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Parties Involved:
Hospira, Inc.
Cross-Appellant
Medicines Company
Appellant

Document Text:

United States Court of Appeals 

for the Federal Circuit ______________________ 

THE MEDICINES COMPANY,

Plaintiff-Appellant

v.

HOSPIRA, INC.,

Defendant-Cross-Appellant

______________________ 

2014-1469, 2014-1504

______________________ 

Appeals from the United States District Court for the 

District of Delaware in No. 1:09-CV-00750, Judge Richard 

G. Andrews.

______________________ 

Decided: July 2, 2015

______________________ 

EDGAR HAUG, Frommer Lawrence & Haug LLP, New 

York, NY, argued for plaintiff-appellant. Also represented by PORTER F. FLEMING, ANGUS CHEN. 

BRADFORD PETER LYERLA, Jenner & Block LLP, Chicago, IL, argued for defendant-cross-appellant. Also 

represented by SARA TONNIES HORTON, AARON A. BARLOW. 

______________________ 

Before DYK, WALLACH, and HUGHES, Circuit Judges.

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2 THE MEDICINES COMPANY v. HOSPIRA, INC. 

HUGHES, Circuit Judge. 

The Medicines Company appeals the U.S. District 

Court for the District of Delaware’s claim construction 

and non-infringement findings. Hospira, Inc. crossappeals the district court’s determination that the asserted claims are not invalid under the on-sale bar, obviousness, or indefiniteness. We conclude that the district 

court clearly erred in finding that the bivalirudin batches 

prepared by Ben Venue Laboratories before the critical 

date were not sold to The Medicines Company and were 

prepared primarily for an experimental purpose. Accordingly, we reverse the district court’s validity determination and hold the asserted claims invalid under the onsale bar. 

I 

The Medicines Company owns U.S. Patent No. 

7,582,727 and U.S. Patent No. 7,598,343. The patents

relate to the drug bivalirudin, a synthetic peptide used as 

an anti-coagulant. Bivalirudin is generally mixed with 

saline or water and administered intravenously. Because 

bivalirudin’s acidity in saline or water makes it undesirable for injection, its pH is adjusted during compounding to 

make it more alkaline.

The Medicines Company sells a bivalirudin drug for 

injection under the Angiomax® brand. From 1997 to 

October 2006, The Medicines Company purchased pharmaceutical batches of Angiomax® from Ben Venue Laboratories. In 2005, Ben Venue created a batch of 

bivalirudin with levels of Asp9-bivalirudin impurity that 

exceeded the Food and Drug Administration’s approved 

maximum of 1.5%. Accordingly, The Medicines Company 

could not use the batch. 

After another batch failure, The Medicines Company

hired a consultant, Dr. Musso, to investigate and resolve 

the issue. Dr. Musso discovered that certain methods of 

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THE MEDICINES COMPANY v. HOSPIRA, INC. 3

adding a pH-adjusting solution during the compounding 

process minimize the Asp9-bivalirudin impurity to less 

than 0.6%. In July 2008, The Medicines Company filed 

applications for the ’343 and ’727 patents, which include 

product-by-process claims describing this discovery. 

Over one year before filing these applications, however, The Medicines Company hired Ben Venue to prepare

three batches of bivalirudin using an embodiment of the 

patented method. Each invoice for these services identifies a “charge to manufacture Bivalirudin lot.” See 

JA17177–79. Each invoice also states that the bivalirudin 

lot was or will be released to The Medicines Company. 

JA17177 (“Release pending final validation report.”); 

JA17178 (same); JA17179 (“Batch released and held at 

Ben Venue pending shipping instructions.”). Each lot was 

marked with a commercial product code and a customer 

lot number, and was released to The Medicines Company 

for commercial and clinical packaging. 

On August 19, 2010, The Medicines Company sued 

Hospira, Inc., alleging that two of Hospira’s ANDA filings 

infringe claims 1–3, 7–10, and 17 of the ’727 patent and 

claims 1–3 and 7–11 of the ’343 patent. The district court 

construed the asserted claims and, after a bench trial, 

found the patents not infringed and not invalid as obvious, indefinite, or under the on-sale bar. The Medicines 

Company appeals the district court’s claim construction 

and finding of non-infringement. Hospira appeals the 

district court’s holdings on obviousness, indefiniteness, 

and the on-sale bar. We have jurisdiction under 28 U.S.C. 

§ 1295(a)(1). 

II

On appeal from a bench trial, we review a district 

court’s legal determinations de novo and factual findings 

for clear error. Braintree Labs., Inc. v. Novel Labs., Inc., 

749 F.3d 1349, 1358 (Fed. Cir. 2014). Invalidity under the 

on-sale bar is a question of law with underlying questions 

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4 THE MEDICINES COMPANY v. HOSPIRA, INC. 

of fact. Robotic Vision Sys., Inc. v. View Eng’g, Inc., 249 

F.3d 1307, 1310 (Fed. Cir. 2001).

 The on-sale bar under 35 U.S.C. § 102(b) applies 

when, before the critical date, the claimed invention

(1) was the subject of a commercial offer for sale; and 

(2) was ready for patenting. Pfaff v. Wells Elecs., Inc., 525 

U.S. 55, 67–68 (1998). 

The district court found that the claimed invention 

was ready for patenting but not commercially offered for 

sale before the critical date. Hospira disputes the district 

court’s finding that the claimed invention was not commercially offered for sale, and The Medicines Company 

disputes the district court’s finding that the claimed

invention was ready for patenting. 

A 

The district court concluded that no commercial sale 

occurred because: (1) Ben Venue only sold manufacturing 

services, not pharmaceutical batches; and (2) the batches 

fall under the experimental use exception. 

While the district court is correct that Ben Venue invoiced the sale as manufacturing services and title to the 

pharmaceutical batches did not change hands, that does 

not end the inquiry. As we have explained, “the intent of 

[invalidating claims under the on-sale bar] is to preclude 

attempts by the inventor or his assignee to profit from 

commercial use of an invention for more than a year 

before an application for patent is filed.” D.L. Auld Co. v. 

Chroma Graphics Corp., 714 F.2d 1144, 1147 (Fed. Cir. 

1983). To ensure the doctrine is not easily circumvented, 

we have found the on-sale bar to apply where the evidence 

clearly demonstrated that the inventor commercially 

exploited the invention before the critical date, even if the 

inventor did not transfer title to the commercial embodiment of the invention. For example, in D.L. Auld Co., we

found the on-sale bar to apply where, before the critical 

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date, an inventor sold products made by the patented 

method. Id.; see also W.L. Gore & Assocs., Inc. v. Garlock, 

Inc., 721 F.2d 1540, 1550 (Fed. Cir. 1983); cf. Kinzenbaw 

v. Deere & Co., 741 F.2d 383, 390–91 (Fed. Cir. 1984)

(finding a third party’s testing of the “warrantability, 

durability, and acceptability” of a commercial embodiment 

of a patented product before the critical date was an 

invalidating public use under § 102(b) because it “served 

Deere’s commercial purposes”). 

We find no principled distinction between the commercial sale of products prepared by the patented method 

at issue in D.L. Auld Co. and the commercial sale of 

services that result in the patented product-by-process

here. The Medicines Company paid Ben Venue for performing services that resulted in the patented product-byprocess, and thus a “sale” of services occurred. See Special Devices, Inc. v. OEA, Inc., 270 F.3d 1353, 1355 (Fed. 

Cir. 2001) (“A ‘sale’ under th[e on-sale bar] occurs when 

the parties offer or agree to reach ‘a contract . . . to give 

and pass rights of property for consideration which the 

buyer pays or promises to pay the seller for the thing 

bought or sold.’” (quoting Zacharin v. United States, 213 

F.3d 1366, 1370 (Fed. Cir. 2000))). As in D.L. Auld Co., 

the sale of the manufacturing services here provided a 

commercial benefit to the inventor more than one year 

before a patent application was filed. Ben Venue’s services were performed to prove to the FDA that The Medicines Company’s product met the already-approved 

specifications for finished bivalirudin product. Additionally, Ben Venue marked the batches with commercial 

product codes and customer lot numbers and sent them to 

The Medicines Company for commercial and clinical 

packaging, consistent with the commercial sale of pharmaceutical drugs. This commercial activity was not 

insignificant; The Medicines Company admits that each 

batch had a commercial value of over $10 million.

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Accordingly, we find that the district court clearly 

erred in finding the Ben Venue sale of services did not 

constitute a commercial sale. To find otherwise would 

allow The Medicines Company to circumvent the on-sale 

bar simply because its contracts happened to only cover 

the processes that produced the patented product-byprocess. This would be inconsistent with our principle 

that “no ‘supplier’ exception exists for the on-sale bar.” 

Special Devices, 270 F.3d at 1357. 

This is not a case where the inventors have requested 

another entity’s services in developing products embodying the invention without triggering the on-sale bar. See 

Trading Techs. Int’l, Inc. v. eSpeed, Inc., 595 F.3d 1340,

1361–62 (Fed. Cir. 2010). The batches were prepared for 

commercial exploitation, and this is not the type of “secret, personal use” described in Trading Technologies. 

Indeed, the preparation of the batches was described as 

an “Optimization Study,” and was performed because 

“several opportunities for further optimization of the 

formulation process were identified” after “successful[] 

validat[ion] in a previous validation study.” J.A. 14882–

83. 

Moreover, “[i]f a product that is offered for sale inherently possesses each of the limitations of the claims, then 

the invention is on sale, whether or not the parties to the 

transaction recognize that the product possesses the 

claimed characteristics.” Abbott Labs. v. Geneva Pharm., 

182 F.3d 1315, 1319 (Fed. Cir. 1999). There is no dispute 

that the batches had the levels of Asp9-bivalirudin required by the claims. Thus, it is irrelevant whether The 

Medicines Company knew that the process limitations of 

the asserted claims reliably and consistently produced 

levels of Asp9-bivalirudin below 0.6%. 

The district court also clearly erred in finding that the 

experimental use doctrine bars the application of the onsale bar to the Ben Venue batches. “[E]xperimental use 

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cannot occur after a reduction to practice.” In re Cygnus 

Telecomm. Tech., LLC Patent Litig., 536 F.3d 1343, 1356 

(Fed. Cir. 2008). The Medicines Company asserts that it 

had not reduced the invention to practice when the batches were made because it did not appreciate the maximum 

impurity level limitation of the claimed invention until 

after twenty-five batches of bivalirudin were manufactured according to The Medicine Company’s new process. 

“However, we have held that where an invention is on 

sale, conception is not required to establish reduction to 

practice.” Scaltech, Inc. v. Retec/Tetra, LLC, 269 F.3d 

1321, 1331 (Fed. Cir. 2001) (citation omitted). In other 

words, “[t]he sale of the [invention] in question obviates 

any need for inquiry into conception.” Abbott Labs., 182 

F.3d at 1318–19. To be sure, Abbott and Scaltech did not 

involve experimental use, and the experimental use 

defense may be available even if the invention had been 

reduced to practice if the inventor was unaware that the 

invention had been reduced to practice (i.e., worked for its 

intended purpose) and continued to experiment. See New

Railhead Mfg., L.L.C. v. Vermeer Mfg. Co., 298 F.3d 1290, 

1297 (Fed. Cir. 2002) (“‘When an evaluation period is 

reasonably needed to determine if the invention will serve 

its intended purpose, the § 102(b) bar does not start to 

accrue while such determination is being made.’ . . . 

Once an inventor realizes that the invention as later 

claimed works for its intended purpose, further ‘experimentation’ may constitute a barring public use.” (quoting 

Seal-Flex, Inc. v. Athletic Track & Court Constr., 98 F.3d 

1318, 1324 (Fed. Cir. 1996))). This is not a situation in 

which the inventor was unaware that the invention had 

been reduced to practice, and was experimenting to 

determine whether that was the case. The batches sold 

satisfied the claim limitations, and the inventor was well 

aware that the batches had levels of Asp9-bivalirudin well 

below the claimed levels of 0.6%.

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8 THE MEDICINES COMPANY v. HOSPIRA, INC. 

B 

An invention is ready for patenting when, before the 

critical date, the invention is reduced to practice; or is 

depicted in drawings or described in writings of sufficient 

nature to enable a person of ordinary skill in the art to 

practice the invention. Hamilton Beach Brands, Inc. v. 

Sunbeam Prods., Inc., 726 F.3d 1370, 1375 (Fed. Cir. 

2013). 

The Medicines Company argues that the district court 

erred in finding its invention was ready for patenting 

because there was no reduction to practice and the inventors had not prepared drawings or written descriptions 

sufficient to enable a person skilled in the art to practice 

the invention. But because the invention was sold, for the 

reasons described supra Section II(A), we find that the 

Ben Venue batches reduced the invention to practice. 

Thus, the district court did not clearly err in finding the 

invention was ready for patenting. 

III

Because the district court did not err in finding that 

the claimed invention was ready for patenting, but clearly 

erred in finding that the claimed invention was not commercially offered for sale before the critical date, we 

reverse the district court’s determination that the on-sale 

bar does not apply. Accordingly, we hold the asserted 

claims invalid, and decline to reach the other issues 

raised by the parties. 

REVERSED

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