NOTE: This disposition is nonprecedential.

United States Court of Appeals 

for the Federal Circuit ______________________

DR. FALK PHARMA GMBH,

Appellant

v.

GENERICO, LLC, FLAT LINE CAPITAL LLC, 

MYLAN PHARMACEUTICALS INC.,

Appellees

______________________

2017-2312

______________________

Appeal from the United States Patent and Trademark 

Office, Patent Trial and Appeal Board in Nos. IPR2016-

00297, IPR2016-01386, IPR2016-01409.

--------------------------------------------------

SALIX PHARMACEUTICALS, INC., DR. FALK 

PHARMA GMBH,

Plaintiffs-Appellants

v.

MYLAN PHARMACEUTICALS INC., MYLAN INC.,

Defendants-Appellees

______________________

2017-2636, 2018-1320

______________________
2 DR. FALK PHARMA GMBH v. GENERICO, LLC

Appeals from the United States District Court for the 

Northern District of West Virginia in No. 1:15-cv-00109-

IMK, Judge Irene M. Keeley.

______________________

Decided: June 12, 2019

______________________

MARY W. BOURKE, Womble Bond Dickinson (US) LLP, 

Wilmington, DE, argued for appellant in 2017-2312 and 

plaintiffs-appellants in 2017-2636. Also represented by 

DANIEL M. ATTAWAY, KRISTEN HEALEY CRAMER, DANA 

KATHRYN SEVERANCE; JOHN W. COX, Atlanta, GA. 

 ROBERT FLORENCE, Parker Poe Adams & Bernstein LLP, 

Atlanta, GA, argued for appellees in 2017-2312 and defendants-appellees in 2017-2636. Appellee Mylan Pharmaceuticals Inc. in 2017-2312 and defendants-appellees in 2017-

2636 also represented by SHARAD KOTAGIRI BIJANKI,

MICHEAL L. BINNS, KAREN L. CARROLL; CHRISTOPHER 

THOMAS, Raleigh, NC.

 ZACHARY DAVID SILBERSHER, Kroub Silbersher & Kolmykov PLLC, New York, NY, for appellees GeneriCo, LLC, 

Flat Line Capital LLC in 2017-2312. Also represented by 

GASTON KROUB. 

 ______________________

Before LOURIE, O’MALLEY, and REYNA, Circuit Judges.

O’MALLEY, Circuit Judge.

This case arises from two parallel proceedings involving U.S. Patent No. 8,865,688 (“the ’688 patent”), which is 

owned by Dr. Falk Pharma GmbH (“Dr. Falk”) and exclusively licensed to Salix Pharmaceuticals, Inc. (“Salix”). Dr. 

Falk appeals from a final written decision of the U.S. Patent Trial and Appeal Board (“Board”) finding that Mylan 
DR. FALK PHARMA GMBH v. GENERICO, LLC 3

Pharmaceuticals Inc., GeneriCo, LLC, and Flat Line Capital LLC (collectively, “appellees”) had proven by a preponderance of the evidence that claims 1 and 16 of the ’688 

patent are unpatentable as obvious. GeneriCo, LLC v. Dr. 

Falk Pharma GmbH, Nos. IPR2016-00296, -01386, -01409 

(P.T.A.B. May 19, 2017). Salix and Dr. Falk appeal from a 

decision of the United States District Court for the Northern District of West Virginia holding, after bench trial, that 

claim 1 of the ’688 patent would not be infringed. Salix 

Pharms., Inc. v. Mylan Pharms., Inc., No. 1:15-cv-00109, 

(N.D. W. Va. Apr. 12, 2016). For the reasons stated below, 

we affirm the Board’s conclusion that claims 1 and 16 are

unpatentable as obvious and dismiss as moot the appeal

from the district court’s judgment of noninfringement of 

claim 1. 

I. BACKGROUND

This case involves a method of treating ulcerative colitis by administering a granulated mesalamine formulation. Salix is the holder of New Drug Application (“NDA”) 

No. 22-301 for mesalamine extended release capsules 

(375 mg), which is sold and prescribed in the United States 

under the trademark Apriso®. The ’688 patent is listed in 

the FDA’s Approved Drug Products with Therapeutic 

Equivalence Evaluations, commonly known as the “Orange 

Book,” as covering Apriso®. 

In 2015, Mylan Pharmaceuticals Inc. and Mylan Inc. 

(collectively, “Mylan”) submitted Abbreviated New Drug 

Application (“ANDA”) No. 20-7271 seeking approval to 

market a generic version of Apriso®, consisting of a 375 mg 

mesalamine oral extended release capsule (“proposed product”). Salix and Dr. Falk received Mylan’s Paragraph IV 

notice letter on May 15, 2015 certifying, inter alia, that certain claims of the ’688 patent are invalid and/or would not 

be infringed by Mylan’s proposed product. On June 26, 

2015, within 45 days of receiving Mylan’s notice letter, Salix and Dr. Falk filed suit alleging that Mylan’s proposed 
4 DR. FALK PHARMA GMBH v. GENERICO, LLC

product, if approved, would infringe the ’688 patent. Mylan 

filed affirmative defenses and counterclaims challenging 

the validity of the ’688 patent, which were dismissed without prejudice pending the final resolution of the Board proceedings in Dr. Falk. Following a three-day bench trial, the 

district court issued an opinion dated September 12, 2017

construing terms and finding that claim 1 of the ’688 patent 

would not be infringed by Mylan’s proposed product. 

On December 8, 2015, after Salix and Dr. Falk sued 

Mylan in district court, GeneriCo and Flat Line filed a petition for inter partes review challenging claims 1 and 16 

of the ’688 patent as obvious over certain prior art references: a September 2007 Press Release, Endonurse, and 

Davis-1985, in view of either Marakhouski or Brunner. 

The Board instituted on June 10, 2016, after when, Mylan 

filed its own petition. The Board joined all proceedings on 

November 30, 2016. Following an oral hearing, the Board 

issued a final written decision dated May 19, 2017 finding 

claims 1 and 16 unpatentable as obvious over the asserted 

references. The following sections detail the relevant technology, prior art, and procedural history. 

A. The ’688 Patent

The ’688 patent relates to a method of maintaining remission of ulcerative colitis with a granulated mesalamine 

formulation. Ulcerative colitis is a chronic inflammatory 

disease of the colonic mucosa, i.e. the lining of the colon, for 

which there is no known cause. ’688 patent, col. 1, ll. 15–

17, 32–34. The inflammation caused by the disease makes 

it difficult for the body to absorb water and electrolytes, resulting in dehydration, weight loss, and serum electrolyte 

disturbances. Id. at col. 1, ll. 19–24. It can also lead to 

erosions, which cause rectal bleeding, and smooth muscle 

spasms, which cause an urgency to defecate. Id. at col. 1, 

ll. 24–28. The background of the patent explains that ulcerative colitis can thus have a “profound emotional and 
DR. FALK PHARMA GMBH v. GENERICO, LLC 5

social impact on the affected individual.” Id. at col. 1, ll. 

32–33. 

People with ulcerative colitis experience periods of remission, but symptoms eventually return in most. Id. at 

col. 1, ll. 51–54. The patent explains that “active therapy” 

treatments aim to treat patients who are actively experiencing symptoms of ulcerative colitis, whereas “maintenance therapy” treatments, such as the treatment claimed 

in the ’688 patent, aim to maintain remission and keep patients in a disease-free or limited disease state. Id. at col. 

1, ll. 51–59. 

The specification explains that the clinical efficacy of 

any available oral treatments depends on delivery of the 

intact molecule to the colonic mucosa. Id. at col. 1, ll. 60–

63. This is because the molecule can breakdown during digestion and prior to entering the colon. Id. at col. 1, ll. 61–

63. Previous delivery methods for oral treatments known 

at the time of invention were problematic due to the “variation . . . in the release of mesalamine, including premature release, the possibility of dose dumping, and 

sensitivity to conditions that increase gastric pH and cause 

premature release of mesalamine (e.g., ingestion of a 

meal).” Id. at col. 2, ll. 3–8. Accordingly, the specification 

states that formulations available at the time of invention 

could not adequately treat people suffering from a variety

of bowel diseases. Id. at col. 2, ll. 12–15. 

The invention of the ’688 patent purports to improve 

upon past methods by administering an effective amount 

of granulated mesalamine formulation. Id. at col. 3, ll. 26–

30. Representative claim 1 recites: 

1. A method of maintaining the remission of ulcerative colitis in a subject comprising 

administering to the subject a granulated mesalamine formulation comprising four capsules each 
6 DR. FALK PHARMA GMBH v. GENERICO, LLC

comprising 0.375 g of granulated mesalamine once 

per day in the morning, without food, wherein:

said method maintains remission of ulcerative colitis in a subject for a period of at least 6 months of 

treatment;

remission is defined as a DAI score of 0 or 1;

the granulated mesalamine formulation is not administered with antacids; and

wherein 85% to 90% of the mesalamine reaches the 

terminal ileum and colon.

Id. at col. 34, ll. 10–22 (emphases added). Challenged claim 

16 is substantially identical to claim 1 but recites the additional step of “advising the subject that granulated mesalamine should not be taken with antacids.” Id. at col. 35, ll. 

4–17. 

As the Board noted in its final written decision, the 

first and fourth limitations recite steps in the claimed 

method whereas the remaining limitations recite the results of the claimed method. The relevant claim limitations 

for the purposes of resolving the issues on appeal include 

the “DAI score” limitation, which recites a result of the 

method, and the “without food” limitation, which recites a 

step of the method. The specification expressly defines the 

term “DAI score”:

Ulcerative colitis disease activity was assessed using a modified Sutherland Disease Activity Index1

(DAI), which is a sum of four subscores based on 

stool frequency, rectal bleeding, mucosal appearance on endoscopy, and physician’s rating of disease activity. Each subscore can range from 0 to 3, 

for a total possible DAI score of 12.

Id. at col. 17, ll. 6–11. The specification also discloses various studies, including phase III clinical trials, that consider the effect of food on absorption. It expressly states 
DR. FALK PHARMA GMBH v. GENERICO, LLC 7

that overall systemic absorption was “essentially unaltered 

by a high-fat meal eaten before dosing” and that “[t]he ability to take mesalamine granules with or without food, 

along with its once-daily dosing, may improve patient compliance and treatment success.” Id. at col. 7, ll. 28–34.

B. Asserted Prior Art

In Dr. Falk, appellees argued before the Board that 

claims 1 and 16 are unpatentable as obvious over the September 2007 Press Release1, Endonurse2, and Davis-19853

in view of either Marakhouski4 or Brunner5. Each asserted 

reference is described below. 

1. September 2007 Press Release & Endonurse

The September 2007 Press Release is Salix’s announcement of the “successful completion and outcome of the first 

of two Phase III registration trials to evaluate the safety 

 

1 Salix Announces Statistically Significant Top-Line 

Results of a Unique Granulated Mesalamine Product Registration Study in Ulcerative Colitis (September 2007), 

http://www.sec.gov/Archives/edgar/containers/fix021/1009356/00011931 2507195530/dex992.htm

2 XIFAXAN® Trials Initiated in C. difficile-Associated Diarrhea, Irritable Bowel Syndrome and Hepatic Encephalopathy, New Article EndoNurse, 12 January 2006. 3 S. S. Davis, The Design and Evaluation of Controlled Release Systems for the Gastrointestinal Tract, 2 J. 

Controlled Release 27–38 (1985).

4 Y. Marakhouski et al., A Double-blind Dose-escalating Trial Comparing Novel Mesalazine Pellets with 

Mesalazine Tablets in Active Ulcerative Colitis, 21 Aliment 

Pharmacol. Ther. 133–140 (2005).

5 M. Brunner et al., Gastrointestinal Transit and Release of 5-aminosalicylic Acid from 153Sm-labelled Mesalazine Pellets vs. Tablets in Male Healthy Volunteers, 17 

Aliment. Pharmacol. Ther. 1163–1169 (2003).
8 DR. FALK PHARMA GMBH v. GENERICO, LLC

and efficacy of” its granulated mesalamine formulation in 

maintaining remission in patients with ulcerative colitis. 

J.A. 970. The results indicated that patients dosed once 

daily “with 1.5 grams of granulated mesalamine remained 

relapse-free over 6 months of treatment” as compared with 

patients dosed with a placebo. J.A. 970. Dr. Falk contends

that the reference does not define “relapse-free” or mention 

whether the treatment was administered with or without 

food. 

Endonurse is another press release from Salix that reports that “[g]ranulated mesalamine is being investigated 

in two 300-subject, multi-center, placebo-controlled, double-blind, randomized trials,” and that “[e]nrollment is ongoing in these Phase III trials designed to evaluate the 

efficacy and safety of granulated mesalamine, dosed four 

375 mg tablets once daily, for the maintenance of remission 

of ulcerative colitis.” J.A. 981. Dr. Falk notes that Endonurse does not provide any results of the trials nor does 

it mention whether the treatment is administered with or 

without food. 

2. Davis-1985

Davis-1985 is an academic paper published in the Journal of Controlled Release that discusses three factors relevant to controlled release delivery systems, including the 

characteristics of the gastrointestinal tract. Specifically, 

Davis-1985 teaches that the presence of food can affect the 

pH of the stomach as well as the process of gastric emptying. It states that “[d]elivery systems, administered to a 

fasted stomach, will empty rapidly from the stomach.” J.A. 

949. It teaches that, “if the important absorption sites for 

the administered drug are in the upper small intestine, the 

measured bioavailability in the fasted state will be considerably different to that measured in the fed state.” J.A. 

949. 

Davis-1985 also discusses the “[p]ositioned release of 

drugs in the colon.” J.A. 951. It notes that the use of 5-
DR. FALK PHARMA GMBH v. GENERICO, LLC 9

aminosalicylic acid, the active ingredient administered in 

the claimed invention, for the treatment of ulcerative colitis is a good example of a treatment in which “it would be 

advantageous to have the delayed, positioned release of a 

drug in the various regions of the colon” rather than in the 

small intestine. J.A. 951. It then teaches that, “[i]n designing a positioned release system[,] one needs to be 

aware of physiological factor(s) that can be exploited to signal the release of the dosage form in the intended region,” 

including slight and variable “pH change.” J.A. 951. Dr. 

Falk contends that Davis-1985 does not mention the impact of food on bioavailability when discussing the positioned release of drugs at the colon and that it only 

discusses the use of 5-aminosalicylic acid in tablet, not pellet, form. 

3. Marakhouski

Marakhouski compares the efficacy of a pellet formulation of 5-aminosalicylic acid with a tablet formulation for 

the treatment of ulcerative colitis. It explains that pellets 

are more advantageous because they offer “a unique combination of delayed and prolonged release characteristics.” 

J.A. 1092. Their small size, Marakhouski explains, “guarantees their continuous transit through the stomach into 

the intestine.” J.A. 1092. This prevents the premature release of the active ingredient regardless of whether it is 

taken with or without food. J.A. 1092 (“Because of their 

small size (approximately 1 mm), the pellets pass the pylorus continuously and not only during an interdigestive 

phase, thus preventing the so-called dose-dumping effect. 

Hence, the pellets can be taken independent of meals.”). 

4. Brunner

Brunner also compares the movement and release of 

pellet and tablet formulations of 5-aminosalicylic acid. 

Brunner explains that the pellet formulation “could show 

some advantages compared with tablets, such as passage 
10 DR. FALK PHARMA GMBH v. GENERICO, LLC

through the stomach independent of concomitant food intake.” J.A. 1103. 

C. The Procedural History

1. Dr. Falk

Appellees filed petitions for inter partes review challenging claims 1 and 16 of the ’688 patent as obvious over 

the September 2007 Press Release, Endonurse, and Davis1985, all in view of either Marakhouski or Brunner. The 

Board instituted on June 10, 2016. In its institution decision, the Board found that Marakhouski discloses administration without food of the same or similar granulated 

mesalamine formulation for treatment of the same disease. 

It also found that it did not matter that “Marakhouski 

makes no comparison between administration with and 

without food” because such a comparison “is not necessary 

to persuade [the Board] to institute review” when advantages such as the ability to administer the drug independent of food provide a motivation to combine 

Marakhouski with the September 2007 Press Release and 

Endonurse. J.A. 300–01. 

The Board held an oral hearing and, on May 19, 2017, 

issued a final written decision construing the DAI score 

limitation and finding claims 1 and 16 unpatentable as obvious over the September 2007 Press Release, Endonurse, 

and Davis-1985, in view of either Marakhouski or Brunner. 

The Board construed the DAI score limitation as “remission is defined as a DAI score of 0 or 1, where the DAI score 

is a sum of four subscores.” J.A. 11. The Board rejected 

Dr. Falk’s proposal to construe the term to mean that the

DAI score is the sum of two, rather than four, subscores. 

The Board explained that the patent specification expressly defines DAI score as the sum of four subscores. J.A. 

11 (citing the ’688 patent, col. 17, ll. 7–12). The Board 

therefore rejected Dr. Falk’s proposed construction and 

adopted a construction consistent with the specification’s 

express definition of DAI score. 
DR. FALK PHARMA GMBH v. GENERICO, LLC 11

The Board then found claims 1 and 16 unpatentable as 

obvious. It found that all claimed limitations, including the 

without food and DAI score limitations, were satisfied by 

the prior art and that there was a motivation to combine 

the asserted references with a reasonable expectation of 

success. Specifically, the Board found that a skilled artisan 

would have been motivated to combine the method of the 

September 2007 Press Release and Endonurse with the 

teachings of either Marakhouski or Brunner that the granulated mesalamine formulation could be administered 

without food. The Board cited as its rationale the fact that 

all four prior art references pertain to the same or similar 

granulated mesalamine formulation for treatment of the 

same disease and because Marakhouski and Brunner teach 

that an advantage of a granulated mesalamine formulation 

is the ability to administer the drug independent of food. 

The Board also concluded that a skilled artisan would have 

been motivated to combine these references with Davis1985. This is because Davis-1985 discloses using the same 

active ingredient, 5-aminosalicylic acid, to treat ulcerative 

colitis and because its teachings are relevant to the question of whether a “drug intended for topical action in the 

colon should be administered with or without food.” J.A. 

38. 

The Board also found that a skilled artisan would have 

had a reasonable expectation of success in maintaining remission of ulcerative colitis by administering granulated 

mesalamine without food. The Board found that the September 2007 Press Release supports this finding because it 

announces a successful outcome of a Phase III trial to evaluate the safety and efficacy of the same or similar granulated mesalamine formulation for treatment of the same 

disease. Notably, the Board found “[t]here is no indication 

in the [September 2007 Press Release] that the granulated 

mesalamine had to be administered with food in order to 

obtain the reported success.” J.A. 40. The Board also relied 

on Marakhouski, which reports successful results from 
12 DR. FALK PHARMA GMBH v. GENERICO, LLC

administering granulated mesalamine without food, Davis-1985, which suggests that a drug intended for delivery 

in the colon is best administered without food, and uncontroverted testimony from appellees’ expert. The Board 

again rejected Dr. Falk’s argument that a skilled artisan 

would need to conduct a food study to determine if the formulation should be administered with or without food. The 

Board reiterated that such comparative studies are not 

necessary in view of the evidence of record especially when 

the claims at issue do not recite an efficacy requirement 

related to the effect of food. 

Finally, the Board considered evidence of objective indicia, including long felt need, failure of others, and unexpected results. The Board found Dr. Falk’s evidence 

unpersuasive and afforded it low probative weight. Specifically, with regard to failure of others, the Board noted that 

Dr. Falk relied only on its own failures, which the Board 

found was insufficient. Based on the above findings, the 

Board concluded that appellees had demonstrated by a preponderance of the evidence that claims 1 and 16 are unpatentable as obvious. 

2. Salix

As noted, Salix and Dr. Falk sued Mylan alleging that 

its submission of ANDA No. 20-7271, if approved, would 

infringe the ’688 patent under 35 U.S.C. § 271(e). Mylan 

filed counterclaims on July 13, 2015, asserting that its proposed product would not infringe and that the patents were 

invalid as obvious. On June 22, 2017, after the Board entered its final written decision in Dr. Falk, the parties 

jointly stipulated to dismissal of these counterclaims pending resolution of the appeal in Dr. Falk.

The district court held a Markman hearing and, on 

April 12, 2016, issued an order construing terms. The parties agreed that the claim term “wherein 85% to 90% of the 

mesalamine formulation reaches the terminal ileum and 

colon” (“the 85% to 90% limitation”) should be given its 
DR. FALK PHARMA GMBH v. GENERICO, LLC 13

plain and ordinary meaning. But Salix argued that the 

plain and ordinary meaning of the term encompasses “the 

understanding that a person of ordinary skill in the art 

would view the percent mesalamine reaching the terminal 

ileum or colon as a lower boundary for therapeutic effectiveness.” J.A. 1274. The district court construed the term 

according to its “plain and ordinary meaning” without 

reading Salix’s requested caveat into the claim. It, instead, 

read the limitation to impose both upper and lower boundaries. The parties did not ask the court to construe the 

claim term “granulated mesalamine formulation” at that 

time.

The district court held a bench trial from March 7 to 

March 9, 2017 on the issue of infringement of claim 1 of the 

’688 patent. At trial, the parties disputed the constructions 

of the granulated mesalamine formulation limitation and 

the 85% to 90% limitation. On November 29, 2017, the district court entered final judgment on behalf of Mylan. Specifically, the district court construed both disputed

limitations and found that Salix had failed to demonstrate 

by a preponderance of the evidence that the proposed product would infringe the granulated mesalamine formulation 

and the 85% to 90% limitations of the ’688 patent. 

Salix and Dr. Falk appeal the district court’s decision 

in Salix and Dr. Falk appeals the Board’s decision in Dr. 

Falk. We have jurisdiction to review both decisions pursuant to 28 U.S.C. § 1295(a)(1) and 28 U.S.C. § 1295(a)(4)(A), 

respectively. 

II. DISCUSSION

In Dr. Falk, Dr. Falk argues on appeal that the Board 

erred in its construction of “remission is defined as a DAI 

score of 0 or 1” and that the Board’s conclusion of obviousness is unsupported under the purportedly proper construction of the term. Dr. Falk also argues that the Board 

erred in its finding that the without food limitation would 

have been obvious. 
14 DR. FALK PHARMA GMBH v. GENERICO, LLC

In Salix, Salix and Dr. Falk argue on appeal that the 

district court erred in its claim construction and noninfringement findings with respect to the granulated mesalamine formulation and the 85% to 90% limitations. For the 

reasons stated below, we affirm the Board’s finding in Dr. 

Falk that claims 1 and 16 are unpatentable as obvious; we 

therefore dismiss as moot the question of whether the district court in Salix erred in finding that Mylan’s proposed 

product would not infringe claim 1.

A. The DAI Score Limitation

Dr. Falk argues that the Board erred when it construed 

“remission is defined as a DAI score of 0 or 1,” as “remission 

is defined as a DAI score of 0 or 1, where the DAI score is a 

sum of four subscores” rather than a sum of two subscores. 

We disagree. 

We review the Board’s constructions de novo except for 

subsidiary fact findings based on extrinsic evidence, which 

we review for substantial evidence. PPC Broadband, Inc. 

v. Corning Optical Commc’ns RF, LLC, 815 F.3d 747, 751 

(Fed. Cir. 2016). The Board construes claims consistent 

with their broadest reasonable interpretation in view of the 

specification.6 Id. Under both this standard and the 

 

6 The U.S. Patent and Trademark Office has indicated that it intends to apply the Phillips claim construction standard to petitions filed on or after November 13, 

2018. See Changes to the Claim Construction Standard for 

Interpreting Claims in Trial Proceedings Before the Patent 

Trial and Appeal Board, 83 Fed. Reg. 51,340 (Oct. 11, 2018) 

(to be codified at 37 C.F.R. pt. 42). Because GeneriCo filed 

its petition before November 13, 2018, we apply the broadest reasonable interpretation standard here (as the Board 

did below). Regardless, as explained herein, we find no error with the Board’s construction based on principles underlying both claim construction standards. 
DR. FALK PHARMA GMBH v. GENERICO, LLC 15

Phillips standard, we construe terms according to their 

plain and ordinary meanings as understood by a skilled artisan unless the patentee acts as his or her own lexicographer and clearly sets forth a definition of the disputed 

claim term in either the specification or the prosecution 

history. In re Schwemberger, 410 F. App’x 298, 303 (Fed. 

Cir. 2010) (citing CCS Fitness v. Brunswick Corp., 288 F.3d 

1359, 1366 (Fed. Cir. 2002)). 

Here, not only did Dr. Falk concede in front of the 

Board that the term DAI score is ordinarily understood in 

the art as the sum of four subscores, J.A. 10, the patentee

expressly defined the term as such in the specification:

Ulcerative colitis disease activity was assessed using a modified Sutherland Disease Activity Index1

(DAI), which is a sum of four subscores based on 

stool frequency, rectal bleeding, mucosal appearance on endoscopy, and physician’s rating of disease activity. Each subscore can range from 0 to 3, 

for a total possible DAI score of 12.

’688 patent, col. 17, ll. 6–11 (emphasis added). Thus, we 

find that the Board did not err in construing DAI score as 

a sum of four subscores. 

Dr. Falk contends that the “Board’s construction contradicts the explicit, repeated definition of ‘remission’ used 

by the inventors.” Appellant’s Br. at 33. It notes that the 

specification at times describes clinical trials in which “remission” and “relapse-free” (which Dr. Falk contends is an 

equivalent term for “remission”) are defined as a DAI score 

of 0 or 1 based on two subscores. This, according to Dr. 

Falk, demonstrates that the specification consistently provides a special definition of “remission” and that this special definition must control.

But, while Dr. Falk is correct that the specification at 

times references a special definition of remission, the claim

language does not claim that special definition. This is 
16 DR. FALK PHARMA GMBH v. GENERICO, LLC

clear when we compare the portions of the specification to 

which Dr. Falk directs the court with the plain language of 

the claims. For example, Dr. Falk directs us to Examples 

8 and 9 in which the specification refers to remission as a 

“revised Sutherland Disease Activity Index [SDAI]” score 

of less than 2 based on two subscores—rectal bleed and mucosal appearance. ’688 patent, col. 26, ll. 51–55 (emphasis 

added); see also id. at col. 25, ll. 33–36; id. at col. 26, ll. 21–

25; id. at col. 28, ll. 7–8. In contrast, the claim language 

plainly recites a definition of “remission” that does not reference a “revised” DAI score; rather it states that “remission is defined as a DAI score of 0 or 1.” Id. at col. 34, ll. 

18. If the patentee intended to define remission as based 

on a revised DAI score rather than a DAI score, it would 

have used the word “revised” in the claim language. Thus, 

we conclude that the district court did not err in its construction. 

B. The Without Food Limitation

Dr. Falk also argues, based on our decision in SAS Institute, Inc. v. ComplementSoft, LLC, 825 F.3d 1341 (Fed. 

Cir. 2016), that the Board violated the Administrative Procedure Act (“APA”) by changing theories on the evidence 

required to show obviousness of the “without food” limitation. According to Dr. Falk, the Board granted institution 

assuming that the limitation recites a food effect—i.e., that 

taking the formulation without food is preferable to taking 

it with food—but, in its final written decision, concluded 

that the claims do not recite such a food effect. In the alternative, Dr. Falk contends that, when assessing whether 

a skilled artisan would have been motivated to combine the

prior art with a reasonable expectation of success to arrive 

at the without food limitation, the Board failed to consider 

evidence regarding the unpredictable impact of food on the

absorption of mesalamine. We address each argument in 

turn. 
DR. FALK PHARMA GMBH v. GENERICO, LLC 17

First, the Board did not change theories on the evidence required to show obviousness of the without food limitation. In SAS, we held that it was improper for the Board

to use a construction of a term in its final written decision 

that differed from its construction of the term in its institution decision. 825 F.3d at 1351 (“What concerns us is not 

that the Board adopted a construction in its final written 

decision, as the Board is free to do, but that the Board

changed theories in midstream.” (internal quotations and 

alterations omitted)). But our decision in SAS is distinguishable from this case because the Board here found that 

the claims do not recite a food effect and because Dr. Falk 

had adequate notice and opportunity to respond to the 

Board’s conclusion that they do not, as evidenced by the 

arguments it raised during both the pre- and post- institution phases of the proceedings.

In its institution decision, the Board responded to Dr. 

Falk’s contention that the claims impliedly contained a 

food effect limitation by stating that, obviousness “turns on 

whether administering granulated mesalamine without 

food would have been predictable and would have led to anticipated success.” J.A. 298. It then stated that relevant to 

this inquiry were “record-supported rationales for why a 

[skilled artisan] seeking to practice the method disclosed in 

[the September 2007] Press Release and Endonurse would 

have known to administer granulated mesalamine without 

food.” J.A. 298–99. In response to Dr. Falk’s argument 

that this inquiry requires a food effect study, the Board 

stated that “[a] comparison between administration with 

and without food is not necessary to persuade [the Board] 

to institute review because Petitioners’ contention regarding a motivation to combine Markhouski’s disclosures with 

[the September] 2007 Press Release and Endonurse is adequately supported by other information.” J.A. 300–01. It 

then concluded that “administering granulated mesalamine without food would have been known, predictable, 

and led to anticipated success.” J.A. 299. These 
18 DR. FALK PHARMA GMBH v. GENERICO, LLC

statements were in response to Dr. Falk’s assertion that a 

food effect limitation existed and that a food effect study

must be disclosed in the prior art; they were not an unqualified agreement with that assertion. Instead, they reflect

agreement with appellees’ view that the prior art’s failure 

to require that the formulation be administered with food 

was the relevant fact for its obviousness analysis.

Consistent with these statements in its institution decision, the Board stated in its final written decision that 

“[t]he requirement to show a reasonable expectation of success pertains to the subject matter of the claims,” and, here, 

because “the claims do not recite a food effect,” there was a 

reasonable expectation of success of arriving at the without 

food limitation even though none of the prior art discloses 

a food effect study. J.A. 43–44. The Board did not accept

Dr. Falk’s contention that food effect studies were needed 

and was not persuaded by Dr. Falk’s expert testimony 

claiming that the impact of food on absorption was unpredictable at the time of the invention. Rather, it consistently indicated that other rationales existed for a 

motivation to combine with a reasonable expectation of 

success despite an absence of a food effect study in the prior 

art. Moreover, Dr. Falk raised, appellees rebutted, and the 

Board addressed during oral argument and in its final written decision the question of whether the claims contain a 

food effect limitation, as distinct from the without food limitation. That Dr. Falk pursued and lost the argument that 

they do not contain such a food effect limitation and that 

the prior art does not disclose one does not amount to inadequate notice and opportunity to respond. Thus, we conclude that the Board’s analysis did not violate the APA. 

Second, the Board did not fail to consider relevant evidence when assessing a motivation to combine with a reasonable expectation of success. Rather, it focused its 

analysis on the correct inquiry under our case law, which 

asks whether a skilled artisan would have “ha[d] a motivation to combine accompanied by a reasonable expectation 
DR. FALK PHARMA GMBH v. GENERICO, LLC 19

of achieving what is claimed in the patent-at-issue.” Intelligent Bio-Sys., Inc v. Illumina Cambridge Ltd., 821 F.3d 

1359, 1367 (Fed. Cir. 2016) (emphasis added). Here, the 

Board correctly found that the claims do not recite a food 

effect. The plain language of the claim merely recites a requirement that the formulation be administered “without 

food.” The language does not indicate the drug formulation 

is more or less effective depending on whether it is administered with or without food. Even Dr. Falk’s own expert, 

when asked if the “claim requires that the administration 

of the drug is more effective without food versus with food,” 

answered, “[n]o . . . . It doesn’t state more effective with 

food or without food.” J.A. 1208. And, although the specification contains food effect studies, the results of those 

studies suggest that the drug formulation may be administered without regard to food. ’688 patent at col. 7, ll. 28–34 

(stating that overall systemic absorption was “essentially 

unaltered by a high-fat meal eaten before dosing” and that 

“[t]he ability to take mesalamine granules with or without 

food, along with its once-daily dosing, may improve patient 

compliance and treatment success.”); id. at col. 16, ll. 62–

64 (studying in Example 4 the pharmacokinetic effect of 

food on absorption and concluding that “[t]he overall rate 

and extent of absorption of mesalamine and its N-acetyl 

metabolite were not affected by a high-fat meal”). Based 

on this reasonable reading of the claims, the Board found 

Dr. Falk’s evidence regarding the alleged unpredictable impact of food was outside the scope of the claims. 

Dr. Falk contends that, even if the claims do not recite 

a food effect, the Board still erred in disregarding Dr. Falk’s 

evidence because evidence relating to unclaimed features 

is relevant to the inquiry of a motivation to combine with a 

reasonable expectation of success. In support of this proposition, Dr. Falk cites to Intelligent Bio-Systems, 821 F.3d 

at 1367–68, in which it contends that this court found evidence relating to an unclaimed feature central to the motivation to combine inquiry and to Institut Pasteur & 
20 DR. FALK PHARMA GMBH v. GENERICO, LLC

Universite Pierre et Marie Curie v. Focarino, 738 F.3d 1337, 

1346 (Fed. Cir. 2013), in which it contends that this court 

similarly found that the Board erred in disregarding evidence relating to an unclaimed feature when assessing a 

motivation to combine with a reasonable expectation of 

success. 

We disagree. In Intelligent Bio-Systems, we stated the 

opposite of what Dr. Falk now contends. 821 F.3d at 1367. 

Indeed, it is well established that “failure to consider the 

appropriate scope of the . . . patent’s claimed invention in 

evaluating the reasonable expectation of success . . . constitutes a legal error that [is] review[ed] without deference.” 

Id. (quoting Allergan, Inc. v. Apotex Inc., 754 F.3d 952, 966 

(Fed. Cir. 2014)). Similarly, in Institut Pasteur, we admonished the Board, not because it failed to consider evidence 

relevant to unclaimed features, but because it failed to consider evidence related to a feature that the Board admitted 

was implicit in the claims. 737 F.3d at 1346. In contrast, 

here, the claims do not recite any food effect—either expressly or implicitly. Therefore, we conclude that the 

Board did not disregard evidence of record, but rather correctly found Dr. Falk’s evidence as falling outside the scope 

of the claims. 

III. CONCLUSION

For the reasons stated above, we affirm the Board’s final written decision in Dr. Falk that claims 1 and 16 of the 

’688 patent are unpatentable as obvious.7 Accordingly, we 

 

7 We have considered Dr. Falk’s remaining arguments and find them unpersuasive. We conclude that the 

Board did not fail to consider evidence of the differences 

between the claimed method and the prior art and that 

substantial evidence supports the Board’s finding of a motivation to combine with a reasonable expectation of success despite these differences. We also conclude that the 
DR. FALK PHARMA GMBH v. GENERICO, LLC 21

dismiss as moot Salix’s appeal from the district court’s 

judgment that claim 1 of the same patent would not be infringed. 

AFFIRMED AS TO APPEAL NO. 17-2312;

DISMISSED AS TO APPEAL NO. 17-2636

COSTS

Costs to Appellees.

 

Board did not err in its analysis of objective indicia of nonobviousness; specifically, the Board balanced the evidence 

submitted by Dr. Falk and afforded it due weight in view 

of our case law.