“Taking each claim . . . as an integrated whole rather than as a collection of independent limitations . . . .”
How later courts described this case
- “Taking each claim . . . as an integrated whole rather than as a collection of independent limitations . . . .”
Written by the judges who cited it.
The opinion
IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
BIOGEN INTERNATIONAL GMBH and
BIOGEN MA, INC.,
Plaintiffs,
v. CIVIL ACTION NO. 1:17CV116
(Judge Keeley)
MYLAN PHARMACEUTICALS INC.,
Defendant.
MEMORANDUM OPINION AND ORDER MAKING
FINDINGS OF FACT AND GRANTING JUDGMENT IN
FAVOR OF THE DEFENDANT, MYLAN PHARMACEUTICALS INC.
I. BACKGROUND
In this patent infringement action, the plaintiffs, Biogen
International GmbH and Biogen MA, Inc. (collectively “Biogen”), and
the defendant, Mylan Pharmaceuticals Inc. (“Mylan”), dispute
whether claims 1-4, 6, 8-13, and 15-16 (“the asserted claims”) of
Biogen’s U.S. Patent No. 8,399,514 (“the ’514 Patent”) are valid
and enforceable (Dkt. Nos. 1 at 14-17, 288 at 1-2).1 The ’514
Patent is associated with Tecfidera®, Biogen’s New Drug Application
(“NDA”) product approved by the FDA for use in the treatment of
multiple sclerosis (“MS”) (Dkt. No. 1 at 15). Mylan has filed an
Abbreviated New Drug Application (“ANDA”), seeking to market a drug
that is bioequivalent to Tecfidera®.
1 All docket and page numbers refer to the numbers assigned by
the Court’s electronic docket.
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The Drug Price Competition and Patent Term Restoration Act of
1984, Pub. L. No. 98-417, 98 Stat. 1585 (otherwise known as the
“Hatch-Waxman Act”), seeks to encourage “pioneering research and
development of new drugs,” as well as the “production of low-cost,
generic copies of those drugs.” Eli Lilly & Co. v. Teva Pharm. USA,
Inc., 557 F.3d 1346, 1348 (Fed. Cir. 2009). To that end, a
manufacturer may obtain Food and Drug Administration (“FDA”)
approval to market a generic drug by making a certification
regarding patents listed in the FDA’s Approved Drug Products with
Therapeutic Equivalence Evaluations (“the Orange Book”) as covering
the NDA drug, and certifying that those patents are “invalid or
will not be infringed by the manufacture, use, or sale of the new
generic drug for which the ANDA is submitted” (“paragraph IV
certification”). Id. (citing 21 U.S.C. § 355(j)(2)(A)(vii)(IV)).
Upon receiving a paragraph IV certification, a patentee may sue the
applicant for patent infringement within 45 days, thus delaying FDA
approval of the ANDA. Id. (citing § 355(j)(5)(B)(iii)).
In this case, where Biogen has sued Mylan under the Hatch-
Waxman Act for infringement of Tecfidera®, the Court is tasked with
deciding whether the asserted claims of Biogen’s ’514 Patent are
2
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invalid for lack of written description under 35 U.S.C. § 112.2 As
discussed below, the Court FINDS that Mylan has demonstrated by
clear and convincing evidence that the asserted claims of the ’514
Patent are invalid for lack of written description.
II. FINDINGS OF FACT3
A. The Parties, Jurisdiction, and Venue
Biogen International GmbH is a corporation organized under the
laws of Switzerland with its principal place of business at Landis
+ Gyr-Strasse 3, 6300 Zug, Switzerland. Biogen MA, Inc. is a
corporation organized under the laws of the Commonwealth of
2 Initially, six patents associated with Tecfidera® were at
issue in this case (Dkt. No. 1). On February 5, 2019, the parties
stipulated to the dismissal of all claims, counterclaims, and
defenses regarding U.S. Patent Nos. 6,509,376; 7,320,999;
7,803,840; and 8,759,393 (Dkt. No. 196). In advance of trial, the
parties further stipulated to stay all remaining claims,
counterclaims, and defenses regarding U.S. Patent No. 7,619,001
(“the ’001 Patent”) until June 20, 2020 (Dkt. Nos. 288, 315 at 12,
336 at 44). After the first day of trial, the parties agreed that,
based on an intervening decision from the Patent Trial and Appeal
Board (“PTAB”) in the related inter partes review (“IPR”)
proceeding, Mylan was collaterally estopped under 35 U.S.C.
§ 315(e)(2) from asserting its obviousness case under 35 U.S.C.
§ 103 (Dkt. No. 357 at 3-6). Thus, based on the parties’ various
stipulations, the only remaining issue at trial was whether the
asserted claims of the ’514 Patent are invalid for lack of written
description under § 112 (Dkt. Nos. 288, 315 at 12, 357 at 3-6).
3 Further findings of fact regarding matters in dispute are
contained in Part III (Discussion).
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Massachusetts with its principal place of business at 225 Binney
Street, Cambridge, Massachusetts 02142. Mylan is a corporation
organized under the laws of West Virginia with its principal place
of business at 781 Chestnut Ridge Road, Morgantown, West Virginia
26505. The Court has subject matter and personal jurisdiction, and
venue is proper.
B. Factual and Procedural Background
Because the asserted claims of the ’514 Patent recite a
specific method for treating MS, the Court begins its analysis with
a brief discussion of this neurologic disorder, as well as Biogen’s
clinical development of Tecfidera®, and the relevant prosecution
history of Biogen’s patent applications related to Tecfidera®.
1. Multiple Sclerosis
MS is a neurologic disorder and autoimmune disease that causes
the immune system to attack myelin, a protective sheathing
surrounding nerve cell axons (Dkt. Nos. 356 at 106-07, 359 at 84-
85). This sheathing protects nerves in the central nervous system,
much like a rubber coating protects wires to a computer or stereo
system (Dkt. No. 356 at 106-07). Although the immune system is a
self-defense system that combats viruses and bacteria that would
harm the human body, MS confuses the immune system into attacking
4
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myelin (Dkt. Nos. 356 at 107, 359 at 84-85).4 This causes
inflammation that results in demyelination and leads to axonal loss
and death of the nerve cell (Dkt. Nos. 356 at 106-07, 359 at 84-
85). Together, this damage results in scarring or lesions on the
brain, which can be imaged by magnetic resonance imaging (i.e., an
MRI) (Dkt. No. 356 at 112, 359 at 86-87). Those images, in turn,
are used to monitor disease progress in patients. Id.
2. Biogen’s Due Diligence of Fumapharm AG
Gilmore O’Neill, M.D. (“Dr. O’Neill”) is a neurologist
specializing in neuromuscular diseases such as MS (Dkt. No. 362 at
109-10). In 2003, while Biogen was negotiating a prospective
licensing agreement with Fumapharm AG (“Fumapharm”), a company
studying fumarates, Dr. O’Neill participated in a confidential due
diligence of Fumapharm (Dkt. No. 362 at 27-28, 52-53; JTX 2133 at
4 As described by Mylan’s expert witness, Benjamin M.
Greenberg, M.D., autoimmune diseases such as MS are much like a
confused house cat that mistakes a curtain, or other house-hold
objects, for an invading mouse (Dkt. Nos. 356 at 107-09). Instead
of attacking the mouse, the confused cat attacks a portion of the
house it is meant to protect. Id. The cat’s breed, and the type of
friendly object it attacks, will help identify which autoimmune
disease is causing the confusion. Id. For example, a Siamese cat
(i.e., multiple sclerosis) may be confused and attack one part of
the house (i.e., the central nervous system), and a Tabby cat
(i.e., psoriasis) may be confused and attack another part of the
house (i.e., the skin). Id. at 107-10.
5
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3-4).5 This included reviewing confidential studies of Fumaderm® (a
mixture of fumarates, including dimethyl fumarate (“DMF”)), a drug
developed by Fumapharm to treat psoriasis, another autoimmune
disease (Dkt. No. 362 at 27-28, 52-53). See supra note 4.
Of significance to the issue at hand, after reviewing these
studies and the underlying pharmacology of DMF, Dr. O’Neill
hypothesized that the peak level of medication in the blood stream,
the “C of DMF,” could be driving the efficacy of DMF (Dkt. No.
max
362 at 53-54). From this, he conceived the idea that, if the drug’s
“efficacy might be driven by the maximal exposure of the medicine
in the [sic] circulation as opposed to a continuous exposure,” a
daily dose of 480mg (in two equally divided doses or “BID”) of DMF
could achieve the correct “maximal exposure” and be efficacious in
treating MS (Dkt. No. 362 at 53-54).
3. Biogen’s Phase II Development of Tecfidera®
After obtaining a licensing agreement with Fumapharm, Biogen
appointed Dr. O’Neill as Medical Director of its BG-12 Development
Program (JTX 2133 at 4-5, 9-10, 14),6 to design and lead the
5 “JTX” refers to the parties’ joint trial exhibits.
6 BG-12 was Biogen’s internal and external name for Tecfidera®
prior to its receipt of FDA approval to market the drug (JTX 2133
at 9-10).
6
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clinical development of Tecfidera® to treat MS. Id. at 4-5, 10-11,
14. As Medical Director, Dr. O’Neill proposed that Biogen
incorporate a 480mg/day dose of DMF (BID) as part of its Phase II
study of Tecfidera® (Dkt. Nos. 358 at 126-27, 362 at 120-21, 125-
26, 140; JTX 2013 at 16-17; JTX 2035 at 14; 2133 at 14-16).7
Biogen opted instead to test 120mg/day of DMF (in one single
dose or “QD”), 360mg/day of DMF (in three equal doses or “TID”),
and 720mg/day of DMF (TID) (Dkt. Nos. 358 at 127-28, 135, 362 at
68-70; JTX 2013 at 17; JTX 2036 at 1; JTX 2133 at 16-17) in its
Phase II study (JTX 2013 at 17; JTX 2153B at 8, 12). The results of
that study, which were published in May 2006, demonstrated that a
720mg/day dose of DMF (TID) was efficacious in treating MS (JTX
2088 at 3-4; JTX 2153B at 8, 12-18), but doses of 120mg/day (QD)
and 360mg/day (TID) were not (JTX 2153B at 8, 12-18).
With these results in hand, Biogen began designing its Phase
III study (JTX 2091; JTX 2100; JTX 2101; JTX 2133 at 25-26; JTX
2142; JTX). Before that study got underway, however, Dr. O’Neill
7 Phase II studies are in vivo clinical trials that test a new
drug in a mid-sized group of human patients (Dkt. No. 356 at 27
(noting that Biogen’s Phase II study included approximately 250
patients)). “In vivo” means inside the body. In other words, an
experiment in vivo is done in a living organism (Dkt. No. 358 at 59
(discussing in vivo test performed in mice)).
7
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left the BG-12 program and was replaced by Katherine Dawson, M.D.
(“Dr. Dawson”) (Dkt. No. 362 at 17, 153-54; JTX 2091 at 1; JTX2133
at 26).
4. Biogen’s Research Regarding the Nrf2 Pathway
It must be noted that Biogen’s BG-12 Development Program was
not focused solely on the clinical development of Tecfidera®.
Matvey E. Lukashev, Ph.D. (“Dr. Lukashev”), a scientist employed by
Biogen, joined the BG-12 program in 2005 (Dkt. No. 358 at 41; JTX
2196), where his work was to “elucidate the mechanism of action”;
he “was not involved in clinical decision-making” (Dkt. No. 358 at
40-41, 42).
“Mechanism of action” is a “scientific fact-based description
of the molecular and cellular events affected by the . . . active
substance of the drug.” Id. at 47. Through his research, Dr.
Lukashev discovered that DMF, with its key regulator, a protein
called KEAP1, activated the Nrf2 pathway. Id. at 48-49. Based on
this mechanism of action, he looked for other compounds that could
do the same. Id. at 52.
Dr. Lukashev’s scope of work thus extended beyond Biogen’s BG-
12 testing program because it included screening compounds other
than DMF that could activate the Nrf2 pathway. Id. at 52-53. When
8
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asked to describe his work, he noted that it was “a more
exploratory nature. It[ was] to explore potential for follow-on
compound discovery, perhaps movement into other indications or
perhaps not previously explored in the clinic in any therapeutic
context, combinations of fumarates with other therapeutics.” Id. at
53. Significantly, Dr. Lukashev denied that his research could be
extrapolated to a clinical dose of DMF; it “was never the focus of
[his] work to inform the clinical dosing of [DMF].” Id. at 53-54,
54.
Although Dr. Lukashev conducted experiments with a range of
concentrations of DMF and monomethyl fumarate (“MMF”) in vitro and
in vivo,8 those experiments “examine[d] details of the molecular
events that could be, in principle, triggered by the active
ingredient in a cell.” Id. at 54, 57-60. Two of these examples were
included in Biogen’s U.S. Provisional Application No. 60/888,921
(“the ’921 Application”) (JTX 2182 at 37-39), and a third was
included in Biogen’s International Patent Application No.
8 “In vitro” means outside the body. In other words, an
experiment in vitro is an artificial experiment performed using a
test tube or petri dish (Dkt. No. 359 at 28 (explaining the meaning
of in vitro)).
9
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PCT/US2008/001602 (“the 0016902 Application”) (PTX 401 at 33).9 Dr.
Lukashev is the only inventor named in the ’921 and 0016902
Applications, entitled “Nrf2 Screening Assays and Related Methods
and Compositions,” which recite methods for screening drug
compounds for their ability to activate the Nrf2 pathway (JTX 2182
at 4, 40-42; PTX 401 at 1-2).
5. Brief Summary of Prosecution History of ’514 Patent
Biogen filed the ’921 Application on February 8, 2007 (JTX
2182), before beginning its Phase III study of Tecfidera®.10 It
later filed the 0016902 Application, which added to the
specification of the ’921 Application, on February 7, 2008 (PTX
401). The 0016902 Application later became U.S. Patent Application
No. 12/526,296 (“the ’296 Application”) on August 7, 2009 (DTX
1016).11
Biogen received the results of its Phase III study in April
2011, after which it twice amended the ’296 Application to change
9 “PTX” refers to Biogen’s trial exhibits.
10 Phase III studies are in vivo clinical trials that test a
new drug in a large number of human patients (Dkt. No. 377 at 16
(noting that Biogen Phase III study involved over 2600 patients
(citing JTX 2088; JTX 2133))).
11 “DTX” refers to Mylan’s trial exhibits.
10
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its title and claims and to add an inventor (DTX 1656; DTX 1657).
Notably, it did not change the specification in the ’296
Application. Id.
Biogen later abandoned the ’296 Application in favor of a
continuing application, U.S. Patent Application No. 13/326,426
(“the ’426 Application”), filed on February 13, 2012 (JTX 2173).
Ultimately, the ’426 Application resulted in the issuance of the
’514 Patent on March 19, 2013 (JTX 2000; JTX 2173). And, it was
through its ’921 Application that Biogen claimed a February 8, 2007
priority date for its ’514 Patent (JTX 2000; JTX 2182).
6. Biogen’s Phase III Development of Tecfidera®
After receiving FDA approval for its Phase III study, Biogen
commenced its first trial (the DEFINE trial) on March 14, 2007, and
its second trial (the CONFIRM trial) on July 28, 2007 (JTX 2108 at
12, 23; JTX 2110 at 28, 38; JTX 2133 at 27-28). Although the
parties dispute when and why Biogen decided to test a 480mg/day
dose of DMF as part of those trials (Dkt. Nos. 376 at 11-12, 377 at
14-15), it is undisputed that, for whatever reason it did so,
Biogen ultimately included a 480mg/day dose of DMF (BID) as part of
its Phase III study.
11
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The Phase III study “showed an unexpected magnitude of
efficacy where the 480mg/day dose ‘met all primary and secondary
endpoints’ including both MRI and clinical endpoints, e.g.,
reduction in annual relapse rate, and did so ‘with a high level of
statistical significance’” (Dkt. No. 377 at 17 (emphasis omitted)
(quoting JTX 2088 at 9-10, 19)). Put simply, the Phase III study
demonstrated that the 480mg/day and 720mg/day doses of DMF were
equally efficacious in treating MS.
7. Biogen’s Prosecution of the ’514 Patent
In light of these unexpected results, Biogen needed a patent
to protect the 480mg/day dose from competition and quickly filed
U.S. Provisional Application No. 14/119,373 (“the ’373
Application”) in May 2011. This application was entitled “Methods
of Treating Multiple Sclerosis and Preserving and/or Increasing
Myelin Content” and listed three inventors, Dr. Dawson, Dr.
O’Neill, and Alfred Sandrock (another Biogen employee) (DTX 1169).
The specification of the ’373 Application thoroughly reviewed data
from Biogen’s Phase III study and asserted 42 claims reciting a
method for treating MS with a 480mg/day dose of DMF (BID). Id.
A month after filing the ’373 Application, in June 2011,
Biogen amended its ’296 Application, filed on August 7, 2009, to
12
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replace the title “Nrf2 Screening Assays and Related Methods and
Compositions” with “Treatment for Multiple Sclerosis” (DTX 1656).
This amendment also deleted all previously listed claims for
methods for screening drug compounds for their ability to activate
the Nrf2 pathway and added sixteen new claims reciting methods for
treating MS with a 480mg/day dose of DMF (BID). Id. In October
2011, Biogen again amended the ’296 Application, this time to add
Dr. O’Neill as a co-inventor with Dr. Lukashev and also to include
three additional claims reciting methods for treating MS with
480mg/day of DMF (BID) (DTX 1657).
At no time throughout this course of amendments did Biogen
amend the “specification” (i.e., the written description) of the
’296 Application (DTX 1656; DTX 1657). This enabled it to claim a
priority date of February 8, 2007, the date on which Biogen had
filed the ’921 Application (JTX 2182).12
12 See Auto. Tech Int’l, Inc. v. Delphi Corp., 776 F. Supp. 2d
469, 488 (E.D. Mich. 2011) (“[A] patent containing enabled and
adequately described claims that issue from a continuation
application may claim the benefit of the priority date of its
parent application because they share identical specifications; a
continuation application may not contain new matter.” (citing 35
U.S.C. § 120)). The parties, however, dispute whether Biogen may
rely on example three (Dkt. Nos. 376 at 22 n.6, 377 at 25 n.4, 384
at 11-12), which was included only in the 0016902 Application (PTX
401 at 33), not Biogen’s earlier ’921 Application (JTX 2182 at 37-
39). This dispute is discussed in detail infra in Part III
13
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Later, on February 13, 2012, Biogen filed a continuing
application of its ’296 Application, which ultimately became the
’426 Application (JTX 2173). The ’426 Application included all
amendments to the ’296 Application, while maintaining the
specification from the ’921 Application. Id. Biogen then abandoned
the ’296 Application and focused its efforts before the U.S. Patent
and Trademark Office (“PTO”) entirely on the ’426 Application. Id.
During prosecution of the ’426 Application, the PTO twice
rejected Biogen’s asserted claims as obvious over the prior art
(JTX 2173 at 382-92, 888-96). In response to each rejection, Biogen
reasserted its claim that the 480mg/day dose of DMF (BID) had
exhibited unexpected efficacy in the treatment of MS. Id. at 453-
55, 914-17.
The PTO eventually overcame its concerns about obviousness
and, on March 19, 2013, issued the ’514 Patent (JTX 2000), which is
listed in the Orange Book for NDA No. 204063, covering Tecfidera®
(Dkt. No. 1 at 15), and claims a priority date of February 8, 2007
(Discussion).
14
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(JTX 2000). With the ’514 Patent in hand, Biogen abandoned the ’373
Application it had filed on May 26, 2011 (DTX 1169).13
8. The Asserted Claims of the ’514 Patent
The asserted claims in the ’514 Patent recite a method for
treating a specific disease (MS), with a specific drug (DMF or
MMF), at a specific dose (480mg/day (BID)) (Dkt. No. 359 at 89-90,
105):
1. A method of treating a subject in need of
treatment for multiple sclerosis
comprising orally administering to the
subject in need thereof a pharmaceutical
composition consisting essentially of (a)
a therapeutically effective amount of
[DMF], [MMF], or a combination thereof,
and (b) one or more pharmaceutically
acceptable excipients, wherein the
therapeutically effective amount of
[DMF], [MMF], or a combination thereof is
about 480 mg per day.
2. The method of claim 1, wherein the
pharmaceutical composition is
administered in the form of a tablet, a
suspension, or a capsule.
3. The method of claim 1, wherein the
therapeutically effective amount is
administered in separate administrations
of 2, 3, 4, or 6 equal doses.
13 An addendum attached to this Memorandum Opinion and Order
provides a timeline of this prosecution history.
15
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4. The method of claim 3, wherein the
therapeutically effective amount is
administered in separate administrations
of 2 equal doses.
. . .
6. The method of claim 1, wherein the
pharmaceutical composition consists
essentially of [DMF] and one or more
pharmaceutically acceptable excipients.
. . .
8. The method of claim 1, wherein the
pharmaceutical composition is
administered to the subject for at least
12 weeks.
9. The method of claim 6, wherein the
therapeutically effective amount is
administered to the subject in 2 equal
doses.
10. The method of claim 9, wherein the
therapeutically effective amount is
administered to the subject for at least
12 weeks.
11. A method of treating a subject in need of
treatment for multiple sclerosis
consisting essentially of orally
administering to the subject about 480 mg
per day of [DMF], [MMF], or a combination
thereof.
12. The method of claim 11, wherein about 480
mg of [DMF] per day is administered to
the subject.
16
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13. The method of claim 12, wherein the [DMF]
is administered in separate
administrations of 2 equal doses.
. . .
15. A method of treating a subject in need of
treatment for multiple sclerosis
comprising orally administering to the
subject pharmaceutical composition
consisting essentially of (a) a
therapeutically effective amount of [DMF]
and (b) one or more pharmaceutically
acceptable excipients, wherein the
therapeutically effective amount of [DMF]
is about 480 mg per day.
16. The method of claim 15, wherein the [DMF]
is administered in separate
administrations of 2 equal doses.
(JTX 2000 at 28-29).
III. DISCUSSION
A. Applicable Law
The first paragraph of 35 U.S.C. § 112 requires a patent’s
specification to include, among other things, “a written
description of the invention . . . .”14 This written description
14 The America Invents Act (“AIA”), Pub. L. No. 112-29, § 4(c),
125 Stat. 284, 296 (2011), added subsection headings to the six
paragraphs that made up the pre-AIA version of § 112. Although
these amendments have no effect on the question presented, the
parties agree that, because the priority date of the ’514 Patent is
February 8, 2007, the pre-AIA version of § 112 applies to the
asserted claims (Dkt. Nos. 376 at 17 n.3, 377 at 21 n. 3).
17
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requirement “allows a person of skill in the art to recognize that
the patentee invented what is claimed.” Synthes USA, LLC v. Spinal
Kinetics, Inc., 734 F.3d 1332, 1341 (Fed. Cir. 2013) (citing Ariad
Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir.
2010) (en banc)). “[T]he test for sufficiency is whether the
disclosure of the application relied upon reasonably conveys to
those skilled in the art that the inventor ha[d] possession of the
claimed subject matter as of the filing date.” Id. (quoting same).
“That requirement is satisfied only if the inventor ‘conveys
with reasonable clarity to those skilled in the art that, as of the
filing date sought, he or she was in possession of the invention,
and demonstrates that by disclosure in the specification of the
patent.’” Nuvo Pharm. (Ir.) Designated Activity Co. v. Dr. Reddy’s
Labs. Inc., 923 F.3d 1368, 1376 (Fed. Cir. 2019) (cleaned up)
(quoting Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d
1341, 1348 (Fed. Cir. 2011)). “[A]ctual ‘possession’ or reduction
to practice outside of the specification is not enough.” Ariad
Pharm. Inc., 598 F.3d at 1352. “[I]t is the specification itself
that must demonstrate possession.” Id.
Whether the ’514 Patent is invalid for lack of written
description is a factual question for Mylan to establish by clear
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and convincing evidence. Rivera v. Int’l Trade Comm’n, 857 F.3d
1315, 1319 (Fed. Cir. 2017).
B. Person of Ordinary Skill in the Art
Determining who constitutes a person of ordinary skill in the
art (“POSA”) is also a factual question, see ALZA Corp. v. Andrx
Pharm., LLC, 603 F.3d 935, 940 (Fed. Cir. 2010), involving a
two-step inquiry: “The first part is determining what exactly is
that ‘relevant art’ at issue, the second is determining who
qualifies as a ‘person of ordinary skill’ in that art.” Seed
Research Equip. Solutions, LLC v. Gary W. Clem, Inc., No.
09-01282-EFM-KGG, 2011 WL 5024351, at *3 (D. Kan. Oct. 20, 2011)
(citing Arachnid, Inc. v. Merit Indus., Inc., 201 F. Supp. 2d 883,
888 (N.D. Ill. 2002)).
“Art” is defined simply as “[a] field of useful endeavor.” And
“relevant art” is the “[a]rt to which one can reasonably be
expected to look for a solution to the problem that a patented
device tries to solve.” Art, Black’s Law Dictionary (11th ed.
2019). “The relevant art is defined by the nature of the problem
confronting the would-be inventor.” Ryko Mfg. Co. v. Nu-Star, Inc.,
950 F.2d 714, 716 (Fed. Cir. 1991) (internal quotation omitted).
“Factors that may be considered in determining level of ordinary
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skill in the art include: (1) the educational level of the
inventor; (2) type of problems encountered in the art; (3) prior
art solutions to those problems; (4) rapidity with which
innovations are made; (5) sophistication of the technology; and (6)
educational level of active workers in the field.” Daiichi Sankyo
Co., Ltd. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007)
(citation omitted). These factors are illustrations, not
exhaustive. Id.
In this case, the parties agree that a POSA is someone with
“at least a medical degree, at least three years of training in
neurology, and at least three years of clinical experience treating
multiple sclerosis patients” (Dkt. Nos. 356 at 113; 359 at 9, 81;
387 at 1). Mylan presented the testimony of Benjamin M. Greenberg,
M.D. (“Dr. Greenberg”), and Biogen presented the testimony of
Daniel R. Wynn, M.D. (“Dr. Wynn”) (Dkt. Nos. 356 at 99-228, 359 at
6-73, 74-144). Each is a neurologist who treats patients with MS
and meets the parties’ definition of a POSA (Dkt. Nos. 356 at 165-
66, 359 at 80).
C. The Parties’ Contentions
Mylan contends that the ’514 Patent is invalid for lack of
written description because the specification described in 2007
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bears no resemblance to the invention claimed in 2011 (Dkt. No. 376
at 16-17). This is so for two reasons. First, as Biogen insisted
throughout its prosecution of the ’514 Patent, a POSA would not
have expected the claimed invention——a 480mg/day dose of DMF
(BID)——to effectively treat MS. Id. at 17-24. Mylan asserts that
nothing in the specification of the ’514 Patent teaches otherwise.
Id.
Second, Mylan contends that, when viewed as an integrated
whole, the combination of selectively-plucked disclosures in the
specification of the ’514 Patent fails to sufficiently describe the
claimed invention——a method of treating MS with a therapeutically
effective amount of DMF, i.e., 480mg/day of DMF (BID). Id. at 24-
29. According to Mylan, “[t]he reason is evident: Biogen grafted
the ’514 claims onto a specification written to cover an entirely
different set of inventions, conceived of by an entirely different
inventor, and filed more than four years before Biogen’s 2011 Phase
III trial results demonstrated the effectiveness of the 480[mg/day]
dose.” Id. at 24 (emphasis in original).
In resisting these arguments, Biogen asserts that Mylan faces
an “added burden” of demonstrating lack of written description in
this case because the PTO previously questioned the sufficiency of
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the written description in the context of an obviousness rejection
(Dkt. No. 377 at 20-21). It also contends that Mylan mistakenly
relies on evidence of obviousness, which is irrelevant to the
written-description analysis. Id. at 22. Turning to the
specification, Biogen maintains that “[t]he ’514 Patent links
through Method 4 each of the three recited elements of the asserted
claims: (1) a method of treating MS with (2) DMF and/or MMF (3) at
a dose of 480 mg per day.” Id. at 23, 23-29. Finally, Biogen argues
that Mylan has misapplied the law and failed to satisfy its burden
of proof. Id. at 29-45. The Court addresses each of these arguments
in turn.
D. The Asserted Claims of the ’514 Patent Are Invalid for Lack of
Written Description Under § 112
1. Mylan Faces No “Added Burden”
As a threshold matter, Biogen’s argument that Mylan faces an
“added burden” in this case misses the mark. As Mylan correctly
notes, “[t]he burden [of proof] does not suddenly change to
something higher——‘extremely clear and convincing evidence’ or
‘crystal clear and convincing evidence’—— simply because” the PTO
previously questioned the sufficiency of the written description in
the context of an obviousness rejection. In Sciele Pharma Inc. v.
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Lupin Ltd., 684 F.3d 1253, 1260 (Fed. Cir. 2012), the Federal
Circuit confirmed the applicable burden of proof for establishing
invalidity based on obviousness: “The presumption of validity found
in [35 U.S.C.] § 282 is reflected in the standard of proof required
to prove invalidity, clear and convincing evidence.” Id. (citing
Microsoft Corp. v. i4i Ltd. P’ship, 564 U.S. 91, 100-01 (2011)). So
too here. “Nothing in § 282’s text suggests that Congress meant to
. . . enact a standard of proof that would rise and fall with the
facts of each case.” Microsoft Corp., 564 U.S. at 109.
2. The Specification Does Not Demonstrate that the Inventors
“Possessed” the Claimed Invention
In order to satisfy the written description requirement of
§ 112, the inventor must “‘convey[] with reasonable clarity to
those skilled in the art that, as of the filing date sought, he or
she was in possession of the invention, and demonstrate[] that by
disclosure in the specification of the patent.’” Nuvo Pharm., 923
F.3d at 1376 (cleaned up) (citation omitted). Significantly,
“actual ‘possession’ or reduction to practice outside of the
specification is not enough.” Ariad Pharm. Inc., 598 F.3d at 1352.
“[I]t is the specification itself that must demonstrate
possession.” Id.
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Here, Mylan contends that the ’514 Patent, when viewed as an
integrated whole, fails to satisfy this statutory requirement
because it does not demonstrate that, as of February 8, 2007, Dr.
Lukashev and Dr. O’Neill “possessed” a method of treating MS with
a therapeutically effective amount of DMF, i.e., 480mg/day (BID)
(Dkt. Nos. 376, 384).15
Spanning 30 columns (JTX 2000 at 15-29), the specification of
the ’514 Patent begins with a general discussion of MS but quickly
turns to a discussion of how “the Nrf2 pathway may be activated in
neurodegenerative and neuroinflammatory diseases as an endogenous
protective mechanism,” and how “[e]merging evidence suggests that
[plant-derived] compounds may exert their neuroprotective effects
by activating cellular stress-response pathways, including the Nrf2
pathway, resulting in the upregulation of neuroprotective genes”
15 In its post-trial brief, Biogen appears to suggest that the
therapeutic efficacy required by the asserted claims differs from
clinical efficacy (Dkt. No. 377 at 39-40). But based on the factual
and evidentiary record in this case, and in light of Biogen’s
consistent representations to the PTO during prosecution and before
the PTAB in the related IPR proceeding, Biogen is estopped from
relying on this distinction. See, e.g., New Hampshire v. Maine, 532
U.S. 742, 743 (judicial estoppel applies “to protect the integrity
of the judicial process by prohibiting parties from deliberately
changing positions according to the exigencies of the moment”
(cleaned up)).
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(JTX 2000 at 15). It then acknowledges that “the exact mechanism of
action of these compounds remains poorly understood.” Id.
The specification provides five methods:
1) methods of screening for at least one new
candidate compound for treating a
neurological disease;
2) methods of evaluating neuroprotective
properties of at least one drug candidate
for treating a neurological disease;
3) methods of comparing (e.g., for
bioequivalence) at least two
pharmaceutical compositions which
comprise fumaric acid derivatives;
4) methods of treating a neurological
disease by administering to the subject
in need thereof at least one compound
that is partially structurally similar to
DMF or MMF; and
5) methods of treating a neurological
disease by a combination therapy that
comprises administration of at least one
first compound that upregulates the Nrf2
pathway and at least one second compound
that does not upregulate the Nrf2
pathway.
Id. at 15-16.
Biogen concedes that “Methods 1-3 are directed to methods of
screening for compounds to treat neurological diseases,” which are
“described, but not claimed, in the ’514 Patent” (Dkt. No. 377 at
16, 24). It also concedes that “Method 5 relates to the use of
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[compounds such as DMF] in combination therapy along with other
compounds having different activity.” Id. at 24. According to
Biogen, “[t]he ’514 Patent links through Method 4 each of the three
recited elements of the asserted claims: (1) a method of treating
MS with (2) DMF and/or MMF (3) at a dose of 480 mg per day.” Id. at
23. This simply is not so. The description of Method 4 is limited
in scope and makes no mention of treating MS with a 480mg/day dose
of DMF (BID):
In some embodiments method 4 comprises
administering to the mammal a therapeutically
effective amount of at least one
neuroprotective compound having Formula I, II,
III, or IV, e.g., a fumaric acid derivative
(e.g. , DMF or MMF).
In some embodiments method 4 provides a
method of slowing or preventing
neurodegeneration in a patient in need
thereof, by administering the compound in an
amount and for a period of time sufficient to
slow or prevent demyelination, axonal loss,
and/or neuronal death, e.g., by at least 30%
relative to a control.
(JTX 2000 at 16).
Also provided are methods of treating a
neurological disease by administering to the
subject in need thereof at least one compound
that is at least partially structurally
similar to DMF and/or MMF.
In some embodiments of method 4, a method
of treating a mammal who has or is at risk for
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a neurological disease is provided. The
methods comprises [sic] administering to the
mammal a therapeutically effective amount of
at least one neuroprotective compound which
has Formula I, II, III, or IV, e.g., a fumaric
acid derivative (e.g., DMF or MMF).
In some embodiments of method 4, a method
of slowing or preventing neurodegeneration
(more specifically, e.g., demyelination,
axonal loss, and/or neuronal death) in a
subject in need thereof by administering the
at least one compound in an amount and for a
period of time sufficient to do at least one
of slow or prevent demyelination, slow or
prevent axonal loss, and slow or prevent
neuronal death, e.g., by at least 30%, 50%,
100% or higher over a control over a period of
at least 5, 10, 12, 20, 40, 52, 100, or 200
weeks, or more.
Id. at 18.
Thus, Method 4 broadly describes treating neurological
diseases with a therapeutically effective amount of DMF; MS is
merely one such disease “among a slew of competing possibilities.”
Novozymes A/S v. DuPont Nutrition Biosciences APS, 723 F.3d 1336,
1349 (Fed. Cir. 2013). Indeed, in Column 3, the specification
explains that, “[i]n some embodiments, the neurological disease is
a neurodegenerative disease such as, for example, ALS, Parkinson’s
disease, Alzheimer’s disease, and Huntington’s disease” (JTX 2000
at 16). In others, “the neurological disease is MS or another
demyelinating neurological disease.” Id.
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Column 16 then provides an exhaustive list of “diseases
suitable for the [five] methods described” in the ’514 Patent:
Examples of neurological diseases suitable for
the methods described herein include
neurodegenerative diseases such as amyotrophic
lateral sclerosis (ALS), Parkinson’s disease,
Alzheimer’s disease, and Huntington’s disease.
Other examples include demyelinating
neurological disease including, in addition to
MS, the following diseases: acute haemorrhagic
Ieucoencephalomyelitis, Hurst’s disease, acute
disseminated encephalomyelitis, optic
neuritis, Devic’s disease, spinal cord
lesions, acute necrotizing myelitis,
transverse myelitis, chronic progressive
myelopathy, progressive multifocal
leukoencephalopathy (PML), radiation
myelopathy, HTLV-1 associated myelopathy,
monophasic isolated demyelination, central
pontine myclinolysis, and leucodystrophy
(e.g., adrenoleucodystrophy, metachromatic
leucodystrophy, Krabbe’s disease, Canavan’s
disease, Alexander’s disease,
Pelizaeus-Merbacher disease, vanishing white
matter disease, oculodentodigital syndrome,
Zellweger’s syndrome), chronic inflammatory
demyelinating polyneuropathy (CIDP), acute
inflammatory demyelinating polyneuropathy
(AIDP), Leber’s optic atrophy, and
Charcot-Marie-Tooth disease.
Additional examples of diseases suitable
for the methods described herein include
polyneuritis and mitochondrial disorders with
demyelination. These disorders may be
co-presented with, and possibly aggravated by
diabetes, e.g., insulin-dependent diabetes
mellitus (IDDM; type I diabetes), or other
diseases.
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Id. at 22.
Because Methods 1-5 can be used for a plethora of neurological
diseases, there are no “blaze marks” in Method 4 that would lead a
POSA specifically to MS. Ariad, 598 F.3d at 1348. Nor, as Biogen
posits, does Method 4 “link” a therapeutically effective amount of
DMF to a dose of 480mg/day (BID). Id. at 1357.
For this proposition, Biogen directs the Court’s attention to
Column 18, the only part of the specification that mentions
480mg/day of DMF:
For example, an effective dose of DMF or MMR
to be administered to a subject orally can be
from about 0.1 g to 1 g per pay [sic], 200 mg
to about 800 mg per day (e.g., from about 240
mg to about 720 mg per day; or from about 480
mg to about 720 mg per day; or about 720 mg
per day). For example, the 720 mg per day may
be administered in separate administrations of
2, 3, 4, or 6 equal doses.16
(JTX 2000 at 23) (footnote added). This passage, however, neither
“links” this “effective dose” to the treatment of MS, nor to a
480mg/day dose of DMF (BID). Mylan’s POSA, Dr. Greenberg, credibly
testified at trial that nothing in Column 18 ties an effective dose
of DMF specifically to the treatment of MS (Dkt. No. 359 at 34-36).
16 Although this passage reads “an effective dose of DMF or
MMR,” the parties agree that “MMR” is a typographical error and
should read “MMF” (Dkt. Nos. 356 at 90, 358 at 73, 362 at 40).
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The cited passage, moreover, offers only a broad range of what an
effective dose “can be”: “0.1 g to 1 g per day”17 or “200 mg to 800
mg per day” (JTX 2000 at 23).
The examples following this broad disclosure also fail to
direct a POSA to the conclusion that a therapeutically effective
amount of DMF is 480mg/day (BID). Strikingly, 480mg dosing is
mentioned only once in three examples: “from about 240 mg to about
720 mg per day; or from about 480 mg to about 720 mg per day; or
about 720 mg per day” (JTX 2000 at 23 (emphasis added)). Although
Biogen and its expert insist that 480mg to 720mg/day is the
narrowest and, therefore, the most preferred range, thereby
teaching a 480mg/day dose (Dkt. Nos. 359 at 49-50, 102, 143-44; 377
at 27, 29), this reading is neither credible nor persuasive.
Based on the results of Biogen’s Phase II study, as of the
claimed priority date of February 8, 2007, a POSA would have known
that 720mg/day of DMF (TID) is a therapeutically effective dose for
treating MS, and that lower doses, such as 360mg/day of DMF (TID)
and 120mg/day of DMF (QD), are not (JTX 2153B at 8, 12). See Zoltek
Corp. v. United States, 815 F.3d 1302, 1308 (Fed. Cir. 2016)
(stating that the written-description “requirement is applied in
17 In other words, 100mg to 1,000mg (Dkt. No. 359 at 34).
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the context of the state of knowledge at the time of the invention”
(citation omitted)). Thus, on reading the specification, a POSA
would be drawn to, if anything, the 720mg/day dose of DMF included
in each dosing example: “from about 240 mg to about 720 mg per day;
or from about 480 mg to about 720 mg per day; or about 720 mg per
day” (JTX 2000 at 23 (emphasis added)). This understanding is
confirmed by the next sentence, which further highlights a
720mg/day dose: “For example, the 720 mg per day may be
administered in separate administrations of 2, 3, 4, or 6 equal
doses.” Id. (emphasis added).
Given the emphasis on 720mg/day of DMF, nothing in this
passage teaches a POSA that a 480mg/day dose of DMF (BID) is
therapeutically effective for treating MS (Dkt. No. 359 at 34-38).
Tellingly, Biogen’s expert, Dr. Wynn, conceded as much on cross
examination. Based on his reading of the ’514 Patent, he testified
he would not know which dose provided in Column 18 would be most
effective for treating MS:
Q. So based upon reading the patent alone, you
wouldn’t know what the preferred dose was for
treating MS? Is that what I just heard you
say?
A. Which would be the most effective dose.
Q. Okay. You wouldn’t know that?
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A. Correct.
. . .
Q. Based on the data the artisan would know at
the time of the filing of the patent, all
three of those ranges include doses which,
according to you, they would know would be
ineffective, right?
A. A dose of 360 or lower would not be felt to
be a preferred dose for treating MS.
Q. Okay. So -- but we get to the fourth dose,
and suddenly now we’re talking about treating
MS, right?
A. I don’t know that the others were not for
treating MS. And, again, from reading this, I
don’t know that 480 would be the preferred
dose for treating MS either.
Q. And that’s -- I think we agree on that.
Reading this patent specification as a person
of skill in the art, you wouldn’t know that
480 milligrams would be a preferred dose for
treating MS. I agreed with you on that, right?
We agree on that?
A. Okay.
(Dkt. No. 359 at 135-37).
After Dr. Wynn attempted to disavow this testimony, id. at
137-38, Mylan effectively impeached his credibility:
Q. All right, Doctor. I’m looking at the
Delaware trial transcript at page 64, lines 13
to 18. Do you see that?
. . .
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A. Yes.
Q. And do you see you were asked a question
there, “Actually, sir, if you had seen this
patent in 2007, you wouldn’t know about the
480 milligram dose, would you?” And what was
your answer?
A. I answered, “I wouldn’t know if it was
clinically effective.”
Q. And then you were asked, “Because there’s
no data on it provided in the specification,
right?” And what did you answer?
A. “Anywhere that I’m aware of.”
Q. All right. That was the testimony you gave
in Delaware, correct, sir?
A. Yes.
Id. at 139.
Biogen’s reliance on Example 3 fares no better. To start,
Biogen may not rely on this example because it was not in the
specification of the ’921 Application (JTX 2182 at 37-39) through
which the ’514 Patent claims priority (JTX 2000). See Delphi Corp.,
776 F. Supp. 2d at 488 (noting that “a continuation application may
not contain new matter” (citing 35 U.S.C. § 120)). Even had it been
included in the ’921 Application, Example 3 plainly does not teach
a therapeutically effective amount of DMF for treating MS in humans
(JTX 2000 at 24-25).
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Although it employs Experimental Autoimmune Encephalomyelitis
(“EAE”), the animal model of MS, not even Dr. O’Neill, who is a
POSA himself and named inventor of the ’514 Patent, could explain
the relevance of Example 3——or any of the examples in the ’514
Patent——to the claimed invention. Id. The same holds true of Dr.
Wynn. On direct examination, he merely testified that Example 3 is
a study of DMF and MMF in conjunction with EAE, an animal model of
MS (Dkt. No. 359 at 95, 98). He never explained how that experiment
teaches a method of treating MS (in humans, not mice) with a
therapeutically effective amount of DMF, i.e., 480 mg/day (BID).
Id.
One need only recall Dr. Lukashev’s trial testimony to discern
the reason for this omission. Dr. Lukashev credibly testified that
the three examples in the ’514 Patent were part of his research,
which “was separate from preclinical development” and unrelated to
the clinical application of DMF (Dkt. No. 358 at 60-61).18 The
examples had “nothing to do with the efficacy [of DMF] in clinical
disease” and would not be “helpful in identifying a therapeutically
effective amount of [DMF].” Id. at 61. Indeed, the results of
18 Dr. Lukashev, while not a POSA, is a named inventor who
supplied the information in the specification (Dkt. No. 358 at 57).
Ignoring his credible testimony would be unreasonable.
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Example 3 “provide[d] evidence of [MMF] and [DMF] activation of
NRF2 in vivo.” Id. at 59-60, 60. Mylan’s POSA, Dr. Greenberg,
concurred with Dr. Lukashev’s testimony (Dkt. No. 359 at 70).
The disparity between the ’514 Patent’s specification and the
claimed invention of the ’921 and the 0016902 Applications (JTX
2182; PTX 401) is not surprising given the stark differences
between Dr. Lukashev and Dr. O’Neill’s respective roles in the BG-
12 Development Program. From the evidence presented at trial, Dr.
Lukashev’s research regarding the activation of the Nrf2 pathway
and screening drug compounds had nothing to do with the clinical
development of Tecfidera® (Dkt. No. 358 at 60-61). That task fell
to Dr. O’Neill and later Dr. Dawson (Dkt. No. 362 at 17, 153-54;
JTX 2091 at 1; JTX2133 at 26). Notably, Dr. O’Neill’s hypothesis,
that a 480mg/day dose of DMF (BID) would be efficacious in treating
MS, evolved from his review of Fumapharm’s confidential studies of
Fumaderm® (Dkt. No. 362 at 27-28, 52-54), not Dr. Lukashev’s
unrelated research regarding the mechanism of action.
In sum, Biogen has attempted to satisfy the written
description requirement of § 112 by selectively plucking specific
words from the specification that correspond to each element of the
claimed invention. The United States Court of Appeals for the
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Federal Circuit has squarely rejected this approach. Nuvo Pharm.,
923 F.3d at 1380 (“We have expressly rejected the ‘argument that
the written description requirement . . . is necessarily met as a
matter of law because the claim language appears in ipsis verbis in
the specification.’” (quoting Enzo Biochem, Inc. v. Gen–Probe Inc.,
323 F.3d 956, 968 (Fed. Cir. 2002))).19 The ’514 Patent thus must
be viewed as an integrated whole rather than a sum of its parts.
Novozymes A/S, 723 F.3d at 1349 (“Taking each claim . . . as an
integrated whole rather than as a collection of independent
limitations . . . .”).
With no support in the text of the specification, Biogen must
rely on Dr. O’Neill’s repeated insistence that he invented the
480mg/day dose of DMF (BID) to treat MS (Dkt. No. 362 at 17-111).
But “inventor testimony cannot establish written description
support where none exists in the four corners of the specification
. . . .” Nuvo Pharm., 923 F.3d at 1381. Put simply, Dr. O’Neill’s
testimony offers no more than “actual possession,” which is
insufficient to satisfy § 112. Ariad, 598 F.3d at 1352 (“[A]ctual
19 In other words, written description is not satisfied simply
because the same words appear in the claims and the specification.
See Ipsissima verba, Black’s Law Dictionary (11th ed. 2019)
(meaning “the very (same) words”).
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‘possession’ . . . is not enough.”). “There must be some
description, such as a constructive reduction to practice,
establishing that the inventor ‘was in possession of the . . .
claimed invention, including all of the elements and limitations.’”
Nuvo Pharm., 923 F.3d at 1380-81 (quoting Univ. of Rochester v.
G.D. Searle & Co., 358 F.3d 916, 926 (Fed. Cir. 2004)).
“The essence of th[is] written description requirement is that
a patent applicant, as part of the bargain with the public, must
describe his or her invention so that the public will know what it
is and that he or she has truly made the claimed invention.” AbbVie
Deutschland GmbH & Co. v. Janssen Biotech, Inc., 759 F.3d 1285,
1298 (Fed. Cir. 2014). “Patents are not rewarded for mere searches,
but are intended to compensate their successful completion.” Nuvo
Pharm., 923 F.3d at 1381 (citing Ariad, 598 F.3d at 1353). “That is
why the written description requirement incentivizes actual
invention, and thus a mere wish or plan for obtaining the claimed
invention is not adequate written description.” Id. (cleaned up)
(citations omitted).
Because the text of the specification in the ’514 Patent does
not demonstrate that, as of February 8, 2007, Dr. Lukashev and Dr.
O’Neill “possessed” the claimed invention——a method of treating MS
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with a therapeutically effective amount of DMF, i.e., 480mg/day
(BID)——Biogen has failed to satisfy its part of the bargain.
3. Extrinsic Evidence Confirms the Lack of Written
Description
If the text were not enough, extrinsic evidence further
“illuminates the absence of critical description . . . .” Nuvo
Pharm., 923 F.3d at 1381. In this case, that evidence is
substantial.
Turning first to the specification of the ’373 Application, it
is undisputed that Biogen filed this application one month after
receiving the “unexpected” results of its Phase III study
establishing the efficacy of a 480mg/day dose of DMF (BID) to treat
MS (DTX 1169). Entitled “Methods of Treating Multiple Sclerosis and
Preserving and/or Increasing Myelin Content,” the application
claimed methods for treating MS with a 480mg/day dose of DMF (BID),
and listed Dr. Dawson, Dr. O’Neill, and Alfred Sandrock as
inventors. Id. As one would expect, the specification provided and
discussed in detail a wealth of data generated during Biogen’s
Phase III study. Id. In contrast, the specification in the ’514
Patent included none of this data or information (compare DTX 1169
with JTX 2000).
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The explanation for this omission is readily apparent from the
record. Despite Dr. O’Neill’s strong belief that a 480mg/day dose
of DMF (BID) would effectively treat MS (Dkt. No. 362 at 61 (“I had
this strong belief and hypothesis that 480 milligrams could work in
the treatment of MS.”)), Biogen did not know that to be true until
its receipt of the “unexpected” results of its Phase III study (JTX
2088 at 9-10, 19). Moreover, upon recognizing that it had no patent
to protect a 480mg/day dose of DMF (BID) from competition, Biogen
quickly filed the ’373 Application with a priority date of May 26,
2011 (DTX 1169). Problematically, that application likely would not
have protected the 480mg/day dose of DMF (BID) from § 112
invalidity challenges based on the prior art before May 26, 2011.
Id.
In an attempt to resolve this problem, Biogen amended its ’296
Application, sitting idle since August 7, 2009 (DTX 1016), which
stemmed from the earlier ’921 and 0016902 Applications (JTX 2182;
PTX 401). It deleted the original title and claims of the ’296
Application, added a new title, new claims, and a new inventor (DTX
1656; DTX 1657). But it left the specification unchanged in an
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effort to obtain the ’921 Application’s priority date of February
8, 2007, and avoid over four years of prior art.20
This strategy came with a cost, however, since Biogen was left
with a specification written in 2007 that bore no resemblance to
the ’514 Patent’s title and claimed invention——a method of treating
MS with a therapeutically effective amount of DMF, i.e., 480mg/day
(BID) (compare DTX 1169 with JTX 2000)——an invention that no one
knew would work until April 2011 when Biogen received the results
of its Phase III study (JTX 2088 at 9-10, 19). Dr. O’Neill’s
testimony supports this conclusion: “I believed from the outset
that 480 milligrams as two divided doses of 240 milligrams a day
would demonstrate efficacy. I was very pleased when we saw the
Phase 3 results to see that 480 milligrams was efficacious and
actually had a high degree of efficacy” (Dkt. No. 362 at 60).
Consequently, “there is nothing in the specification of the
patent[]-in-suit showing ‘that the inventor[s] actually invented
the invention claimed.’” Nuvo Pharm., 923 F.3d at 1380 (emphasis
omitted) (quoting Centocor Orth Biotech Inc., 636 F.3d at 1348).
20 To underscore this strategy’s importance, one need look no
further than the PTAB’s decision in the parties’ related IPR
proceeding, where Biogen successfully defeated Mylan’s invalidity
challenge based on obviousness over prior art. Mylan Pharm. Inc.,
2020 WL 582736.
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The Court is well aware that the Federal Circuit “does not
require experimental data demonstrating effectiveness.” Id.
(citation omitted). Nor does it “require theory or explanation of
how or why a claimed composition will be effective.” Id. (citation
omitted). But “the lack of any disclosure of examples may be
considered when determining whether the claimed invention is
adequately described.” Boston Scientific Corp. v. Johnson &
Johnson, 647 F.3d 1353, 1364 (Fed. Cir. 2011).
Here, the disparities between the specifications——including
related examples——of the ’373 Application and the ’514 Patent are
stark (compare DTX 1169 with JTX 2000). And because a POSA would
not have expected a 480mg/day dose of DMF (BID) to be efficacious
in 2007 (in fact, according to Biogen’s own employee and expert
testimony, the efficacy of the 480mg/day dose of DMF (BID) was
“unexpected” four years later in April 2011 (Dkt. Nos. 359 at 115
(Dr. Wynn agreeing with Dr. Dawson’s declaration)), the ’514
Patent’s omissions in this regard are particularly telling. To
start, the ’514 Patent does not include examples discussing
efficacy data regarding relapse and disability, lesion loads,
quality of life, preserving/increasing myelin content, or clinical
trials, all of which was included in Biogen’s abandoned ’373
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Application (compare DTX 1169 at 28-29 with JTX 2000). There are no
graphs or data regarding proportion of relapses, distribution of
relapses, risk of relapse, progression of disability, distribution
of new or newly enlarging lesions, change in baseline, annualized
relapse rate, MRI results, lesion volume, or brain atrophy (compare
DTX 1169 at 2-19 with JTX 2000). Nor are there summaries, brief or
detailed, of the claimed invention (compare DTX 1169 at 20-28 with
JTX 2000).
Further, the ’514 Patent does not include any Phase I data
from the BG-12 Development Program or the confidential data
reviewed by Dr. O’Neill during the Fumapharm due diligence (Dkt.
No. 362 at 52-55 (discussing what Fumapharm data consisted of); JTX
2000). Nor does it include information about the “C of DMF,” on
max
which he based his entire hypothesis (Dkt. No. 362 at 53-54 (“I
believed and I hypothesized was that the -- a frequency of twice a
day of a Cmax could be driving efficacy. . . . That is a Cmax of
DMF.)).
This case bears a striking resemblance to Nuvo
Pharmaceuticals, where the Federal Circuit considered whether the
patents-in-suit adequately described the claimed effectiveness of
uncoated proton pump inhibitors (“PPIs”). 923 F.3d at 1372, 1376.
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The generic defendants had argued that the written description was
insufficient because a POSA “would not have expected uncoated PPIs
to be effective, and nothing in the specification would teach a
[POSA] otherwise.” Id. at 1377. The Federal Circuit agreed:
In light of the fact that the specification
provides nothing more than the mere claim that
uncoated PPI might work, even though [POSAs]
would not have thought it would work, the
specification is fatally flawed. It does not
demonstrate that the inventor possessed more
than a mere wish or hope that uncoated PPI
would work, and thus it does not demonstrate
that he actually invented what he claimed . .
. .
Id. at 1381.
So too here. At every stage of this case and the related IPR
proceeding, Biogen defended against Mylan’s obviousness challenge
by insisting that a POSA would not have expected a 480mg/day dose
of DMF to be efficacious in treating MS (Dkt. No. 356 at 56
(Biogen’s opening statement: “Dr. O’Neill’s claimed invention of
using 480 milligrams per day of DMF to treat MS exhibited an
unexpected magnitude of efficacy rendering the claimed method
nonobvious on this basis alone.” (emphasis added))). See also Mylan
Pharm. Inc., 2020 WL 582736, at *16 (stating that Biogen “provides
argument and evidence . . . that the 480 mg/day dose had an
unexpected magnitude of efficacy as compared to a much higher 720
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mg/day dose” (emphasis added)). This statement only underscores the
failure of the specification to teach a POSA, who would expect
otherwise, that a 480mg/day dose of DMF (BID) is efficacious in
treating MS. See Nuvo Pharm., 923 F.3d at 1381.
Biogen cannot successfully distinguish Nuvo from the case at
hand (Dkt. No. 377 at 34-41). In Nuvo, the specification of the
patents-in-suit explicitly acknowledged that a POSA would not have
expected uncoated PPIs to work. Id. (discussing Nuvo). Because
there is no such acknowledgment in the ’514 Patent’s specification,
Biogen contends that Nuvo’s holding is inapposite. Id. This is a
distinction without a difference, however. Although the
specification at issue in Nuvo explicitly acknowledged what a POSA
would not have expected to work, it is well established (as
Biogen’s own brief acknowledges (Dkt. No. 377 at 33-34)) that a
specification “need not include information that is already known
and available to the experienced public.” Space Sys./Loral, Inc. v.
Lockheed Martin Corp., 405 F.3d 985, 987 (Fed. Cir. 2005) (citation
omitted). Thus, the specification of the ’514 Patent need not
explicitly acknowledge that the experienced public (i.e., a POSA)
would not have expected a 480mg/dose of DMF (BID) to be efficacious
in treating MS.
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IV. CONCLUSION
Mylan has established by clear and convincing evidence that
the asserted claims of the ’514 Patent are invalid for lack of
written description. First, the text of the specification does not
reasonably convey to a POSA that Dr. Lukashev and Dr. O’Neill
“actually invented” a method of treating MS with a therapeutically
effective amount of DMF, i.e., 480mg/day BID, as of February 8,
2007. This reading of the text is confirmed by the testimony of Dr.
Greenberg, Dr. Lukashev, Dr. O’Neill, and Dr. Wynn. Second, the
context of the ’514 Patent’s prosecution history and the
significant omissions from the specification further underscore the
failure to adequately describe the claimed invention. Biogen’s
attempt to avoid this conclusion by combining a few selectively-
plucked disclosures from the specification of the ’514 Patent has
been squarely rejected by the Federal Circuit.
Therefore, for the reasons discussed, the Court FINDS that
Mylan has satisfied its burden of demonstrating, by clear and
convincing evidence, that the asserted claims of the ’514 Patent
are invalid for lack of written description under § 112.
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The Court DIRECTS the Clerk to transmit copies of this Order
to counsel of record.21
DATED: June 18, 2020.
/s/ Irene M. Keeley
IRENE M. KEELEY
UNITED STATES DISTRICT JUDGE
21 Because the parties’ remaining claims, counterclaims, and
defenses regarding the ’001 Patent are stayed until June 20, 2020
(Dkt. Nos. 288, 315 at 12, 336 at 44), the Court’s decision
regarding the invalidity of the asserted claims of the ’514 Patent
does not deny all requested relief. Accordingly, absent a request
from the parties, the Court declines to enter a separate judgment
order pursuant to Federal Rule of Civil Procedure 58.
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ADDENDUM
CHRONOLOGY OF RELEVANT DATES
February 8, 2007: Biogen filed the ’921 Application, entitled
“Nrf2 Screening Assays and Related Methods and
Compositions,” which recited methods for
screening drug compounds for their ability to
activate the Nrf2 pathway and listed Dr.
Lukashev as the only inventor (JTX 2182);
February 7, 2008: Biogen filed the 0016902 Application, which
maintained the same title, claims, and
inventor as the ’921 Application but added to
its specification (PTX 401);
March 14, 2007: Biogen began its first clinical trial of the
Phase III study, which tested——for the first
time——a 480mg/day dose of DMF (BID);
August 7, 2009: The 0016902 Application became the ’296
Application (DTX 1016);
April 2011: Biogen received the Phase III test results,
which demonstrated the “unexpected” efficacy
of treating MS with 480mg/day of DMF (BID);
May 26, 2011: Biogen filed the ’373 Application, entitled
“Methods of Treating Multiple Sclerosis and
Preserving and/or Increasing Myelin Content,”
which claimed methods for treating MS with
480mg/day of DMF (BID) and listed Dr. Dawson,
Dr. O’Neill, and Alfred Sandrock as inventors
(DTX 1169);
June 20, 2011: Biogen amended the ’296 Application, deleting
its title and related claims but leaving its
specification unchanged (DTX 1656);
October 28, 2011: Biogen again amended the ’296 Application in
2011, adding Dr. O’Neill as an inventor but
leaving its specification unchanged (DTX
1657);
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ADDENDUM
February 13, 2012: Biogen filed the ’426 Application, a
continuing application of the ’296 Application
which was then abandoned (JTX 2173) ;
March 19, 2013: The PTO issues the ’514 Patent, which claims
priority from the ’921 Application filed on
February 8, 2007 (JTX 2000; JTX 2182); and
May 2016: Biogen abandoned the ’373 Application with its
claimed priority date of May 26, 2011.
48