Patent Docs

FDA Approves Another Interchangeable Biosimilar Drug

By Kevin E. Noonan --

On October 15th, the Food and Drug Administration approved its second interchangeable biosimilar drug.  That drug is Cyltezo (adalimumab-adbm), produced by Boehringer Ingelheim, which obtained biosimilar approval on August 25, 2017.  In this recent approval, the FDA determined that Cyltezo is interchangeable with AbbVie's Humira (adalimumab), its reference product.  Cyltezo is the first monoclonal antibody biosimilar to be deemed an interchangeable biosimilar drug product.

One of the benefits of interchangeability is that physicians' input (and approval) is not needed for substitution, which can be implemented at the pharmacy level.  The approval was based on the provisions of the Biological Price Competition and Innovation Act of 2009 (BPCIA), enacted with the Affordable Care Act (commonly known as "Obamacare") codified at 42 U.S.C. § 262 et seq.  Subsection (k) relates to the standards for biosimilarity; the FDA (and the statute itself) distinguish between biosimilarity and interchangeability inter alia by applying a heightened standard for interchangeability.  Specifically, the statute requires that an interchangeable product is biosimilar and can be expected to produce the same clinical result as the reference product in any given patient; and that for a biological product that is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between use of the biological product and the reference product is not greater than the risk of using the reference product without such alternation or switch.  42 U.S.C. §§ 262(I)(3) and 262(k)(4).

The FDA approved Cyltezo for several uses in adult patients: these include moderately to severely active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, moderately to severely active Crohn's disease, moderately to severely active ulcerative colitis, and moderate to severe chronic plaque psoriasis.  In juvenile patients (two years of age and older), Cyltezo was approved for moderately to severely active polyarticular juvenile idiopathic arthritis and for Crohn's disease in patients six years of age and older.

Cyltezo was approved as a single-dose, pre-filled glass syringe at two amounts (40 mg/0.8 mL, 20 mg/0.4 mL), to be administered subcutaneously by a physician or other medical staff acting under physician supervision.  The approval notes some side effects, the most common of which are upper respiratory and sinus infections, injection site reactions, headache, and rash, although more serious albeit more rare side effects include malignancies.  The severity of these possible side effects provoked the FDA to include a so-called boxed warning to health care professionals regarding infections and lymphoma.

FDA Commissioner Janet Woodcock issued a statement on the occasion of Cyltezo's approval, saying that:

The biosimilar and interchangeable approval pathway was created to help increase access to treatment options for patients with serious medical conditions.  We continue to be steadfast in our commitment to provide patients with alternative high-quality, affordable medications that are proven to be safe and effective.

This approval is the thirty-first approval and thirtieth biosimilar product approved under the BPCIA.

CVC Files Reply to ToolGen's Opposition to CVC's Substantive Preliminary Motion No. 2

By Kevin E. Noonan --

On May 20th, Junior Party the University of California, Berkeley; the University of Vienna; and Emmanuelle Charpentier (collectively, "CVC") filed their Substantive Preliminary Motion No. 2 in Interference No. 106,127 (which names ToolGen as Senior Party), asking the Patent Trial and Appeal Board to deny ToolGen benefit of priority to U.S. Provisional Application No. 16/717,324, filed October 23, 2012 ("P1"), pursuant to 37 C.F.R. §§ 41.121(a)(1)(ii) and 41.208(a)(3) and Standing Order ¶ 208.4.1.  The significance of the Board granting this motion would be that CVC would be Senior Party, with all the presumptions benefiting from Senior Party status.  On July 5th, ToolGen filed is Opposition to this Motion.  On August 27th, CVC filed its Reply.

In its Motion No. 2, CVC argued that the Board should deny ToolGen priority benefit to the '324 application because this application does not disclose an operative embodiment falling within the scope of the interference Count, based on party admissions.  Specifically, CVC argued that in the prosecution of the '324 patent application leading to allowance (and declaration of this interference), ToolGen had argued to the Patent Examiner (and PTAB) that "a codon-optimized Cas9 nucleic acid is required for CRISPR-Cas9 to function in eukaryotic cells" and that "a skilled artisan would have no idea what the outcome may be if one were to codon optimize a Cas9 nucleic acid."  This position was consistent with the prokaryotic source of Cas9, and the Board and Examiner relied upon these arguments to find allowable claims in the '324 application (now claims designated as corresponding to the Count in this interference) according to CVC.  All such claims require use of a Cas9-encoding nucleic acid that is codon-optimized for expression in eukaryotic cells, and CVC asserted that ToolGen added this limitation to the claims to overcome anticipation and obviousness rejections based on the prior art.

But, CVC argued, ToolGen's '324 application does not disclose a codon-optimized Cas9 nucleic acid, nor (by ToolGen's own argument according to CVC) would the skilled worker be able to discern such a nucleic acid with any reasonable basis for expecting such an embodiment could be produced using the disclosure in the '324 application.  Accordingly, CVC argued in its motion, ToolGen cannot in this interference renounce these arguments and rely on the priority date of the '324 patent to constitute a constructive reduction to practice for eukaryotic CRISPR-Cas9 embodiments falling within the scope of the interference Count.  Thus, according to CVC, the Board should deny ToolGen priority benefit to the '324 application (and redeclare the interference naming CVC as Senior Party).  The brief contained examples from the '324 prosecution history and at oral argument before the Board in support of its allegations.

ToolGen, characterizing CVC's arguments (as did CVC, citing Zedner v. United States, 547 U.S. 489 (2006), and Springs Window Fashions LP v. Novo Industries, L.P., 323 F.3d 989, 995 (Fed. Cir. 2003)) as sounding in judicial estoppel, argued this is a "misrepresentation of the prosecution history" and that the '324 application provides a constructive reduction to practice of eukaryotic CRISPR as defined under CVC's portion of the Count in this interference (and that CVC does not effectively challenge this disclosure) but not ToolGen's portion of the Count. ToolGen affirmatively argued that the '324 application "describes a successful experiment using a codon-optimized nucleic acid encoding Cas9 to yield a Cas9 protein complex that functions in eukaryotes to cleave DNA" in support of this assertion.  But more fundamentally, ToolGen argued, Count 1 in the interference does not require codon-optimized Cas9 as part of a eukaryotic CRISPR complex and thus CVC's argument (and Motion) should fail.  The Opposition then addressed the issues raised by CVC, most tellingly setting forth what it contended was a proper explication of the colloquies with the Board during ex parte prosecution that did not support CVC's estoppel arguments.

In it Reply, CVC reiterates its argument that P1 does not disclose a codon-optimized Cas9 species and that their allowed claims depend on arguments made in ex parte prosecution that eukaryotic CRISPR was dependent on such species and that codon-optimization was unpredictable.  Thus, CVC continues to contend, failure to describe a codon-optimized Cas9 protein is fatal to ToolGen's priority claim.  And, according to CVC, ToolGen did not rebut these arguments in its Opposition and thus the Board should grant CVC's motion and deny ToolGen priority benefit to its P1 provisional application.

The brief recaps the legal and evidentiary bases for its arguments, done in the explicatory pattern the interference rules require, selecting quotes from ToolGen's prosecution history that support its arguments and rhetorical flourishes seeming intended to impugn (regarding a ToolGen argument as "an attempt to sow confusion"; "attempts to sidestep the issue").  Of note is CVC's argument that purports to resolve (in its favor) the differing provenance of the "secret sauce" issue with regard to codon-optimized Cas9 ("it is undisputed that during this exchange ToolGen distinguished its claimed invention from the prior art based on codon optimization being required").  The core of CVC's argument, repeated in various incarnations throughout its Reply, is that:

Even if a POSA understood, as ToolGen argues, "reconstituting a nucleic acid sequence using a codon usage table to be codon optimization" or that codon optimization was a routine technique, P1 would at most teach that a Cas9 nucleic acid could be codon optimized.  . . .  But, in view of ToolGen's unpredictability assertions, a POSA would still be in the dark as to the identity of which codon-optimized nucleic acid sequence of the myriad different sequences would express a functional Cas9.  Thus, to be accorded benefit, P1 must describe the specific codon-optimized nucleic acid sequence(s) that would express a functional Cas9.  . . .  P1 fails to do that [citations to the record omitted].

Finally, even the existence of working examples of CRISPR in a eukaryotic cell is not enough, according to CVC, who state "ToolGen's second argument that its P1 describes a codon-optimized Cas9 because it includes working examples is wrong as a matter of law.  . . .  'Proof of a reduction to practice' does not salvage an application that does not otherwise 'describe or identify the invention,'" citing In re Alonso, 545 F.3d 1015, 1021 (Fed. Cir. 2008), according to CVC.

Broad Files Reply to ToolGen Opposition to Broad's Contingent Preliminary Motion No. 2

By Kevin E. Noonan --

On May 28th, Junior Party the Broad Institute, Harvard University and MIT (collectively, "Broad") filed its Preliminary Motion No. 2 in CRISPR Interference No. 106,126 (where ToolGen is the Senior Party), contingent on the Board's grant of Broad's Substantive Preliminary Motion No. 1 to substitute (in part) a new Count No. 2 in place of Count 1 in the '126 Interference as instituted (see "Broad Files Substantive Preliminary Motion No. 1 in CRISPR Interference").  In its Motion No. 2, Broad asked the Board to add their U.S. Application Nos. 15/160,710 (having allowable claims 1, 40, and 41) and 15/430,260 (allowable claims 74, 94, and 95) to the Interference and designate the allowable claims as corresponding to Proposed Count 2.  In the alternative (i.e., should the Board deny Broad's Substantive Preliminary Motion No. 1), Broad in its Motion No. 2 asked the Board to designate claim 1 of the '710 application and claim 95 of the '260 application as corresponding to current Count 1.  On August 6th, ToolGen filed its Opposition to Broad's Contingent Preliminary Motion No. 2, and on September 24th Broad filed its Reply.

In its Opposition, ToolGen asserted several bases for the Board to deny Broad's Motion No. 2.  ToolGen argued that had shown (in its Opposition to Broad Preliminary Motion No. 1) that Broad's motion to substitute the Count should be denied (in which case this motion would become moot).  ToolGen further contended that "Broad has neither demonstrated that the claims should be added, nor that alternative remedies are unavailable."  ToolGen also argued that Broad has not borne its burden under 37 C.F.R. § 41.208(b) and SO ¶ 203.2 showing why these claims should be added to this Interference and why alternative remedies are unavailing or inadequate.  With regard to such alternative remedies, ToolGen argued that Broad has not explained why any such remedies would be inadequate, despite the existence of such remedies (for example, asking the Board to declare another interference which could be combined with the current one between the parties).  ToollGen further argued that Broad's Motion No. 2 was unnecessary, because either Broad would prevail under Proposed Count 2 and the claims at issue in this motion would grant, or Broad will not prevail and Broad will be estopped from pursuing them under the principles of interference estoppel.  Finally, ToolGen argued that the motion was unauthorized and exceeded the scope of the Motions List submitted to the Board in this interference.

Broad's Reply begins by disputing ToolGen's contention that SO ¶ 203.2 requires them to show a "compelling reason" why these claims should be added to the Interference should the Board grant Broad's Preliminary Motion No. 1.  All that the Rule requires, according to Broad, is that the claims correspond to the Count, which they do (being directed to "generic" species of CRISPR comprising either dual- or single-molecule guide RNA.  Nevertheless, Broad argues they have provided compelling reasons (including remedying the "unjust structure" of the Interference) and these amount to reasons not "irrelevant" as ToolGen argued in its Opposition according to Broad.  The Reply sets out in detail how Broad's Motion No. 1 addresses the requirements of SO ¶ 203.2, including the basis for their contention that no alternative remedy would suffice to bring Broad "justice" in this interference.

Broad also argues that its Motion was authorized by the Board, including that certain of the claims corresponding to the Count are directed to single-molecule guide RNA (sgRNA) species and others are generic according to Broad's nomenclature, making its case that it was not attempting to mislead the Board (while at the same time making its case that ToolGen had tried to do so in its Opposition).  Broad provides a quotation from the hearing on motions to illustrate the consistency of "its position that the broader eukaryotic invention [encompassing generic guide RNA species] is the proper subject matter of this Interference":

. . . there are claims that Broad has that do not use the terminology 'guide RNA,' and also gets into our second motion, which we have been informed that we have other allowable claims that we—that we could potentially move to be brought in as part of the count being broaden[ed] to encompass those best proofs, because the subject matter on our side includes both the dual molecule and the single molecule . . . [emphasis in brief].

Moreover, Broad asserts that the Board was not unaware or confused about their arguments and the consistency or strategic aim of their motions request.

Finally, Broad dismisses ToolGen's argument that Broad had requested relief from the Board to designate these claims as corresponding to Count 1, saying that while they have not requested this relief they are "unaware of any authority preventing the PTAB at this stage of the Interference from adding allowable claims from applications not currently involved in the Interference if those claims correspond to Count 1; the claims limited to sgRNA configurations can be designated as corresponding to Count 1, if the PTAB believes such a designation is appropriate."

Webinar on Impact of Automation and AI on IP Profession

Schwegman Lundberg & Woessner will be offering a webinar entitled "How Automation and AI are Changing Professional Opportunities in the IP Profession" on October 19, 2021 at 12:00 pm (CT).  Russ Slifer, Ellen Franco, and Adam Reece of Black Hills IP; Manjeet Rege, Director of the Center for Applied Artificial Intelligence, University of St. Thomas; and Zhakalazky Carrion and Leonie Mann of Schwegman Lundberg & Woessner will discuss new career opportunities and fading career options in the AI-driven legal industry at present and in the future.

While there is no cost to participate in the program, those interested in attending the webinar can register here.

Webinar on Patent Term Extensions in Australia

Spruson & Ferguson will be offering a webinar entitled "Practical Insights into Patent Term Extensions in Australia" on October 21, 2021 at 4:00 pm (ET).  Daniel Sieveking and Elizabeth Barrett of Spruson & Ferguson will provide a summary of various criteria regarding patent term extension (PTE) eligibility and the PTE application process in Australia, and also provide practical recommendations arising from recent decisions, including two recent decisions of the Australian Federal Court:  Ono Pharmaceutical Co. Ltd v Commissioner of Patents [2021] FCA 643, and Merck Sharp & Dohme Corp. v Sandoz Pty Ltd [2021] FCA 947.

While there is no cost to participate in the program, those interested in attending the webinar can register here.

ToolGen Reply to Broad Opposition to ToolGen Preliminary Motion No. 1

By Kevin E. Noonan --

On May 20th, Senior Party ToolGen filed its Substantive Motion No. 1 for benefit of priority to U.S. Provisional Application No. 61/837,481, filed June 20, 2013 ("P3" or "ToolGen 5 P3"), or alternatively, International Application No. PCT/KR2013/009488, filed October 23, 2013 ("PCT").  Junior Party the Broad Institute, Harvard University, and the Massachusetts Institute of Technology (collectively, "Broad") filed its Opposition to this motion, and on September 24th ToolGen filed its Reply.

As set forth in ToolGen's motion, the Board had granted ToolGen the benefit of its U.S. Provisional Application No. 61/717,324, filed October 23, 2012 ("P1"), resulting in ToolGen having an earlier priority date than Broad.  ToolGen submitted this motion to be accorded benefit of priority to two later-filed, related applications:  U.S. Provisional Application No. 61/837,481, filed June 20, 2013 ("P3" or "ToolGen 5 P3"), or alternatively, International Application No. PCT/KR2013/009488, filed October 23, 2013 ("PCT").  In its motion, ToolGen explains that it is submitting this motion contingent on the Board granting CVC's Substantive Motion No. 2, which attacks ToolGen's entitlement to priority to the P1 priority document in Interference No. 106,127.  The brief sets out graphically the relationship of these priority documents:

The brief then set out the basis for ToolGen's claim of priority, specifically its arguments for satisfaction of the written description and enablement requirements under 35 U.S.C. § 112(a) regarding two embodiments falling within the scope of the Interference Count.

In its Opposition, Broad asked the Board to defer consideration of ToolGen's Motion, properly pointing out that Broad (unlike CVC in the '127 Interference) has not challenged ToolGen's benefit of priority to its P1 provisional application.  Accordingly, Broad asserted that ToolGen's motion is premature and "completely irrelevant" at this time.  Broad further asserted that this motion may "potentially" become relevant "only if multiple contingencies in this and other proceedings—that may or may not ever come to pass—do actually arise."  These include that:

1) the PTAB finds ToolGen is not entitled to the benefit of its P1 application in the co-pending 127 Interference,

2) Broad requests and is granted permission to file a motion here challenging ToolGen's benefit to P1 based on estoppel from that determination in the 127 Interference, and

3) the PTAB grants Broad's motion, depriving ToolGen here of benefit of its P1.

Broad's justification included that the Board considering this motion under these circumstances would be "waste of judicial resources" as well as improperly constituting an advisory opinion.  The interference rules provide that the Board has discretion to defer consideration of motions under 37 C.F.R. § 41.125 as applied in Berman v. Housey, 291 F.3d 1345, 1352 (Fed. Cir. 2002).  Broad urged the Board to exercise that discretion regarding ToolGen's Preliminary Motion No. 1.  Broad's brief explicated in further detail the contingent nature of the circumstances needing to arise for ToolGen's motion to be timely, in support of its opposition and request for the Board to defer consideration thereof.

Broad argued that priority to either of ToolGen's U.S. Provisional Application No. 61/837,481, filed June 20, 2013 ("P3" or "ToolGen P3"), or alternatively, International Application No. PCT/KR2013/009488, filed October 23, 2013 ("PCT"), would never be relevant because "ToolGen will be unable to beat Broad's dates of [conception and reduction to practice]" if Broad is granted priority in the '115 Interference.  This argument also sounds in representations made by ToolGen during prosecution regarding what was needed to provide a skilled worker with a reasonable expectation of success:

Rather, the only thing that would have alleviated the unpredictability in the art and allayed the concerns of one of ordinary skill at this time would have been the actual demonstration of a Type II Cas9 system successfully introducing site-specific double-stranded breaks in a target nucleic acid sequence within a eukaryotic, e.g., mammalian, cell . . . [emphasis in brief].

Here, Broad resurrects an argument made in Interference No. 106,115, that eukaryotic CRISPR is an invention for which conception can only be shown by successful reduction to practice (under a theory of "simultaneous conception and reduction to practice" first enunciated thirty years ago regarding conception of a nucleic acid encoding a particular protein; see Amgen v. Chugai, Fed. Cir. 1990).

In its Reply, ToolGen boldly asks the Board to dismiss rather than defer its Preliminary Motion No. 1 should the Board deny CVC's Preliminary Motion No. 1 in co-pending Interference No. 106,126 to deny ToolGen priority benefit to its U.S. Provisional Application No. 61/717,324, filed October 23, 2012 ("P1").  In addition, ToolGen raises the procedural requirement that decisions on Motions must be decided prior to initiation of the Priority Phase.  And finally, ToolGen argues that should the contingency arise and the Board grant CVC's motion and deny ToolGen priority benefit to its P1 provisional application the Board should grant its Preliminary Motion No. 1 because Broad's opposition was procedural in nature and not on the merits.

Regarding the many contingencies Broad identifies in its Opposition, ToolGen argues that Broad has not brought a motion or advanced an argument to deny ToolGen the benefit of priority to its P1 application.  And at this point Broad should not be permitted to benefit from the Board deferring the priority benefit issue until after the priority phase has begun because that would be procedurally improper according to ToolGen, relying on 37 C.F.R. § 41.121(a)(1), the Standing Order at 6:22-24 and Hum. Genome Scis., Inc. v. Genentech, Inc., 589 F. Supp. 2d 512, 514 (D. Del. 2008), dismissed 368 F. App'x 116 (Fed. Cir. 2009).  And to the extent any contingency resulting in ToolGen's loss of priority benefit to the P1 application should arise, ToolGen argues, its Preliminary Motion No. 1 was not addressed on the merits in Broad's Opposition and thus its Motion No. 1 is unopposed.

Snyders Heart Valve LLC v. St. Jude Medical, LLC (Fed. Cir. 2021)

By Kevin E. Noonan --

The Supreme Court's decision in United States v. Arthrex, Inc., 141 S. Ct. 1970 (2021), at the end of its last term resulted in many cases with pending certiorari petitions that were based on Appointment Clause challenges to be remanded to the Federal Circuit, and many (if not most) of those were remanded back to the Patent Trial and Appeal Board.  The decision handed down by the Federal Circuit on Tuesday in Snyders Heart Valve LLC v. St. Jude Medical, LLC is an exception, the Court considering the appeal on the merits and reversing the Board's determination that St. Jude had shown by a preponderance of the evidence that challenged claims 1–3, 8, 9, 22, 23, 31–35, 37–39, and 45 of U.S. Patent No. 6,821,297 were invalid as being either anticipated by U.S. Patent No. 5,855,601 to Bessler or obvious over the '601 patent "in combination with other prior art references."

This is the second appeal of several IPRs between the parties; in an earlier case, St. Jude Medical, LLC v. Snyders Heart Valve LLC (Fed. Cir. 2020), the Board found Snyders' U.S. Patent No. 6,540,782, directed to an artificial heart valve and systems for introducing the valve, to be neither anticipated over U.S. Patent No. 5,957,949 nor rendered obvious over a combination of the '949 patent with U.S. Patent No. 4,339,831 to Johnson and U.S. Patent No. 5,413,599 to Imachi.  The Federal Circuit affirmed this decision.  In the same appeal, the Federal Circuit reversed the Board's finding that certain of the challenged claims of the '782 patent were anticipated by the Bessler '601 patent based on erroneous claim construction.

In this case, the Court proceeded to a decision on the merits because "all parties agree[d] that Snyders ha[d] waived its Appointments Clause challenge and that remand to the Patent Office for Director review is not proper."  But the parties differed, with Snyder asking the Court to reverse based on its decision in the earlier appeal and St. Jude asking that the case be remanded to the Board for its reconsideration in the first instance in view of the intervening Federal Circuit decision.

The Court agreed with Snyders and rendered a decision reversing the PTAB on the same basis that the Board's unpatentability decision was reversed in the earlier appeal, in a decision by Judge O'Malley joined by Judges Newman and Taranto (this was the same panel that heard the earlier appeal; there, Judge Taranto wrote the unanimous opinion).  The panel reiterated in brief their reasons for reversing the Board in its earlier decision, which bears at least a synopsis here.  According to that earlier opinion, the '782 patent disclosed and claimed an artificial heart valve that can be administered using a catheter (thereby forgoing open heart surgery) and can be placed without removing the patient's damaged valve.  The opinion asserted that the claimed artificial valve has three components: "a valve element, a frame, and a band."  System claims for introducing the valve recite components for installing the artificial valve comprising "a holder, a manipulator, and an ejector."

Claim 1 of the '782 patent is representative of the artificial heart valve claims at issue:

1.  An artificial valve for repairing a damaged heart valve having a plurality of cusps separating an upstream region from a downstream region, said artificial valve comprising:
a flexibly resilient frame sized and shaped for insertion in a position between the upstream region and the downstream region, the frame having a plurality of peripheral anchors for anchoring the frame in the position between the upstream and the downstream region and a central portion located between the plurality of peripheral anchors;
    a band attached to the frame limiting spacing between adjacent anchors of said plurality of peripheral anchors; and
    a flexible valve element attached to the central portion of the frame and adjacent the band, said valve element being substantially free of connections to the frame except at the central portion of the frame and adjacent the band, said valve element having an upstream side facing said upstream region when the frame is anchored in the position between the upstream region and the downstream region and a downstream side opposite the upstream side facing said downstream region when the frame is anchored in the position between the upstream region and the downstream region, said valve element moving in response to a difference between fluid pressure in said upstream region and fluid pressure in said downstream region between an open position in which the element permits downstream flow between said upstream region and said downstream region and a closed position in which the element blocks flow reversal from said downstream region to said upstream region, wherein the valve element moves to the open position when fluid pressure in said upstream region is greater than fluid pressure in said downstream region to permit downstream flow from said upstream region to said downstream region and the valve element moves to the closed position when fluid pressure in said downstream region is greater than fluid pressure in said upstream region to prevent flow reversal from said downstream region to said upstream region [relevant claim limitations in italics].

Relevant to the Court's decision in this appeal, and with regard to the Board's decision on the second IPR challenging claims of the '782 patent, the Federal Circuit found error in the Board's construction of the term "how the frame is sized and shaped," which Snyders had argued was incorrect because "it covers frames sized and shaped for installation with the native valve removed, rather than only with the troubled native valve remaining in place."  With regard to this limitation, the Board had found that "'[t]he claim language does not require the frame be sized and shaped for insertion into a damaged heart valve,' but 'only that the frame is sized and shaped for insertion in a position between the upstream region and the downstream region.'"  This was error in the panel's view because the Board did not consider the further disclosure in the '601 patent that the native valve was required to be replaced, which the challenged '782 patent claims expressly did not require.  The panel opinion found support for the argument that structural features of the claimed artificial valve were consistent with this lack of a requirement for native valve removal in the plain meaning of the claim language, as well as express disclosure to that effect in the '782 specification.  Specifically, the specification disclosed that "the frame is sized and shaped for insertion between the plurality of cusps C of the damaged heart valve in a position between an upstream region and a downstream region" (emphasis in opinion).  The significance for the Court was that this language indicated that the term "sized and shaped" "is not meant to refer only to placement in a position between the upstream and downstream regions, but also to fitting between the cusps of the intact native valve."  This interpretation is consistent, according to the opinion, with further disclosure in the '782 specification of the benefit of not needing to remove the native heart valve as an improvement over the prior art and in particular the deficiencies in the '601 patent in this regard.  Because the '601 patent did not meet the "size and shape" limitation as construed by the Federal Circuit, the panel reversed the Board's determination that the '782 patent claims were invalid for anticipation.

In this appeal, the Court rejected St. Jude's argument for remand that there were differences between the '782 and '297 patents relevant to the Court's decision.  The opinion states that "[t]he claims and written descriptions in the two patents are the same in all relevant respects" and accordingly the Court's construction of the "sized and shaped" limitation in the claims of the '782 patent govern proper construction of the claims of the '297 patent at issue here.  Even though the Court recognized that the written descriptions in the two specifications are not identical the Court asserted that "all portions of the '782 written description which we found 'resolve[] the interpretive question' of the proper construction of the 'sized and shaped' limitation appear in the '297 patent's written description."  The Court dismissed St. Jude's other obviousness arguments as being "vague" or that they did not overcome Snyders' arguments to the contrary based on the structure of the replacement valves or that the arguments were directed to limitations other than the "sized and shaped" limitation that the Court considered dispositive.  The panel concluded that:

[A]s in [the panel's earlier decision], our rejection of the Board's claim construction of 'sized and shaped for insertion' precludes an unpatentability finding as to the challenged claims of the '297 patent.  St. Jude relied only on its now rejected claim construction argument before the Board.  It never disputed Snyders' assertion that Bessler requires removal of the native valve before insertion of its valve.  Thus, St. Jude has not preserved any argument on which it might prevail.

On this basis the Federal Circuit reversed the Board invalidity findings.

Snyders Heart Valve LLC v. St. Jude Medical, LLC (Fed. Cir. 2021)
Nonprecedential disposition
Panel: Circuit Judges Newman, O'Malley, and Taranto
Opinion by Circuit Judge O'Malley