Transcript Thomas, Nanette S. "INTERESTING AND PENDING DECISIONS

INTERESTING AND PENDING
DECISIONS FROM THE FEDERAL
CIRCUIT
JANUARY, 2004
Nanette S. Thomas
Senior Intellectual Property Counsel
Becton Dickinson and Company
Franklin Lakes, NJ 07417
Table of Contents
Interesting Decisions
Slide Number
Inequitable Conduct:
Ulead Systems v. Lex Computer
Infringement Exemptions:
Integra LifeSciences v. Merck (§271(e)(1))
Bayer AG v. Housey Pharm (§271(g))
Madey v. Duke University (Research)
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Unjust Enrichment:
Univ. of Colorado v. American Cyanamid
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Pending Decisions
Patent Term Extension: Pfizer v. Reddy
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Willful Infringement: Knorr-Bremse Systeme v. Dana
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Inequitable Conduct
Ulead Systems Inc. v. Lex Computer &
Mgmt. Corp. (Fed. Cir. Dec. 9, 2003)
“Historically issues of unenforceability have arisen in
cases involving inequitable conducting occurring in the
prosecution of patents. But, we see no reason why the
doctrine [of enforceability] should not extend into other
contexts, like the present one, where the allegations is
that inequitable conduct has occurred after the patent
has issued and during the course of establishing and
paying the appropriate maintenance fees.”
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Inequitable Conduct
Ulead Systems Inc. v. Lex Computer &
Mgmt. Corp. (Fed. Cir. Dec. 9, 2003)
Lex filed an affidavit of small entity status and paid
reduced fees unaware of the existence of the licenses
that caused the loss of small entity status.
The Federal Circuit, inter alia, vacated and remanded
the district court’s summary judgment because the
evidence before the district court raises genuine issues
on the question of intent for inequitable conduct.
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Infringement Exemption:
§271 (e)(1)
Integra LifeSciences. I, Ltd. v. Merck KGaA, 331
F.3d 860 (Fed. Cir. 2003)
Merck’s use of Integra’s patented peptide in experiments to
identify the best drug candidate, which would be subject to
future clinical testing under the FDA process, did not come
within the statutory safe harbor §271 (e)(1).
“Therefore, the 271(e)(1) safe harbor covers those preexpiration activities ‘reasonably related’ to acquiring FDA
approval of a drug already on the market.”
Merck filed petition for Panel Rehearing and Rehearing En
Banc on July 21, 2003
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Infringement Exemption:
§271 (g)
Bayer AG v. Housey Pharms., Inc., 340 F.3d
1367 (Fed. Cir. 2003)
Bayer brought a declaratory judgment action seeking,
that Housey’s patents, which covered methods of
screening compounds to determine their potential as
drug products, were not infringed under §271 (g) and
Housey counterclaimed for infringement. Bayer’s
products and data imported into the US were identified
overseas, but not made by Housey’s patents and
§271 (g) did not apply.
The Federal Circuit affirmed the district court’s
dismissal of Housey’s infringement claims.
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Infringement Exemption:
§271 (g)
Bayer AG v. Housey Pharms., Inc., 340 F.3d
1367 (Fed. Cir. 2003)
The court interpreted §271(g) to be limited to “made
by a process patented in the United States [and] it
must have been a physical article that was
manufactured”; and that “processes of identification
and generation of data are not steps in the
manufacture of a final drug product.”
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Infringement Exemption: Judicially
Created Experimental Defense
Madey v. Duke University, 307 F.3d 1351
(Fed. Cir. 2002), cert. Denied, 123 S.Ct. 2639
(2003)
“In short, regardless of whether a particular institution or
entity is engaged in an endeavor for commercial gain, so
long as the act is in furtherance of the alleged infringer’s
legitimate business and is not solely for amusement, to
satisfy idle curiosity, or for strictly philosophical inquiry,
the act does not qualify for the very narrow and strictly
limited experimental use defense. Moreover, the profit of
non-profit status of the user of the user is not
determinative.”
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Unjust Enrichment
University of Colorado Foundation v. American
Cyanamid Co., 342 F.3d 1298 (Fed. Cir. 2003).
The Federal Circuit affirmed an award of unjust
enrichment against Cyanamid for wrongful use of
Doctor’s research results to obtain a patent and use a
patent for incremental profits under Colorado law.
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Unjust Enrichment
University of Colorado Foundation v. American
Cyanamid Co., 342 F.3d 1298 (Fed. Cir. 2003).
The Federal Circuit held that federal patent law does not
preempt the unjust enrichment claim:
“Here, although federal patent law plainly does not
provide for explicit pre-emption, 35 U.S.C. Sections 1376 (2000), a state may not offer patent-like protection
to intellectual creations that would otherwise remain
unprotected as a matter of federal law.”
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Patent Term Extension:
35 U.S.C. §156
Pfizer Inc. v. Dr. Reddy’s Laboratories Ltd
(67 U.S.P.Q. 1525) (Unpublished)
“The crux of this case is whether Pfizer’s Patent Term
Extension…Include[s] amlodipine and all of its salts [besylate
and maleate], and therefore the products that Dr. Reddy seeks
to market. Or if the extension only includes amlodipine
besylate, the Norvasc product.”
The court found that the only product within the scope of the
PTE is amlodipine desylate, the active ingredient in Norvasc
and dismissed the complaint.
Appeal was filed to the Federal Circuit and the arguments were
heard on July 9.
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Willful Infringement
Knorr-Bremse Systeme Fuer Nutzfahzeuge
GMBH v. Dana Corp., 344 F.3d 1336 (Fed. Cir.
2003) (en banc)
The Federal Circuit, sua sponte, has decided to take
this case en banc to reconsider its precedent
concerning the drawing an adverse inference where
the accused infringer did not obtain an opinion of
counsel or, if one was obtained, it was not introduced
into evidence.
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