Cephalon Inc. v. Hetero Labs Ltd. et al
Filing
472
MEMORANDUM. Signed by Judge Gregory M. Sleet on 6/10/2016. (mdb)
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
IN RE BENDAMUSTINE CONSOLIDATED
CASES
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Civil Action No. 13-2046-GMS
CONSOLIDATED
MEMORANDUM
I.
INTRODUCTION
In this consolidated patent infringement action, plaintiff Cephalon, Inc. alleges that
pharmaceutical products proposed by defendants Accord Healthcare Inc., Intas Pharmaceuticals
Ltd., Hetero Labs Ltd., Hetero USA, Inc., Hospira Inc., InnoPharma, Inc., and Sagent
Pharmaceuticals, Inc. (collectively, "the Defendants") infringe the asserted claims of the patentsin-suit. The court held a six-day bench trial in this matter on December 1 through December 8,
2015. (D.I. 449--454.) Presently before the court are the parties' post-trial proposed findings of fact
and conclusions of law concerning the validity of the patents-in-suit. (D.I. 455; D.I. 459.)
Pursuant to Federal Rule of Civil Procedure 52(a), and after having considered the entire
record in this case and the applicable law, the court concludes that: (1) the asserted claims of the
patents-in-suit are not invalid as obvious under 35 U.S.C. § 103; (2) claims 1, 3, and 5 of the '270
patent are not invalid as anticipated under 35 U.S.C. § 102(b); (3) claims 1 and 19 of the '270
patent are not invalid due to the on-sale bar under 35 U.S.C. § 102(b); (4) claims 19-21 of the '270
patent are invalid as derived under 35 U.S.C. § 102(f); and (5) each of the parties' 52(c) motions
are granted in part and denied in part. These findings of fact and conclusions of law are set forth
in further detail below.
II.
FINDINGS OF FACT 1
A.
The Parties
1.
Plaintiff Cephalon, Inc. ("Cephalon") is a corporation operating and existing under the laws
of Delaware, with its principal place of business at 41 Moores Road, Frazer, Pennsylvania 19355.
2.
Defendant Accord Healthcare, Inc. is a corporation organized and existing under the laws
of the State of North Carolina, with its principal place of business at 1009 Slater Road, Suite 210B, Durham, North Carolina, 27703.
3.
Defendant Intas Pharmaceuticals Ltd. is a corporation organized and existing under the
laws of India, with its principal place of business at Chinubhai Center Off. Nehru Bridge, Ashram
Road, Ahmedabad 380009, Gujarat, India.
4.
Accord Healthcare, Inc. is a wholly owned subsidiary of Intas Pharmaceuticals Ltd.
(collectively, "Accord").
5.
Defendant Hetero USA, Inc. is a corporation organized and existing under the laws of the
State of Delaware, with its principal place of business at 1035 Centennial Avenue, Piscataway,
New Jersey 08854.
6.
Defendant Hetero Labs Ltd. ("Hetero Labs") is a corporation organized and existing under
the laws of India, with its principal place of business at 7-2-A2, Hetero Corporate Industrial
Estates, Sanath Nagar, Hyderabad-500 018 A.P. India.
7.
Hetero Labs Ltd. is a parent company ofHetero USA, Inc. (collectively, "Hetero").
8.
Defendant Hospira Inc. ("Hospira") is a corporation organized and existing under the laws
of Delaware, with its principal place of business at 275 North Field Dr., Lake Forest, Illinois
60045.
.
9.
Defendant InnoPharma, Inc. ("InnoPharma") is a corporation organized and existing under
the laws of the State of Delaware, with its principal place of business at 10 Knights bridge Road,
Piscataway, New Jersey 08854.
1
Prior .to trial, the parties submitted an exhibit of uncontested facts in conjunction with their Pretrial Order.
(D.I. 433, Schedule A.) The court takes most of its findings of fact from the parties' uncontested facts. Where
necessary, the court has overruled objections to the inclusion of these facts. The court has also reordered and
renumbered some paragraphs, corrected some spelling and formatting errors, and made minor edits for the purpose of
concision and clarity that it does not believe alters the meaning of the paragraphs from the Pretrial Order. Otherwise,
any differences between this section and the parties' statement of uncontested facts are unintentional.
The court's findings of fact with respect to matters that were the subject of dispute between the parties are
included in the Discussion and Conclusions of Law section of this opinion, preceded by the phrase "the court finds"
or "the court concludes."
2
10.
Defendant Sagent Pharmaceuticals, Inc. ("Sagent") is a corporation organized and existing
under the laws of Delaware, with its corporate offices and a principal place of business at 1901 N.
Roselle Road, Ste. 700, Schaumburg, IL 60195-3194.
11.
The court has subject matter jurisdiction and personal jurisdiction over all parties.
B.
Background
12.
These consolidated actions arise out of Defendants' submission of several Abbreviated
New Drug Applications ("AND As") under§ 505G) of the Federal Food, Drug and Cosmetic Act
to the United States Food and Drug Administration ("FDA"), seeking approval to market and sell
bendamustine hydrochloride for injection, 25 mg/vial and 100 mg/vial.
13.
Bendamustine hydrochloride is an alkylating agent that has been used to treat cancer. As
early as 1963, bendamustine hydrochloride was synthesized and was later shown to have
therapeutic utility in the treatment of diseases such as chronic lymphocytic leukemia, Hodgkin's
disease, non-Hodgkin's lymphoma, multiple myeloma, and breast cancer.
14.
From 1971 to 1992, bendamustine was available to treat cancer in East Germany under the
trade name Cytostasan®. After 1992, bendamustine hydrochloride has been marketed in Germany
under the trade name Ribomustin®.
15.
Cephalon, Inc. is the holder of approved NDA Nos. 22249 and 22303 for multiple
TREANDA® products, indicated for the treatment of patients with chronic lymphocytic leukemia
("CLL") and indolent B-cell non-Hodgkin's lymphoma ("NHL") that has progressed during or
within six months of treatment with rituximab or a rituximab-containing regimen. The FDA
approved the Treanda® 100 mg/vial product for the CLL indication on March 20, 2008 and on
October 31, 2008, for the second-line indolent B-cell NHL indication. The FDA approved the
Treanda® 25 mg/vial product on May 1, 2009 for those same indications.
16.
The patents-in-suit are listed in the FDA publication "Approved Drug Products with
Therapeutic Equivalence Evaluations," commonly referred to as "the Orange Book" with respect
to Cephalon's NDA No. 22249 directed to TREANDA® (bendamustine hydrochloride) for
Injection, 25 mg/vial and 100 mg/vial products.
C.
The Patents-in-Suit
(1)
The '190 Patent
17.
U.S. Patent No. 8,436,190 ("the '190 patent"), entitled "Bendamustine Pharmaceutical
Compositions," issued on May 7, 2013 to Jason Edward Brittain and Joe Craig Franklin.
18.
The' 190 patent issued from U.S. Patent Application No. 11/330,868, which was filed on
January 12, 2006. U.S. Patent Application No. 11/330,868 claims priority to U.S. Provisional
Application No. 60/644,354, filed on January 14, 2005.
3
19.
The term of the '190 patent will expire on October 26, 203 0. Pediatric exclusivity is set to
expire on April 26, 2031.
(2)
The '863 Patent
20.
U.S. Patent No. 8,609,863 ("the '863 patent"), entitled "Bendamustine Pharmaceutical
Compositions," issued on December 17, 2013 to Jason Edward Brittain and Joe Craig Franklin.
21.
The '863 patent issued from U.S. Patent Application No. 13/719,379, which was filed on
December 19, 2012. U.S. Patent Application No. 13/719,379 is a continuation of U.S. Patent
Application No. 13/654,898, filed on October 18, 2012, which is a continuation of U.S. Patent
Application No. 11/330,868, filed on January 12, 2006. U.S. Patent Application No. 11/330,868
claims priority to U.S. Provisional Application No. 60/644,354, filed on January 14, 2005.
22.
The term of the '863 patent will expire on January 12, 2026. Pediatric exclusivity is set to
expire on July 12, 2026.
(3)
The '270 Patent
23.
U.S. Patent No. 8,791,270 ("the '270 patent"), entitled "Bendamustine Pharmaceutical
Compositions," issued on July 29, 2014 to Jason Edward Brittain and Joe Craig Franklin.
24.
The '270 patent issued from U.S. Patent Application No. 13/969,724, which was filed on
August 19, 2013. U.S. Patent Application No. 13/969,724 is a continuation of U.S. Patent
Application No. 13/719,409, filed on December 19, 2012, which is a continuation of U.S. Patent
Application No. 13/654,898, filed on October 18, 2012, which is a continuation of U.S. Patent
Application No. 11/330,868, filed on January 12, 2006. U.S. Patent Application No. 11/330,868
claims priority to U.S. Provisional Application No. 60/644,354, filed on January 14, 2005.
25.
The term of the '270 patent will expire on January 12, 2026. Pediatric exclusivity is set to
expire on July 12, 2026.
(4)
The '756 Patent
26.
U.S. Patent No. 8,895,756 ("the '756 patent"), entitled "Bendamustine Pharmaceutical
Compositions," issued on November 25, 2014 to Jason Edward Brittain and Joe Craig Franklin.
27.
The '756 patent issued from U.S. Patent Application No. 13/719,409, which was filed on
December 19, 2012. U.S. Patent Application No. 13/719,409 is a continuation of U.S. Patent
Application No. 13/654,898, filed on October 18, 2012, which is a continuation of U.S. Patent
Application No. 11/330,868, filed on January 12, 2006. U.S. Patent Application No. 11/330,868
claims priority to U.S .Provisional Application No. 60/644,354, filed on January 14, 2005.
28.
The '756 patent will expire on January 12, 2026. Pediatric exclusivity is set to expire on
July 12, 2026.
4
D.
The Asserted Claims
29.
Cephalon asserts claims 5 and 8 of the '190 patent against Accord and Hospira.
30.
Claims 5 and 8 of the '190 patent read:
5. The lyophilized pharmaceutical composition according to claim 4, 2 wherein
said bendamustine or bendamustine hydrochloride is present in said pharmaceutical
composition at a concentration of about 12 to 17 mg/ml, said mannitol is present in
said pharmaceutical composition at a concentration of about 20-30 mg/ml, and said
tertiary-butyl alcohol is present in said pharmaceutical composition at a
concentration of about 10-50% (v/v).
8. The lyophilized pharmaceutical composition according to claim 5 containing
not more than about 0.5% bendamustine ethylester.
31.
Cephalon asserts claim 1 of the '863 patent against Accord and Hospira.
32.
Claim 1 of the '863 patent reads:
1. A stable lyophilized preparation compnsmg bendamustine hydrochloride,
mannitol, and a trace amount of tertiary-butyl alcohol (TBA), wherein the ratio by
weight of bendamustine hydrochloride to mannitol is 15:25.5.
33.
Cephalon asserts claims 1 and 19-21 of the '270 patent against all of the Defendants, and
claims 3 and 5 of the '270 patent against Accord, Hetero, Hospira, and Sagent.
34.
Claims 1, 3, 5 and 19-21 ofthe '270 patent read:
1. A pharmaceutical composition that has been reconstituted from a lyophilized
preparation of bendamustine or bendamustine hydrochloride, said composition
containing not more than about 0.9% (area percent ofbendamustine) of HPl:
HO]
Cl
f
Nl(YN'\__
~/
O\_OH.
\_/
\
(HPI)
3. The pharmaceutical composition of claim 1, wherein the amount of HPl is not
more than 0.5% (area percent of bendamustine).
5. The pharmaceutical composition of claim 1, wherein the amount of HP 1 is not
more than 0.4% (area percent of bendamustine).
2
Claim 4 of the '190 patent reads: A lyophilized pharmaceutical composition made from the pharmaceutical
composition according to claim 1. Claim 1 of the '190 patent reads: A pharmaceutical composition comprising
bendamustine or bendamustine hydrochloride, mannitol, tertiary-butyl alcohol and water.
5
19. The pharmaceutical composition of claim 7, 3 containing not more than about
0.5% (area percent ofbendamustine) of a compound of Formula IV:
Cl
coo~.
)
a~v:v
I
Fonnula IV
20. A method of treating cancer in a patient comprising administering to the patient
a pharmaceutical composition of bendamustine hydrochloride according to claim
7.
21. The method according to claim 20, wherein the cancer is chronic lymphocytic
leukemia, Hodgkin's disease, non-Hodgkin's lymphoma, multiple myeloma, or
breast cancer.
35.
Cephalon is asserting claims 1 and 4 of the '756 patent against Accord, Hetero, Hospira,
and Sagent.
36.
Claims 1 and 4 of the '756 patent read:
1. A vial containing a reconstituted solution of bendamustine hydrochloride and
mannitol in sterile water for injection, wherein the ratio by weight ofbendamustine
hydrochloride to mannitol in the vial is 15:25.5, and wherein the bendamustine
hydrochloride is present in the vial at a concentration of 100 mg per 20 mL.
4. A 20 mL vial containing 100 mg of bendamustine hydrochloride and 170 mg
of mannitol reconstituted in sterile water for injection.
E.
The Accused Products
(1)
The Hetero ANDA
37.
Hetero Labs filed ANDA No. 204081 ("the Hetero ANDA") with the FDA, under 21
U.S.C. § 355G), seeking approval to engage in the commercial manufacture, use, offer for sale or
sale within the United States, or importation into the United States, of a bendamustine
hydrochloride powder for IV (infusion), 25mg/vial and 100 mg/vial ("Hetero's ANDA Product").
38.
The Hetero ANDA lists Hetero USA, Inc. as the U.S. agent for the Hetero ANDA.
3
Claim 7 of the '270 patent reads: A pharmaceutical composition ofbendamustine hydrochloride, containing
less than or equal to 4.0% (area percent ofbendamustine) ofbendamustine degradants.
6
39.
The Hetero ANDA contains certifications pursuant to 21 U.S.C. § 355G)(2)(A)(vii)(IV)
("Paragraph IV certifications") alleging that the claims of the '190, '863, '270, and '756 patents
are invalid, unenforceable and/or would not be infringed by the manufacture, use, importation, sale
or offer for sale of Hetero's ANDA Product.
40.
By letters dated November 6, 2013; May 19, 2014; October 6, 2014; November 20, 2014;
and January 6, 2015, Hetero Labs sent notice to Cephalon that it was seeking approval to market
Hetero's ANDA Product prior to the expiration ofthe'190 patent, the '863 patent, the '270 patent,
and the '7 56 patent.
(2)
The InnoPharma ANDA
41.
InnoPharma filed ANDA No. 2054 76 ("the InnoPharma ANDA") with the FDA, under 21
U.S.C. § 355G), seeking approval to engage in the commercial manufacture, use, offer for sale or
sale within the United States, or importation into the United States, of a bendamustine
hydrochloride powder for IV (infusion), 25mg/vial and 100 mg/vial ("InnoPharma's ANDA
· Product").
42.
InnoPharma's ANDA contains Paragraph IV certifications alleging that the claims of the
'190, '863, '270, and '756 patents are invalid, unenforceable and/or would not be infringed by the
manufacture, use, importation, sale or offer for sale oflnnoPharma's ANDA Product.
43.
By letters dated November 8, 2013; March 26, 2014; and April 2, 2015, InnoPharma sent
notice to Cephalon that it was seeking approval to market InnoPharma's ANDA Product prior to
the expiration of the '190 patent, '863 patent, the '270 patent, and the '756 patent.
(3)
The Hospira ANDA
44.
Hospira filed ANDA No. 204086 ("the Hospira ANDA") with the FDA, under 21 U.S.C.
§ 355(j), seeking approval to engage in the commercial manufacture, use, offer for sale or sale
within the United States, or importation into the United States, of bendamustine hydrochloride for
injection, for intravenous infusion, 25mg/vial and 100 mg/vial ("Hospira' s ANDA Product").
45.
Hospira's ANDA contains a Paragraph IV certification alleging that the claims of the' 190
are invalid, unenforceable and/or will not be infringed by the manufacture, use, or sale ofHospira's
ANDA Products.
46.
By letter dated November 19, 2013, Hospira sent notice to Cephalon that it was seeking
approval to market Hospira's ANDA Product prior to the expiration of the '190 patent.
(4)
The Accord ANDA
47.
Accord filed with FDA, under 21 U.S.C. § 355(j), ANDA No. 205574 ("the Accord
ANDA") seeking approval to engage in the commercial manufacture, use, offer for sale or sale
within the United States, or importation into the United States, of a bendamustine hydrochloride
powder for IV (infusion), 25mg/vial and 100 mg/vial ("Accord's ANDA Product").
7
48.
The Accord ANDA and amendments thereto contain Paragraph IV certifications alleging
that the claims of the '190, '863, '270, and '756 patents are invalid, unenforceable and/or would
not be infringed by the manufacture, use, importation, sale or offer for sale of Accord's ANDA
Product.
49.
By letters dated November 18, 2013; February 28, 2014; September 8, 2014; and February
12, 2015, Accord sent notice to Cephalon that it was seeking approval to market Accord's ANDA
Product prior to the expiration of the '190 patent, the '863 patent, the '270 patent, and the '756
patent.
(5)
The Sagent ANDA
50.
Sagent filed ANDA No. 206186 ("the Sagent ANDA") with FDA, under 21 U.S.C. §
355U), seeking approval to engage in the commercial manufacture, use, offer for sale or sale within
the United States, or importation into the United States, of a bendamustine hydrochloride powder
for IV (infusion), 25mg/vial and 100 mg/vial ("Sagent' s ANDA Product").
51.
Sagent' s ANDA contains Paragraph IV certifications alleging that the claims of the '190
patent, the' 863 patent, the '270 patent, and the '756 patent are invalid, unenforceable and/or would
not be infringed by the manufacture, use, importation, sale or offer for sale of Sagent's ANDA
Product.
52.
By letters dated July 25, 2014; November 5, 2014; and March 17, 2015, Sagent sent notice
to Cephalon that Sagent had filed the Sagent ANDA seeking approval to market Sagent's ANDA
Product prior to the expiration of the '190 patent, the '863 patent, the '270 patent, and the '756
patent.
F.
Procedural History
53.
In Complaints dated November 6, 2014 and February 23, 2015, Cephalon filed suit against
Hetero asserting infringement of the '270 patent and the '756 patent. (Civil Action No. 1:13-cv2046-GMS (D.I. 34); Civil Action No. 1:15-cv-179-GMS (D.I. 1).)
54.
In Complaints dated December 20, 2013; May 9, 2014; September 25, 2014; and February
23, 2015, Cephalon filed suit against InnoPharma asserting infringement of the '190 patent, the
'863 patent, the '270 patent, and the '756 patent. (Civil Action No. 1:13-cv-2081-GMS (D.I. 1);
Civil Action No. 1:14-cv-590-GMS (D.I. 1); Civil Action No. 1:14-cv-1238-GMS (D.I. 1); Civil
ActionNo.1:15-cv-178-GMS (D.I. l).)
55.
In Complaints dated December 26, 2013, September 26, 2014, February 23, 2015, and
April 10, 2015, Cephalon filed suits against Hospira asserting infringement of the' 190 patent, the
'863 patent, the '270 patent, and the '756 patent. (Civil Action No. 1: 13-cv-2094-GMS (D.I. 1);
Civil Action No. 1:14-cv-1242-GMS (D.I. 1); Civil Action No. 1:15-179-GMS (D.I. 1); Civil
Action No. 1:13-cv-02046-GMS (D.I. 277).)
8
56.
In Complaints dated December 26, 2013, April 9, 2014, September 18, 2014, and February
23, 2015, Cephalon filed suit against Accord asserting infringement of the '524 patent, the '190
patent, the '863 patent, the '270 patent, the '279 patent, the '836 patent, and the '756 patent. (Civil
Action No. 1: 13-cv-2095-GMS (D.I. 1; D.I. 14; D.I. 28); Civil Action No. 1: 15-cv-178-GMS (D.I.
1).)
57.
In Complaints dated September 2, 2014; February 13, 2015; and February 23, 2015,
Cephalon filed suit against Sagent Pharmaceuticals, Inc. ("Sagent"), asserting infringement of the
'524 patent, the '190 patent, the '863 patent, the '270 patent, the '279 patent, the '836 patent, and
the '756 patent. (Civil Action No. 1:14-cv-1116-UNA (D.I. 1); Civil Action No. 1:13-cv-2046GMS (D.I. 188); Civil Action No. 1:15-179-GMS (D.I. 1).
58.
On November 24, 2014, the court consolidated Civil Action Nos. 1 :13-cv-2081-GMS,
1:14-cv-590-GMS, 1:14-cv-1238-GMS, 1:13-cv-2094-GMS, 1:14-cv-1242-GMS, 1:13-cv-2095GMS, and 1:14-cv-1116-UNA, into Civil Action No. 1:13-cv-2046-GMS.
59.
On November 24, 2015, the Defendants stipulated to infringement of the asserted claims
for the purposes of this litigation. (D .I. 441.)
60.
On April 8, 2015, the court consolidated Civil Action Nos. 1:15-cv-178-GMS and 1:15cv-179-GMS with Civil Action No. 13-2046-GMS. (See Civ. Action No. 1 :15-cv-178-GMS (D.I.
27); Civ. Action No. 1:15-cv-179-GMS (D.I. 25).)
61.
The court held a six-day bench trial in this matter on December 1 through December 8,
2015. (D.I. 449-454.)
III.
DISCUSSION AND CONCLUSIONS OF LAW
A.
Defendants' Obviousness Challenge to All Asserted Claims
The Defendants _challenge the validity of each of the asserted claims as obvious in light of
the prior art. For the reasons that follow, the court finds that the Defendants have failed to establish
a prima facie case of obviousness by clear and convincing evidence.
(1)
The Legal Standard
35 U.S.C. § 103(a) provides that a patent may not be obtained "if the differences between
the subject matter sought to be patented and the prior art are such that the subject matter as a whole
would have been obvious to a person having ordinary skill in the art." 35 U.S.C. § 103(a).
Obviousness is a question of law that is predicated on several factual inquiries. See Richardson9
Vicks v. Upjohn Co., 122 F.3d 1476, 1479 (Fed. Cir. 1997). Specifically, the trier of fact is directed
to assess four considerations: (1) the scope and content of the prior art; (2) the level of ordinary
skill in the art; (3) the differences between the claimed subject matter and the prior art; and (4)
secondary considerations of non-obviousness, such as commercial success, long felt but unsolved
need, failure of others, acquiescence of others in the industry that the patent is valid, and
unexpected results. See Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966).
A party seeking to challenge the validity of a patent based on obviousness must
demonstrate by "clear and convincing evidence"4 that the invention described in the patent would
have been obvious to a person of ordinary skill in the art at the time the invention was made.
Importantly, in determining what would have been obvious to one of ordinary skill in the art, the
use of hindsight is not permitted. See KSR Intern. Co. v. Teleflex, Inc., 550 U.S. 398, 421 (2007)
(cautioning the trier of fact against "the distortion caused by hindsight bias" and "arguments reliant
on ex post reasoning" in determining obviousness). In KSR, the Supreme Court rejected the rigid
application of the principle that there should be an explicit "teaching, suggestion, or motivation"
in the prior art, the nature of the problem, or the knowledge of a person having ordinary skill in
the art, in order to find obviousness. See KSR, 550 U.S. at 415. The KSR Court acknowledged,
however, the importance of identifying "a reason that would have prompted a person of ordinary
skill in the relevant field to combine the elements in a way the claimed new invention does in an
obviousness determination." Takeda Chem. Indus. v. Alphapharm Pty. Ltd., 492 F.3d 1350, 135657 (Fed. Cir. 2007) (citation omitted).
4
"Clear and convincing evidence is evidence that places in the fact finder 'an abiding conviction that the
truth of[the] factual contentions are 'highly probable."' Alza Corp. v. Andrx Pharms., LLC, 607 F. Supp. 2d 614, 631
(D. Del. 2009) (quoting Colorado v. New Mexico, 467 U.S. 310, 316 (1984)).
10
"Obviousness does not require absolute predictability of success," but, rather, requires "a
reasonable expectation of success." See Medichem SA. v. Rolado, SL., 437 F.3d 1157, 1165 (Fed.
Cir. 2006) (quoting In re O'Farrell, 853 F.2d 894, 903-04 (Fed. Cir. 1988)). To this end,
obviousness "cannot be avoided simply by a showing of some degree ofunpredictablily in the art
so long as there was a reasonable probability of success." Pfizer, Inc. v. Apotex, Inc., 480 F.3d
1348, 1364 (Fed. Cir. 2007). Moreover, while the Federal Circuit has noted that pharmaceutics can
be an "unpredictable art" to the extent that results may be unexpected, it also recognizes that, per
KSR, evidence of a "finite number of identified, predictable solutions" or alternatives "might
support an inference of obviousness." See Eisai Co. Ltd. v. Dr. Reddy's Labs. Ltd., 533 F.3d 1353,
1359 (Fed. Cir. 2008).
(2)
The Level of Ordinary Skill in the Art
The Plaintiffs experts testified that a person of ordinary skill in the art with respect to the
patent-in-suit would have a bachelor's degree in pharmaceutical sciences or a related field and at
least five years of experience, or an advanced degree in pharmaceutical sciences or a related field
with at least three years of experience in formulating, characterizing or analyzing pharmaceutical
products, and the ability to collaborate with individuals in other areas of science, including
medicine and drug development. (D.I. 455 at 8.) The Defendants' experts testified that a person of
ordinary skill in the art would have an advanced degree in pharmaceutics, pharmaceutical
chemistry, medicinal chemistry or a related field, or would have less education but considerable
professional experience in one or more of those fields, and experience with drug lyophilization,
designing and preparing liquid drug formulations, designing and preparing formulations of drugs
that are unstable in water, and the ability to understand work presented or published by others in
11
the field. (D.I. 459 at 4.) The court concludes that the parties' definitions of a person of ordinary
skill in the art do not differ in a meaningful way. 5
(3)
The Scope and Content of the Prior Art and Differences Between the
Claimed Subject Matter and the Prior Art
a.
Motivation to Improve Ribomustin
The Defendants argue that a person of skill in the art would have started with Ribomustin,
as did the inventors. They assert that a person of skill would have been motivated to improve
Ribomustin in order to reduce degradants, reduce the vial size, and improve the reconstitution time.
The prior art on the composition of Ribomustin is limited to the 2002 Ribomustin Product
Monograph (DTX0576) and the 1996 Rote Uste (DTX0575). Neither discuss the pre-lyophilized
solution of Ribomustin, but they disclose the marketed vial sizes, the amount of bendamustine
hydrochloride and mannitol in each vial, the reconstitution volume, and the amount of time
required to reconstitute (i.e. dissolve) the drug. (DTX0576 at 7-8, 55-56.)
The Defendants argue that the Olthoff patent (DTX0343), Mass publication (DTX0577)
and Gust publication (DTXO 149) would have motivated a person of skill to reduce the degradants
in Ribomustin. Olthoff described bendamustine as a "relatively instable compound" that "almost
completely hydrolyzed in aqueous solutions after a short period of time." (DTX0343.001 l .) Maas
studied the stability of Ribomustin after reconstitution in sterile water in sterile water and dilution
in saline. Using HPLC analyses, Maas identified the degradant HPl and disclosed the
decomposition kinetics ofbendamustine at room temperature. (DTX0577.0003-5; Tr. at 362:16363:6 (Kamat).) Gust further studied bendamustine degradants and reported the same four
impurities identified in the asserted claims: HPl, HP2, NPl, and BMlEE. (DTX0149.0008.)
5
The parties' experts testified that their obviousness conclusions would remain the same regardless of which
definition of a person of ordinary skill in the art the court adopts. (D.I. 459 at 4 n.4.)
12
Although Maas describes Ribomustin' s degradants, it also states that "no stability problems
can be expected" for Ribomustin "since there is a stability of 9 hours for these bendamustine
preparations at room temperature." (DTX577.0004.) Based on Maas, a POSA would not have
expected Ribomustin to degrade during reconstitution (which the Ribomustin Monograph
disclosed as taking 5 to 10 minutes) or administration (which the Ribomustin Monograph disclosed
as taking 30 to 60 minutes). (Tr. at 904:1-8 (Winter); DTX0567.008.) Furthermore, the prior art
does not disclose the amounts of degradants in Ribomustin or its pre-lyophilization solution. A
person of skill would need to know whether the impurities present in Ribomustin reached an
unacceptable level before going through the effort to reduce them. 6 The court concludes that Maas
and Gust would not have motivated a person of skill to improve Ribomustin.
The Defendants also argue that Ribomustin's large vial size and slow reconstitution times
would motivate a person of skill in the art to improve its formulation. The Ribomustin Monograph
disclosed a 40 mL dosage vial. (DTX0576.008.) The Defendants' expert, Dr. Kamat, explained
that a smaller vial size would promote efficiency and cost-effectiveness. (Tr. at 378:9-14
(Kamat).) The Plaintiffs expert, Dr. Winter, agreed that a person of skill would consider the
benefits of reducing vial size. The Ribomustin Monograph also disclosed that reconstitution of
Ribomustin in water "usually takes 5 to 10 minutes." (DTX0576.008.) The 2003 textbook
"Lyophilization-Introduction and Basic Principles" taught that "[i]f a product requires more than
5 min to reconstitute, then steps should be taken to decrease the reconstitution time."
(DTX0438.0447.) The Plaintiffs expert, Dr. Ippoliti, testified that saving even a few minutes in
6
Salmedix was aware that Ribomustin had unacceptably high levels of impurities, and stability and purity were
among Mr. Brittain's motivations in creating an improved product. (Tr. at 66:5--67:7; 91:20-24; 92: 15-19
(Kabakoff).) But although this may have motivated the inventor, it would not motivate a person of skill in the art
who had no knowledge of what the levels of impurities were. For all the public knew, Ribomustin could have been
an exceptionally pure product.
13
reconstitution time would provide significant benefits. (Tr. at 328:3-9 (Ippoliti).) In light of the
potential benefits, the Plaintiff does not provide any convincing arguments why a person of skill
would not have considered improving the vial size and reconstitution time of Ribomustin.
Accordingly, the court concludes that vial size and reconstitution time would have motivated a
person of skill to improve Ribomustin.
b.
Motivation to create lyophilized product
Both parties' experts agreed that for a drug which degrades in water, a person of skill would
prefer creating a liquid formulation over a lyophilized one, and would not attempt to develop a
new lyophilized product unless the liquid formulation failed. (Tr. at 907:24-908:11 (Winter); Tr.
at 394:7-19 (Kamat); Tr. at 564:25-565:12 (Kwan).) Indeed, the inventor, Mr. Brittain, began
working on lyophilization only after initially failing to produce a liquid product. (Tr. at 139:11140:16 (Brittain).) Dr. Winter testified that a person of skill formulating a lyophilized product
would need to consider numerous interrelated factors, including solubility of the active compound
and its bulking agents, the stability of the active compound in the pre-lyophilization solution, the
lyophilization cycle, the vial size and fill volume, the quality of the lyophilized cake, the stability
of the lyophilized product, the levels of residual solvents, reconstitution time, regulatory concerns,
cost, and reconstitution diluent volume. (Tr. at 897:7-898:2 (Winter).) The interdependence of
several of these factors means that a person of skill would need to perform many experiments to
obtain the desired result. (Tr. at 898:3-900:6 (Winter).) In short, creating a new lyophilized
product would not lead to predictable outcomes. Based on this, the court concludes a person of
skill seeking to improve the formulation of Ribomustin would not have been motivated to start
with lyophilization. This decreases the likelihood of the court finding the final lyophilized product
is obvious.
14
c.
Prior Art Regarding TBA/Water Co-Solvent Systems
Assuming a person of skill would have chosen to create an improved lyophilized
formulation ofbendamustine, the next step would be to choose a solvent for the pre-lyophilization
solution. The prior art does not disclose which solvent was used in the lyophilization of
Ribomustin. The Defendants contend the prior art publications from Teagarden (DTX0334) and
Ni (JTX079) would have motivated a person of skill to use a mixture of tert-butyl alcohol (also
known as TBA or tert-butanol) and water.
Dr. Kamat testified that because bendamustine is susceptible to degradation by hydrolysis,
a person of skill would seek to reduce the amount of water in the lyophilization solution. 7 (Tr. at
373:17-25 (Kamat).) Teagarden taught that non-aqueous solvents could be used to improve a drug
product's stability, reconstitution time, and solubility. (DTX0334.000.) Further, Teagarden stated
that "the co-solvent system that has been most extensively evaluated was the tert-butanol/water
combination." (DTX0334.0001.) Teagarden enumerated many advantages the TBA/water cosolvent system has over other co-solvent systems, and out of twenty-two compounds disclosed, it
identified eight different drug preparations where TBA or TBA/water was used as the
lyophilization solvent. (DTX0334.003 at Table 2.) The Defendants argue that from Teagarden, a
person of skill would expect that the TBA/water co-solvent system would improve the stability of
bendamustine. (Tr. at 494:23--496:12 (Kwan).) The Defendants also point to Ni, which studied
TBA and TBA/water lyophilization solvent systems with SarCNU, a compound which is water
soluble but highly unstable in water. (JTX079 at 39.) Ni taught that the greater concentration of
7
The court notes that it has not accepted the Defendants' premise that impurity levels would have motivated a
person of skiII to improve Ribomustin in the first instance.
15
TBA in the lyophilization solution, the less a water sensitive drug will degrade. (Tr. at 370:15371 :25 (Kamat).)
The Plaintiff responds by first noting that water was the most commonly used
lyophilization solvent in 2005. (Tr. at 900:7-10 (Winter); 432:14-17 (Kamat).) The Plaintiffs
expert, Dr. Winter, testified that he had never used TBA as a solvent in any of the marketed
pharmaceutical lyophilized products he developed in his nearly 30 years of experience. (Tr. at
900:11-23 (Winter).) Even Dr. Kamat admitted he was only aware of one commercialized
pharmaceutical product made using TBA as a co-solvent as of 2005. (Tr. at 396:15-397:15
(Kamat).) The court finds this particularly telling. Dr. Winter testified that a person of skill working
with a water-sensitive drug would still consider using water as the solvent because the drug is only
dissolved in the pre-lyophilization solution for a limited period of time before it is freeze-dried.
(Tr. at 901 :6-15 (Winter).) He also explained that there were other methods to reduce degradation
other than using a co-solvent, such as adjusting the pH value, using a different temperature, or
considering alternative drying techniques. (Tr. at 901:16-902:4 (Winter).) The court found Dr.
Winter's testimony persuasive.
The Plaintiff also notes that the Defendants did not present any references which studied
using a TBA/water system with bendamustine hydrochloride, or even the same type of compound,
a nitrogen mustard. Further, the Plaintiff argues that the Defendants ignored solvent effects, which
describe the impact a solvent has on a reaction such as hydrolysis. (Tr. at 718:14-18 (Welton).) In
this case, the solvent effects would impact the stability on the compound. Dr. Welton testified that
a person of skill would need to understand the reaction mechanism in order to predict how a
particular solvent would affect the reaction. (Tr. at 722:24-723:8 (Welton).) According to Dr.
16
Welton, a person of skill would need to understand how a compound degrades to predict whether
a particular solvent would have a stabilizing effect on that compound.
In this case, bendamustine hydrochloride is a nitrogen mustard that undergoes hydrolysis
through a neighboring group participation reaction. (Tr. at 726: 15-727: 9, 728 :23-73 3 :9 (Welton).)
As of 2005, "almost nothing" was known in the prior art about the solvent effects on neighboring
group participation reactions. (Tr. at 732:22-24 (Welton).) The Defendants' references do not
disclose analogous reaction mechanisms. Dr. Welton explained that Ni studied a nitrosourea
compound, which has a different degradation reaction mechanism than a nitrogen mustard. (Tr. at
744:6-745:13 (Welton).) Therefore, a person of skill reading Ni could not predict a favorable
outcome using TBA with bendamustine hydrochloride. Further, Ni concludes that anhydrous TBA
best stabilized SarCNU, rather than a co-solvent mixture with water. (Tr. at 747:13-748:16
(Welton).) This would not suggest to a person of skill in the art that a TBA/water co-solvent system
would be the best option. In Dr. Welton's opinion, the claims are not obvious because the prior art
did not provide "a sufficient predictive capacity or likelihood of success of using TBA." (Tr. at
714:10-15 (Welton).)
Like Ni, Teagarden did not discuss bendamustine or analogous compounds. (Tr. at 914:25915: 1 (Winter); Tr. at 750:2-14 (Welton).) Teagarden highlighted the disadvantages involved in
selecting a co-solvent system. Teagarden noted that co-solvent systems "can cause a multitude of
problems" such as "toxicity concerns, operator safety concerns due to a high degree of
flammability or explosion potential, ... high cost to use, ... and lack of regulatory familiarity."
(DTX999.0002.) Therefore, the "advantages and disadvantages of their use must be carefully
weighed before they are chosen to be used in the manufacture of a pharmaceutical product." (Id.)
Further, because the impact of a co-solvent on reconstitution is "dependent on several factors,"
17
Teagarden explained that "one will need to evaluate this property on a case by case basis."
(DTX999.0009.) Teagarden did not offer enough information from which a person of skill could
obtain a reasonable expectation of success in using a TBA/water co-solvent system with
bendamustine hydrochloride. To the contrary, Teagarden showed that the process of selecting a
co-solvent system is complex and would have required substantial experimentation.
Based on the court's determination that a person of skill would not have been motivated
by a need to reduce an unknown level of impurities, the prevalence of water as a lyophilization
solvent, and the unpredictability and disadvantages in choosing a co-solvent system, the court
concludes that a person of skill would not have been motivated to use a TBA/water co-solvent
system.
d. Routine Experimentation and Reasonable Expectation of Success
The limitations of the eleven asserted claims can fall into three major categories: 1) claimed
concentrations and ratios of TBA and mannitol (claim 5 of the '190 patent and claim 1 of the '863
patent); 2) 20 mL vial size and reconstitution volume (claim 4 of the '756 patent and claim 1 of
the '756 patent); and 3) impurity levels (claim 8 of the '190 patent and claims 1, 3, 5, and 19-21
of the '270 patent). The crux of the Defendants' obviousness argument is that after a person of
skill chose to develop an improved lyophilized bendamustine hydrochloride product using a
TBA/water co-solvent system and mannitol as a bulking agent, 8 that person would arrive at the
claimed limitations through routine experimentation.
Dr. Kwan testified that the lyophilization process involves 1) determining the solubility of
the drug in water and co-solvent systems; 2) identifying a suitable bulking agent and determining
8
The Plaintiff does not seem to dispute that mannitol was an obvious choice for a bulking agent. Mannitol was used
in the Ribomustin formulation and was the preferred bulking agent in pharmaceutical formulations at the time.
(DTX0576.0007; DTX0370.0004; Tr. at 355:4-7 (Kamat).) The Plaintiff does, however, argue that the claimed
ratios and concentrations of mannitol were not obvious.
18
an optimum range of the bulking agent in the pre-lyophilization solution; 3) evaluating
lyophilization factors such as fill volume, cake quality, and reconstitution time; and 4) optimizing
the final composition. (Tr. at 467:13-469:12 (Kwan).) Dr. Kamat testified that a person of skill
would have a reasonable expectation of success following this process. (Tr. at 390:8-11 (Kamat).)
Although this process may be routine, the court is not convinced that it is as straightforward
as the Defendants profess. As discussed above, a person of skill would not have started with
lyophilization precisely because of its complexity. The Defendants point out the fact that Mr.
Brittain followed this exact process and obtained the claimed composition of bendamustine
hydrochloride after two and a half months. (D.I. 459 at 14-15.) But the Defendants' analysis
discounts the fact that Mr. Brittain was actually in a position superior to the theoretical person of
skill in the art. Mr. Brittain worked for the pharmaceutical company Salmedix, which entered into
a License Agreement with the maker of Ribomustin, Fujisawa Deutschland GmbH ("Fujisawa"),
in order to develop a bendamustine hydrochloride product for the United States market. (Tr. at
63:12-64:15 (Kabakoff).) This License Agreement gave Mr. Brittain access to a wealth of
confidential information on the formulation ofRibomustin. He therefore could make the informed
choices necessary to obtain his final product with less experimentation than an outsider would
have to conduct.
Thus, the biggest flaw in the Defendants' defense is the scant level of publicly available
information. In the words of the defendant's own expert, bendamustine "was a very unknown kind
of compound." (Tr. at 374:9-10 (Kamat).) A person of skill could have followed precisely in Mr.
Brittain's footsteps, but the court finds that it would not have been ~bviou's to do so. Because the
court concludes that a person of skill would not have chosen to create a lyophilized product using
a TBA/water co-solvent system, the court cannot find that these numerous claim limitations would
19
have been obvious. Because the Defendants have failed to meet their burden to present a prima
facie case of obviousness, the court does not consider the parties' secondary considerations.
B.
Defendants' § 102 Challenges to Asserted Claims of the '270 Patent
(1)
Anticipation
"[I]nvalidity by anticipation requires that the four comers of a single[] prior art document
describe every element of the claimed invention, either expressly or inherently, such that a person
of ordinary skill in the art could practice the invention without undue experimentation." Advanced
Display Sys., Inc. v. Kent State Univ., 212 F.3d 1271, 1282 (Fed. Cir. 2000). Inherent anticipation
"requires that the missing descriptive material is 'necessarily present,' not merely probably or
possibly present, in the prior art." Trintec Indus., Inc. v. Top-US.A. Corp., 295 F.3d 1292, 1295
(Fed. Cir. 2002) (quoting In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999)). "A reference
includes an inherent characteristic if that characteristic is the 'natural result' flowing from the
reference's explicitly explicated limitations." Eli Lilly & Co. v. Barr Labs, Inc., 251F.3d955, 970
(Fed. Cir. 2001). The mere fact that a certain thing may result from a given set of circumstances is
not sufficient." In re Oelrich, 666 F.2d 578, 581 (C.C.P.A. 1981) (quoting Hansgirg v. Kemmer,
102 F.2d 212, 214 (C.C.P.A. 1939)).
Therefore, if the teachings of the prior art can be practiced in a way that yields a product
lacking the allegedly inherent property, the prior art in question does not inherently anticipate. See
Glaxo Inc. v. Novopharm Ltd., 52 F.3d 1043, 1047-48 (Fed. Cir. 1995) (finding no inherent
anticipation where testing evidence demonstrated that the prior art example could yield crystals of
either the claimed polymorph or a different polymorph). Whether a prior art reference anticipates
a patent claim is a question of fact and must be proven by clear and convincing evidence. See
Advanced Display Sys., 212 F.3d at 1281.
20
The Defendants contend that claims 1, 3, and 5 of the '270 patent are anticipated by Maas.
These claims cover a pharmaceutical composition that has been reconstituted from a lyophilized
preparation ofbendamustine hydrochloride containing not more than 0.9%, 0.5%, and 0.4% of the
HPl impurity, respectively. Maas studied the degradation of a reconstituted pharmaceutical
composition of Ribomustin and characterized the amount of degradants, including HP 1.
(DTX0577.0001; DTX0577.0003.) The Defendants' expert, Dr. Jarosz, testified that even though
Maas did not calculate the overall amount of HP 1 in the studied samples, the reaction rate Maas
computed can be used to obtain the impurity levels. (Tr. at 653:2-20 (Jarosz).) According to Dr.
Jarosz, the Maas study inherently. disclosed that 0.4% HPl formed in 20 minutes from
reconstituted Ribomustin. (Tr. at 651 :8-11 (Jarosz). Maas normalized the data such that the initial
purity reading after dilution was 100%. (DTX146.0005-6; Tr. at 693:20-694:11 (Jarosz).) This
means that Maas only reported the relative purity of Ribomustin, and did not disclose the amount
ofHPl in Ribomustin before reconstitution. (Tr. at 653:17-20; 693:20-694:11 (Jarosz).) Without
knowing the absolute concentration of impurities, the court cannot conclude that Maas anticipates
the claimed impurity levels.
The Defendants also point to a Ribomustin photostability study which observed 0.48%
HPl. (DTX0090.0150.) Unfortunately for the Defendants, this study is irrelevant. It does not
corroborate Maas because it did not analyze the same batch of Ribomustin as used in the Maas
reference. (Tr. at 675:13-16 (Jarosz).) Further, there is no evidence about how the batches used
for the photostability study were dissolved, so the court cannot find that the study met the limitation
of a "pharmaceutical composition that has been reconstituted." (Tr. at 675:4-12 (Jarosz).) Claims
1, 3, and 5 of the '270 patent are not invalid as anticipated by Maas.
21
(4)
On-Sale Bar
Section 102(b) of the Patent Act prohibits granting a patent for an invention that was "on
sale" in the U.S. more than one year before the patent application date. 35 U.S.C. § 102(b). The
"critical date" in a Section 102(b) inquiry is defined as exactly one year before a patent application
is filed. Id. The on-sale bar applies when two conditions are satisfied before the critical date of one
year before the filing date of the application: 1) a product embodying the claimed invention is the
subject of a commercial offer for sale; and 2) the claimed invention is ready for patenting. See
Pfaff v. Wells Electronics, Inc., 525 U.S. 55, 67 (1998). A claimed invention is ready for patenting
if it is reduced to practice or if there is "proof that prior to the critical date the inventor had prepared
drawings or other descriptions of the invention that were sufficiently specific to enable a person
skilled in the art to practice the invention." Id. Whether an invention was on sale more than one
year before the patent's application date is a question of law for the court to decide based on
underlying factual determinations. See Abbot Lab. v. Geneva Phann., Inc., 182 F.3d 1315, 1317
(Fed. Cir. 1999); Ferag AG v. Quipp Irie., 45 F.3d 1562, 1566 (Fed. Cir. 1995).
The court concludes the Defendants have failed to meet their burden under Pfaff. To satisfy
the first condition stated in Pfaff, the Defendants must show that the patented formulation of
bendamustine hydrochloride was commercially offered for sale in the United States. Because
Ribomustin was never marketed in the U.S., the Defendants rely on the License Agreement
between Salmedix and Fujisawa. (JTX37.) Under the License Agreement, Fujisawa granted
Salmedix "an exclusive right and license ... to develop, manufacture, have manufactured, market,
sell, import, distribute, and promote" a product for the U.S. market. (Id. at 2.) Fujisawa also
provided Salmedix with batches of bulk bendamustine hydrochloride and unlabeled vials of
Ribomustin to allow them to "conduct development work." (Id. at 8.) In exchange, Salmedix
22
agreed
to
pay
Fujisawa
up . to
$2.5
million
m
license
fees
and
royalties
if
Salmedix launched a product in the U.S. (Id. at 10.) The language of the License Agreement clearly
indicates that it did not contemplate commercial sale, but was instead a development license.
The actions of the scientists at Salmedix corroborate the fact that no commercial sale took
place here. Salmedix used the batches of Ribomustin it obtained to conduct phase 2 clinical trials
and laboratory research. Mr. Brittain used the unlabeled vials of Ribomustin to develop the
formulation claimed in the asserted patents. (Tr. at 165:16-166: 17 (Brittain).) Salmedix only used
the product obtained from Fujisawa for experimental, development purposes. This does not satisfy
the "commercial" sale requirement for the on-sale bar. Accordingly, the court concludes that the
'270 patent is not invalid based on Section 102(b).
(5)
Derivation
Section 102(±) prohibits the issuance of a patent to a person who derives the conception of
an invention from any other source. See Price v. Symsek, 988 F.2d 1187, 1190 (Fed. Cir. 1993).
To prove derivation under § 102(±), the patent challenger must establish prior conception of the
invention by another and communication of that conception to the patentee. Id.
The Defendants argue that the inventors derived claims 19-21 of the '270 patent from
Fujisawa. Claim 19 covers a pharmaceutical composition of bendamustine hydrochloride
containing less than or equal to 4.0% (area percent ofbendamustine) ofbendamustine degradants,
and not more than 0.5% of degradant BMlEE. Claims 20 and 21 cover the method of using that
composition to treat various forms of cancer. As part of their License Agreement, Fujisawa
provided Salmedix with several batches of Ribomustin and the Common Technical Specification,
which reported degradant levels for several batches of Ribomustin. JTX-128A at CEPH_01680813-01680820. Each Ribomustin batch had total degradant levels of less than 4.0% and
23
total BMlEE levels of less than 0.5% (area percent of bendamustine). Id. This falls within the
patent claims.
The Plaintiff argues that the Defendants have failed to prove conception or enablement
because the Ribomustin Technical Specification specified a product with no more than 5.0% total
impurities and no more than 0.6% BMlEE. The fact that some batches of Ribomustin may have
contained higher levels of degradants is, however, not dispositive. The eight batches analyzed by
Fujisawa contained impurities which fell well below the patented levels, so it is unreasonable to
presume that scientists at Fujisawa did not conceive of these levels of impurities. Mr. Brittian also
testified that he received the "soup to nuts" concerning manufacturing Ribomustin from Fujisawa.
(Tr. at 119:1-8 (Brittain).) The court concludes that claims 19-21 of the '270 patent were derived
from Fujisawa and are therefore invalid.
IV.
CONCLUSION
For the reasons stated above, the court concludes that: ( 1) the asserted claims of the patents-
in-suit are not invalid as obvious under 35 U.S.C. § 103; (2) claims 1, 3, and 5 of the '270 patent
are not invalid as anticipated under 35 U.S.C. § 102(b); (3) claims 1 and 19 of the '270 patent are
not invalid due to the on-sale bar under 35 U.S.C. § 102(b); (4) claims 19-21 of the '270 patent
are invalid as derived under 35 U.S.C. § 102(f); and (5) each of the parties' 52(c) motions are
granted in part and denied in part. An appropriate order will follow.
Date: June J2_, 2016
24
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