Case 0:15-cv-61631-JIC Document 245 Entered on FLSD Docket 07l18l'2016 Page 1 of 5
`
`UNITED STATES DISTRICT COURT
`
`SOUTHERN DISTRICT OF FLORIDA
`
`CASE NO. ‘I5-61631-CIV-COHNISELTZER
`
`(CONSOLIDATED WITH 15-62081 -CIV-COHNISELTZER)
`
`AMGEN INC. and AMGEN
`
`MANUFACTURING LIMITED,
`
`Plaintiffs,
`
`v.
`
`APOTEX INC. and APOTEX CORP.,
`
`Defendants.
`
`I
`
`PARTIAL FINDINGS REGARDING
`
`APOTEX’S ASSERTION OF INVALIDITY OF THE ’138 PATENT
`
`Apotex Inc. and Apotex Corp. (collectively, “Apotex") concluded its presentation
`
`of evidence on July ‘I4, 2016 in this nonjury, patent infringement matter.
`
`Plaintiffs
`
`Amgen Inc. and Amgen Manufacturing Limited (collectively, “Amgen”) have moved
`
`pursuant to Federal Rule of Civil Procedure 52(0) for partial findings on Apotex’s Fifth
`
`Affirmative Defense (Invalidity) and Second Counterclaim (Declaratory Judgment on
`
`Invalidity of the ’138 Patent) in each of Apotex’s Answers, Affirmative Defenses, and
`
`Counterclaims in this consolidated action (ECF Nos. 47, 64).
`
`In particular, Amgen
`
`moved for partial findings regarding Apotex’s claim that the ’138 Patent is invalid for
`
`anticipation, lack of written description,
`
`indefiniteness, and obviousness. Having “fully
`
`heard” Apotex pursuant to Rule 52(c), the Court hereby finds in favor of Amgen and
`
`against Apotex on each of these issues and makes the following partial findings of fact
`
`and conclusions of law.
`
`Amgen Exhibit 2004
`Apotex Inc. et 211. V. Amgen Inc. et aI., lPR2016-01542
`Page I
`
`
`
`UNITED STATES DISTRICT COURT
`
`SOUTHERN DISTRICT OF FLORIDA
`
`CASE NO. ‘I5-61631-CIV-COHNISELTZER
`
`(CONSOLIDATED WITH 15-62081 -CIV-COHNISELTZER)
`
`AMGEN INC. and AMGEN
`
`MANUFACTURING LIMITED,
`
`Plaintiffs,
`
`v.
`
`APOTEX INC. and APOTEX CORP.,
`
`Defendants.
`
`I
`
`PARTIAL FINDINGS REGARDING
`
`APOTEX’S ASSERTION OF INVALIDITY OF THE ’138 PATENT
`
`Apotex Inc. and Apotex Corp. (collectively, “Apotex") concluded its presentation
`
`of evidence on July ‘I4, 2016 in this nonjury, patent infringement matter.
`
`Plaintiffs
`
`Amgen Inc. and Amgen Manufacturing Limited (collectively, “Amgen”) have moved
`
`pursuant to Federal Rule of Civil Procedure 52(0) for partial findings on Apotex’s Fifth
`
`Affirmative Defense (Invalidity) and Second Counterclaim (Declaratory Judgment on
`
`Invalidity of the ’138 Patent) in each of Apotex’s Answers, Affirmative Defenses, and
`
`Counterclaims in this consolidated action (ECF Nos. 47, 64).
`
`In particular, Amgen
`
`moved for partial findings regarding Apotex’s claim that the ’138 Patent is invalid for
`
`anticipation, lack of written description,
`
`indefiniteness, and obviousness. Having “fully
`
`heard” Apotex pursuant to Rule 52(c), the Court hereby finds in favor of Amgen and
`
`against Apotex on each of these issues and makes the following partial findings of fact
`
`and conclusions of law.
`
`Amgen Exhibit 2004
`Apotex Inc. et 211. V. Amgen Inc. et aI., lPR2016-01542
`Page I
`
`
`
`Case 0:15-cv-81831-JIC Document 245 Entered on FLSD Docket 07r'18r'2018 Page 2 of 5
`
`STANDARD
`
`Rule 52(c) provides that "[i]f a party has been fully heard on an issue during a
`
`nonjury trial and the court finds against the party on that
`
`issue,
`
`the court may enter
`
`judgment against the party on a claim or defense that, under the controlling law, can be
`
`maintained or defeated only with a favorable finding on that issue.” Fed. R. Civ. P. 52(c). A
`
`Rule 52(c) motion is properly granted when a party presents “no evidence" in support of a
`
`claim or defense. See, e.g., Cueva v. Atistate ins. Co., 142 F.3d 442 (9th Cir. 1998).
`
`Further, courts grant “partial findings under Rule 52(0) with respect to .
`
`.
`
`. patent invalidity
`
`defense[s].” Eian Corp. v. Andrx Pharm., inc, No. 98-7164, 2008 WI. 4709251, at *8 (S.D.
`
`Fla. Aug. 13, 2008).
`
`Amgen’s "138 patent is presumed to be valid. 35 U.S.C. § 282. To prevail on any of
`
`its invalidity defenses, Apotex must provide clear and convincing evidence that Amgen's
`
`patent is invalid. See Finnigan Corp. v.
`
`int’! Trade Comm’n, 180 F.3d 1354, 1365 (Fed.
`
`Cir. 1999) (“The burden is on the party asserting invalidity to prove it with facts
`
`supported by clear and convincing evidence.” (citation and quotation marks omitted)).
`
`PAR11AL FINDINGS
`
`A.
`
`Anticipation
`
`Anticipation is a question of fact. Eli Lilly & Co. v. Zenith Goidline Pharms, inc,
`
`471 F.3d 1369, 1375 (Fed. Cir. 2006). A reference is anticipatory under § ‘l02(b) when
`
`it discloses each and every element of the claimed invention, whether it does so
`
`explicitly or inherently.
`
`id. The reference must “enable one of ordinary skill in the art to
`
`make the invention without undue experimentation.”
`
`impax Labs,
`
`inc. v. Avenfis
`
`Page 2
`
`
`
`Case 0:15-cv-61631-JIC Document 245 Entered on FLSD Docket 07i18i2016 Page 3 of 5
`
`Pharms. Inc, 545 F.3d 1312, 1314 (Fed. Cir. 2008); see in re LeGri'ce, 49 C.C.P.A.
`
`1124, 301 F.2d 929, 940-44 (1962).
`
`The Court finds that Apotex failed to meet its burden of establishing by clear and
`
`convincing evidence that the ’138 patent is invalid for anticipation. The Court thus finds
`
`that each of the asserted claims 1-3, 6, 7, 13, 15-17, 22-23 of the ’138 Patent is not
`
`invalid for anticipation under 35 U.S.C. § 102.
`
`B.
`
`Written Description
`
`“[C]ompliance with the ‘written description’ requirement of § 112 is a question of
`
`fact." Vas—Catn inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir. 1991). For a claim to
`
`be invalid for lack of written description, the specification must fail to convey to one
`
`skilled in the relevant art
`
`that
`
`the inventors were in possession, at the time the
`
`specification was filed, of the claimed subject matter. See Moba, B. V.
`
`1/. Diamond
`
`Automation, inc, 325 F.3d 1306, 1320 (Fed. Cir. 2003). Inventors are not required to
`
`disclose in their patent specification every species encompassed by their claims, even
`
`in an unpredictable art. See in re Alton, 76 F.3d 1168, 1175 (Fed. Cir. 1996) (‘‘If a
`
`person of ordinary skill in the art would have understood the inventor to have been in
`
`possession of the claimed invention at the time of filing, even if every nuance of the
`
`claims is not explicitly described in the specification,
`
`then the adequate written
`
`description requirement is met.”).
`
`The Court finds that Apotex failed to meet its burden of establishing by clear and
`
`convincing evidence that the ’138 patent is invalid for lack of written description. The
`
`Court thus finds that each of the asserted claims 1-3, 6, 7, 13, 15-17, 22-23 of the ’138
`
`Page 3
`
`
`
`Case 0:15-cv-61631-JIC Document 245 Entered on FLSD Docket 07i18l'2016 Page 4 of 5
`
`Patent
`
`is not
`
`invalid for lack of written description under 35 U.S.C. § 112,
`
`first
`
`paragraph.
`
`C.
`
`lndefiniteness
`
`A claim can only be held invalid for indefiniteness when those skilled in the art
`
`could not reasonably understand its meaning in light of the patent specification, such
`
`that it is not capable of any reasonable construction and the scope of the claim cannot
`
`be determined. See, e.g., Marley Mouldings Ltd. v. Mikron indus, inc, 417' F.3d 1356,
`
`1359 (Fed. Cir. 2005); Metabolite Labs, inc. v. Lab. Corp. of Am. Holdings, 370 F.3d
`
`1354, 1366 (Fed. Cir. 2004).
`
`The Court finds that Apotex failed to meet its burden of establishing by clear and
`
`convincing evidence that the ’138 patent is invalid for indefiniteness. The Court thus
`
`finds that each of the asserted claims 1-3, 6, 7, 13, 15-17, 22-23 of the ’138 Patent is
`
`not invalid for lack of definiteness under 35 U.S.C. § 112, second paragraph.
`
`D.
`
`Obviousness
`
`A party seeking to challenge the validity of a patent based on obviousness must
`
`prove that the invention described in the patent would have been obvious to a person of
`
`ordinary skill
`
`in the art at the time the invention was made. Procter & Gambie Co. v.
`
`Teva Pharms. USA, inc, 566 F.3d 989, 994 (Fed. Cir. 2009). Establishing prima facie
`
`obviousness requires the Court
`
`to engage in a two-part
`
`inquiry. The Court must
`
`determine: (1) whether the prior art would have suggested to those of ordinary skill
`
`in
`
`the art that they should make the claimed composition or device, or carry out the
`
`claimed process; and (2) whether the prior art would also have revealed that
`
`in so
`
`making or carrying out, those of ordinary skill would have a reasonable expectation of
`
`Page 4
`
`
`
`Case 0:15-cv-61631-JIC Document 245 Entered on FLSD Docket 07i'18l'2016 Page 5 of 5
`
`success.
`
`in re l/aeck, 947 F.2d 488, 493 (Fed. Cir. 1991).
`
`The Court finds that Apotex failed to meet its burden of establishing by clear and
`
`convincing evidence that the ’138 patent is invalid for obviousness. The Court thus
`
`finds that each of the asserted claims 1-3, 6, 7, 13, 15-17, 22-23 of the ’138 Patent is
`
`not invalid for obviousness under 35 U.S.C. § 103.
`
`CONCLUSION
`
`For the reasons given above, it is hereby ORDERED AND ADJ UDGED that:
`
`Each of the asserted claims 1-3, 6, 7, 13, 15-17, 22-23 of the ’138 Patent is n_ot
`
`invalid for (i) anticipation under 35 U.S.C. § 102, (ii) lack of written description under 35
`
`U.S.C. § 112,
`
`first paragraph,
`
`(iii)
`
`indefiniteness under 35 U.S.C. § 112, second
`
`paragraph, and (iv) obviousness under 35 U.S.C. § 103. Accordingly, the Court enters
`
`judgment in favor of Amgen and against Apotex on Apotex’s Fifth Affirmative Defense
`
`(Invalidity) and Second Counterclaim (Declaratory Judgment on Invalidity of the ’138
`
`Patent) in each of Apotex’s Answers, Affirmative Defenses, and Counterclaims in this
`
`consolidation action (ECF Nos. 47, 64) solely with respect to the matters addressed in
`
`these partial findings. The Court notes that no judgment is rendered herein with respect
`
`to any claim or defense of invalidity based on lack of enablement.
`
`DONE AND ORDERED in Chambers at Fort Lauderdale, Broward County,
`
`Florida, this 14th day of July, 2016.
`
`
`
`
`
`Page 5
`
`
`
`(3
`JA ES 1. CO}.-IN
`' d States District Judg
`
`Copies provided to:
`Counsel of record via CMIECF
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
