78 at 28.) CONCLUSIONS OF LAW A. BURDENS OF PROOF [HN1] "Because a patent is presumed valid under 35 U.S.C. § 282, there follows a presumption that the named inventors on a patent are the true and only inventors." Gemstar-TV Guide International, Inc. v. International Trade Commission, 383 F.3d 1352, 1381 (Fed. Cir.

2007). “Throughout the obviousness determination, a patent retains its statutory presumption of validity, see 35 U.S.C. § 282, and the movant retains the burden to show the invalidity of the claims by clear and convincing evidence as to underlying facts.” McGinley v. Franklin Sports, Inc., 262 F.3d 1339, 1349 (Fed. Cir.

But Mylan was not challenging FDA’s due diligence determination; Mylan instead alleged that There is no legitimate dispute that those material failures of section 156 are a defense in a patent infringement trial. 35 U.S.C. § 282(c).13 d. Mylan’s Likelihood of Success in the Patent Litigation A reasonable jury could also conclude that Mylan was more likely than not to prevail based upon the testimony of patent litigation experts. Plaintiffs’ expert, Mr. Johnston,14 is a former Chief 13 As previously explained, this claim supports injunctive relief to invalidate the extended term of the patent, but not damages, which Mylan conceded would not even begin to accrue until more than three years after the Namenda patent settlement was reached.

Merck also objects to this interrogatory as premature on the ground that Fresenius has not yet specified through invalidity contentions any grounds alleging invalidity due to obviousness, despite bearing the burden of proving invalidity. The ’300 patent is presumed valid under 35 U.S.C. § 282, and Fresenius bears the burden of establishing invalidity by clear and convincing evidence. Merck further objects to this interrogatory to the extent it prematurely seeks expert discovery.

Al-Site Corp. v. VSI Intern., Inc., 174 F.3d 1308, 1323 (Fed. Cir. 1999) (“The presumption of validity under 35 U.S.C. § 282 carries with it a presumption that the Examiner did his duty and knew what claims he was allowing.”), citing Intervet Am., Inc. v. Kee- Vet Labs., Inc., 887 F.2d 1050, 1054 (Fed. Cir.

See Sport Squeeze, Inc. v. Pro-Innovative Concepts, Inc., No. 97–CV–115 TW(JFS), 1999 WL 395328, n.1 (S.D. Cal. Apr. 1, 1999) (finding that “the construction of the claims in a patent does not depend on how those patents were commercially implemented”); Am. Medical Sys., Inc. v. Laser Peripherals, LLC., 712 F.Supp.2d 885, 903-904 (D.Minn. 2010) (holding that statements criticizing the Patent Office are inadmissible because they “seek to call into question the statutory presumption of validity established in 35 U.S.C. § 282 (2006)”). A two-step analysis is employed in making an infringement determination.

Case 1:04-cv-11960-RWZ Document 27 Filed 02/16/2005 Page 4 of 5 LIBNY/4378017.1 5 For all of the foregoing reasons, Red Bend respectfully submits that this Court should deny BIS’s Motion to Add to the Scheduling Order a Deadline by Which Defendants Shall Identify Relevant Prior Art. In the alternative, if the Court grants the present motion, Red Bend respectfully submits that the deadline by which defendants shall identify relevant prior should be double the time set forth in 35 U.S.C. § 282, namely two months before trial, rather than September 15, 2005. Respectfully Submitted, /s/ Anastasia Fernands________ Anastasia Fernands (BBO# 633131) GOODWIN PROCTER LLP 53 State Street Boston, MA 02109 Tel: 617-570-1000 Fax: 617-523-1231 Ethan Horwitz Georgia Yanchar GOODWIN PROCTER LLP 599 Lexington Avenue New York, New York 10022 Tel: 212-813-8800 Fax: 212-353-3555 ATTORNEYS FOR RED BEND SOFTWARE, INC., RED BEND, LTD., TIME WARNER INC., ICQ, INC. and INSTALLSHIELD SOFTWARE CORP. Dated: February 16, 2005 Case 1:04-cv-11960-RWZ Document 27 Filed 02/16/2005 Page 5 of 5

14 Navico’s feigned confusion over how to analyze cartographic data using a marine route 13 Defendants’ expert was tellingly silent on the issue despite Defendants’ lofty burden. See 35 U.S.C. § 282; Intel, 319 F.3d at 1366 (“Any fact critical to a holding on indefiniteness [] must be proven by the challenger by clear and convincing evidence.”). 14 Indeed, Navico itself apparently had no difficulty understanding “marine route calculation algorithm” when it affirmatively used the phrase to describe the invention to the Patent Office long before this suit was filed. Doc. 99- 16 at 8 (“Rather, [the ‘703 patent] discloses routes that are calculated in real time, based on dynamic analysis of cartographic data and using marine route calculation algorithms....”).

V. ARGUMENT A. Defendants Failed to Overcome the Burden of Production Regarding the Presumption of Validity While not addressed in the Supreme Court's opinion in Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 134 S. Ct. 2347 (2014), the question of whether the statutory presumption of validity applies to § 101 challenges was squarely before the Federal Circuit en banc and all nine judges that addressed the question unanimously agreed it does6: [I]t bears remembering that all issued patent claims receive a statutory presumption of validity. 35 U.S.C. § 282; Microsoft Corp. v. i4i Ltd. P'ship, ––– U.S. ––––, 131 S.Ct. 2238, 180 L.Ed.2d 131 (2011).

V. ARGUMENT A. Defendants Failed to Overcome the Burden of Production Regarding the Presumption of Validity While not addressed in the Supreme Court's opinion in Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 134 S. Ct. 2347 (2014), the question of whether the statutory presumption of validity applies to § 101 challenges was squarely before the Federal Circuit en banc and all nine judges that addressed the question unanimously agreed it does6: [I]t bears remembering that all issued patent claims receive a statutory presumption of validity. 35 U.S.C. § 282; Microsoft Corp. v. i4i Ltd. P'ship, ––– U.S. ––––, 131 S.Ct. 2238, 180 L.Ed.2d 131 (2011).