Document ID: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-ca13-15-01588/USCOURTS-ca13-15-01588-0/pdf.json

Parties Involved:
Ranbaxy Laboratories Limited
Not party
Ranbaxy, Inc.
Not party
Teva Pharmaceuticals USA, Inc.
Appellee
Warner Chilcott (US), LLC
Appellant
Warner Chilcott Company, LLC
Appellant
Watson Laboratories, Inc. - Florida
Not party

Document Text:

NOTE: This disposition is nonprecedential.

United States Court of Appeals 

for the Federal Circuit ______________________ 

WARNER CHILCOTT COMPANY, LLC, WARNER 

CHILCOTT (US), LLC,

Plaintiffs-Appellants

v.

TEVA PHARMACEUTICALS USA, INC.,

Defendant-Appellee

RANBAXY, INC., RANBAXY LABORATORIES 

LIMITED, WATSON LABORATORIES, INC. - 

FLORIDA,

Defendants

______________________ 

2015-1588

______________________ 

Appeal from the United States District Court for the 

District of New Jersey in No. 2:11-cv-06936-SRC-CLW, 

Judge Stanley R. Chesler.

______________________ 

Decided: March 18, 2016

______________________ 

 JEFFREY B. ELIKAN, Covington & Burling LLP, Washington, DC, argued for plaintiffs-appellants. Also represented by GEORGE FRANK PAPPAS, KEVIN B. COLLINS,

BRADLEY KEITH ERVIN. 

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2 WARNER CHILCOTT CO. v. TEVA PHARMACEUTICALS USA, INC. 

 ELIZABETH HOLLAND, Goodwin Procter LLP, New 

York, NY, argued for defendant-appellee. Also represented by ROBERT V. CERWINSKI, LINNEA P. CIPRIANO;

CHRISTOPHER T. HOLDING, Boston, MA; WILLIAM M. JAY, 

Washington, DC; DAVID ZIMMER, San Francisco, CA. 

______________________ 

Before LOURIE, DYK, and HUGHES, Circuit Judges.

LOURIE, Circuit Judge. 

Warner Chilcott Company, LLC and Warner Chilcott 

(US), LLC (collectively, “Warner Chilcott”) appeal from 

the decision of the United States District Court for the 

District of New Jersey holding claim 16 of U.S. Patent 

7,645,459 (“the ’459 patent”) and claim 20 of U.S. Patent 

7,645,460 (“the ’460 patent”) invalid as obvious. Warner 

Chilcott Co., LLC v. Teva Pharm. USA, Inc., 89 F. Supp. 

3d 641 (D.N.J. 2015) (“Opinion”). Because the district 

court did not err in concluding that the asserted claims

are invalid, we affirm. 

BACKGROUND

Warner Chilcott owns the ’459 and ’460 patents, 

which are directed to oral dosage forms comprising

risedronate (a bisphosphonate) and disodium ethylenediaminetetraacetic acid (herein referred to as “EDTA”), 

and methods of treating diseases characterized by abnormal calcium and phosphate metabolism, e.g., osteoporosis. 

Because risedronate complexes with calcium ions in food, 

its absorption is significantly diminished when administered in a fed state, viz., taken with or soon after a meal. 

A chelating agent, such as EDTA, can preferentially bind 

calcium ions, thus blocking calcium–risedronate complex 

formation in a fed state and thereby freeing up 

risedronate for absorption. However, the chelating agent 

may also bind the calcium ions from the intestinal wall in 

a fasted state, and thereby increase absorption in a more 

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WARNER CHILCOTT CO. v. TEVA PHARMACEUTICALS USA, INC. 3

undesirable fashion by widening the tight junctions 

between cells. During prosecution of the patents, the 

examiner originally rejected the claims as obvious over 

prior art disclosing the use of EDTA for increasing 

bisphosphonate absorption. The patentee overcame that

rejection by adding the limitation “pharmaceutically 

effective absorption,” which is defined by the specification1 as: 

an amount of a chelating compound high 

enough to significantly bind the metal ions 

and minerals in food but low enough not to 

significantly alter absorption of the 

bisphosphonate as compared to absorption 

in the fasted state. That is, absorption is 

similar with or without food. Given the 

high variability of bisphosphonate absorption, fed exposure within about 50% of 

fasting exposure is expected to be “pharmaceutically effective absorption.”

’459 patent, col. 4 ll. 59–66.

Warner Chilcott’s commercial embodiment of the ’459 

and ’460 patents is Atelvia®, an oral formulation for 

treating osteoporosis, comprising 35 mg risedronate and 

100 mg EDTA. Teva Pharmaceuticals USA, Inc. (“Teva”)

filed an Abbreviated New Drug Application (“ANDA”)

with the U.S. Food and Drug Administration, seeking 

approval for a generic version of Atelvia®. Warner Chilcott filed suit, asserting infringement of the ’459 and ’460 

patents by the filing of Teva’s ANDA. The only claims at 

issue during trial were claim 16 of the ’459 patent and 

claim 20 of the ’460 patent, both of which Teva had stipulated to infringing. 

1 The ’459 and ’460 patent specifications are substantially similar, and therefore are referred to jointly.

 

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The asserted dependent claims, with the text of the 

parent claims incorporated, read as follows:

16. An oral dosage form having pharmaceutically 

effective absorption comprising:

(a) [about 35 mg] of risedronate sodium;

(b) [about 100 mg] of disodium EDTA; and

(c) an enteric coating [that is a methacrylic acid copolymer] which provides for release of the risedronate sodium and the 

disodium EDTA in the lower gastrointestinal tract of a mammal.

’459 patent, col. 38 l. 49 – col. 39 l. 13. 

20. An oral dosage form having pharmaceutically 

effective absorption comprising:

(a) [about 35 mg of ] risedronate sodium;

(b) [about 100 mg] of disodium EDTA; and

(c) an enteric coating [that is a methacrylic acid copolymer] which provides for immediate release of the risedronate sodium 

and the disodium EDTA in the small intestine of a mammal.

’460 patent, col. 24 l. 47 – col. 25 l. 20. 

The district court held a bench trial and concluded 

that the asserted claims were invalid as obvious. The 

court noted that the parties agreed that Brazilian Patent 

Application BR2001-06601 (“BR ’601”) contains all of the 

limitations of the claims except “pharmaceutically effective absorption.” Opinion, 89 F. Supp. 3d at 646. 

First, the district court found that the claimed 35 mg 

risedronate dose was disclosed as the most commonly 

prescribed regimen (a 35 mg dose), and by BR ’601’s 

teaching of an “effective quantity” of bisphosphonate. Id.

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at 653–54. The court next found that BR ’601 discloses 

20–175 mg EDTA, which includes the claimed 100 mg

amount. Id. at 654–56. Because the compounds “work 

independently of each other and are not interdependent,” 

as confirmed by the specification’s broad disclosure of 

greatly varying ratios of bisphosphonate to EDTA that all

supposedly exhibit pharmaceutically effective absorption, 

the court found that the claimed 100 mg amount of EDTA 

was not critical within the range disclosed in the prior art. 

Id. at 655–56. The court therefore found that BR ’601 

discloses the claimed ingredients and amounts “in the 

same combination, for substantially the same function.” 

Id. at 657.

The district court then analyzed whether BR ’601 discloses the “pharmaceutically effective absorption” limitation. The court found that BR ’601 teaches using an 

amount of EDTA sufficient to bind ions in food, albeit an 

amount inherently low enough not to significantly alter 

absorption. Id. at 657–58. The court credited expert 

testimony that substantially more than 175 mg of EDTA

would be required to increase intestinal permeability even 

in the fasted state. Id. at 658. The court, however, found 

insufficient evidence to show that any embodiment of BR 

’601 would necessarily produce similar fed/fasted absorption, and thus found that the reference did not inherently 

disclose pharmaceutically effective absorption. Id. at 

658–59. Accordingly, the court found that BR ’601 did not 

anticipate the asserted claims. Id. at 659.

Instead, the district court concluded that BR ’601 renders the claims obvious. The court found that one of skill 

would have recognized the food-effect problem with 

bisphosphonates and the solution of using chelators to 

block calcium ions. Id. at 661. The court characterized 

that solution as having been “well explored in the literature,” and reviewed the references teaching that EDTA 

increases absorption by reducing calcium–bisphosphonate 

complex formation, as well as references explicitly noting 

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that EDTA may also do so by damaging the tight junctions and thereby enhancing permeability. Id. at 661–68. 

The court also found that other references teach using a 

chelator to solve the food effect and suggest using EDTA 

for less variable absorption. Id. at 661–62. The court 

noted that another reference disclosed eliminating the 

food effect for a different drug that also has reduced 

absorption due to calcium-complexes, by using an amount 

of EDTA equimolar to the calcium ions expected in the 

stomach. Id. at 662. The court further found that the 

reference teaches that 250 of mg EDTA does not change 

absorption in a fasted state and thus provides similar 

bioavailability irrespective of diet. Id.

The district court additionally rejected Warner Chilcott’s arguments of teaching away by the prior art, instead finding that the art was either irrelevant or the 

earlier concerns were addressed by later references like 

BR ’601. Id. at 662–68. Instead, the court determined 

that one of skill in the art would have been motivated to 

modify or combine BR ’601 with other prior art references 

to achieve the claimed invention, based on the teachings 

found within the references, with a reasonable expectation of success in achieving similar absorption in 

fed/fasted states. Id. at 675–80.

The district court also considered Warner Chilcott’s 

evidence of objective considerations, but concluded that 

that evidence did not show nonobviousness. The court 

found some long-felt need for improving patient compliance, although there existed alternatives such as weekly 

dosing, but relatedly, no proof of improved compliance as 

an unexpected result of the claimed invention, id. at 668; 

simultaneous invention by a third party, Takeda, id. at 

670–71; insufficient evidence of skepticism by skilled 

artisans, id. at 671–72; and no nexus between the claimed 

invention and Teva’s alleged failures or copying, id. at

672. The court therefore concluded that the asserted 

claims would have been obvious in view of the prior art.

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WARNER CHILCOTT CO. v. TEVA PHARMACEUTICALS USA, INC. 7

Warner Chilcott timely appealed to this court. We 

have jurisdiction pursuant to 28 U.S.C. § 1295(a)(1).

DISCUSSION

Patents are presumed to be valid, and overcoming 

that presumption requires clear and convincing evidence. 

35 U.S.C. § 282; Microsoft Corp. v. i4i Ltd. P’ship, 564 

U.S. 91, 131 S. Ct. 2238, 2242 (2011). A patent claim is 

invalid as obvious if an alleged infringer proves that the 

differences between the claims 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) 

(2006).2

Obviousness is ultimately a conclusion of law premised on underlying findings of fact, including the scope 

and content of the prior art, the differences between the 

claimed invention and the prior art, and the evidence of 

secondary factors, such as long-felt need, industry skepticism, and copying. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 

398, 427 (2007); Graham v. John Deere Co., 383 U.S. 1, 

17–18 (1966). “The presence or absence of a motivation to 

combine references in an obviousness determination is

[also] a pure question of fact.” Alza Corp. v. Mylan Labs., 

464 F.3d 1286, 1289 (Fed. Cir. 2006). In addition to 

common knowledge or teachings in the prior art itself, a 

“design need or market pressure or other motivation” may 

provide a suggestion or motivation to combine prior art 

elements in the manner claimed. Rolls Royce, PLC v. 

United Techs. Corp., 603 F.3d 1325, 1339 (Fed. Cir. 2010); 

2 Because the ’459 and ’460 patents were filed 

before the effective date of the America Invents Act, the 

earlier, pre-Act version of § 103(a) applies to this appeal. 

See Leahy–Smith America Invents Act, Pub. L. No. 112-

29, 125 Stat. 284, 293 (2011).

 

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accord KSR, 550 U.S. at 420. Moreover, when there are 

“a finite number of identified, predictable solutions,” one 

of skill in the art “has good reason to pursue the known 

options within his or her technical grasp.” KSR, 550 U.S. 

at 421.

On appeal from a bench trial, we review a district 

court’s conclusions of law de novo and its findings of fact 

for clear error. Golden Blount, Inc. v. Robert H. Peterson 

Co., 365 F.3d 1054, 1058 (Fed. Cir. 2004). A factual 

finding is only clearly erroneous if, despite some supporting evidence, we are left with the definite and firm conviction that a mistake has been made. United States v. U.S. 

Gypsum Co., 333 U.S. 364, 395 (1948).

Warner Chilcott argues that the district court misinterpreted “pharmaceutically effective absorption” and 

erroneously equated the invention with overcoming the 

food effect. Instead, Warner Chilcott insists, the limitation requires similar fed and fasted absorption of the 

drug, not merely absorption of an effective amount in 

either fed or fasted state. Warner Chilcott further contends that the specific amounts of risedronate and EDTA 

are critical, as only the claimed formulation has been 

shown to achieve such absorption. Based on the prior 

art’s warnings against the clinical use of EDTA, Warner 

Chilcott contends, one of skill in the art would have been 

dissuaded from using as high as 100 mg of EDTA to 

increase drug absorption, particularly if that increase was

understood to be effectuated at least in part by altering 

the permeability of the intestinal wall. As a result, 

Warner Chilcott disputes the district court’s finding of a

motivation to modify the prior art to achieve the claimed 

invention. Warner Chilcott lastly faults the district court

for discounting the objective evidence of nonobviousness, 

including evidence of Teva’s copying of the claimed formulation, particularly because Teva’s expert failed to account

for such evidence in his analysis. 

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Teva responds that the prior art teaches the use of 

EDTA not only to overcome the food effect but also to 

achieve similar fed/fasted absorption. Teva points out 

that the specification teaches that broad ranges of EDTA 

produce the claimed pharmaceutically effective absorption, and contends that 100 mg is not a critical amount 

because the compounds work independently and therefore 

changes to the proportions would not affect drug absorption. Moreover, Teva emphasizes, the claims do not 

require identical fasted/fed absorption, only similar 

results with up to ±50% variation. Teva further counters 

that the prior art teaches increasing bisphosphonate 

absorption by blocking calcium-complex formation, with

an equimolar amount of EDTA to calcium ions at the site 

of drug release, to achieve a constant rate of absorption. 

Teva argues that the prior art only inconsistently teaches 

away from using EDTA, and only from much larger 

quantities, and that BR ’601 addresses the clinical viability concerns with a delayed release formulation. Teva 

also asserts that the objective evidence presented only 

further supports the obviousness of providing relatively 

constant absorption regardless of fasted/fed state.

We agree with Teva that the district court did not err 

in concluding that the asserted claims would have been 

obvious to one of skill in the art at the time of the invention. The inventors were not faced with a dearth of prior 

art: as the district court found, the broad disclosure of BR 

’601 nearly anticipates, and the only claim limitation it 

lacks is “pharmaceutically effective absorption.” Warner 

Chilcott gives the pharmaceutically effective absorption 

limitation the prominence that it must. Although common sense tells us that any pharmaceutical composition 

entitled to a patent would have to be pharmaceutically 

effective, as would any such formulation approved by the 

FDA, the fact is that, without that limitation specifically 

referring to the fed/fasted absorption defined in the specification, the asserted claims would not have issued from 

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10 WARNER CHILCOTT CO. v. TEVA PHARMACEUTICALS USA, INC. 

the original prosecution. Although Warner Chilcott

defined the limitation such that it is not equivalent to 

merely overcoming the food effect, the district court found 

that pharmaceutically effective absorption would have 

been a logical and obtainable goal for a drug with bioavailability that is significantly affected by coadministration with food. 

We further agree with the district court that Teva 

proved by clear and convincing evidence that it would 

have been obvious in view of the prior art to use a chelating agent to bind calcium ions to mitigate the food effect 

for risedronate and thereby achieve similar fed/fasted 

absorption. The district court articulated its understanding of the prior art references and the teachings that 

would have led one of ordinary skill in the art to use 

EDTA to sufficiently reduce or negate the food effect to 

obtain the claimed invention. Moreover, in view of the 

broad disclosures in the specification providing embodiments with varying amounts of EDTA, and nothing in the 

asserted claims teaching one of skill in the art that or how 

only the specific 100 mg amount produces pharmaceutically effective absorption, Warner Chilcott failed to show 

the criticality of the claimed amount. We discern no clear 

error in the district court’s factual findings on the teachings of the prior art or the motivation to modify or combine the art. We therefore find no error in the district 

court’s conclusion that the asserted claims would have 

been obvious in view of the prior art. 

CONCLUSION

We have considered the remaining arguments and 

conclude that they are unpersuasive. For the foregoing 

reasons, we conclude that the district court did not err in 

holding that claim 16 of the ’459 patent and claim 20 of 

the ’460 patent are invalid as obvious under 35 U.S.C. 

§ 103, and we therefore affirm the district court’s decision.

AFFIRMED

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