By Kevin E. Noonan —

The Honorable Pauline Newman, Circuit Judge for the U.S. Court of Appeals for the Federal Circuit, has been battling her suspension from the Court imposed by the Judicial Council for two years (including proceedings leading up to the suspension; see "Judge Newman and the On-Going Attempts to Remove Her from the Federal Circuit"; "Judge Newman Matter Continues"; "Federal Circuit Special Committee Responds to Judge Newman's Counsel's Request for Clarification Regarding Misconduct Hearing"; "Federal Circuit Special Committee Recommends One-Year Suspension of Judge Newman"; "Judge Newman Suspended for One Year by Federal Circuit"; "Judge Newman's Suit Continues";  "Special Committee of the Judicial Council of the Federal Circuit Replies").  Recently, her efforts came to naught, as the D.C. District Court dismissed her suit against her colleagues (see "Judge Newman's Suit Comes to an End") and the Judicial Counsel renewed her suspension for another year (see "Special Committee's Suspension Recommendation Adopted by Federal Circuit; "Judge Newman Suspension Renewed").  Judge Newman has filed an appeal in the D.C. Circuit (see "Judge Newman Files Appeal with D.C. Circuit") and the Judicial Council of the Federal Circuit has responded.  Last month, Judge Newman filed her Reply.

The brief addresses the arguments set forth in the Judicial Council's brief responding to Judge Newman's principal arguments on appeal:  that Congress cannot legitimately enact legislation that permits removal (actual or constructive) of an Article III Judge outside the impeachment provisions of the Constitution, and that the District Court erred in failing to construe the statute to permit the Judicial Council's de facto removal of Judge Newman from the bench; that the Judicial Council's assertions that their suspension was temporary is inconsistent with the record; that prior precedent (McBryde v. Comm. to Rev. Cir. Council Conduct & Disability Ords. of Jud. Conf. of U.S.) was not controlling; and that permitting the Judicial Council to participate in this process violates Judge Newman's due process rights.

The brief begins by highlighting the Achilles heel of the Judicial Council's justifications for how it had conducted the inquiry directed towards Judge Newman, saying that "Defendants-Appellees fail to dispute that as a result of her unlawful suspension Judge Newman does not exercise any functions of her office."  The tack the Council has taken in its Responsive brief, and throughout is that the Judicial Conduct and Disability Act, 28 U.S.C. §§ 351-364, gives the Council the authority to act as it has, and that Judge Newman has the "keys" to her return to the bench by complying with the Council's demand that she submit to neuropsychological testing by physicians of the Council's choice.  The brief also disputes, and argues that the Council does not "address, much less rebut, Judge Newman's argument that this Court has authority to ensure that the Judicial Council, as an administrative body, does not act beyond its statutory remit."  While seeming not to dispute that the Act permits suspension from a judge's duties only "on a temporary basis for a time certain," it is clear that, absent the Judge's compliance, the suspension will never be lifted.  The situation is unprecedented, Judge Newman argues, stating that "a complete involuntary suspension from judicial duties has never been attempted irrespective of the seriousness of misconduct by a federal judge" (emphasis in brief), nor has there a "single instance of a case where a misconduct investigation of a circuit judge was conducted within that judge's own circuit."  And, the brief argues, no Judicial Council has ever before asserted the power to debar a "duly nominated, confirmed, and appointed United States Circuit Judge" from the "powers and duties" of her judicial office other than by impeachment by the House of Representatives (this lack of historical precedent being "highly probative" according to the brief, citing several authorities).

Judge Newman summarizes her argument in three major points.  The first is that the D.C. Circuit Court has the duty to construe the statute and this includes ruling on the constitutionality of a Judicial Council removing an Article III judge from the court other than by recommending impeachment to the House.  Either the Council has exceeded its authority under the Act, or the Act permits the Council's actions, in which case it is unconstitutional to the extent that it permits such removals.  And the fact that the removal is at the hands of federal judges acting as a judicial council does not justify abrogation of the Constitution's guarantee of life tenure, which guarantee "protects the independence of individual judges from their colleagues as much as from other branches."

The second prong of Judge Newman's argument is that the District Court erred by relying on McBryde v. Comm. to Rev. Cir. Council Conduct & Disability Ords. Of Jud. Conf. of U.S., 264 F.3d 52, 64-67 (D.C. Cir. 2001), as precedent that it could not considered "as applied" constitutional challenges.  According to the brief, the Court had "explicitly reserved the issue now presented here: whether a long-term disqualification can constitute an unconstitutional removal from office."  The crux of this argument was that the Court made this reservation in the context of having jurisdiction over whether an agency decision exceeded the statutory authority under which the agency acted, and that when acting under the Act a judicial council was acting as an agency not as a court.

The third argument involved Judge Newman's due process complaint, to which she was constitutionally entitled the brief asserts.  The brief argues that there is no disputing in the Responsive brief that the Judicial Council was acting as "investigators" and "witnesses" and thus not as neutral judges required to ensure due process is received in an adjudicatory proceeding.

Regarding the first argument, Judge Newman asserts that what is properly before the D.C. Circuit Court is her facial challenge on the constitutionality of the Act, based on what she asserts is the Judicial Council's "complete debarment from judicial functions" which "necessarily prevents a judge from exercising judicial power and therefore effects a functional 'removal' from office" (emphasis in brief).  In this argument, Judge Newman presents the Court with two alternatives:  either the Judicial Council's indeterminate suspension was improper under a narrow construction of the Act, or the Act is unconstitutional if within its proper scope it permits divesting an Article III judge from her office.  In addressing the Judicial Council's argument that Judge Newman had waived this argument (which she denies), her brief reminds the Court of their duty "to construe the statute and give meaning to the statutory language," citing Crowell v. Benson, 285 U.S. 22, 62 (1932) (emphasis in brief).  The brief disputes the Responsive brief's characterization of Judge Newman's argument to the extent that it is anything but that the Act does not permit judicial councils to remove a judge from the performance of her judicial functions indefinitely and, if the Act permits this outcome, it is unconstitutional.

And in that case, that the Act does permit suspensions for indefinite terms, then "the Act can never be validly applied" and is unconstitutional on its face.  The brief recognizes that there are some limits that can be placed on a judge's purview under the Act but that the power to suspend a judge from all judicial functions is not (constitutionally) one of them.  "[H]aving a framed commission on the wall while being unable to exercise any powers granted by that very commission, is meaningless," the brief asserts in making its distinction between the question of the length of the suspensions a judicial council is entitled to impose to be constitutional (and the mere fact that Judge Newman technically still has her seat is not enough; "the Constitution 'deals with substance, not shadows'" the brief asserts, citing  Cummings v. Missouri, 71 U.S. (4 Wall.) 277, 325 (1867).  And distinguishing McBryde, the brief concedes that "an act of Congress that authorizes some forms of judicial intra-branch discipline (e.g., censure, reprimand, or diminution of caseload) does not raise the same constitutional concerns."

Further on this point, the brief rebuts what it terms the "parade of horribles" in the Responsive brief with regard to the purported negative consequences that would ensue should the Court agree with Judge Newman on the merits (which is somewhat illuminating reading but not particularly germane to the issues here).  But in this portion of the brief Judge Newman takes the opportunity to address the argument that disabled judges would not be able to be divested of their office by, first, stating that "this simply reflects the Constitution's limits on the power of the Judicial Council," and second that while "not ideal circumstances "the Constitution, for better or worse, placed the determination of when to step down from the bench in the hands of the judge herself and of Congress as a backstop—not in a judge's colleagues' hands" (while noting in an aside that Judge Newman is not a disabled judge).

Finally, the brief addresses and rebuts the Judicial Council's argument that the interpretation of the Act they advance does not threaten judicial independence.  In this regard, the brief cites Northern Pipeline Construction Co. v. Marathon Pipe Line Co. that "[t]he guarantee of life tenure insulates the individual judge from improper influences not only by other branches but by colleagues as well and thus promotes judicial individualism," 458 U.S. 50, 59 n.10 (1982) (emphasis in brief).

On Judge Newman's second line of argument, the brief makes short work of the argument in the Responsive brief that Judge Newman's suspension is only temporary.  The brief argues that suspensions by judicial councils are not empowered to "induce compliance" as the Responsive brief contends.  Instead, the Act empowers a judicial council to impose suspensions as remedies for past conduct, and Judge Newman notes that the Judicial Council in this case has itself "abjured the claim that Judge Newman's suspension is meant to be 'coercive.'"  The brief uses the case of Judge John Adams to illustrate the distinctions, wherein while Judge Adams was required to be subject to a psychiatric exam the suspension imposed was "without any possibility of renewal," In re Complaint of Judicial Misconduct, No. 06-13-90009 (6th Cir. Judicial Council, June 27, 2018).  The brief also reminds the Court (or brings to its attention) the fact that "even before the formal disciplinary process against Judge Newman began, Chief Judge Moore demanded Judge Newman's resignation."  "The entire history of this process shows that Defendants-Appellees have already concluded that Judge Newman has no place on the bench and they are willing to remove her irrespective of what medical evidence shows," the brief asserts.

The brief then sets forth an expanded version of the argument that the McBryde precedent does not stand for what the Responsive brief would have the Court believe that it does.  The legal principle upon which Judge Newman continues to rely is that the existence of "intervening authority" (here, the reservation enunciated in footnote 5 of McBryde) relieves this panel from being bound by McBryde under Carpenters Loc. Union No. 26 v. U.S. Fid. & Guar. Co., 215 F.3d 136, 141 (1st Cir. 2000).

Finally, the brief turns to Judge Newman's due process arguments, colorfully addressing the Responsive brief's reliance on Judge Newman's opportunity to proffer her arguments by stating "Even Soviet justice permitted attorney arguments" in response.  What due process requires, Judge Newman argues, is "a neutral and detached judge in the first instance," citing Concrete Pipe & Prods. of Cal., Inc. v. Constr. Laborers Pension Tr. for S. Cal., 508 U.S. 602, 617 (1993) (quoting Ward v. Village of Monroeville, 409 U.S. 57, 61-62 (1972)), which has not been available to Judge Newman according to her brief.  The brief rebuts the assertion that the misconduct allegations are predicated on Judge Newman's failure to comply by reminding the Court that "the reason Judge Newman has declined to cooperate is precisely because the evaluation of any medical report would be done by people who are, by their own admission, witnesses to the underlying allegations" (emphasis in brief).  The basis for this situation has been the unprecedented insistence by this Judicial Council to retain jurisdiction over this matter instead of transferring it to a judicial council in another Circuit, she argues.  The reasonableness of Judge Newman's request for transfer and the importance of the due process implications are illustrated in the brief by the history of such proceedings in other circuits and the behavior (recusal) of judges in similar circumstances as the judges on the Federal Circuit's judicial council here.  "The unprecedented nature of these proceedings, overseen by judges who are also witnesses, weighs heavily in favor of their unlawfulness," this brief strongly argues.

The saga continues.

By Kevin E. Noonan —

The Federal Circuit heard oral argument in Auribundo's appeal of the district court's decision in favor of plaintiff Merck, in a case captioned In re Sugammadex (alternatively, Aurobindo v. Merck Sharp and Dohme).  The issue before the Court is whether Patent Term Extension under 35 U.S.C. § 156 in a reissue patent should be calculated from the original grant date of a patent or from the grant date of a subsequent reissue (wherein the length of PTE can be significantly shorter if the latter date is chosen).  The panel consisted of Judges Dyk, Mayer, and Reyna.  Auribindo was represented by Eric Werlinger, Merck was represented by Danny Krinski, and Maureen Queler argued for the U.S. Patent and Trademark Office.

Auribundo's argument (methodically structured to go through the different sections of the statute at issue) was focused on the statutory text and in particular the meaning of the word "term" in 35 U.S.C. § 156 (the part of the Hatch-Waxman Act providing for patent term extension, PTE).  According to counsel, Congress enacted the PTE statute in the context of the reissue statute, arguing that patent law has contained statutory provisions for reissuing patents for 150 years.  Judge Dyk asked the first question (from what was a fairly hot bench) about the effects of the same claim being in the original patent and the reissue.  Specifically, Judge Dyk wanted to know why such a reissue patent should be treated any differently if there had been no change in the claim to the approved product.  Judge Dyk called it counter-intuitive that Congress would draft § 156(c) in such a way that it would make a difference, and Counsel argued that Congress was aiming for the statute to have a "bright line" definition without getting into "claim-by-claim" analysis.  Judge Dyk, sounding somewhat incredulous asked if Aurobindo's position was that "you could lose your PTE in a reissue even if the same claim [for the approved product] survived reissue"?  Counsel hied back to the statutory language, seeming to hint that "policy reasons" for Congress intending the answer to Judge Dyk's question to be "no" could not trump the plain meaning of the statute.  On the question of losing patent term, Counsel argued that Merck delayed ("a number of years") in filing for reissue even though they knew "full and well" that their patent did not contain the species claim for which the reissue was filed.  Judge Dyk found those answers not to be responsive to his question of why Congress would want two different outcomes for PTE between the original patent and its reissue.  Counsel's response was that this wasn't want Congress wanted, but rather to establish a "single regime" that would accommodate all patents applying for PTE.

Counsel returned to his theme that policy should not be a determinant, and instead that the Court should look to the plain meaning of the statute.  Judge Dyk noted that the plain meaning of § 156(a) for the term to be extended could refer to the term of the original patent.  Judge Dyk pressed counsel to get an answer to his question, and counsel argued that the word "original" refers to the situation before PTE is applied not before the patent was reissued.  Judge Dyk interrupted this argument with a direct assertion that "you would lose" if the § 156(a) definition of "term" was directed to the original patent.  "Not necessarily true" was counsel's response, based on the idea that what is meant is "when do we start counting" (presumably the time lost for which PTE is earned).

Counsel then referred to Merck's argument that the term of the reissue incorporated the term of the original patent and made three responsive arguments.  First, that Section 251 recites that the reissue patent takes the unexpired part of the term of the original patent ("a piece of it, not the whole thing"), and if Congress intended the reissue to take the entire term they could have said so (but they didn't).  Second, Section 251(c) incorporated Sections 151 through 154, and Section 154 defines when the term begins, i.e., the issue date.  Third, that the issue date of a reissue patent is a "legally distinct and meaningful moment" based on Section 252 (that provides that date to be when the reissue patent "takes effect").

Moving on to Section 252, counsel explicated how the Federal Circuit had earlier addressed the section.  He said, "PTE is not granted in litigation," and Judge Dyk reminded counsel that Sections 251 and 252 were enacted "long before" Section 156, so why not interpret Section 156 on its own terms?  Counsel argued context:  that Congress was aware of Sections 251 and 252 and the "mechanics" of reissuing patents when it enacted Section 156.  Counsel characterized how Congress has behaved regarding the interactions of the reissue statute and Section 156 as being "purposeful silence."  This silence is meaningful, counsel argued, and reading the statute as Merck asserts would violate canons of construction regarding the meaning of the word "issue" in the various sections.

Judge Reyna asked about the possibility of "absurd" results?  Counsel did so with relish, speaking about the circumstances under which PTE could be lost by minor differences (a matter of days) resulting in 5 years of PTE or none at all.  Counsel embraced these possibilities, asserting that such outcomes are not uncommon in patent law, here as a consequence of a purported "bright line" drawn by the statute regarding PTE.  These possibilities are not sufficient to deviate from the "otherwise" plain text of the statute according to Aurobindo's counsel.  Judge Reyna stated that the statute is not plain and counsel disagreed, asserting that neither Merck nor the PTO has identified a "facial ambiguity" in the text of the statute.  Judge Dyk disagreed, returning to Section 156(a) as referring to the "term of the patent" phrase clearly referring to the original patent.  Counsel attempted to rely on Section 156(f) for a definition of the term "patent" but Judge Dyk did not agree that the definition helped.

Finally, counsel turned to Section 156(c) because in applying it the phrase "the term of the patent eligible for extension" cannot refer to the original patent because it no longer existed when PTE was obtained for the reissue patent.  Counsel also brought up the situation where a broadening reissue is obtained where the claim or claims relevant to the approved product was first obtained in such a reissue; this would create a problem, which Judge Dyk dismissed as not being eligible for extension.

Counsel for Merck (who underwent much less questioning by the panel) addressed the argument that Merck is attempting to avoid the statutory text, specifically with regard to Sections 251 and 252.  Judge Reyna asked why the Court should reference the original patent where the claims are "dead" under Section 252.  Counsel argued that the original patent's claims are dead but the reissued patent is essentially the same regarding the claims that recite the approved drug product.  Judge Reyna noted that the statute does not recite the "claims" but rather the "patent."  Counsel argued that Section 251 ("reissuing a/the patent") indicates that the statute is referring to "one and the same patent with one and the same term."  Considering a patent that claimed a drug under FDA review and was subject to effective loss of patent term thereby and then reissued, this "one and the same" interpretation is the only interpretation that gives a sensible result under the Hatch-Waxman Act, counsel argued.

Counsel obliquely answered the allegation by Aurobindo's counsel of Merck's delay being strategically intentional by noting that the decision in In re Tanaka clarified the opportunity for reissue under these circumstances and prompted its filing.  He also emphasized that the original patent and the reissue had a claim (claim 4) unaffected by the reissue that encompassed the approved drug.  Nor should the fact that the patent was reissued prior to FDA approval and PTE length determination make any difference according to counsel, confirmed by Sections 251 and 252 (which referred to a single term that remains the same term).  When beginning to address the effect on litigation under Section 252, Judge Dyk interrupted, saying "well, it isn't litigation"; when counsel disagreed, the Judge went on to say "not the kind of litigation [Congress] was talking about" when the statute was enacted.  Counsel mentioned in response that filing the ANDA and filing the complaint in response thereto occurred after the reissue, and thus the intervening rights provisions of Section 252 "compels that the claims be treated as if they had been present all along" (further supported by the "continuous effect clause" in the statute).

Another issue counsel addressed was the effect of a broadening reissue, which he was careful to emphasize (again) was not the case here (nor does Merck advocate for PTE under such circumstances).  Counsel also mentioned that this situation had not arisen in any of the ~40 cases where reissue applications were the basis for PTE request, and that (perhaps) Section 156(a) was the more appropriate section of the statute to consider when deciding this question.  In response to counsel's assertion that under these circumstances the court need not address this issue here, Judge Dyk disagreed, saying that the Court's decision must take this into account ("we [can't] view this with blinders on") and counsel was quick to say "if the court wishes to decide [that question] it should result in affirmance either way" under both Sections 156(a) and 156(c).  And this interpretation was also supported by the "continuous effect" clause under Section 252, he reiterated, under circumstances as here "where there is a substantially identical claim" that survived the reissue.  And here, the change effected by the reissue was not a change to the claim the encompassed the drug.

Turning to policy, counsel argued there was no "gamesmanship" involved due to the timing of the reissue request being recognition after Tanaka that Merck could so seek it.  Also to be considered according to counsel was that at the date of the reissue request filing the drug had not been approved, no one knew how long FDA review would take or if it would be approved at all.  Further, without drawing the court's attention to this being an absurd result, counsel suggested that it would be unlikely that Congress intended that the "relative ordering" of reissue and FDA approval should make a difference of whether PTE was curtailed by that ordering ("it doesn't make any sense" otherwise), if only because neither when FDA review is completed nor the date the PTO grants the reissue patent was within the patentee's control.  Counsel also asserted that Section 156 is an remedial statute to enable patentees to recover lost term for patents reciting claims to the approved drug.

Finally, counsel addressed the argument that a reissue patent needed to be treated as a different patent than the original patent because the latter is "dead."  Counsel contends that the "dead" case law stems from Seattle Box Co. v. Indus. Crating Packing, which also says "the statute permits the claims in the reissue to reach back to the claims in the original" provided that those claims are identical (i.e., unchanged by the reissue proceedings).

Ms. Queler, arguing for the U.S. Patent and Trademark Office, began a strong presentation by saying that, taken in the context of the Patent Act as a whole, the "issue date" used in determining patent term adjustment under Section 156 is best interpreted under Sections 251 and 252 as the date the original patent was issued.  As Merck's counsel had argued, the PTO interprets Section 252 to require that a reissue patent has "the same effect" as the original patent.  Judge Dyk once again stated his uncertainty regarding his view that Section 252 does not relate to PTE because that section was enacted well before Section 156.  PTO counsel addressed this argument by saying it is counterintuitive (it "doesn't make sense") to assess the patent term in an administrative procedure differently than in litigation involving such a patent.  She cited Section 251 to require that a reissue expires on the same date (pre-AIA, 17 years from issue) as the original patent.  Everything, she stated, is tied to the original patent and it "would simply not make sense" to under these statutory provisions to have the expiration date be derived from a different date.

For the PTO, she argues, the paradox raised by Aurobindo's calculus is that a patentee would be entitled to less PTE as the amount of FDA delay increases.  This is nonsensical; if Merck had waited to file its reissue patent until after FDA approval, they would have been entitled to the full PTE to which they were entitled.  The best reading is to use the original patent issue date according to the PTO.

Judge Reyna asked whether it is the case that these instances are rare, and counsel agreed that they are, saying that there had been only about 40-50 instances responsive to questions from Judge Reyna and that that in almost all such cases the PTO had used the original patent issue date for determining PTE.

A line of questioning arose that was to some extent amusing and illustrates how delving deeply into these questions can obscure a simple solution.  Judge Dyk asked about the situation where a claim for the approved drug product is cancelled in reissue.  This question was because Section 156 is concerned with patents and not claims, could the reissue patent still be entitled to PTE even though it no longer (due to reissue) recited a claim encompassing the approved drug product?  Counsel responded by reminding the Court that Section 156(a) requires a patent requesting PTE to be only one "which claims a product," so such a reissue patent would not be entitled to PTE.  The Judge was concerned about an original patent having a claim that encompassed the approved drug product being granted PTE but then cancelling that claim upon reissue.  Counsel addressed the situation where PTE was obtained before the reissue occurs, but Judge Dyk asked about the situation where the reissue happens before PTE is granted.  The Judge believes the construction of Section 156 needs to accommodate such a circumstance to ensure that a reissued patent that had a claim or claims that encompassed the drug product, but cancelled any/all claims that encompassed the approved drug, is not entitled to and does not get PTE.  Counsel responded that PTE could not be obtained for a patent that does not encompass the approved drug product.  Judge Dyk then asked counsel to confirm that if PTE was applied for after the reissue that cancelled all drug-related claims such PTE would be denied and asked her how to get to that outcome under the language of the statute.  Counsel again resorted to Section 156(a), but the Judge said that would be the case for a new claim (i.e., in a broadening reissue).  PTO counsel also stated that the Office does not have a policy on this scenario because it has never arisen (it is theoretical and highly unlikely in practice).  She suggested that such an unlikely eventuality should not motivate changes in statutory interpretation of Sections 251 and 252 that would have the consequences discussed in this case.

Stepping back, it seems evident that this scenario is a tempest in a teapot (however entertaining).  Any patent (reissue or not) no longer reciting any claim that encompasses the approved drug product could not be asserted in litigation (ANDA or otherwise) and would likely lead to an immediate and successful motion to dismiss, risking sanctions for asserting a patent where the patentee took affirmative steps to cancel the claims on the FDA-approved product and then tried to assert such a patent in litigation.  Moreover, such a patent could not be properly Orange Book listed for failure to satisfy the requirement that any Orange Book listed patent must recite claims to the drug product or methods for using the product to treat a disease, ailment, or disorder.  (The FTC had recently started a delisting campaign for improper listing, threatening sanctions, for listing patents for which the propriety of listing was much less uncertain than in the case argued here.)

Judge Reyna raised the possibility for gamesmanship — "shenanigans" — and asked whether the likelihood would increase if PTE was to be determined using the reissue date rather than the earlier date.  Counsel responded by speculating that the patentee could delay seeking a reissue (which would be contrary to the public interest in not disclosing the errors motivating the reissue) but wait until the original patent was granted PTE (which extension of term would remain with the reissue under the express terms of the statute).

On rebuttal, Aurobindo's counsel went through with increased vigor a number of issues raised by Merck and the PTO.  Counsel argued that the Court should recognize that the arguments raised by Plaintiff and amicus were not identical.  He also argued that the term "term" was not defined in the statute (at least expressly) and thus should be construed for the ordinary meaning (such as by using a dictionary definition).  He disputed Merck's position that the reissue and original patent are the same patent, citing Seattle Box for contrary precedent from the Federal Circuit (and unnamed Supreme Court precedent to the same effect).  He mentioned that Merck amended its complaint to recite the reissue patent and updated the Orange Book as evidence that Merck itself recognized they were not the same patent ("a different bundle of rights"); Judge Dyk interjected to mention that what Merck thought doesn't determine proper claim construction.  Counsel responded that Merck's opinion matters because it illustrates an attempt to obliquely provide an alternative definition for the term "issue" that Merck cannot give through a plain text analysis.  He also made the distinction that reissue is itself distinct from the original patent (which is what Congress wanted).  Judge Dyk interjected that it appeared Auribindo thinks that someone was thinking of these issues when the statutes were enacted and counsel responded that Congress is presumed to have done so.  Counsel also criticized the PTO's amended MPEP § 2766 for proposing that broadening reissue patents are entitled to the original patent issue date only if the original and reissue both recite claims to the drug product, which while sensible policy is, according to counsel, even further from the text of the statute.  Finally, counsel asserted that Skidmore deference is not appropriate, because using conventional canons of construction, the interpretive issues can be resolved and because the Office has not provided a coherent articulation for Section 156.

It would be imprudent for an observer to assert any definitive predictions regarding how the Federal Circuit will rule, but the tenor of the argument seems to have favored Merck's (and the PTO's) position.