IP Update - December 2008

Contents

Patents / Obviousness - Desirable Enantiomer

Unobvious Over Racemate

Patents / Hatch-Waxman Act - FDA's Rejection

of Paragraph IV Certification Valid in Light of Prior Delisting by

NDA Holder

Patents / Hatch-Waxman Act - Baseless Paragraph IV

Certification Letters Lead to Exceptional Case

Patents / Claim Construction - Narrow Claim

Construction Based on Clear Specification

Patents / Claim Construction - The Twin Axioms of

Claim Construction

Patents / Obviousness-type Double Patenting -

Earlier Granted Genus Claim Bars Later-Filed Species

Claims

Patents / Reexamination Stays - Wake Up and Smell

the Coffee: Reexamination Stays Can Effectively Deny a Preliminary

Injunction Motion

Patents / Indefiniteness - PTO Announces a New

Test for Claim Indefiniteness

Patents / Patentable Subject Matter - Mere Use of

a General Purpose Computer Does Not Sustain Eligibility

Patents / Infringement - To Prove Infringement,

an Accused Device Must Meet All the Limitations of a Claim

Trademarks / First Amendment - First Amendment

Trumps Trademarks to Protect Video Game's Virtual Strip

Club

Trademark Infringement - Collegiate Color Schemes

Protectable as Trademarks

Trademarks / Ability to Register - It Sure Is FUN

to Be Evocative – Especially If You Are a

Trademark

Copyrights / Publication Without Notice - Mon

Dieu! Publication in a Foreign Country Without Notice Leaves No

"Impressionist"

Desirable Enantiomer Unobvious Over

Racemate

By Astrid R. Spain

Almost exactly two years after affirming a district court

decision that granted a preliminary injunction against Apotex, the

U.S. Court of Appeals for the Federal Circuit affirmed the lower

court's decision that Sanofi's patented isomer was

unobvious over its known racemate described in Sanofi's own

prior art patents. Sanofi-Synthelabo v. Apotex,

Inc.., Case No. 07-1438 (Fed. Cir., Dec. 12, 2008)

(Newman, J.).

Sanofi markets Plavix®, a platelet aggregation inhibiting

agent used to reduce thrombotic events such as heart attacks and

strokes. The active ingredient in Plavix® is the bisulfate salt

of the d-enantiomer of a free base referred to by the parties as

MATTPCA and is specifically claimed in Sanofi's

patent-in-suit.

Apotex filed an Abbreviated New Drug Application (ANDA) pursuant

to the Hatch-Waxman Act seeking U.S. Food and Drug Administration

(FDA) approval to manufacture and sell a generic version of

clopidogrel bisulfate. Apotex filed a Paragraph IV certification

with its ANDA asserting that the patent-in-suit is invalid. Sanofi

sued Apotex and Apotex counterclaimed, asserting that the patent is

invalid and unenforceable in view of Sanofi's United States and

Canadian reference patents, which both derive from the same French

priority filing.

Stereoisomers are molecules that have the same atomic

composition but different spatial arrangements. Enantiomers are a

pair of stereoisomers, referred to as (+) and (-), that are

non-superimposable mirror images of each other and often have

distinct physical properties. A racemate (or racemic mixture) is an

equal mixture of two enantiomers. The active ingredient in

Plavix® displays the rare chemical property of "absolute

stereoselectivity"—one enantiomer (the

dextrorotatory enantiomer) provided all of the favorable activity

without any significant degree of the unfavorable

characteristics.

On appeal, the Federal Circuit rejected the argument that

Sanofi's earlier patent that disclosed the racemate anticipated

the claims of the patent-in-suit, which were directed to the

desirable d-enantiomer. The Court concluded that the prior art

patent lacked a specific description and enablement of the

enantiomeric form. The Court noted that anticipation requires the

specific description as well as enablement of the claimed subject

matter. A properly anticipating reference must disclose all

elements of the claim within the four corners of the document and

must also disclose those elements arranged as in the claim. The

Court pointed out that the Plavix® d-enantiomer is shown in the

prior art only as one of several compounds with desirable

biological properties. Accordingly, the Court concluded that the

district court did not clearly err in finding that the reference

disclosure would not have led one of ordinary skill to recognize

either an explicit or inherent disclosure of its d-enantiomer, as

well as the bisulfate salt.

With respect to obviousness, the district court "held that

the unpredictable and unusual properties of the dextrorotatory

enantiomer, and the therapeutic advantages thereby provided,

weighed in favor of nonobviousness, and that Apotex had not met its

burden of establishing otherwise." In affirming the district

court's holding, the Federal Circuit cited numerous instances

in which Apotex's expert witnesses appeared to admit the

unexpected properties of clopidogrel. The Court pointed out that

experts for both sides agreed that, while it was generally known

that enantiomers can exhibit different biological activity, this

degree and kind of stereoselectivity is rare and could not have

been predicted. In addition, the Court noted that the opposing

experts further agreed that the event of a pharmaceutically

suitable crystalline salt forming from a particular acid-base

combination is unpredictable. Finally, the Court noted that Sanofi

presented evidence that the prior art taught away from the use of

sulfuric acid with an enantiomer, because the strong acid could

encourage re-racemization.

FDA's Rejection of Paragraph IV

Certification Valid in Light of Prior Delisting by NDA

Holder

By Peter Schuyler

Deciding an issue of first impression regarding the Hatch-Waxman

Act, the U.S. Court of Appeals for the District of Columbia Circuit

recently vacated a lower court's injunction that had ordered

the Food and Drug Administration (FDA) to relist a patent in the

FDA's Orange Book and to restore an Abbreviated New Drug

Application (ANDA) filer's Paragraph IV patent certification.

Teva Pharmaceuticals, USA, Inc. v. Leavitt, Case No.

08-5141 (D.C. Cir., Nov. 7, 2008) (Brown, J.; Williams, J.,

concurring).

On August 21, 2001, Teva submitted an ANDA that contained a

Paragraph IV certification for U.S. Patent No. 5,158,952 (the

'952 patent), for a generic version of Risperdal, a

schizophrenia drug marketed by Janssen Pharmaceuticals. The FDA

informed Teva that the '952 patent had been delisted and asked

Teva to submit a revised ANDA. Teva voluntarily complied. Six years

later, however, Teva filed a citizen petition requesting that the

FDA relist the '952 patent and confirm Teva's eligibility

for a 180-day period of marketing exclusivity based on its original

ANDA. After the FDA denied Teva's request, Teva asked the D.C.

district court for a preliminary injunction, which it granted. The

FDA appealed the district court's decision to the U.S. Court of

Appeals for the D.C. Circuit.

Teva claimed its certification was valid because the printed

version of the Orange Book still listed the '952 patent as of

the filing date of its ANDA. Prior to the filing date, Janssen had

requested the delisting of the '952 patent, and the FDA updated

its online Orange Book at least a month prior to Teva's filing

date to reflect the delisting. Thus, the unique question raised by

this case is the effect of a Paragraph IV certification made after

a patent has been withdrawn by the NDA holder, but before the

patent has been deleted from the printed version of the Orange

Book.

On appeal, the D.C. Circuit held that Teva failed to meet the

"clear and unambiguous requirements" of the Hatch-Waxman

statute because its certification did not identify a patent that

claimed Risperdal, since the '952 patent had been previously

withdrawn by Janssen. The Court noted that the statute requires the

NDA (New Drug Application) holder to ascertain whether a patent

covers its drug. The Court accepted the FDA's explanation that

it operates in a purely ministerial role when listing patents in

the Orange Book according to instructions from the NDA holder. In a

concurring opinion, Judge Williams concluded that while the statute

does not mandate a ministerial role, the FDA's adoption of that

role is not unreasonable. This decision did not disrupt this

Court's early decision in Ranbaxy v. Leavitt, 469 F.3d

120 (D.C. Cir., Nov. 14, 2006) (previously discussed in IP

Update Vol. 9, No. 12), which held that the FDA may not delist

a patent after a valid Paragraph IV certification has been

submitted.

Baseless Paragraph IV Certification

Letters Lead to Exceptional Case

By Brian Baker

Concluding that a district court did not abuse its discretion,

the U.S. Court of Appeals for the Federal Circuit upheld the lower

court's finding of an exceptional case under 35 U.S.C. §

271(e)(4) and award of $16,800,000 for attorneys' fees,

expenses and expert fees. Takeda Chemical Industries, Ltd. v.

Mylan Laboratories, Inc., Case Nos. 07-1269, -1270 (Fed. Cir.,

Dec. 8, 2008) (Lourie, J.; Bryson, J., concurring).

Alphapharm and Mylan sought approval under the Hatch-Waxman Act

to produce generic versions of pioglitazone. Takeda sells

pioglitazone under the trademark Actos®, which is approved for

treating Type 2 diabetes. The Abbreviated New Drug Applications

(ANDAs) related to pioglitazone included Paragraph IV certification

letters claiming that Takeda's patent covering pioglitazone was

invalid for obviousness. Takeda sued both companies for

infringement. At trial, Alphapharm and Mylan each changed the focus

of their invalidity arguments from those advanced in their

certification letters. Alphapharm shifted its theory of obviousness

and prior art focus, while Mylan abandoned the defense in its

certification and advanced inequitable conduct arguments. After an

extensive bench trial, the district court found the patent-in-suit

non-obvious and enforceable.

Takeda then moved for an award of attorneys' fees against

both Mylan and Alphapharm on the theory that this was an

exceptional case. When a patent has been...