© 2015 schiff hardin llp. all rights reserved. teva v. sandoz april 2015

© 2015 Schiff Hardin LLP. All rights reserved.

Patent Enforcement

Teva v. SandozApril 2015

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© 2015 Schiff Hardin LLP. All rights reserved.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”


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.”


• Question of law

• Judge gets to decide

• Intrinsic evidence compelling

• Expert evidence possible, but rare

• De Novo Review

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Clear Rules of the Road


Teva’s Copaxone

Teva as patent owner

$4 billion blockbuster

Teva willing to go the distance, challenging 20 years of precedent that Markman established

http://www.google.com/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&ved=0CAcQjRw&url=http://pl.wikipedia.org/wiki/Octan_glatirameru&ei=ykvYVIG6G82HyAS6poLAAg&bvm=bv.85464276,d.aWw&psig=AFQjCNFGQUBthBD5GdBuDIBafqM7vT3MpQ&ust=1423547707616743


Disputed Term

“a molecular weight of 5 to 9 kilodaltons”

Question: how does one determine molecular weight?


Ways of Calculating

• Number Average molecular weight

• Peak Average molecular weight

• Weight Average molecular weight


Teva Says Peak Average, But…


Battle of the Experts

http://www.google.com/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&ved=0CAcQjRw&url=http://www.boissoandassociates.com/index.cfm/forensic-economic-litigation-services/&ei=XkzYVI7vKYSfyASZrICwDw&bvm=bv.85464276,d.aWw&psig=AFQjCNEtdNerNpDsx0mJ2aFpeba_ZLSIGg&ust=1423547859405850


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)


Federal Circuit decision

http://www.google.com/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&ved=0CAcQjRw&url=http://archive.constantcontact.com/fs068/1104865327757/archive/1105671844452.html&ei=60zYVOXCOYipyQSJ9oGgAg&bvm=bv.85464276,d.aWw&psig=AFQjCNE5O8jI_ZIHrnBTloJ2DLI5-N1ZSw&ust=1423547904934193


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”


Teva: Supreme Court Ruling

Takeaway: the “shift theory” was a question of fact!


Teva: Supreme Court basis

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


Did this change Markman?


Supreme Court DISSENT (Justices Thomas and Alito)


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


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


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)

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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”

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Federal Circuit: Status Quo

Lexington Luminance LLC v. Amazon.com Inc., No. 2014-1384, 2015 WL 524270 (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)

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Fed. Cir. has reversed 5/13

Affirmed Reversed

Pacing Techs., 778 F.3d 1021 MobileMedia, 780 F.3d 1159

Southco, 2015 WL 1609846 Lexington 2015 WL 524270

TMI Products, 2015 WL 1515271 FenF, 2015 WL 480392

Cadence Pharm., 2015 WL 1284235

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 1501565

Flexiteek, 2015 WL 1244475

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Federal Circuit: Teva For Experts Only

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“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. 2014-1384, 2015 WL 524270 (Fed. Cir. Feb. 9, 2015)


Federal Circuit: Teva For Experts Only

*FenF, 2015 WL 480392 (Fed. Cir. Feb. 6, 2015)

*In re Papst, 778 F.3d 1255 (Fed. Cir. 2015)

*Vasudevan, 2015 WL 1501565 (Fed. Cir. Apr. 3, 2015)

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District courts also using Phillips…

Greatbatch Ltd. v. AVX Corp., No. 13-723-LPS, 2015 WL 1383656 (D. Del. Mar. 20, 2015):

“Where the intrinsic record unambiguously describes the scope of the claimed invention, reliance on extrinsic evidence is improper.”

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Sticking to Intrinsic

*InterDigital, 2015 WL 1006386 (D. Del. Mar. 6, 2015)*Intellectual Ventures, 2015 WL 1393386 (D. Del. Mar. 24, 2015)*Knapp Logistics, 2015 WL 1518004 (D. Colo. Mar. 16, 2015)*iLife, 2015 WL 868103 (W.D. Pa. Feb. 27, 2015)

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Carefully Using Extrinsic

*dunnhumby, 2015 WL 1542365 (N.D. Ill. Apr. 1, 2015)*Eisai, 2015 WL 1228958 (D. Del. Mar. 17, 2015)*Unimed, 2015 WL 1094601 (D. Del. Mar. 11, 2015)*Guitar Apprentice, 2015 WL 1567838 (W.D. Tenn. Feb. 26, 2015)

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Relying predominantly on extrinsic

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Other Issues

What else is going on?

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Relevance of extrinsic evidence

Vasudevan, No. 2014-1094, 2015 WL 1501565, 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.

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Prior DCT Constructions

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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.


Dictionaries

Used under heading “Intrinsic Evidence,” but apparently only to show consistent with intrinsic evidence. dunnhumby, 2015 WL 1542365, at *11-12 (N.D. Ill. Apr. 1, 2015).

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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.

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What’s ahead?


Teva: What If?

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• Clear definition in patent

• No definition

• Figure without numbers

• Claim term self-defining

• Nautilus applied (POSA vs Law)


Prognostications

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• More will seek expert testimony

• More indefiniteness arguments

• More express definitions in patents

• More definitions in prosecution

• More district court fact-finding


Thank You

http://www.apppharma.com/




© 2015 schiff hardin llp. all rights reserved. teva v. sandoz april 2015

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