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Patent Enforcement Teva v. Sandoz April 2015 introduction.

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Presentation on theme: "Patent Enforcement Teva v. Sandoz April 2015 introduction."— Presentation transcript:

1 Patent Enforcement Teva v. Sandoz April 2015 introduction

2 Markman (SCT 1996) What a claim means: “is a question of law, to be determined by the court” Whether an accused product infringes: “is a question of fact, to be submitted to a jury”

3 Why Question of Law? “Patent construction in particular is a special occupation, requiring, like all others, special training and practice. The judge, from his training and discipline, is more likely to give a proper interpretation to such instruments than a jury; and he is, therefore, more likely to be right, in performing such a duty, than a jury can be expected to be.”

4

5 Clear Rules of the Road Question of law Judge gets to decide
Intrinsic evidence compelling Expert evidence possible, but rare De Novo Review

6 Teva’s Copaxone Teva as patent owner $4 billion blockbuster
Teva willing to go the distance, challenging 20 years of precedent that Markman established

7 Disputed Term “a molecular weight of 5 to 9 kilodaltons”
Question: how does one determine molecular weight?

8 Ways of Calculating Number Average molecular weight
Peak Average molecular weight Weight Average molecular weight

9 Teva Says Peak Average, But…

10 Battle of the Experts

11 Teva: District Court decision
Judge heard expert testimony from both parties Judge believed Teva’s expert was more credible on the “shift theory” So term is definite: molecular weight measures “the weight of the most prevalent molecule” (peak)

12 Federal Circuit decision

13 Teva: Federal Circuit decision
Panel reviewed the decision de novo Found no reason to prefer one expert’s proposal over the other as a matter of law Concluded claim was invalid as indefinite without any sound definition for “molecular weight”

14 Teva: Supreme Court Ruling
January 20, 2015 bad facts bad law, didn't need to address here Takeaway: the “shift theory” was a question of fact!

15 Teva: Supreme Court basis
Rule 52(a)(6) does not allow for de novo review for fact questions; the standard must be “clear error”

16 Did this change Markman?
Markman had said “subsumed” = “subsumed within the necessarily sophisticated analysis of the whole document ” See Markman, 517 U.S. at 389

17 Supreme Court DISSENT (Justices Thomas and Alito)

18 Initial Reaction? Uncertainty.
Some said little will change: Difference only when real fact issue like credibility (Dissent footnote 1) Difference only for indefiniteness case, and should be limited as such Only when expert testimony presented Supreme Court didn’t change intrinsic/extrinsic distinction

19 Initial Reaction? Uncertainty.
Some said everything will change: A party will prefer factual support A court might seek protection in factual findings Expert testimony is now invited The “T” word: Mini Trials

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21 What has actually happened?
Federal Circuit Phillips decision back in the limelight: Intrinsic >> Extrinsic Phillips v. AWH Corp., 415 F.3d 1303, 1318 (Fed. Cir. 2005) (en banc)

22 Federal Circuit: Status Quo
Enzo Biochem, 780 F.3d 1149 (Fed. Cir. 2015) District Court = relied on extrinsic for its claim construction Federal Circuit = extrinsic cannot contradict clear intrinsic Federal Circuit still reversed as a matter of law, because even if fact-finding not erroneous, still “did not override our analysis”

23 Federal Circuit: Status Quo
Lexington Luminance LLC v. Amazon.com Inc., No , 2015 WL (Fed. Cir. Feb. 9, 2015): “the district court erred by adopting a construction based on general-purpose dictionaries that is inconsistent with the intrinsic record” (so de novo still proper)

24 Fed. Cir. has reversed 5/13 Affirmed Reversed
Pacing Techs., 778 F.3d 1021 MobileMedia, 780 F.3d 1159 Southco, 2015 WL Lexington 2015 WL TMI Products, 2015 WL FenF, 2015 WL Cadence Pharm., 2015 WL In re Papst, 778 F.3d 1255 Fenner Investments, 778 F.3d 1320 Enzo Biochem, 780 F.3d 1149 In re Cuozzo, 778 F.3d 1271 Vasudevan, 2015 WL Flexiteek, 2015 WL

25 Federal Circuit: Teva For Experts Only
“In this case, we review the district court's claim constructions de novo, because the intrinsic record fully determines the proper constructions and the district court's constructions were not based on expert testimony.” -Lexington Luminance LLC v. Amazon.com Inc., No , 2015 WL (Fed. Cir. Feb. 9, 2015)

26 Federal Circuit: Teva For Experts Only
*FenF, 2015 WL (Fed. Cir. Feb. 6, 2015) *In re Papst, 778 F.3d 1255 (Fed. Cir. 2015) *Vasudevan, 2015 WL (Fed. Cir. Apr. 3, 2015)

27 District courts also using Phillips…
Greatbatch Ltd. v. AVX Corp., No LPS, 2015 WL (D. Del. Mar. 20, 2015): “Where the intrinsic record unambiguously describes the scope of the claimed invention, reliance on extrinsic evidence is improper.” This is the surprise, since thought they would go rogue and defend/support themselves

28 Sticking to Intrinsic *InterDigital, 2015 WL (D. Del. Mar. 6, 2015) *Intellectual Ventures, 2015 WL (D. Del. Mar. 24, 2015) *Knapp Logistics, 2015 WL (D. Colo. Mar. 16, 2015) *iLife, 2015 WL (W.D. Pa. Feb. 27, 2015)

29 Carefully Using Extrinsic
*dunnhumby, 2015 WL (N.D. Ill. Apr. 1, 2015) *Eisai, 2015 WL (D. Del. Mar. 17, 2015) *Unimed, 2015 WL (D. Del. Mar. 11, 2015) *Guitar Apprentice, 2015 WL (W.D. Tenn. Feb. 26, 2015)

30 Relying predominantly on extrinsic

31 Other Issues What else is going on?

32 Relevance of extrinsic evidence
Vasudevan, No , 2015 WL , at *3 (Fed. Cir. Apr. 3, 2015) Fed. Cir. held that it was entitled to review the relevance of extrinsic evidence—there a factual stipulation from another case involving a different defendant—de novo.

33 Prior DCT Constructions
Because subsidiary factual findings based on extrinsic evidence are questions of fact, court definitely not bound by another court’s interpretation of a particular term, which it based on a dictionary definition. See id. at *20.

34 Dictionaries Used under heading “Intrinsic Evidence,” but apparently only to show consistent with intrinsic evidence. dunnhumby, 2015 WL , at *11-12 (N.D. Ill. Apr. 1, 2015).

35 So far, so good… In sum, since Teva’s publication in January 2015, district courts have relied predominantly (and decidedly) on intrinsic evidence. And the Federal Circuit has predominantly continued to review claim construction de novo. So, for better or for worse, not much has changed.

36 What’s ahead?

37 Teva: What If? Clear definition in patent No definition
Figure without numbers Claim term self-defining Nautilus applied (POSA vs Law)

38 Prognostications More will seek expert testimony
More indefiniteness arguments More express definitions in patents More definitions in prosecution More district court fact-finding Anecdotally expert for 112, dropped that patent, indef as part of cc

39 Thank You


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