`
`
`
`Respondent.
`
`v.
`
`AKORN, INC.,
`
`
`
`____________________
`
`ON PETITION FOR A WRIT OF CERTIORARI TO THE
`UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT
`
`____________________
`APPLICATION FOR EXTENSION OF TIME TO FILE
`A PETITION FOR A WRIT OF CERTIORARI
`____________________
`
`No. 18A-__
`
`IN THE
`Supreme Court of the United States
`____________________
`
`SENJU PHARMACEUTICAL CO., LTD. AND MITSUBISHI CHEMICAL CORPORATION,
`
`Petitioners,
`
`
`
`
`
`
`
`
`
`
`
`
`Lisa Pensabene
`Anton Metlitsky
` (Counsel of Record)
`Daniel O’Boyle
`O’MELVENY & MYERS LLP
`7 Times Square
`New York, N.Y. 10036
`(212) 326-2000
`ametlitsky@omm.com
`
`
`
`
`
`
`
`APPLICATION FOR EXTENSION OF TIME TO FILE A PETITION
`FOR A WRIT OF CERTIORARI
`To: Chief Justice John G. Roberts Jr., Circuit Justice for the United
`
`
`
`States Court of Appeals for the Federal Circuit:
`
`1.
`
`Under this Court’s Rules 13.5 and 22, Applicants Senju
`
`Pharmaceutical Co., Ltd. and Mitsubishi Chemical Corporation request an
`
`extension of thirty (30) days to file a petition for a writ of certiorari in this case.
`
`Their petition will challenge the decision of the Federal Circuit in Senju
`
`Pharmaceutical Co., Ltd. v. Akorn, Inc., 733 F. App’x 1024 (Fed. Cir. 2018), the
`
`slip copy of which is attached. App. 1-2. In support of this application,
`
`Applicants state:
`
`2.
`
`The Federal Circuit issued its opinion on August 8, 2018, and it
`
`denied a timely petition for panel rehearing and rehearing en banc on December
`
`11, 2018. App. 3-4. Without an extension, the petition for a writ of certiorari
`
`would be due on March 11, 2019. With the requested extension, the petition
`
`would be due on April 10, 2019. This Court’s jurisdiction will be based on 28
`
`U.S.C. § 1254(1).
`
`3.
`
`This case is a serious candidate for review, presenting two
`
`important and recurring questions of appellate procedure and patent law.
`
`
`
`a. Senju is a pharmaceutical company that invests significant
`
`resources in the research and development of innovative therapeutic products
`
`that address unmet medical needs in eye care. This case concerns its ’319
`
`patent, which covers DUREZOL (difluprednate ophthalmic emulsion), a topical
`
`1
`
`
`
`corticosteroid product for treating pain and inflammation associated with eye
`
`surgery and endogenous anterior uveitis (inflammation of the uveal tract, which
`
`lines the inside of the eye behind the cornea).
`
`
`
`At the time of the invention of the ’319 patent, patients recovering
`
`from ocular surgery were in need of a stable, safe, and effective anti-
`
`inflammatory medication that could be used topically in the eye without
`
`irritation. C.A. App. 219. There were various products on the market that were
`
`prescribed for this purpose, e.g., anti-inflammatory eyedrops such as Pred Forte
`
`and Econopred Plus, both prednisolone acetate suspensions. But these products
`
`were unstable. C.A. App. 270-271. In suspensions, the active ingredient,
`
`normally non-water soluble, remains in solid form but is suspended in liquid.
`
`When stored, the active in these suspensions would separate from the aqueous
`
`liquid in which it was suspended, such that the products required vigorous
`
`shaking, 40 shakes or more, before use. C.A. App. 269-271. Because patients
`
`typically do not follow shaking instructions, the amount of drug delivered by
`
`these products varies from dose to dose, with the initial dose containing a
`
`disproportionate amount of aqueous liquid compared to active, and later doses
`
`frequently delivering a higher concentration of the active. See C.A. App. 270-
`
`271.
`
`
`
`Senju scientists looking to solve this problem had a number of
`
`options for further research. First, they had to select an active ingredient.
`
`Despite numerous potential anti-inflammatory agents, Senju scientists chose
`
`2
`
`
`
`difluprednate, a potent corticosteroid known to increase intraocular pressure
`
`(“IOP”), a serious side effect. C.A. App. 246-247.
`
`
`
`Second, Senju had to select a formulation. The evidence shows
`
`there were many dosage forms at the time known to be suitable for ocular
`
`administration—suspensions, solutions, and ointments being the most
`
`prevalent. See C.A. App. 227. Consistent with the conventional wisdom for
`
`other actives, the prior art Kimura reference had proposed a difluprednate
`
`suspension. Emulsions, on the other hand, were known at the time to cause
`
`irritation due to high concentrations of surfactants, which caused heavy eye
`
`blinking and low bioavailability. See C.A. App. 229, C.A. App. 251. Moreover,
`
`the Ding reference had shown that cyclosporin, a known cyclic oligopeptide
`
`active, when
`
`formulated as a castor oil emulsion, showed
`
`increased
`
`bioavailability in the lacrimal gland (which difluprednate was not known to
`
`treat), while showing inferior bioavailability compared to other formulations in
`
`the conjunctiva, a tissue that difluprednate was known to treat. See C.A. App.
`
`555 (Kimura) (difluprednate treats conjunctiva, among other tissues); C.A. App.
`
`699 (Ding) (bioavailability test results show castor oil cyclosporin emulsion is
`
`inferior to other formulations in treating the conjunctiva and other surface eye
`
`tissues).
`
`
`
`Despite having little reason to choose a difluprednate emulsion
`
`based on the prior art, Senju scientists did just that, and compared its
`
`bioavailability against a difluprednate suspension, the formulation described in
`
`3
`
`
`
`the Kimura patent. C.A. App. 221, Patent Owner Response (“POR”) at 48.
`
`Senju unexpectedly discovered that its emulsion was non-irritating and that
`
`half the dose of its difluprednate emulsion increased bioavailability in the
`
`aqueous humor—located in the interior of the eye—by a factor of two. C.A. App.
`
`220-222. The emulsion therefore delivered four times the difluprednate
`
`compared to the suspension. C.A. App. 220-222, C.A. App. 455. This surprising
`
`result was summarized in a declaration by Kenichi Haruna, which was
`
`presented to the PTO during examination and was a basis for granting the ’319
`
`patent. C.A. App. 221-222.
`
`
`
`b. In April 2006, the ’319 patent was licensed in the United States
`
`to Sirion, which conducted clinical studies on DUREZOL, a difluprednate
`
`emulsion used as anti-inflammatory eyedrops after ocular surgery and to treat
`
`uveitis (a form of ocular inflammation). C.A. App. 986. After DUROZOL’s
`
`substantial success in the United States, Akorn filed an ANDA in December
`
`2014 seeking to copy DUREZOL. C.A. App. 218. Patent litigation followed in
`
`January 2015. C.A. App. 218-219. In May 2015, Akorn filed its IPR petition.
`
`C.A. App. 66-128. After considering Akorn’s Petition and Senju’s Preliminary
`
`Response, the Board instituted IPR2015-01205 to review the patentability of
`
`claims 1-4, 6-10, 12-14, and 18 of the ’319 patent. C.A. App. 194. On November
`
`22, 2016, the Board issued a Final Written Decision, ruling that those claims of
`
`the ’319 patent are obvious. C.A. App. 26.
`
`
`
`In the IPR, Akorn relied on (i) the Kimura patent’s teaching of a
`
`4
`
`
`
`difluprednate suspension to treat (among other tissues) the conjunctiva, and (ii)
`
`Ding’s teaching that cyclosporin shows enhanced delivery to the lacrimal gland
`
`but poor delivery to the conjunctiva using an emulsion. C.A. App. 5-7, C.A. App.
`
`10-12. Akorn argued that a person of ordinary skill in the art would have been
`
`motivated to combine this prior art because (i) suspensions generally were
`
`understood to exhibit poor dose uniformity and bioavailability, and (ii) Ding
`
`purportedly showed that these problems could be solved by migrating any non-
`
`water-soluble anti-inflammatory active agent—including steroids, even though
`
`the active in Ding was not a steroid—from suspensions to a castor oil emulsion.
`
`C.A. App. 96-103.
`
`
`
`In response, Senju presented substantial evidence that a
`
`hypothetical artisan of ordinary skill at the time of the invention would not
`
`have been motivated to combine the Kimura and Ding references on which
`
`Akorn relied. Crucially, however, Senju did not limit is presentation to such
`
`evidence. Rather, Senju also presented real-world evidence of non-obviousness.
`
`
`
`For example, Senju presented general objective evidence of non-
`
`obviousness, including the unexpected results and industry praise described
`
`above. See POR at 44-48 and 55-57. Particularly relevant here, Senju also
`
`presented evidence to specifically rebut Akorn’s theory of obviousness—viz.,
`
`that at the time of the invention, the skilled artisan would have understood that
`
`steroid eye drops formulated as suspensions generally suffered from dose
`
`uniformity and biovailability problems, and that it would have been obvious
`
`5
`
`
`
`that these problems could be solved simply by migrating the active steroid from
`
`a suspension to an emulsion. This objective evidence rebutting Akorn’s theory
`
`of obviousness fell into two categories.
`
`
`
`First, Senju presented evidence that, as a matter of fact, industry
`
`actors in the real world routinely continue to formulate steroid eye drops as
`
`suspensions, and do not formulate them as emulsions, suggesting that an
`
`emulsion steroid formulation was far from obvious. POR at 13-15. Second,
`
`Senju presented evidence that Akorn’s own expert had invented “an ophthalmic
`
`formulation containing both loteprednol etabonate [a steroid] and cyclosporine
`
`(a non-steroid),” and “filed a patent application on gel formulations for the
`
`combination product, not emulsion formulations,” POR at 16, explaining that if
`
`Akorn’s own expert invented a steroid eye drop without thinking of formulating
`
`it as an emulsion, that is real-world evidence that hypothetical artisan at the
`
`time of the invention would not have been motivated to do so.
`
`
`
`c. On November 22, 2016, the Board issued a Final Written
`
`decision, ruling that the claims of the ’319 patent are obvious over the
`
`combination of Kimura and Ding. C.A. App. 26. Among numerous other errors,
`
`the Board did not even mention, let alone consider, the categories of objective,
`
`real-world evidence of non-obviousness discussed above—namely, actual
`
`practice in the industry and Senju’s own expert’s patent.
`
`
`
`d. The court of appeals affirmed the Board’s decision without
`
`opinion the morning after oral argument, citing Federal Circuit Rule 36.
`
`6
`
`
`
`4.
`
` The Federal Circuit’s decision raises two important questions for
`
`this Court. The first is whether the Federal Circuit’s continued practice of
`
`affirming Board orders without opinion under its Rule 36 violates 35 U.S.C.
`
`§ 144, which requires that court to issue a “mandate and opinion” for every
`
`appeal from the Patent Office. (Emphasis added). The second is whether the
`
`Board (or any other factfinder) must consider all objective evidence of non-
`
`obviousness in determining whether a patent is invalid for obviousness.
`
`
`
`The Rule 36 question. Ever since the advent of inter partes review
`
`under the America Invents Act, the Federal Circuit has formed a well-
`
`recognized habit of failing to issue opinions in appeals from Board decisions,
`
`and instead relying on Federal Circuit Rule 36 to affirm such decisions in a
`
`cursory order without opinion. Indeed, in recent years, the Federal Circuit has
`
`resolved more appeals arising from the Patent Office without opinion than with
`
`opinion. See Jason Rantanen, Data of Federal Circuit Appeals and Decisions,
`
`PatentlyO (June 2, 2016), https://patentlyo.com/patent/2016/06/circuit-appeals-
`
`decisions.html. And that is so not only in cases that raise purely factual
`
`questions, but also in cases (such as this one) presenting pure legal issues,
`
`which are reviewed de novo.
`
`That practice is not only harmful to litigants and to the patent system,
`
`but violates a statutory mandate in 35 U.S.C. § 144 to issue opinions in appeals
`
`from the Patent Office. Under Federal Circuit Rule 36, the court of appeals
`
`permits itself to “enter a judgment of affirmance without opinion.” Fed. Cir. R.
`
`7
`
`
`
`36. But Congress expressly prohibits that practice in appeals from the Patent
`
`Office. In 35 U.S.C. § 144, Congress directed the Federal Circuit to “issue to the
`
`Director [of the Patent Office] its mandate and opinion, which shall be entered
`
`of record in the Patent and Trademark Office and shall govern the further
`
`proceedings in the case.” (Emphasis added). The Federal Circuit’s practice of
`
`nevertheless issuing judgments of affirmance “without opinion,” Fed. Cir. R. 36,
`
`in appeals from the Patent Office—and, indeed, doing so in a majority of such
`
`appeals—flatly violates that congressional mandate. And because the Federal
`
`Circuit has shown itself to be wedded to this extra-statutory practice, only this
`
`Court’s review can bring the Federal Circuit’s approach to Patent Office
`
`Appeals back in line with the governing statutory scheme.
`
`
`
`The objective-evidence-of-non-obviousness question. The second
`
`question presented is whether a fact-finder such as the Board is required to
`
`consider all objective evidence of non-obviousness when considering a patent’s
`
`validity.
`
`The Board here failed entirely to consider the two categories of objective
`
`evidence of non-obviousness described above. First, the Board did not even
`
`acknowledge, let alone evaluate, Senju’s showing that in the real world,
`
`industry participants that market steroid eye drops mostly formulate them as
`
`suspensions, and no one (other than Senju’s licensee) formulates steroid eye
`
`drops as an emulsion. If, as Akorn posits, it was obvious that suspensions’
`
`bioavailability problems could be solved by migrating the active steroid to an
`
`8
`
`
`
`emulsion, then others would have done so. The fact that no one has is highly
`
`probative evidence contradicting Akorn’s theory of obviousness.
`
`So too is Senju’s evidence that Akorn’s own expert failed to propose an
`
`emulsion formulation in a patent application for a combination steroid and
`
`cyclosporin eye drop, even though the patent application describes Ding in its
`
`specifications (including that Ding proposed a cyclosporin emulsion in
`
`particular). Akorn’s theory is that a hypothetical artisan looking at Ding would
`
`think it obvious to formulate steroid eye drops as emulsions. Yet the evidence is
`
`undisputed that Dr. Xia—an actual artisan—considered Ding and did not
`
`propose an emulsion formulation. Again, this is highly probative, objective
`
`evidence of non-obviousness, and the Board’s failure to even acknowledge it, let
`
`alone consider it, was flatly contrary to this Court’s established precedent.
`
`
`
`
`
`The court of appeals apparently accepted Akorn’s argument on
`
`appeal that the evidence just described fell within none of the traditionally
`
`named “secondary considerations” that are often raised and evaluated in
`
`obviousness cases, “such . . . as commercial success, long felt but unsolved
`
`needs, failure of others, etc.” Graham v. John Deere Co., 383 U.S. 1, 17-18
`
`(1966). That position conflicts directly with this Court’s decision in KSR
`
`International Co. v. Teleflex Inc., 550 U.S. 398 (2007). The traditional
`
`“secondary factors” come up most often because they are potentially relevant in
`
`every case—for example, a product’s commercial success is always probative
`
`(though not always dispositive) evidence of innovation. But sometimes, a
`
`9
`
`
`
`particular form of evidence will only be relevant because it bears directly on a
`
`challenger’s particular theory of obviousness. That kind of evidence is just as
`
`much of an objective guard against hindsight bias as the more common
`
`“secondary considerations,” and a factfinder like the Board is just as obligated
`
`to consider it before ruling on obviousness. That is why this Court expressly
`
`held that a factfinder must “look at any secondary considerations that would
`
`prove instructive.” KSR, 550 U.S. at 415 (emphasis added). The Federal
`
`Circuit’s failure to apply that established rule warrants this Court’s review.
`
`5.
`
`This application for a 30-day extension seeks to accommodate
`
`Applicants’ legitimate needs.
`
` Appellants’ internal and mutual review,
`
`deliberations and decisions to seek this Court’s review were within the last two
`
`weeks. No prejudice to Akorn would arise from the short extension. In light of
`
`counsel’s many other obligations—including an oral argument in New York
`
`appellate court on March 5, 2019, in Century Indemnity Corp. v. Brooklyn
`
`Union Gas (N.Y. App. Div. No. 2018-3023), an amicus curiae brief due in this
`
`Court on March 8, 2019, in Rucho v. Common Cause, No. 18-422, and a brief
`
`due on March 12, 2019 in the California Court of Appeal in Chevron U.S.A., Inc.
`
`v. County of Monterey (Cal. App. No. H045791)—and the complex record
`
`involved in this case, counsel would not be able to adequately prepare a petition
`
`for certiorari raising the important questions discussed above by the current
`
`due date.
`
`6.
`
`For these reasons, Applicants request that the due date for their
`
`10
`
`
`
`petition for a writ of certiorari be extended to April 10, 2019.
`
`
`
`
`
`
`11
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Dated: February 28, 2019
`
`
`Respectfully submitted,
`
`By: /s/ Anton Metlitsky
`
`Lisa Pensabene
`Anton Metlitsky
` (Counsel of Record)
`Daniel O’Boyle
`O’MELVENY & MYERS LLP
`7 Times Square
`New York, N.Y. 10036
`(212) 326-2000
`ametlitsky@omm.com
`
`
`
`12
`
`
`
`No. 18A-__
`
`IN THE
`Supreme Court of the United States
`____________________
`
`SENJU PHARMACEUTICAL CO., LTD. AND MITSUBISHI CHEMICAL CORPORATION,
`
`Petitioners,
`
`
`v.
`
`AKORN, INC.,
`
`
`
`
`____________________
`CORPORATE DISCLOSURE STATEMENT
`____________________
`
`
`
`
`
`Respondent.
`
`
`
`Petitioners are Senju Pharmaceutical Co., Ltd. and Mitsubishi Chemical
`
`Corporation. The following corporate disclosure statement is provided in
`
`accordance with S. Ct. R. 29.6. Petitioner Senju Pharmaceutical Co., Ltd. is a
`
`non-governmental corporate party to this action. Senju has no parent
`
`corporation and no company owns 10% or more of its stock. Petitioner
`
`Mitsubishi Chemical Corporation is a non-governmental corporate party to this
`
`action. Mitsubishi is a wholly owned subsidiary of Mitsubishi Chemical
`
`Holdings Corp.
`
`
`
`
`
`
`13
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Dated: February 28, 2019
`
`
`Respectfully submitted,
`
`By: /s/ Anton Metlitsky
`
`Lisa Pensabene
`Anton Metlitsky
` (Counsel of Record)
`Daniel O’Boyle
`O’MELVENY & MYERS LLP
`7 Times Square
`New York, N.Y. 10036
`(212) 326-2000
`ametlitsky@omm.com
`
`
`
`14
`
`
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