EXHIBIT A
`
`

`

`Case: 17-1499 Document: 57-1 Page: 1 Filed: 12/22/2017
`UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT
`
`(1 of 12)
`
`NOTICE OF ENTRY OF
`JUDGMENT ACCOMPANIED BY OPINION
`
`OPINION FILED AND JUDGMENT ENTERED: 12/22/2017
`
` The attached opinion announcing the judgment of the court in your case was filed and judgment was entered on
`the date indicated above. The mandate will be issued in due course.
`
` Information is also provided about petitions for rehearing and suggestions for rehearing en banc. The questions
`and answers are those frequently asked and answered by the Clerk's Office.
`
` No costs were taxed in this appeal.
`
` Regarding exhibits and visual aids: Your attention is directed Fed. R. App. P. 34(g) which states that the clerk
`may destroy or dispose of the exhibits if counsel does not reclaim them within a reasonable time after the clerk gives
`notice to remove them. (The clerk deems a reasonable time to be 15 days from the date the final mandate is issued.)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`FOR THE COURT
`
`
`/s/ Peter R. Marksteiner
`Peter R. Marksteiner
`Clerk of Court
`
`
`
`17-1499, 17-1500, 17-1558, 17-1559 - Allergan Sales, LLC v. Sandoz, Inc.
`United States District Court for the Eastern District of Texas, Case Nos. 2:15-cv-00347-JRG, 2:12-cv-00207-JRG
`
`

`

`Case: 17-1499 Document: 57-2 Page: 1 Filed: 12/22/2017
`
`(2 of 12)
`
`NOTE: This disposition is nonprecedential.
`
`United States Court of Appeals
`for the Federal Circuit
`______________________
`
`ALLERGAN SALES, LLC,
`Plaintiff-Cross-Appellant
`
`v.
`
`SANDOZ, INC., ALCON LABORATORIES, INC.,
`ALCON RESEARCH, LTD.,
`Defendants-Appellants
`______________________
`
`2017-1499, 2017-1500, 2017-1558, 2017-1559
`______________________
`
`Appeals from the United States District Court for the
`Eastern District of Texas in Nos. 2:12-cv-00207-JRG,
`2:15-cv-00347-JRG, Judge J. Rodney Gilstrap.
`______________________
`
`Decided: December 22, 2017
`______________________
`
`JONATHAN ELLIOT SINGER, Fish & Richardson, PC,
`
`San Diego, CA, argued for plaintiff-cross-appellant. Also
`represented by SUSAN E. MORRISON, ROBERT M. OAKES,
`Wilmington, DE; DEANNA JEAN REICHEL, Minneapolis,
`MN.
`
`JOHN C. O’QUINN, Kirkland & Ellis LLP, Washington,
`
`DC, argued for defendants-appellants. Also represented
`
`

`

`Case: 17-1499 Document: 57-2 Page: 2 Filed: 12/22/2017
`
`(3 of 12)
`
`
`
` 2
`
` ALLERGAN SALES, LLC v. SANDOZ, INC.
`
`by SEAN M. MCELDOWNEY, CALVIN ALEXANDER SHANK;
`BRYAN SCOTT HALES, Chicago, IL.
`______________________
`
`Before MOORE, MAYER, and HUGHES, Circuit Judges.
`
`HUGHES, Circuit Judge.
`
`Allergan Sales, LLC sued generic drug manufacturers
`under the Hatch-Waxman Act, alleging infringement of
`U.S. Patent Nos. 7,030,149, 7,320,976, and 8,748,425.
`The U.S. District Court for the Eastern District of Texas
`found the asserted claims not invalid but only claims of
`the ’425 patent infringed. We find no reversible error in
`the district court’s finding of no invalidity. Nevertheless,
`because we find that the accused proposed generic drug
`contemplates administering dosages of a specific composi-
`tion that is not claimed in any of the patents, we affirm-
`in-part and reverse-in-part.
`
`I
`
`Allergan holds the approved new drug application for
`Combigan®, which is used to lower intraocular pressure
`in
`glaucoma and
`ocular hypertension patients.
`Combigan® is a “fixed combination” ophthalmic solution
`consisting of 0.2% brimonidine tartrate and 0.68% timolol
`maleate for twice-daily dosage.
`
`Allergan claims that the ’149, ’976, and ’425 patents
`cover Combigan®. These patents share a common specifi-
`cation, which describes:
`(1) a “Brimonidine Tartrate
`0.20% (w/v)” and “Timolol Maleate 0.68% (w/v) (Equiva-
`lent to 0.50% (w/v) timolol)” pharmaceutical composition;
`and (2) a clinical study using that composition for twice
`daily administration. See, e.g., J.A. 347–50. In particu-
`lar, Allergan claims that claim 4 of the ’149 patent,
`claim 1 of the ’976 patent, and claims 1–8 of the ’425
`patent protect Combigan® and its administration.
`
`

`

`Case: 17-1499 Document: 57-2 Page: 3 Filed: 12/22/2017
`
`(4 of 12)
`
`ALLERGAN SALES, LLC v. SANDOZ, INC.
`
`3
`
`Claim 4 of the ’149 patent recites a method of reduc-
`ing the number of daily administrations of 0.2% brimoni-
`dine and 0.5% timolol in a single composition from three
`times a day to two times a day “without loss of efficacy.”
`J.A. 350.
`
`Claim 1 of the ’976 patent recites a method of admin-
`istering “a therapeutically effective amount” of composi-
`tion comprising 0.2% brimonidine and 0.5% timolol twice
`daily. J.A. 356.
`
`Claim 1 of the ’425 patent recites administering twice
`daily a single combination comprising 0.2% brimonidine
`tartrate and 0.5% timolol free base to “reduce[] the inci-
`dence of one or more adverse events” listed in the claim.
`J.A. 366. Claims 2–8 of the patent depend from claim 1,
`each specifically reciting only one of the adverse events
`enumerated in claim 1. Id.
`
`Sandoz, Inc., Alcon Laboratories, Inc., and Alcon Re-
`search, Ltd. (collectively, Sandoz) filed and maintained an
`abbreviated new drug application (ANDA) with the U.S.
`Food and Drug Administration, seeking its approval to
`market generic versions of Combigan®. Allergan sued
`Sandoz for direct, induced, and contributory infringement,
`asserting numerous patents in three different actions,
`only the last two of which proceeded to a consolidated
`bench trial on the ’149, ’976, and ’425 patents.
`
`The district court found the asserted claims of the pa-
`tents not invalid as obvious. The court also found that
`claim 4 of the ’149 patent satisfies the written description
`requirement. The court finally determined that Sandoz’s
`ANDA does not infringe claim 4 of the ’149 patent or
`claim 1 of the ’976 patent, but does infringe claims 1–8 of
`the ’425 patent.
`
`Sandoz appeals the district court’s no-invalidity and
`infringement determinations. Allergan cross-appeals the
`
`

`

`Case: 17-1499 Document: 57-2 Page: 4 Filed: 12/22/2017
`
`(5 of 12)
`
`
`
` 4
`
` ALLERGAN SALES, LLC v. SANDOZ, INC.
`
`finding of non-infringement. We have jurisdiction under
`28 U.S.C. § 1295(a)(1).
`
`II
`
`We review the district court’s legal determinations de
`novo and factual findings for clear error. Braintree Labs.,
`Inc. v. Novel Labs., Inc., 749 F.3d 1349, 1358 (Fed. Cir.
`2014). Obviousness is a question of law that we review de
`novo, and we review any underlying factual questions for
`clear error. Honeywell v. United States, 609 F.3d 1292,
`1297 (Fed. Cir. 2010). “Whether a claim satisfies the
`written description requirement is a question of fact that,
`on appeal from a bench trial, we review for clear error.”
`Alcon Res. Ltd. v. Barr Labs., Inc., 745 F.3d 1180, 1190
`(Fed. Cir. 2014). Infringement is a question of fact that
`we review for clear error. Id. at 1186.
`
`A
`
`Sandoz first argues that all asserted claims are inva-
`lid as obvious. A claim is invalid if, at the time the inven-
`tion was disclosed, a person having ordinary skill in the
`art would have found the patented invention obvious in
`light of the prior art. See 35 U.S.C. § 103; KSR Int’l Co. v.
`Teleflex, Inc., 550 U.S. 398, 415–16 (2007). But patents
`are presumed to be valid and overcoming that presump-
`tion requires clear and convincing evidence. 35 U.S.C.
`§ 282; Microsoft Corp. v. i4i Ltd. P’ship, 564 U.S. 91, 95
`(2011).
`
`The district court found the asserted claims not inva-
`lid as obvious, reasoning that Sandoz presented substan-
`tially the same arguments and evidence in an earlier
`dispute with Allergan in which we held that claim 4 of the
`’149 patent recited an efficacy limitation that is neither
`suggested nor inherent in any prior art in the record. J.A.
`74–76; see also Allergan, Inc. v. Sandoz Inc., 726 F.3d
`1286, 1293–94 (Fed. Cir. 2013). Relying on that preceden-
`tial decision, the court found that all asserted claims
`
`

`

`Case: 17-1499 Document: 57-2 Page: 5 Filed: 12/22/2017
`
`(6 of 12)
`
`ALLERGAN SALES, LLC v. SANDOZ, INC.
`
`5
`
`recited analogous efficacy limitations, neither suggested
`nor inherent in prior art produced by Sandoz. J.A. 163.
`
`Sandoz contends that the court erred because the as-
`serted claims merely recite the inherent results of admin-
`istering an obvious combination. We disagree. As we
`concluded in the earlier dispute regarding claim 4 of the
`’149 patent, the concomitant administration of brimoni-
`dine and timolol ophthalmic composition twice daily is
`obvious in view of the prior art. See J.A. 122–25; Aller-
`gan, 726 F.3d at 1294. Each asserted claim, however,
`expressly recites an additional efficacy limitation that
`further restricts the method of administering the compo-
`sition twice daily: (1) “without loss of efficacy” in claim 4
`of the ’149 patent, see J.A. 350; (2) “a therapeutically
`effective amount” in claim 1 of the ’976 patent, see J.A.
`356; and (3) “reduc[ing] the incidence of one or more
`adverse events” in claim 1 of the ’425 patent,1 see J.A.
`366. See also Allergan, 726 F.3d at 1293. Those efficacy
`limitations are not disclosed by any prior art reference in
`the record. To the contrary, the prior art shows that the
`combination dosed twice daily produces a loss of efficacy
`in the afternoon. J.A. 107–116; see also Allergan, 726
`F.3d at 1294. The efficacy limitations are also not inher-
`ent in the administration of the ophthalmic composition, a
`finding adequately supported by the record. See, e.g., J.A.
`2572–75, 3007–09, 3117–19, 3243–45. Accordingly, the
`asserted claims merely recite those administrations of the
`composition that satisfy the efficacy limitations—but not
`those that end up in, for example, a loss of efficacy, exam-
`ples of which abound in the prior art offered by Sandoz.
`
`In light of the foregoing, the district court did not err
`by finding that Sandoz failed to present clear and convinc-
`
`
`
`1 Claims 2–8 include similar limitations, but each
`claim specifically recites only one of the adverse events
`enumerated in claim 1. See J.A. 366.
`
`

`

`Case: 17-1499 Document: 57-2 Page: 6 Filed: 12/22/2017
`
`(7 of 12)
`
`
`
` 6
`
` ALLERGAN SALES, LLC v. SANDOZ, INC.
`
`ing evidence to overcome the presumption that the assert-
`ed claims are valid.
`
`B
`
`Sandoz next argues that claim 4 of the ’149 patent is
`invalid for lack of written description in the specification
`based on its expert testimony that the claim encompasses
`hundreds of brimonidine and timolol combinations.
`
`The written description requirement provides that a
`patentee’s application for a patent must “clearly allow
`persons of ordinary skill in the art to recognize that [he]
`invented what is claimed.” Ariad Pharm., Inc. v. Eli Lilly
`& Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc)
`(quoting Vas–Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563
`(Fed. Cir. 1991)). “[T]he test for sufficiency is whether the
`disclosure of the application relied upon reasonably
`conveys to those skilled in the art that the inventor had
`possession of the claimed subject matter as of the filing
`date.” Id. Relevant here, a sufficient description of a
`genus requires the “disclosure of either a representative
`number of species falling within the scope of the genus or
`structural features common to the members of the genus
`so that one of skill in the art can visualize or recognize the
`members of the genus.” Id. at 1350. Even a single repre-
`sentative embodiment can support written description of
`a claimed genus. See, e.g., Invitrogen Corp. v. Clontech
`Labs., Inc., 429 F.3d 1052, 1073 (Fed. Cir. 2005); Bilstad
`v. Wakalopulos, 386 F.3d 1116, 1124–25 (Fed. Cir. 2004).
`
`Claim 4 of the ’149 patent recites 0.2% brimonidine
`and 0.5% timolol. J.A. 350. Given the construction of the
`terms brimonidine and timolol to include their free base
`and salt forms, see J.A. 1594, 1597, the district court
`correctly credited Allergan’s expert testimony at trial that
`a person of ordinary skill in the art would have under-
`stood the claim to encompass only six possible combina-
`tions of brimonidine and timolol and their respective free
`base and salt forms, see J.A. 150—not, as Sandoz claims,
`
`

`

`Case: 17-1499 Document: 57-2 Page: 7 Filed: 12/22/2017
`
`(8 of 12)
`
`ALLERGAN SALES, LLC v. SANDOZ, INC.
`
`7
`
`hundreds of combinations. More critically, the specifica-
`tion discloses one of those six possible combinations, 0.2%
`brimonidine tartrate and 0.68% timolol maleate composi-
`tion. See J.A. 347. Tellingly, Sandoz’s expert failed to
`identify any additional composition beyond that particu-
`lar combination. J.A. 150–51. It was also undisputed at
`trial that the only salt of brimonidine available as of the
`filing of the ’149 patent was brimonidine tartrate and that
`only one salt of timolol actually available—timolol male-
`ate. J.A. 151–52. The specification therefore discloses a
`representative—indeed, the sole—embodiment of the
`claimed genus and a person of ordinary skilled in the art,
`reading the specification, would have immediately dis-
`cerned the claimed limitation. Accordingly, the district
`court did not err by finding that the claim satisfies the
`written description requirement.
`
`C
`
`Sandoz finally argues that the district court erred in
`finding infringement of claims 1–8 of the ’425 patent.
`Allergan asserted only literal infringement of those
`claims. “To establish literal infringement, every limita-
`tion set forth in a claim must be found in an accused
`product, exactly.” Advanced Steel Recovery, LLC v. X-
`Body Equip., Inc., 808 F.3d 1313, 1319 (Fed. Cir. 2015)
`(quoting Southwall Techs., Inc. v. Cardinal IG Co., 54
`F.3d 1570, 1575 (Fed. Cir. 1995)).
`
`The district court found that the proposed generic
`contains 0.5% timolol free base and therefore infringed
`the claims of the ’425 patent. J.A. 116–18, 158. That
`finding is erroneous for two related reasons. Claims 1–8
`are narrowly and specifically drawn, reciting administra-
`tion of 0.2% brimonidine tartrate and 0.5% timolol free
`base. J.A. 366. Both Combigan® and the proposed gener-
`ic, however, contain 0.68% timolol maleate, an ophthalmic
`compound distinct from 0.5% timolol free base. See, e.g.,
`J.A. 2786–87 (Sandoz’s expert explaining why the pro-
`
`

`

`Case: 17-1499 Document: 57-2 Page: 8 Filed: 12/22/2017
`
`(9 of 12)
`
`
`
` 8
`
` ALLERGAN SALES, LLC v. SANDOZ, INC.
`
`posed generic does not contain 0.5% timolol free base).
`The district court relied on the equivalency of the two
`compounds in finding literal infringement—that is, 0.5%
`timolol free base recited in claims 1–8 as chemically
`equivalent to 0.68% timolol maleate contained in the
`proposed generic. See J.A. 117, 158. Because chemical
`equivalency is not sufficient for literal infringement of
`these claims, the court clearly erred.
`
`The Hatch-Waxman Act provides for a technical in-
`fringement upon submission of an ANDA, but only “for a
`drug claimed in a patent.” 35 U.S.C. § 271(e)(2)(A). Here,
`Combigan® contains a 0.2% brimonidine tartrate and
`0.68% timolol maleate solution, as its FDA-approved label
`makes clear. J.A. 2310; see also J.A. 116–17. But claims
`1–8 of the ’425 patent expressly recite 0.5% timolol free
`base, not 0.68% timolol maleate. Therefore, as a matter of
`law, Combigan® is not the “drug claimed in” the ’425
`patent, and Sandoz’s ANDA does not infringe under
`§ 271(e)(2)(A). See also Warner-Lambert Co. v. Apotex
`Corp., 316 F.3d 1348, 1354 (Fed. Cir. 2003) (“[I]t is not an
`act of infringement to submit an ANDA for approval to
`market a drug for a use when neither the drug nor that
`use is covered by an existing patent.”).
`
`In sum, the district court erred by finding that Aller-
`gan showed literal infringement of claims 1–8 of the ’425
`patent.
`
`D
`
`Allergan argues on its cross-appeal that the district
`court erred in finding that Sandoz’s proposed generic does
`not infringe claim 4 of the ’149 patent and claim 1 of the
`976 patent. Allergan again asserted only literal in-
`fringement with respect to those claims. Both the claims
`specifically recite 0.2% brimonidine. But the proposed
`generic contains 0.2% brimonidine titrate, a distinct
`pharmaceutical compound
`that reduces
`to 0.132%
`brimonidine—indeed, Allergan’s expert confirmed so. J.A.
`
`

`

`Case: 17-1499 Document: 57-2 Page: 9 Filed: 12/22/2017
`
`(10 of 12)
`
`ALLERGAN SALES, LLC v. SANDOZ, INC.
`
`9
`
`2710–11; see also J.A. 117. As such, the district court did
`not err by finding that Allergan failed to show literal
`infringement of claim 4 of the ’149 patent and claim 1 of
`the ’976 patent.
`
`III
`
`We have considered remaining arguments and find
`them unpersuasive. Accordingly, we affirm the district
`court’s finding of no invalidity of the asserted claims and
`non-infringement of the claims of the ’149 and ’976 pa-
`tents, but reverse the finding of infringement of claim 1 of
`the ’425 patent.
`
`AFFIRMED-IN-PART AND REVERSED-IN-PART
`
`No costs.
`
`

`

`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Case: 17-1499 Document: 57-3 Page: 1 Filed: 12/22/2017
`
`(11 of 12)
`
`UNITED STATES COURT OF APPEALS
`FOR THE FEDERAL CIRCUIT
`Questions and Answers
`
`Petitions for Rehearing (Fed. Cir. R. 40)
`and
`Petitions for Hearing or Rehearing En Banc (Fed. Cir. R. 35)
`
`Q. When is a petition for rehearing appropriate?
`
`A. Petitions for panel rehearing are rarely successful
`because they most often fail to articulate sufficient grounds
`upon which to grant them. For example, a petition for panel
`rehearing should not be used to reargue issues already
`briefed and orally argued; if a party failed to persuade the
`court on an issue in the first instance, a petition for panel
`rehearing should not be used as an attempt to get a second
`“bite at the apple.” This is especially so when the court has
`entered a judgment of affirmance without opinion under
`Fed. Cir. R. 36. Such dispositions are entered if the court
`determines the judgment of the trial court is based on
`findings that are not clearly erroneous, the evidence
`supporting the jury verdict is sufficient, the record supports
`the trial court’s ruling, the decision of the administrative
`agency warrants affirmance under the appropriate standard
`of review, or the judgment or decision is without an error of
`law.
`
`Q. When is a petition for hearing or rehearing en banc
`appropriate?
`
`A. En banc decisions are extraordinary occurrences. To
`properly answer the question, one must first understand the
`responsibility of a three-judge merits panel of the court. The
`panel is charged with deciding individual appeals according
`to the law of the circuit as established in the court’s
`precedential opinions. While each merits panel is
`empowered to enter precedential opinions, the ultimate
`duty of the court en banc is to set forth the law of the
`Federal Circuit, which merit panels are obliged to follow.
`
`Thus, as a usual prerequisite, a merits panel of the court
`must have entered a precedential opinion in support of its
`judgment for a suggestion for rehearing en banc to be
`appropriate. In addition, the party seeking rehearing en
`banc must show that either the merits panel has failed to
`follow identifiable decisions of the U.S. Supreme Court or
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Federal Circuit precedential opinions or that the merits
`panel has followed circuit precedent, which the party seeks
`to have overruled by the court en banc.
`
`Q. How frequently are petitions for rehearing granted by
`merits panels or petitions for rehearing en banc accepted
`by the court?
`
`A. The data regarding petitions for rehearing since 1982
`shows that merits panels granted some relief in only three
`percent of the more than 1900 petitions filed. The relief
`granted usually involved only minor corrections of factual
`misstatements, rarely resulting in a change of outcome in
`the decision.
`
`En banc petitions were accepted less frequently, in only 16
`of more than 1100 requests. Historically, the court itself
`initiated en banc review in more than half (21 of 37) of the
`very few appeals decided en banc since 1982. This sua
`sponte, en banc review is a by-product of the court’s
`practice of circulating every precedential panel decision to
`all the judges of the Federal Circuit before it is published.
`No count is kept of sua sponte, en banc polls that fail to
`carry enough judges, but one of the reasons that virtually
`all of the more than 1100 petitions made by the parties
`since 1982 have been declined is that the court itself has
`already implicitly approved the precedential opinions before
`they are filed by the merits panel.
`
`Q. Is it necessary to have filed either of these petitions
`before filing a petition for certiorari in the U.S. Supreme
`Court?
`
`A. No. All that is needed is a final judgment of the Court of
`Appeals. As a matter of interest, very few petitions for
`certiorari from Federal Circuit decisions are granted. Since
`1982, the U.S. Supreme Court has granted certiorari in only
`31 appeals heard in the Federal Circuit. Almost 1000
`petitions for certiorari have been filed in that period.
`
`October 20, 2016
`
`

`

`Case: 17-1499 Document: 57-4 Page: 1 Filed: 12/22/2017
`
`(12 of 12)
`
`UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT
`
`INFORMATION SHEET
`
`FILING A PETITION FOR A WRIT OF CERTIORARI
`
`There is no automatic right of appeal to the Supreme Court of the United States from judgments
`of the Federal Circuit. You must file a petition for a writ of certiorari which the Supreme Court
`will grant only when there are compelling reasons. (See Rule 10 of the Rules of the Supreme
`Court of the United States, hereinafter called Rules.)
`
`Time. The petition must be filed in the Supreme Court of the United States within 90 days of the
`entry of judgment in this Court or within 90 days of the denial of a timely petition for rehearing.
`The judgment is entered on the day the Federal Circuit issues a final decision in your case. [The
`time does not run from the issuance of the mandate, which has no effect on the right to petition.]
`(See Rule 13 of the Rules.)
`
`Fees. Either the $300 docketing fee or a motion for leave to proceed in forma pauperis with an
`affidavit in support thereof must accompany the petition. (See Rules 38 and 39.)
`
`Authorized Filer. The petition must be filed by a member of the bar of the Supreme Court of the
`United States or by the petitioner representing himself or herself.
`
`Format of a Petition. The Rules are very specific about the order of the required information
`and should be consulted before you start drafting your petition. (See Rule 14.) Rules 33 and 34
`should be consulted regarding type size and font, paper size, paper weight, margins, page limits,
`cover, etc.
`
`Number of Copies. Forty copies of a petition must be filed unless the petitioner is proceeding in
`forma pauperis, in which case an original and ten copies of the petition for writ of certiorari and
`of the motion for leave to proceed in forma pauperis. (See Rule 12.)
`
`Where to File. You must file your documents at the Supreme Court.
`
`
`Clerk
`Supreme Court of the United States
`1 First Street, NE
`Washington, DC 20543
`(202) 479-3000
`
`No documents are filed at the Federal Circuit and the Federal Circuit provides no information to
`the Supreme Court unless the Supreme Court asks for the information.
`
`Access to the Rules. The current rules can be found in Title 28 of the United States Code
`Annotated and other legal publications available in many public libraries.
`
`Revised December 16, 1999
`
`
`