In re Cyclobenzaprine Hydrochloride Extended-Release..., Not Reported in...
`2010 WL 3766530
`
`2010 WL 3766530
`Only the Westlaw citation is currently available.
`United States District Court,
`D. Delaware.
`
`In re CYCLOBENZAPRINE HYDROCHLORIDE EXTENDED–RELEASE CAPSULE PATENT LITIGATION.
`
`Civ. No. 09–MD–2118–SLR.
`|
`Sept. 21, 2010.
`
`MEMORANDUM ORDER
`
`SUE L. ROBINSON, District Judge.
`
`*1 At Wilmington this 21st day of September, 2010, having considered defendants' motion to exclude plaintiff's
`admission of evidence of defendants' inability to obtain FDA approval as evidence of “failure of others” for purposes
`of non-obviousness, as well as the papers filed in connection therewith;
`
`IT IS ORDERED that said motion (D.I. 200 at ¶ 107) is denied, as follows:
`
`1. Legal standard. “All relevant evidence is admissible, except as otherwise provided ...” Fed. R Evid. 402. “Relevant
`evidence means evidence having any tendency to make the existence of any fact that is of consequence to the
`determination of the action more probable or less probable than it would be without the evidence .” Fed.R.Evid. 401.
`Rule 401's basic standard of relevance is a liberal one. Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 587 (1993). The
`trial judge is obligated to act as a “gatekeeper” and has broad discretion to balance the probative value of the evidence
`against its potential prejudicial harm. See Magnivision, Inc. v. Bonneau Co., 115 F.3d 956, 961 (Fed.Cir.1997).
`
`2. “A patent may not be obtained ... if the differences between the subject matter sought to be patented and the prior art
`are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having
`ordinary skill in the art.” 35 U.S.C. § 103(a). Obviousness is a question of law, which depends on several underlying
`factual inquiries.
`
`Under § 103, the scope and content of the prior art are to be determined; differences between the
`prior art and the claims at issue are to be ascertained; and the level of ordinary skill in the pertinent
`art resolved. Against this background the obviousness or nonobviousness of the subject matter is
`determined. Such secondary considerations as commercial success, long felt but unsolved needs,
`failure of others, etc., might be utilized to give light to the circumstances surrounding the origin of
`the subject matter sought to be patented.
`
`KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1734 (2007) (quoting Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966)).
`
`3. Discussion. The Federal Circuit has implicitly accepted that failure to obtain FDA approval is relevant evidence of
`failure of others. Knoll Pharm. Co. v. Teva Pharm. USA, Inc., 367 F.3d 1381, 1385 (Fed.Cir.2004). In Pfizer Inc. v.
`Teva Pharmaceuticals USA, Inc., 460 F.Supp.2d 659, 662 (D.N.J.2006), the court went one step further, and expressly
`stated that “[n]ot getting to market with FDA approval is an appropriate benchmark for failure [of others].” Given this
`acceptance by other courts and the liberal standards of Rule 401, this court finds that failure to obtain FDA approval
`is relevant evidence of failure of others.
`
` © 2016 Thomson Reuters. No claim to original U.S. Government Works.
`
`1
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`AstraZeneca Exhibit 2191
`Mylan v. AstraZeneca
`IPR2015-01340
`
`Page 1 of 2
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`In re Cyclobenzaprine Hydrochloride Extended-Release..., Not Reported in...
`2010 WL 3766530
`
`4. Defendants argue that, even if failure to obtain FDA approval is evidence of failure of others, the failure in question
`occurred after the issue date of the patent and should be excluded. (D.I. 200, ex. 3.2 at 18) However, this contradicts Knoll
`which explained that knowledge of an invention's advantages acquired after its patent application was filed is admissible
`in response to a litigation challenge. Knoll, 367 F.3d at 1385.
`
`*2 5. The most relevant case that defendants cite in support of their argument is Eisai Co. v. Teva Pharmaceuticals
`USA, Inc., 247 F.R.D. 440 (D.N.J.2007). The Eisai court held that “failure of others is inherently limited to events pre-
`dating issuance of the patent.” Id. at 444.
`
`6. This court finds Eisai unpersuasive. The Eisai court reasoned that Knoll does not support the position that failure of
`others post-dating the patent's issuance date is relevant. Id. at 443. It discounted the argument that, because the Knoll
`court did not expressly limit the evidence of failure of others to a pre-invention time period, it was implicitly admissible.
`Id. In so holding, the Eisai court appears to ignore Knoll's direction that “[e]vidence developed after the patent grant
`is not excluded from consideration.... There is no requirement that an invention's properties and advantages were fully
`known before the patent application was filed ... in order for that [knowledge] to be introduced into evidence in response
`to litigation attack.” Knoll, 367 F.3d at 1385.
`
`7. Other secondary considerations such as commercial success and copying occur after a patent's issue date. Application of
`Tiffin, 443 F.2d 394, 398 (C.C.P.A.1971), see also Santarus, Inc. v. Par Pharm., Inc., 720F.Supp.2d 427, 2010 WL 1506017
`at * 24 (D.Del. Apr. 14, 2010) (reasoning that post-invention skepticism can be evidence of non-obviousness). Because
`science necessarily builds upon past discoveries, failure of others after a patent's issue date may be more persuasive than
`failures that occur before. See generally Kristen C. Buteau, Denuterated Drugs: Unexpectedly Nonobvious, 10 J. High
`Tech. L. 22 (2009). If others continue to fail despite having the patent as prior art, such failures may illustrate just how
`radically different the patent was from past discoveries. This would be highly relevant to a finding of non-obviousness.
`
`8. Finally, at oral orgument, defendants argued the failure of others to obtain FDA approval is irrelevant because the
`FDA instituted a new testing methodology after the patent issued. 1 Even if this is true, any change to FDA testing
`procedures goes to the weight of the evidence and not its admissibility.
`
`All Citations
`
`Not Reported in F.Supp.2d, 2010 WL 3766530
`
`Footnotes
`1
`The transcript has not yet been docketed.
`
`End of Document
`
`© 2016 Thomson Reuters. No claim to original U.S. Government Works.
`
` © 2016 Thomson Reuters. No claim to original U.S. Government Works.
`
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