viii)(I), and Amneal argues that "this implies that patents on other kinds of drug components are not authorized," citing Syngenta Crop Protection, LLC v. Willowood, LLC, 944 F.3d 1344, 1361 (Fed. Cir. 2019) (emphasis added).  Amneal objects to Teva's "plug[ging]" the "component" aspect of the definition of the term "drug" into the statute, due to the specificity of the statutory language for "the drug for which the applicant submitted the application."  Citing Genus Medical Techs. again Amneal further argues that "the FDCA prohibits the FDA from treating a device as if it were a drug" and thus ("by extension") the statute should prohibit FDA from listing patents that claim only devices from being listed as if they claimed a drug.

Amneal argues that the plain meaning of the Listing Statute does not authorize listing of "any drug product" (emphasis in brief) but only if the patent "claims the [NDA] drug" under 21 U.S.C. § 355(b)(1)(A)(viii)(I) and further that this interpretation is supported by the legislative history (which indicates "congressional intent to curtail the listing of device component patents specifically").  This interpretation, Amneal argues, is also consistent with FDA's definition of a "drug product," the inclusion of which in the Listing Statute necessarily contains the NDA-approved drug product itself.  (Amneal points out that in other contexts Teva itself argued that "drug product patents must require the presence of the active ingredient to qualify for listing in the Orange Book," citing Warner Chilcott (US), LLC v. Teva Pharms. USA, Inc., No. 18-1241 (Fed. Cir. 2018)).  If a "drug product" requires the presence of an approved drug substance in the product, Amneal argues that a "drug product patent" must also do so (emphasis in brief), and if a drug product patent must also claim the FDA-approved drug, "at a minimum" such a patent "must . . . require the presence of the particular drug substance in the NDA product."

Taken together none of the asserted patents meet these requirements, Amneal asserts.

Turning to Teva's arguments, Amneal asserts they are "both erroneous and problematic" for four reasons: they "stray from controlling black letter patent law" under 35 U.S.C. § 112 and erroneously equating "claiming with being infringed"(emphasis in brief); the interpretation would make superfluous the "claiming the drug" requirement; Teva's arguments "ignore[] FDA's definition of 'drug product'"; and "would open up the Orange Book to patents on any aspect of the NDA product or any component that happens to be found in the NDA product."  So doing would be contrary to the existence of the "powerful exclusionary rights bestowed on Orange Book patents" (naming an automatic preliminary injunction, i.e., the 30-month stay, and automatic permanent injunction for the prevailing NDA holder). Amneal also mentions that requiring Orange Book-listed patents to recite the approved drug product "provides a clear rule that will allow stakeholders to more confidently order their affairs when it comes to the listing of patents in the Orange Book" (elsewhere calling this a "commonsense notion").

Specifically, Amneal argues that the claims in an Orange Book-listed patent must recite the NDA-approved drug, not merely by infringed by the accused generic product as Teva contends, if only because Federal Circuit precedent, Hoechst-Roussel Pharms., Inc. v. Lehman, 109 F.3d 756, 758-59 (Fed. Cir. 1997), has acknowledged the statutory requirement that the patent "particularly pointing out and distinctly claiming the subject matter which the inventor . . . regards as the invention" under 35 U.S.C. § 112(b).  Amneal makes a simple and straightforward argument, that because "the words of the claim do the claiming," citing Corning Glass Works v. Sumimoto Elec. U.S.A., Inc., 868 F.2d 1251, 1258 (Fed. Cir. 1989) (emphasis in brief), the absence of those words (specifically, of the NDA-approved drug substance, albuterol sulfate) precludes Teva from properly Orange Book listing the asserted claims.  Once again, Amneal asserts the legislative history of amendments to the Listing Statute to illustrate Congress's concerns, including a direction to the General Accounting Office "to submit data on claims in listed patents 'that claim a device that is used for the delivery of the drug, but do not claim such device in combination with an active ingredient or formulation of a drug,'" Orange Book Transparency Act of 2020, Pub. L. No. 116-290, 134 Stat. 4889, 4892 (Jan. 5, 2021).  This history, Amneal argues, also forms the basis for the Court to narrowly construe the Listing Statute, because it "demonstrates [that] these requirements were introduced expressly to preclude Orange Book listing of the very type of device patents at issue here."  This "plain meaning" interpretative analysis is supported by the Takeda case from the Second Circuit and In re Lantus Direct Purchaser Antitrust Litig., 950 F.3d 1, 7-8 (1st Cir. 2020), relied upon by the District Court, Amneal argues.  Amneal also cites a 1997 Guidance from FDA "explaining" that "a drug product patent must explicitly 'refer to' the NDA product," where Amneal contends "refer to" be interpreted to mean "recite in the claims" of such a patent.  Teva's arguments that "being infringed" is equivalent to "claiming" is contrary to Federal Circuit precedent, Amneal argues, including Hoechst, and is not supported by the Apotex case, relied upon by Teva.  In that case, Amneal argues, the Court merely held that infringement is a necessary, but not sufficient condition (emphasis in brief), and in any case Amneal contends, statements relied upon by Teva are merely dicta (because they were directed to whether the Federal Circuit had jurisdiction).  Amneal similarly dismisses the relevance of Envirotech Corp. v. Al George, Inc., 730 F.2d 753, 759 (Fed. Cir. 1984), and Teva's proffered interpretation of Takeda.

Amneal further challenges Teva's construction of the Listing Statute as rendering the "claims the drug" requirement to be superfluous and that it is "far more expansive than afforded by a fair reading of the Listing Statute" so as to encompass "any component found in the [approved] NDA product" (emphasis in brief).  Amneal challenges Teva's argument that requiring the "NDA drug substance" to be present would render the "drug substance" category superfluous, because the statute contains two categories of patents:  "A drug substance patent requires only the drug substance per se, whereas a drug product patent requires both the drug substance and some further aspect(s) of the drug product."  And the requirement is not merely for "a" drug but for "the" NDA-approved drug "for which the applicant submitted the application" under 21 U.S.C. § 355(b)(1)(A)(viii)(I), which is also the most unambiguous way of understanding the meaning of the term in the context of the Listing Statute, Amneal argues.

Amneal puts its greatest reliance in this regard on the Genus Medical Techs. LLC case, wherein the Court held that "the FDA is prohibited from regulating as a 'drug' anything that meets the statutory definition of a 'device,' even if that item also meets the definition of a 'drug'" because FDA is prohibited from Orange Book-listing patents that claim only a device, Amneal argues.  ("Teva's interpretation cannot be correct, because it would permit precisely what the FDCA prohibits.")  Devices are not drug formulation "ingredients" (which can be listed under the category as components of a "formulation" or "composition") in Amneal's view.

Amneal also addresses Teva's attempts to overcome ("decouple") the undisputed absence of any mention of the drug substance, albuterol sulfate, from the asserted claims of the Orange Book-listed patents at issue.  Simply put, the proper consequence of this absence is for the Court to recognize that these patents to not "claim" the NDA drug product and thus should be delisted, according to Amneal.

Amneal further argues that its interpretation of the Listing Statute "best aligns" with Hatch-Waxman Act goals regarding the balance between exclusivity for brand drugmaker's NDA-approved drugs (and the "extraordinary" injunctive rights conferred by the statute) and opportunities for generic competition.  Adopting Teva's interpretation of the Listing Statute, on the other hand, would permit "patents having nothing to do with the drug development efforts for a given product" to be listed in the Orange Book "as long as the claimed invention, no matter how inconsequential, was found in some part of the NDA product."  And Teva (in addition to listing the asserted patents in this litigation in connection with 21 different products) retains the right to assert them against generic drugmakers under other subsections of 35 U.S.C.§ 271, albeit without the extraordinary advantages conferred by 35 U.S.C.§ 271(e)(2).

Finally, in this regard Amneal rebuts Teva's "baseless and hyperbolic" policy arguments (which will be discussed in future posts on the two amicus briefs submitted in support of Teva).

Amneal asserts in a separate section of the brief that the claims of any properly Orange Book-listed claims must recite the presence of the approved drug, albuterol substrate, and further that there is no need for claim construction because, on their face none of the listed patents asserted by Teva satisfy this requirement.

Teva's Reply to Amneal is discussed here.

Vascular Solutions LLC v. Medtronic, Inc. (Fed. Cir. 2024)

By Kevin E. Noonan --

The metes and bounds of how courts should consider indefiniteness under 35 U.S.C. § 112(b) were addressed most recently by the Supreme Court in Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898 (2014).  Regardless, however, of the Court's attempts to properly construe this portion of the Patent Statute (and the Federal Circuit's attempts to comply with those rubrics), the Federal Circuit's recent decision in Vascular Solutions LLC v. Medtronic, Inc. illustrates once again that in patent law very little is simple or straightforward.  And as set forth below, the Court's decision has led to the District Court judge recusing himself from any further involvement in this case.

The case arose over Medtronic's alleged infringement of forty claims from seven patents owned by Plaintiffs (including Teleflex, which was the name party in the opinion):  U.S. Patent Nos. 8,048,032; 8,142,413; RE45,380; RE45,760; RE45,776; No. RE46,116; and RE47,379; each of these patents descending from U.S. Patent Application No. 11/416,629, filed May 3, 2006.  According to the opinion, the claimed invention was directed to a "coaxial guide catheter that is deliverable through standard guide catheters by utilizing a guidewire rail segment to permit delivery without blocking use of the guide catheter."  The structure of these catheters are illustrated in this Figure (annotated by Medtronic's expert):

where the yellow portion was "substantially rigid" and closest to the physician using the catheter (termed "proximal"); the blue portion was reinforced (presumably for stability); and the pink portion was closest to the heart ("distal").  The proximal portion comprised a side opening (in the red circle) permitting "interventional cardiology devices" to be delivered through the catheter to the heart (although this was not the only orientation permitted by the claims, forming the physical basis for the indefiniteness dispute between the parties).  Claims of the '032 and '776 patents are set forth in the opinion as illustrative; italicized language is relevant to the issues before the Court:

The '032 patent:

[Claim 11] A device for use with a standard guide catheter, the standard guide catheter having a continuous lumen extending for a predefined length from a proximal end at a hemostatic valve to a distal end adapted to be placed in a branch artery, the continuous lumen of the guide catheter having a circular cross-section and a cross-sectional inner diameter sized such that interventional cardiology devices are insertable into and through the lumen to the branch artery, the device comprising:
    an elongate structure having an overall length that is longer than the predefined length of the continuous lumen of the guide catheter, the elongate structure including:
    a flexible tip portion defining a tubular structure having a circular cross-section that is smaller than the circular cross-section of the continuous lumen of the guide catheter and a length that is shorter than the predefined length of the continuous lumen of the guide catheter, the flexible tip portion being sized having a cross-sectional outer diameter sized to be insertable through the cross-sectional inner diameter of the continuous lumen of the guide catheter and defining a coaxial lumen having a cross-sectional inner diameter through which interventional cardiology devices are insertable;
    a reinforced portion proximal to the flexible tip portion;
    and
    a substantially rigid portion proximal of and connected to, and more rigid along a longitudinal axis than, the flexible tip portion and defining a rail structure without a lumen and having a maximal cross-sectional dimension at a proximal portion that is smaller than the cross-sectional outer diameter of the flexible tip portion,
    such that when at least a distal portion of the flexible tip portion is extended distally of the distal end of the guide catheter with at least proximal portion of the reinforced portion remaining within the continuous lumen of the guide catheter, at least a portion of the proximal portion of the substantially rigid portion extends proximally through the hemostatic valve in common with interventional cardiology devices that are insertable into the guide catheter.

[Claim 13] The device of claim 11 wherein the substantially rigid portion further includes a partially cylindrical portion defining an opening extending for a distance along a side thereof defined transverse to a longitudinal axis that is adapted to receive an interventional cardiology device passed through continuous lumen of the guide catheter and into the coaxial lumen while the device is inserted into the continuous lumen, the opening extending substantially along at least a portion of a length of the substantially rigid portion.

[Claim 18] The device of claim 11 wherein the substantially rigid portion includes, starting at a from distal to proximal direction, a cross-sectional shape having a full circumference portion, a hemicylindrical portion and an arcuate portion.

'776 patent:

[Claim 25] A guide extension catheter for use with a guide catheter, comprising:
    a substantially rigid segment;
    a tubular structure defining a lumen and positioned distal to the substantially rigid segment;
    and
    a segment defining a partially cylindrical opening positioned between a distal end of the substantially rigid segment and a proximal end of the tubular structure, the segment defining the partially cylindrical opening having an angled proximal end, formed from a material more rigid than a material or material combination forming the tubular structure, and configured to receive one or more interventional cardiology devices therethrough when positioned within the guide catheter,
    wherein a cross-section of the guide extension catheter at the proximal end of the tubular structure defines a single lumen.

The opinion recognizes that the claims of the '032 patent include the side opening as part of the substantially rigid portion/segment, while other claims (such as claim 25 of the '776 patent) recite the side opening as separate and distal to the substantially rigid portion/segment.

Initially the dispute was between Teleflex and QXMédical, LLC (no longer a party in this lawsuit), wherein QXMédical filed for a declaratory judgment of non-infringement and Teleflex counterclaimed.  Claim construction in that case construed the term "substantially rigid" to mean "rigid enough to allow the device . . . to be advanced within the guide catheter."  In addition, the District Court construed the term to mean "1) 'the substantially rigid portion must have a considerable degree of flexibility,' and (2) 'the substantially rigid portion must be rigid enough to push the tubular structure through the guide catheter and into the coronary artery.'"  The opinion does not disclose the outcome of that case, but rather sets forth the proceedings before the District Court between Medtronic and Teleflex here, where Teleflex sued for infringement of the '380, '776, '379, and '760 patents by Medtronic's' Telescope product.  During this litigation, Teleflex moved for a preliminary injunction and applied the construction in the earlier QXMédica case in support.  The District Court denied Teleflex's preliminary injunction motion and proceedings were stayed while Medtronic prosecuted "multiple inter partes review (IPR) petitions [ultimately 15 IPRs]."  While the opinion notes some of the claims were invalidated by the Patent Trial and Appeal Board (PTAB) in these IPRs the asserted claims in this case survived and the PTAB's determinations were affirmed by the Federal Circuit.

At this point in the proceedings, Teleflex followed with another preliminary injunction motion, and in consideration thereof the District Court recognized two groups of limitations with regard to the side opening feature:  "Group One," wherein the opening was part of the proximal substantially rigid portion; and "Group Two," where it was not part of the proximal substantially rigid portion, illustrated by Teleflex by this figure:

The District Court denied this second motion, finding that Medtronic had provided "a strong argument . . . that 'substantially rigid portion' should be construed to mean only that portion of the device that acts as a pushrod."  In its decision, the District Court also found fault with Teleflex's claim construction position, which the court understood would require that "the same device could simultaneously infringe two mutually exclusive claims within that patent" (emphasis in District Court opinion), wherein "the same substantially rigid portion shrinks or grows as necessary to accommodate two mutually exclusive limitations" (emphasis in District Court opinion).  For its part, the District Court rejected both parties' claim construction positions regarding the "substantially rigid" limitation, construing that term to require the side opening to be limited to the proximal portion of the catheter (i.e., the Group One embodiments).  Before ruling on this construction, the District Court took recourse to an independent expert (Andrei Iancu, former director of the U.S. Patent and Trademark Office) to provide a written report to the court on how the term should be best construed.  Also rejecting the parties' arguments (Medtronic's' being that the term was indefinite), Mr. Iancu in his report opined that the proper construction was that "the first proximal section of a multi-section guide extension catheter, that ends where there is a material drop in the overall rigidity of the guide extension catheter at or distally to the proximal end of the coaxial lumen where an interventional cardiology device is inserted"; he expressly rejected Medtronic's' indefiniteness contentions.

The District Court agreed with Medtronic, holding that the two alternatives for the physical embodiments of the term were mutually exclusive and that under Teleflex's construction the same device could be found to infringe these mutually exclusive claims.

The Federal Circuit vacated and remanded to the District Court, in an opinion by District Court Judge Mazzant, sitting by designation from the District Court for the Eastern District of Texas, joined by Chief Judge Moore and Judge Prost.  The opinion begins by asserting that the District Court erred in basing its indefiniteness determination on the claims being "mutually exclusive."  The consequence of the District Court's construction of mutual exclusivity is that "(1) claims in a patent cannot vary in the way they claim the disclosed subject matter, and (2) independent claims must be totally consistent with other independent claims."  The Federal Circuit states that "[c]laiming is not restricted in this way" and that:

"The art of claiming sometimes involves drafting claims in a variety of ways to encompass the disclosed subject matter, so long as the claims themselves inform, 'with reasonable certainty,' those skilled in the art about the scope of the invention," citing Nautilus, Inc. v. Biosig Instruments, Inc.

The opinion instructs the District Court on remand to conduct claim construction on a "clam-by-claim" basis and that "at the claim construction stage, the claims are not necessarily 'mutually exclusive' since each independent claim is a different ordered combination of limitations."

The opinion also rejects the notion that the term "substantially rigid portion/ segment" needs to be consistent across claims.  The Court recognizing this to be a functional limitation the panel holds that a portion of the catheter that is substantially rigid needs to be "substantially rigid enough to achieve some function, citing Hill-Rom Servs., Inc. v. Stryker Corp., 755 F.3d 1367, 1374–75 (Fed. Cir. 2014).  Thus, as applied here:

In some claims, such as claims 13 and 18 of the '032 patent, the substantially rigid portion/segment includes the side opening.  In other claims, such as claim 25 of the '776 patent, the side opening is distal to the substantially rigid portion/segment.  No matter if the side opening is within or distal to the substantially rigid portion/segment, that portion/segment of the catheter must maintain the substantial rigidity to achieve some function—in this case, the function of allowing the device to be advanced within the guide catheter.

Addressing the requirement for consistency in claim construction under, for example, Rexnord Corp. v. Laitram Corp., 274 F.3d 1336, 1342 (Fed. Cir. 2001), and Samsung Elecs. Co., Ltd. v. Elm 3DS Innovations, LLC, 925 F.3d 1373, 1378 (Fed. Cir. 2019), the opinion asserts that its decision clarifies that while the term "substantially rigid portion" must be construed consistently across all the asserted claims, in functional claims such as these "that construction can be a functional construction that does not specify the boundary of the 'substantially rigid portion.'"  And the panel rejects Medtronic's' contention that reading the claims in this way would confuse the skilled artisan, finding the remedy for any such confusion in the recitation of the limitation in each individual claim.  The Court further characterizes as "premature" Medtronic's assertions regarding the effects on determinations of infringement (i.e., that the Court's construction would permit the same device to infringe claims that "measure the boundary" of the term differently which, in view of the preeminent role that claim construction plays in infringement determinations rings somewhat hollow).

It is somewhat ironic that in an opinion written by a District Court judge sitting by designation, the claim construction task mandated by the Federal Circuit can be expected to be more difficult and less straightforward, which is likely to be the consequence of this decision.  In something of an ironic twist, the District Court judge, Chief Judge Patrick J. Schiltz of the District of Minnesota filed a recusal order stating that the court cannot impartially resolve the dispute as the basis for the recusal.  Further, the order asserts that the court "has no idea how to reconcile the facts presented to the court with the Federal Circuit's holding," and "does not believe that it can set aside its previous conclusions to make an impartial determination [it thus being] best that this case be handled by a different judge who can write on a clean slate."  And the District Court judge to whom the case was first assigned, Jerry W. Blackwell, himself recused without explanation on Monday.  The case is now assigned to Judge Nancy E. Brasel.  Chief Judge Schlitz's recusal order goes into additional detail regarding the court's inability to apply the Federal Circuit's ruling to the facts of the case before the court that led to his finding of indefiniteness that was overturned by the Federal Circuit.  While Federal Circuit decisions have no doubt in the past created confusion when remanded to district courts for further proceedings, this case suggests (as have others; see In Defense of the Federal Circuit: A Response to Judge Wood) that at least some of the Court's decisions in recent years have failed to satisfy its Congressional mandate to clarify U.S. patent law.

Vascular Solutions LLC v. Medtronic, Inc. (Fed. Cir. 2024)
Panel: Chief Judge Moore, Circuit Judge Prost, and District Judge Mazzant*
Opinion by District Judge Mazzant
* Honorable Amos L. Mazzant, III, District Judge, U.S. District Court for the Eastern District of Texas, sitting by designation.

Teva v. Amneal -- Amneal's Responsive Brief & Teva's Reply Brief

By Kevin E. Noonan --

The Federal Circuit has been petitioned by plaintiff Teva Branded Pharmaceutical Products R&D, Inc. to reverse a decision in favor of Defendant Amneal Pharmaceuticals wherein the District Court entered an injunction ordering Teva to delist five Orange Book-listed patents, in Teva Pharms. Inc. v. Amneal Pharms. LLC.  This post concerns Teva's Reply brief answering Amneal's Responsive brief to Teva's Opening Brief on appeal.

To recap, the issues arose in litigation over Amneal's ANDA directed to its generic version of Teva's ProAir® HFA (albuterol sulfate) Inhalation Aerosol product.  In this litigation, Teva asserted five Orange Book-listed patents:  U.S. Patent Nos. 8,132,712 ("the '712 patent"), 9,463,289 ("the '289 patent"), 9,808,587 ("the '587 patent"), 10,561,808 ("the '808 patent"), and 11,395,889 ("the '889 patent") (representative claims for these patents can be found here).

The District Court granted Amneal's motion on the pleadings (asserted in its counterclaims as required by statute) that these patents were improperly listed in the Orange Book as not being directed to an FDA-approved drug nor method of using such a drug for treating a disease or disorder and granted an injunction compelling Teva to delist these patents.  Teva appealed, the Federal Circuit entering a stay on the order to delist during pendency of the appeal.

On appeal Teva made two arguments:  the first is based on a legal and technical definition of how the term "drug product" is defined in the statute, and the second is whether the District Court erred procedurally, including whether claim construction was required to properly determine the first question.

Amneal's Responsive Brief

In its responsive brief, Amneal (unsurprisingly) argued that the District Court made the right decision (and to be fair has the easier argument, in view of the intrinsic tug of the argument that Orange Book-listed patents should, at a minimum, recite the drug product itself, in this case albuterol sulfate).  In its argument, Amneal emphasized (literally) that FDA's definition of a "drug product" recites "a finished dosage form . . . that contains a drug substance, generally, but not necessarily, in association with one or more other ingredients," citing 21 C.F.R. § 314.3 (emphasis added) (in contrast to Teva, Amneal cites the FDA rules rather than the statutory language).  Amneal contended that "the drug substance" is albuterol sulfate per se and not the combination of the drug and the inhaler that is the subject matter of the claims destined to be delisted if the District Court decision is affirmed.  As Amneal stated in its argument, "[i]t is undisputed, however, that the Asserted Patent claims do not recite, identify or refer to the drug substance—albuterol sulfate—as a part of the claimed inventions" (at least not expressly).  Amneal argued that, to overcome these infirmities, Teva and its amici (actually only two of seven) "seek in effect to rewrite the Listing Statute" by changing the plain meaning of the term "claims" therein to mean "reads on any part of" (which is an abbreviated but not entirely unfair characterization).  Where Amneal identified the principle distinction between the parties' positions was in the definition of the term "drug product."  Further, Amneal disputed the need for claim construction because "even if the claims were construed as Teva proposes, the Asserted Patents still would not qualify for listing in the Orange Book" as they do not recite albuterol sulfate as an affirmative limitation therein.

Teva's Reply Brief

In Teva's Reply to Amneal initially the brief notes that FDA approved it ProAir HFA as a drug, that the inhaler component is the dosage form, and patents claiming dosage forms must be listed under 21 U.S.C. § 321(g)(1)(D).  And this listing does precisely what the Hatch-Waxman regime intended:  notifying generic drug applicants of the patents that can be asserted in ANDA litigation (i.e., it provides the intended statutory benefit to them).  Teva continues by reasserting the consequences of affirming the District Court, including delisting "any genus patent, any patent that claims some but not all components of a drug product, and any patent that claims one but not all of the active ingredients in a drug product" (emphasis in brief).

Teva further reiterates its positions in its Opening Brief:  that the statutory term "claim" should be interpreted to mean "read on" rather than "recite" (clearly a broader construction that resolves Teva's issue regarding the absence of the NDA-approved drug, albuterol sulfate, from the claims of the asserted patents); in this regard, Teva relies on the same precedent (and arguments) asserted in its Opening Brief.  Teva rebuts Amneal's arguments regarding the definiteness requirement in the statute (35 U.S.C. § 112(b)) as not requiring express recitation of the NDA-approved drug but rather (citing the statutory language) that the claim "inform, with reasonable certainty, those skilled in the art about the scope of the invention," citing Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 901 (2014).  This requirement would not be necessary, Teva contends,"if the entire scope of a patent were explicitly recited in detail in the claims."  Properly understood, what the statute entails is providing notice of the boundaries of the right to exclude and to define limits," Teva argues, citing Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1348 (Fed. Cir. 2010) (en banc).

As applied to the Listing Statute, Teva asserts Jazz Pharms., Inc. v. Avadel CNS Pharms., LLC, 60 F.4th 1373, 1379 (Fed. Cir. 2023), for the principle that claims must be construed based on "not just 'the words of the claims themselves'" but also "the remainder of the specification, the prosecution history, and extrinsic evidence concerning relevant scientific principles, the meaning of technical terms, and the state of the art," citing Phillips v. AWH Corp., 415 F.3d 1303, 1314 (Fed. Cir. 2005) (en banc) (citation omitted).  Teva, in making this argument, seeks (it appears) to refute Amneal's more straightforward argument that the absence of any recitation of the NDA-approved drug in the asserted claims is dispositive.  "'Claim language, standing alone' is not the correct standard of law and is contrary to uniform precedent" Teva asserts, quoting Nature Simulation Sys. Inc. v. Autodesk, Inc., 50 F.4th 1358, 1364 (Fed. Cir. 2022).  "Claim language," Teva asserts, "is a boundary, not a laundry list" and "[a] genus claim unambiguously encompasses every species in the genus without mentioning any one of them."  This is where Teva asserts Amneal errs in its responsive brief.

Teva first argues that its asserted patents "claim" a drug so long as it claims a component of the FDA-approved drug product.  Citing Apotex, Teva argues that "[t]he listing decision thus requires what amounts to a finding of patent infringement [literal infringement, Teva specifies], except that the 'accused product' is the drug that is the subject of the NDA."  Amneal doesn't address this, Teva asserts, and thus its attempts to "make something of the modest distinctions between the scope of a claim and the scope of infringement fall flat."  This conclusion is supported, Teva asserts, by Teva Pharms. USA, Inc. v. Leavitt, 548 F.3d 103, 106 (D.C. Cir. 2008), and In re Actos End-Payor Antitrust Litig., 417 F. Supp. 3d 352, 369 (S.D.N.Y. Sept. 30, 2019).  Teva rebuts Amneal's attempts to distinguish Apotex, construing the language of the statute to support its interpretation (and rebutting Amneal's dismissal of Apotex as dicta because that court's decision was directed to interpreting the Listing Statute to determine whether the case raised a substantial question of patent law for jurisdictional purposes).  Teva also asserts the Jazz Pharma case as supporting its interpretation of the Apotex decision.

On somewhat less firm grounds, Teva argues that a patent that claims a component of an NDA drug claims "the drug" based on the express definition of the term "drug" under 21 U.S.C. § 321(g)(D).  After distinguishing Amneal's (and the FTC's) analogy to construing claims to car brakes to encompass the car itself, Teva argues that "the term 'drug' is expressly defined to include its components" unlike the hypothetical car.  Teva also addresses the distinctions raised by Amneal regarding statutory language to "drugs" and "drug substance" patents and conflicts between them (as well as Congress's amendments to the statute to include as listable drug substance as well as drug patents, citing Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc., 586 U.S. 123, 131-32 (2019).  (Indeed, Teva argues that some of these statutory changes were motivated by "a unique requirement to list patents claiming polymorphs" and, accordingly, "not all drug substance patents will also qualify as drug product patents."  Teva states that (incorrectly) Amneal argues that "a patent on a component, including a drug substance, cannot be a 'drug product patent'" where according to Teva's interpretation of the statute "FDA recognizes that there is."  Teva further argues that there is no "incongruity" between there being a broad definition of the term "drug" and the phrase "claims the drug for which the applicant submitted the application" in the statute because (in Teva's interpretation) this merely ensures that an applicant cannot list patents that claim "a" drug but claims the NDA-approved drug product.  But this interpretation "does not rule out patents on the components that are submitted to FDA" which, Teva argues, is the situation here.

Teva also insists that FDA approved its ProAir HFA product as a drug, not a device.  If Amneal (or its supportive amici) believe this is not the proper policy then this is an issue for Congress not the courts, Teva argues, because the statute mandates that FDA treat combination products as drugs "in their entirety" (under a single application whenever appropriate" under 21 U.S.C. § 353(g)(1)(B)).  Contrary to Amneal's argument, Teva asserts that "FDA does not regulate 'the device part' of a combination product as a device on its own [but r]ather, a combination product in its entirety is regulated either as a drug or as a device, and the statutory scheme expressly contemplates that the device parts will sometimes be regulated as drug under  21 U.S.C. § 353(g)(1).  (Indeed, Teva maintains that Congress amended the statute in 1990 to "remove the exclusion of devices and their counterparts to 'facilitate the regulation of combination products,' as drugs," citing Genus Medical Technologies LLC v. FDA, 994 F.3d 631, 644 (D.C. Cir. 2021), and the Safe Medical Devices Act of 1990, Pub. L. No. 101-629, § 16(b), 104 Stat. 4511, 4526 (Nov. 28, 1990).

Teva also disputes Amneal's arguments that its interpretation of the Listing Statute renders come provisions to be surplusage.  With regard to the statutory phrase "claims the drug" Teva argues that FDA has excluded "[p]atents claiming packaging, patents claiming metabolites, and patents claiming intermediates."  These patents may indeed raise infringement liability under the infringement clause of the Listing Statute but they cannot raise liability under the "claims the drug" clause, citing Hoechst-Roussel Pharms., Inc. v. Lehman, 109 F.3d 756, 759 & n.2 (Fed. Cir. 1997), for patents claiming metabolites, for example.  Nor should the Court find persuasive Amneal's arguments regarding other changes in the statute under the Orange Book Transparency Act of 2020, Pub. L. No. 116-290, 134 Stat. 4889 (2021), codified at 21 C.F.R. § 314.53(b)(1) because, Teva argues, "both the text and the legislative history refute the notion that Congress sought to change listing practices in the significant way Amneal hypothesizes."  Regarding Congress's motivations and directions to the GAO related to this statutory change, Teva disputes Amneal's implications that Congress intended to prevent device patents from being Orange Book listed.  Instead, Teva contends Congress was trying to determine the number of patents claiming the device-drug combination and those claiming the device per se (a heavily nuanced argument that comes perilously close to mimicking Amneal's contentions).  Nevertheless, "[c]urrent regulation and practice is to list precisely the types of patents Amneal complains are at issue here," Teva argues, and (turnabout being fair play) Teva notes that "[u]ntil recently, Amneal itself recognized as much with respect to its patents on epinephrine injection products—which likewise did not mention the active ingredient."

Teva devotes a separate section to its arguments that the asserted patents are properly drug product patents.  This basis for affirming the District Court asserted by Amneal in its responsive brief was not part of the court's legal reasoning below, Teva states (terming it "an afterthought").  Regardless, Teva argues that the argument "cannot be reconciled with the text of either the Delisting Statute or the Listing Statute" (emphasis in brief), inter alia, because "Congress did not provide for delisting patents on the basis that it does not claim a drug product," citing 21 U.S.C. § 355(j)(5)(C)(ii)(I) (and Teva argues the patents ordered to be delisted did claim a drug product by virtue of being combination patents).  (Teva takes the opportunity to disparage the lack of legal reasoning, in its view, the FTC mustered in supporting Amneal's arguments in this regard, explicated in a detailed footnote.)  This portion of Teva's argument reaches the important difference between the parties (and amici): while agreeing that a "drug product" is a "finished dosage form, e.g., tablet, capsule, or solution, that contains a drug substance, generally, but not necessarily, in association with one or more other ingredients" under 21 C.F.R. § 314, does this definition include mechanical devices used to administer the drug? Teva's answer is expansive:  a patent claims a drug product "if it reads on one or more components of a drug," in this case "whether albuterol sulfate, the propellant, the inhaler device, or the entire inhaler, with its constituent parts."  Amneal contends that whatever else is claimed it must include the drug substance itself:  "because a drug product contains a drug substance, it insists that every drug product patent must expressly recite a drug substance (i.e., active ingredient)."  Teva's argument is bound up with the definitions and legal strictures of the relevant statutes ("the relevant regulation defines a 'drug product' as 'contain[ing] a drug substance, generally, but not necessarily, in association with one or more other ingredients," citing 21 C.F.R. § 314.3(b) (emphasis in brief)).  In contrast, Amneal's position is a simple and straightforward one:  how can a patent claim a drug product if the claims do not recite the drug substance itself?

Teva also disputes whether its asserted patents are "formulation or composition" patents.  Teva claims they are, relying on FDA rules having "expressly recognized" that metered aerosols can be listed as "finished dosage forms."  Teva cannot rely on FDA definitions for the term "composition" (Teva's brief concedes there isn't one) and falls back on patent law definitions of "compositions of matter" as "all compositions of two or more substances and all composite articles, whether they be the results of chemical union, or of mechanical mixture, or whether they be gases, fluids, powders, or solids," citing In re Nuijten, 500 F.3d 1346, 1357 (Fed. Cir. 2007), and Jazz Pharms.  This language indicates that "composition patents" include patents on "composition articles" which easily (for Teva) includes "multiple physical components," citing, of all things, Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 591 (2013).  Importantly here Teva argues that this use of the term is consistent with how the FDCA statute and FDA regulations use the term "component" with regard to drug products.  And Teva points out that what Amneal (and the FTC) define as a composition (i.e., "a mixture of active and inactive ingredients") is more properly termed a formulation, citing HZNP Meds. LLC v. Actavis Lab'ys UT, Inc., 940 F.3d 680, 683 (Fed. Cir. 2019), for this distinction (supported in a footnote by reference to the Hatch-Waxman letter, cited by Amneal, to the effect that "a formulation patent as a subcategory of composition patents" at https://www.fda.gov/media/149035/download?attachment.)

The brief then addresses Teva's assertion that at a minimum claim construction is required, which the District Court pointedly did not perform.  Teva maintains its position that "a patent can claim an active ingredient without naming it," citing genus claims as an example (emphasis in brief).  Again here Teva takes the opportunity to denigrate the FTC's position (reminding the reader that it is "an agency with no specialized patent knowledge") that "limitations cannot be imported into the claims" (emphasis in brief), stating that claim construction is needed to ascertain properly whether the limitation is present in the claim in the first place.

Finally, Teva restates its contentions that following Amneal's arguments will "destabilize the Hatch-Waxman regime" because the line drawn to balance the rights of branded drugmakers and their generic counterparts is one for Congress, not the courts to set down, citing PDS Consultants, Inc. v. United States, 907 F.3d 1345, 1360 (Fed. Cir. 2018).  Here, Congress had drawn the line, Teva argues, so that its patents are properly listed.  The brief calls "deeply flawed" arguments by Amneal and certain amici that permitting patents like the ones at issue here to be Orange Book-listed "stifles generic competition."  One reason is, Teva maintains, that "FDA typically takes more than 30 months to review an ANDA, meaning that the [statutory 30-month stay] does not actually delay approval" (although to be fair it cannot be said that the ANDA litigation process under §271(e)(2) accelerates approval, either).  Teva argues that this case illustrates that the current situation does not prevent generic competition because "[m]ultiple generic versions of ProAir HFA are already on the market; the first [being] approved in 2020" and Teva itself is marketing an authorized generic version of its branded ProAir HFA inhaler.  Teva extols the benefits of the Hatch-Waxman regime and its "highly ordered process" in contrast to "chaotic, hurried, and risky preliminary-injunction proceedings" arising from § 271(a) litigation proceedings.  Lost will be the notice provisions provided by Orange Book listing Teva asserts, an outcome warned against by the Association for Accessible Medicines in a comment to FDA stating that "[i]nformation on those device-related patents that 'read on' the approved drug product and that is subsequently listed in the Orange Book would be beneficial to the generic drug industry by allowing the normal pre-approval patent resolution to take place . . . ."

The views of several amici will be discussed in future posts.

Teva Pharms. Inc. v. Amneal Pharms. LLC (D.N.J. 2024)

By Kevin E. Noonan --

The Federal Circuit has been petitioned by plaintiff Teva Branded Pharmaceutical Products R&D, Inc. to reverse a decision in favor of Defendant Amneal Pharmaceuticals wherein the District Court entered an injunction ordering Teva to delist five Orange Book-listed patents, in Teva Pharms. Inc. v. Amneal Pharms. LLC.

To recap, the issues arose in litigation over Amneal's ANDA directed to its generic version of Teva's ProAir® HFA (albuterol sulfate) Inhalation Aerosol product.  In this litigation, Teva asserted five Orange Book-listed patents:  U.S. Patent Nos. 8,132,712 ("the '712 patent"), 9,463,289 ("the '289 patent"), 9,808,587 ("the '587 patent"), 10,561,808 ("the '808 patent"), and 11,395,889 ("the '889 patent") having these representative claims:

8,132,712:

1.  A dose counter for a metered-dose inhaler, the counter comprising: an actuator; a rotary gear; a driver for driving the rotary gear in a step-wise fashion in response to displacement of the actuator, the rotary gear comprising a wheel mounted on a spindle which wheel having a plurality of ratchet teeth around its periphery; a pawl to prevent reverse rotation of the rotary gear; and a display coupled to the rotary gear, the display having a visible array of incrementing integers on a surface thereof indexable by a single integer in response to each step of the step-wise rotary motion of the rotary gear; wherein the pawl comprises at least two ratchet teeth each for engaging with the ratchet teeth of the wheel to prevent reverse rotation of the rotary gear, the at least two ratchet teeth being radially spaced such that one of the at least two ratchet teeth of the pawl engages with the ratchet teeth of the wheel following each step of the step-wise rotary motion of the rotary gear.

18.  The use of a dose counter for preventing miscounting in a metered dose inhaler, the dose counter comprising: an actuator; a rotary gear; a driver for driving the rotary gear in a step-wise fashion in response to displacement of the actuator, the rotary gear comprising a wheel mounted on a spindle which wheel having a plurality of ratchet teeth around its periphery; a pawl to prevent reverse rotation of the rotary gear; and a display coupled to the rotary gear, the display having a visible array of incrementing integers on a surface thereof indexable by a single integer in response to each step of the step-wise rotary motion of the rotary gear; wherein the pawl comprises at least two ratchet teeth each for engaging with the ratchet teeth of the wheel to prevent reverse rotation of the rotary gear, the at least two ratchet teeth being radially spaced such that one of the at least two ratchet teeth of the pawl engages with the ratchet teeth of the wheel following each step of the step-wise rotary motion of the rotary gear.

9,463,289:

1.  An inhaler for metered dose inhalation, the inhaler comprising:
    a main body having a canister housing,
    a medicament canister, which is moveable relative to the canister housing and retained in a central outlet port of the canister housing arranged to mate with a canister fire stem of the medicament canister, and
    a dose counter having an actuation member having at least a portion thereof located in the canister housing for operation by movement of the medicament canister,
    wherein the canister housing has an inner wall, and a first inner wall canister support formation extending inwardly from a main surface of the inner wall, and
    wherein the canister housing has a longitudinal axis X which passes through the center of the central outlet port,
    the inner wall canister support formation, the actuation member, and the central outlet port lying in a common plane coincident with the longitudinal axis X.

9,808,587:

1.  An inhaler for metered dose inhalation, the inhaler comprising:
    a main body having a canister housing,
    a medicament canister, which is moveable relative to the canister housing and retained in a central outlet port of the canister housing arranged to mate with a canister fire stem of the medicament canister, and
    a dose counter having an actuation member having at least a portion thereof located in the canister housing for operation by movement of the medicament canister,
    wherein the canister housing has an inner wall, and a first inner wall canister support formation extending inwardly from a main surface of the inner wall,
    wherein the canister housing has a longitudinal axis X which passes through the center of the central outlet port, and
    wherein the first inner wall canister support formation, the actuation member, and the central outlet port lie in a common plane coincident with the longitudinal axis X such that the first inner wall canister support formation protects against unwanted actuation of the dose counter by reducing rocking of the medicament canister relative to the main body of the inhaler.

10,561,808:

1.  A dose counter for an inhaler, the dose counter having a counter display arranged to indicate dosage information, a drive system arranged to move the counter display incrementally in a first direction from a first station to a second station in response to actuation input, wherein a regulator is provided which is arranged to act upon the counter display at the first station to regulate motion of the counter display at the first station to incremental movements.

11,395,889:

1.  An incremental dose counter for a metered dose inhaler having a body arranged to retain a canister for movement of the canister relative thereto, the incremental dose counter having a main body, an actuator arranged to be driven and to drive an incremental output member in a count direction in response to canister motion, the actuator being configured to restrict motion of the output member in a direction opposite to the count direction, such that the actuator acts as an anti-back drive member when the actuator is in a non-depressed position, and wherein the incremental dose counter further comprises a second anti-back member configured to restrict motion of the output member in a direction opposite to the count direction when the actuator is disengaged from the output member by a bump surface.

The District Court granted Amneal's motion on the pleadings (asserted in its counterclaims as required by statute) that these patents were improperly listed in the Orange Book as not being directed to an FDA-approved drug nor method of using such a drug for treating a disease or disorder, and granted an injunction compelling Teva to delist these patents.  Teva appealed, the Federal Circuit entering a stay on the order to delist during pendency of the appeal.

On appeal, Teva makes two arguments:  the first is based on a legal and technical definition of how the term "drug product" is defined in the statute, and the second is whether the District Court erred procedurally, including whether claim construction was required to properly determine the  first question.  That first question is the more difficult one, to the extent to which Teva must convince the Court that the 1st Circuit erred in the Lantus decision and the District Court erred in interpreting the 2nd Circuit's decision in the Takeda case, both of which were decided consistently with the decision against Teva by the District Court.

With regard to its statutory construction argument, Teva maintains that not only did it comply with the listing statute but that it was compelled by the statute to do so.  "A drug product patent must be listed in the Orange Book for a specific NDA (i.e., a brand-name product) if the patent 'claims the drug for which the applicant submitted the application'" under 21 U.S.C. § 355(b)(1)(A)(viii)(I) according to Teva's brief.  This argument can only be persuasive should "the drug for which the applicant submitted the application" be interpreted to encompass per se the inhaler device (and related administration-related accoutrement and not need to include express recitation of the drug administered thereby).  That interpretation further depends on the Federal Circuit being persuaded that the drug itself is impliedly contained in the claims to the "drug product," as interpreted by Teva, analogously to recitations of either genus claims to particular classes of drugs or more broadly to formulation claims reciting excipients and the like.  Teva argues that accepting the arguments by Amneal (and their supportive amici) would greatly reduce the number of Orange Book-listed patents in ways that would harm the careful "balance'" struck under the Hatch-Waxman framework in disclosing to generic competitors (and the public) what patents could be asserted against ANDA-seeking drugmakers under 35 U.S.C. § 271(e)(2).

According to Teva, the District Court erred in what it means to claim a drug product, focusing not on that is recited in the claim but what generic drug product would be adjudged to be infringed.  In the context of Orange Book listing, Teva argues that under the statute, that definition "includes not just an 'article' that treats an illness or affects the body's functioning, but also any 'component' of such an 'article'" under 21 U.S.C. § 321(g)(1)(B)-(D).  This is because "FDA's rulemaking expressly contemplates that patents claiming a 'dosage form' will be listed in the Orange Book and identifies 'metered aerosols' like those at issue here as one example of a 'dosage form.'"

The brief relies on this definition of the term "drug" in the statute:

(A) articles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C).

21 U.S.C. § 321(g)(1) (italics emphasizing the portion of the statute expressly relied upon by Teva).  This definition is both "express" and "expansive," Teva argues, and applies to the listing statute as well, according to the brief.  Teva acknowledges that mere packaging cannot be listed but contends that its inhalers are part of the approved "finished dosage form" of the approved product and therefore the asserted patents to such inhalers et al. were properly listed.  Inclusion of subsection (D) above "ensures that the term 'drug' will reach the entirety (any 'component') of any drug product (any 'article[]' used to treat disease)," Teva argues.

Relying on FDA regulations (68 Fed. Reg. 36,676, 36,680 (June 18, 2003)), the brief asserts that metered aerosols are "expressly categorized" as a dosage form, wherein 'drug delivery systems used and approved in combination with a drug'—a category that includes 'metered dose inhalers'—are distinguishable from the type of 'packaging and containers' that are not properly listed in the Orange Book," Teva citing Orange Book, Appendix C, at C- 1 (44th ed. 2024) in support for this argument.  Moreover, Teva argues that "FDA classifies MDIs [metered dose inhalers] like ProAir as "single-entity combination products," meaning a drug and a device "combined or mixed and produced as a single entity," wherein "[c]ombination products 'constitute a combination of a drug, device, or biological product'" under 21 U.S.C. § 353(g)(1)(A)" that are "regulated either as a drug or a device" under 21 U.S.C. § 353(g)(1).  Regarding MDIs, Teva argues that FDA has classified them as "drug-device combination products for which 'the primary mode of action . . . is attributable to the drug component,'" citing FDA guidance from 1993 (which states that "an aerosol delivery device will be considered a drug product . . . when the primary purpose of the device is delivering or aiding in the delivery of a drug and the device is distributed with the drug").  (This determination also applies to dose counters according to the brief.).  In this way Teva contends the Court must treat the inhaler as it would an excipient or other component of a drug formulation covered under the statute and relevant FDA regulations because that is how FDA approved the combination.

The District Court, in Teva's telling, erred in ruling that the asserted claims must be delisted because none of those claims expressly recited the active ingredient of the drug product, albuterol sulfate, and did so without claim construction (despite the decision depending on whether the drug was claimed in any of the asserted claims).  The brief also asserts that the District Court apparently vacillated "between stating that the claims must recite the active ingredient and stating that the claims must recite the full product itself," finally resting on the purported need for the claims to recite expressly albuterol sulfate.  But Teva asserts another interpretation of the District Court's holding would require a properly Orange Book-listed patent would need to "recite every aspect of a drug (active ingredients, inactive ingredients, excipients, etc.)" which would permit listing only of "claim[s] with limitations explicitly directed to every part of the drug product [that] would satisfy the opinion," which would be "a dramatic narrowing of the scope of the Listing Statute and contrary to established law, citing in this regard Cadence Pharms. Inc. v. Exela PharmSci Inc., 780 F.3d 1364, 1369 (Fed. Cir. 2015), as an example.

Teva asserts that the statute requires that its claims must, under 21 U.S.C. § 355(b)(1)(A)(viii), claim "the drug for which the applicant submitted the application" and the test for whether this is the case is if the accused product would infringe the asserted claims ("The scope of what a patent 'claims' is effectively coterminous with the products that infringe a patent.").  "Critically," the brief asserts (and this is the crux of whether Teva will be successful before the Federal Circuit), a "patent need not read on the entirety of a product to 'claim[]' the product," citing SunTiger, Inc. v. Sci Rsch. Funding Grp., 189 F.3d 1327, 1336 (Fed. Cir. 1999)("[i]f a claim reads merely on a part of an accused device, that is enough for infringement"), "[n]or, in the case of pharmaceuticals, must a patent recite the active ingredient by name in order to claim the drug" (basing this assertion on generic claims "whose active ingredient is one species within the genus," citing In re Omeprazole Patent Litig., 536 F.3d 1361, 1365-66 (Fed. Cir. 2008), and Indivior Inc. v. Dr. Reddy's Lab'ys, S.A., 930 F.3d 1325, 1349-50 (Fed. Cir. 2019)).  Thus, Teva argues that the Federal Circuit has held that a patent that "'claims the drug for which the applicant submitted the application'—and therefore 'must be listed'— if it contains a product claim that reads on the drug that is the subject of the NDA,'" citing Apotex, Inc. v. Thompson, 347 F.3d 1335, 1343-44 (Fed. Cir. 2003).  And under 21 U.S.C. § 321(g)(1)(D), that would include the claims Teva asserted before the District Court (because the term "drug" "covers the entirety of the drug product and any component thereof—not just the active ingredient").  This is because, Teva argues, the FDA-approved "drug product" is the ProAir HFA (the device in combination with albuterol sulfate) -- and "[t]he statutory scheme treats combination products like ProAir HFA as drug products where—as is the case with ProAir HFA—the product's 'primary mode of action' is that of a drug" under 21 U.S.C. § 353(g)(1)(D)(i).

The two "out-of-circuit" cases the District Court relied upon for its contrary determination -- United Food & Commercial Workers Local 1776 v. Takeda Pharmaceutical Co., 11 F.4th 118 (2d Cir. 2021), and In re Lantus Direct Purchaser Antitrust Litigation, 950 F.3d 1 (1st Cir. 2020) – either actually supported Teva's position (Takeda) or were wrongly decided (Lantus), the brief asserts.  In the former case the court used an "infringement-type [judicial] analysis," which Teva argues was required but not performed by the district court.  And the latter case (as did the District Court here) equated "claims" for a drug with "mention[ing]," the drug in the claims, which is Teva's basis for asserting error.  The brief also notes that these were both antitrust cases, not patent cases, and as such did not address patent-specific issues important in this case.  In Takeda, according to Teva, the Second Circuit adopted the approach Teva espoused, that "a patent claims any product that falls within the bounds of the claim—a determination that must be made through an infringement-type analysis."  And that case was directed to a combination product, with the Second Circuit holding that a patent on only one component of the combination did not "read on" the approved drug comprising the combination.  Regarding Lantus, which held that "if a patent 'do[es] not mention the drug for which the sNDA was submitted, the patent does not "claim the drug" under the Listing Statute,'" the District Court also did not perform claim construction.  Moreover, Teva's brief contends "Lantus's reasoning is inapplicable by its own terms to Teva's claims directed to the entire inhaler product [because the] patent at issue in Lantus did 'not include a claim for an injector pen more broadly,' but rather 'mention[ed] that the drive mechanism is intended for use in a "drug delivery device"'" and in that case the listed claim, despite claiming "a device intended for use as an injector pen [did] not claim any injector pen" (rather it claimed merely a component part of the injector pen).  In this case, "three of the Asserted Patents plainly claim the entire inhaler . . . and thus claim the equivalent of the injector pen—precisely what the court in Lantus thought was missing."

At a minimum, Teva argues, the District Court's decision was error because it was decided on the pleadings and not properly supported by claim construction, because the listing question is one of patent law needing "ordinary claim construction principles" to be applied in making a determination whether an accused infringing product infringes (and there is more to this analysis than "whether a claim name-checks the active ingredient or the drug" according to the brief).  The brief cites several Federal Circuit decisions and those from other circuit courts, including Jazz Pharms., Inc. v. Avadel CNS Pharms., LLC, 60 F.4th 1373 (Fed. Cir. 2023); Biogen Int'l GmbH v. Mylan Pharms. Inc., 18 F.4th 1333, 1336 (Fed. Cir. 2021); Teva Pharmaceuticals USA, Inc. v. Leavitt, 548 F.3d 103 (D.C. Cir. 2008); Am. Bioscience, Inc. v. Thompson, 269 F.3d 1077, 1080 (D.C. Cir. 2001), for the primacy of this principle.  Teva argues that the asserted claims in fact contain terms that encompass the active drug -- albuterol sulfate -- including "[a]n inhaler for metered dose inhalation" recited in the '289 and '587 patents; "medicament canister" recited in the '289, 587, and '712 patents; "an inhaler" recited in the '808 patent; "a metered dose inhaler" recited in the '889 and '712 patents; and "cannister" recited in the '889 patent.

These errors by the District Court require the Federal Circuit to vacate the judgment and remand for further consideration, Teva argues.  Further Teva asserts that this would pose no burden on the District Court, which is construing claims in these patents during the litigation that has proceeded on other grounds not affected by the order to delist.  And doing so would help clarify circumstances like this under the Hatch-Waxman framework, Teva argues, which is beneficial because it "facilitate[s] a scheme that allows the parties to obtain patent certainty before the launch of a drug, thereby supporting the development of both brand and generic medicines" (emphasis in brief); without doing so the consequence of the District Court's decision will result in "significant uncertainty and risk" because "many more infringement disputes would be resolved only after launch of a generic product, including preliminary injunction proceedings, a post-launch jury trial, and an award of money damages."

Teva concludes these arguments by imploring the Federal Circuit not to "disrupt" the balance struck by Congress that "[a]ll drug product patents must be listed in the Orange Book for every drug they claim, for as long as a claim of infringement can reasonably be made under those patents," and that "[t]raditional Paragraph IV invalidity and noninfringement challenges to those listed patents provide an expeditious pathway toward patent certainty."  It must be said that the highest burden towards that end will be the ineluctable lure of the more simple-minded concept that claims not reciting the drug product should not be Orange Book listed, regardless of the nuances found in Teva's explication of the statute and FDA ruled implementing its provisions.  The arguments against such statutory interpretations, by Amneal and almost all the amici, will be set forth in later posts.