Purdue Pharma L.P. et al v. Mylan Pharmaceuticals Inc. et al

Filing 67

REPORT AND RECOMMENDATIONS re 23 MOTION to Dismiss Based upon Pursuant to Fed. R. Civ. P. 12(b)(6) filed by Mylan, Inc., Mylan Pharmaceuticals Inc. Please note that when filing Objections pursuant to Federal Rule of Civil Procedure 72(b)(2), briefi ng consists solely of the Objections (no longer than ten (10) pages) and the Response to the Objections (no longer than ten (10) pages). No further briefing shall be permitted with respect to objections without leave of the Court. Objections to R&R due by 3/20/2017. Signed by Judge Sherry R. Fallon on 3/1/17. (cak)

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
PURDUE PHARMA L.P. et al.,
Plaintiffs,

v.

)
)
)
)

)

Civil Action No. 15-1155-RGA-SRF

)
MYLAN PHARMACEUTICALS INC. and )
MYLAN INC.,
)
)
Defendants.
)

REPORT AND RECOMMENDATION
I.

INTRODUCTION
Presently before the court in this patent infringement action is a motion to dismiss for

failure to state a claim upon which relief can be granted pursuant to Federal Rule of Civil
Procedure 12(b)(6), filed by defendants Mylan Inc. ("Mylan") and Mylan Pharmaceuticals Inc.
("MPI") (collectively, "defendants"). (D.I. 23) For the following reasons, I recommend that the
court deny the motion.

II.

BACKGROUND

A.

The Patent-In-Suit

This action arises out of defendants' submission of Abbreviated New Drug Application
("ANDA") No. 203915 to the United States Food and Drug Administration ("FDA") on
November 2, 2015. (D.I. 1 at iii! 1, 31) Plaintiffs Purdue Pharma L.P., Purdue Pharmaceuticals
L.P., The P.F. Laboratories, Inc., and Rhodes Technologies (collectively, "plaintiffs") assert that
defendants' ANDA filing constitutes infringement of United States Patent No. 9,073,933 ("the
'933 patent"), which relates to plaintiffs' OxyContin® brand oxycodone hydrochloride. (Id. at

iii! 1-2)

OxyContin® is an extended-release pain medication. (Id. at if 2)

The '933 patent, entitled "Oxycodone Hydrochloride Having Less Than 25 PPM 14Hydroxycodeinone," was issued on July 7, 2015, naming Robert Chapman, Lonn S. Rider, Qi
Hong, Donald Kyle, and Robert Kupper as the inventors. (Id at if 30) The ' 933 patent is
directed to an oxycodone hydrochloride active pharmaceutical ingredient ("API") with low
levels of 14-hydroxycodeinone (" 14-hydroxy"), and the processes for making the oxycodone
hydrochloride composition. ('933 patent, col. 1:25-27) 14-hydroxy belongs to a class of
potentially toxic compounds known as alpha, beta unsaturated ketones ("ABUKs") found in
oxycodone compositions. (Id, col. 6:51-54); Chapman v. Casner, 315 F. App'x 294, 295 (Fed.
Cir. 2009).
In a July 1, 2014 office action, the United States Patent and Trademark Office ("PTO")
issued a non-final rejection of then-pending claims 71-90 of the '933 patent as unpatentable for
obviousness-type double patenting 1 over certain prior art references. Specifically, the examiner
rejected the claims as being unpatentable over claims 1to14 of U.S. Patent No. 7,683,072 ("the
' 072 patent"), claims 1 to 9 of U.S. Patent No. 7,674,799 ("the ' 799 patent"), and claims 38 to 55
of U.S. Patent No. 7,674,800 ("the '800 patent;" together with the ' 072 patent and the '799
patent, the "low-ABUK patents"), among others.2 (D.I. 25, Ex. 8 at 711/14 Office Action, ifif 10,
12, 13) The

low~ABUK

patents share a common specification and priority date with the '933

patent and, like the '933 patent, are directed to reducing the amount of 14-hydroxy in an
oxycodone hydrochloride preparation.
1

Claims 71-90 of the '933 patent were also rejected as obvious pursuant to 35 U.S.C. § 103
because the examiner found the claims to be unpatentable over U.S. Patent No. 6,177,567
("Chiu"), which teaches the preparation of oxycodone by hydrogenation of 14-hydroxy, and
other references. (D.I. 25, Ex. 8 at 7/1/14 Office Action, if 6)
2
The Southern District of New York issued a decision invalidating the low-AB UK patents on
January 14, 2014, prior to the office actions and ultimate allowance of the '933 patent. In re
OxyContin Antitrust Litig. , 994 F. Supp. 2d 367 (S.D.N.Y. 2014).
2

In response to the obviousness-type double patenting rejection, plaintiffs filed terminal
disclaimers on October 1, 2014 3 to dispose of the double-patenting rejection, stating that
"[a]pplicants traverse these rejections, but submit herewith terminal disclaimers ... in an effort
to expedite prosecution." (Id., 10/1/14 Response at 13) Plaintiffs expressly stated that "[t]hese
terminal disclaimers are being submitted solely for the purpose of removing the double patenting
rejections. The filing of these terminal disclaimers is neither an admission of the propriety of the
rejections nor an admission that the inventions claimed in present claims 71-90 are not
'independent and distinct' from the inventions of' the low-ABUK patents. (Id)
The PTO issued a final rejection of the '933 patent application on October 31, 2014,
rejecting claims 71-90 as obvious under§ 103 after concluding that it would have been obvious
to one skilled in the art to prepare an oxycodone hydrochloride composition with a reduced
amount of 14-hydroxy by dehydrating 8a in view of the FDA's instructions to prepare
oxycodone salt with reduced amounts of 14-hydroxy. ('933 patent, 10/31/14 Final Rejection at ii
3) The examiner further noted that parent patent application 11/391,897 (the "Chapman
application") was invalidated based on an obviousness rejection during an interference
proceeding. On January 29, 2015, the examiner held a telephonic interview with plaintiffs to
discuss the adverse decision on the claims at issue in the interference proceedings regarding the
Chapman application. Plaintiffs filed a response after final rejection on March 4, 2015, further
amending the claims to distinguish them from the Chapman application by independently
requiring 8a as an element of the claimed composition or process. The PTO issued a notice of

3

Plaintiffs re-filed the terminal disclaimers on May 8, 2015, noting that the previously-filed
terminal disclaimers "inadvertently omitted the name of one of the assignees of the instant
application (i.e., Rhodes Technologies)." A terminal disclaimer review decision was issued on
May 27, 2015 approving the terminal disclaimers.
3

allowance of the amended claims 71-90, renumbered as claims 1-20, on March 23, 2015, after
concluding that the arguments filed on March 4, 2015 were persuasive in overcoming the
obviousness rejections and the addition of the 8a limitation rendered the claims patentably
distinct from the claims at issue in the Chapman interference proceedings.

B.

The Teva Litigation

Plaintiffs previously sued Teva Pharmaceuticals, USA ("Teva") in the Southern District
of New York, 4 alleging infringement of the low-AB UK patents. In re OxyContin Antitrust Litig. ,
994 F. Supp. 2d 367 (S.D.N.Y. 2014). The claims of the '799 and '072 patents are directed to
oxycodone hydrochloride, with the '799 patent claiming an "oral dosage form" of low-ABUK
oxycodone hydrochloride. Id. at 387-88. The asserted claims of the '800 patent recite a process
for preparing an oxycodone salt substantially free of 14-hydroxy. Id. at 387. The Southern
District ofNew York held that Teva infringed all of the asserted product-by-process claims, but
concluded that those claims were invalid for obviousness pursuant to 35 U.S.C. § 103. Id. at 403
("For purposes of validity, the Court considers only the product limitations of a claim, not
process limitations or source limitations that add no patentable significance to the end product.").
The court acknowledged that plaintiffs discovered 8a as the source of the 14-hydroxy problem,
4

Plaintiffs also previously sued Mylan for infringement of the low-ABUK patents. The Federal
Circuit set forth the procedural history of the litigation over the low-AB UK patents as follows:
In March 2011, Purdue sued Teva for infringement of the low-ABUK patents in
response to Teva's filing of an ANDA seeking FDA approval to market generic
versions of Reformulated OxyContin®. Between November 2011 and January
2013, Purdue filed similar lawsuits against Epic, Mylan, and Amneal. In addition,
in June 2012, Grunenthal and Purdue jointly sued Teva for infringement of the
'383 patent. The two Teva cases were consolidated and joined with the Epic,
Mylan, and Amneal cases, along with six actions involving other defendants, in
multi-district litigation for pretrial purposes.

Purdue Pharma L.P. v. Epic Pharma, LLC, 811 F.3d 1345, 1350 (Fed. Cir. 2016) ("Teva").
4

and noted that 8a was unknown in the prior art, but the court ultimately did not consider the
derived-from-Sa language in the low-ABUK patent claims in reaching its conclusion because
process limitations in product-by-process claims are disregarded in the obviousness inquiry, and
8a was "largely irrelevant to the process used by Purdue to obtain the product claimed by the
patents." Id. at 405.
On February 1, 2016, the Federal Circuit affirmed the Southern District of New York's
decision regarding the invalidity of the low-AB UK patents, relying on principles specific to
product-by-process claims and concluding that the district court did not err in disregarding the 8a
limitations in the obviousness inquiry. Teva, 811 F.3d at 1352-54. The district court's invalidity
determination was therefore upheld with respect to claims 3 and 19 of the '799 patent, claims 3034 and 76-79 of the '800 patent, and claims 1, 4, and 5 of the '072 patent. Id.; In re OxyContin,
994 F. Supp. 2d at 438. On April 1, 2016, plaintiffs petitioned for rehearing en bane of the
Federal Circuit's decision in the Teva appeal. (D.I. 28, Ex. 1) Plaintiffs' petition for rehearing
en bane was denied by the Federal Circuit on May 4, 2016, and plaintiffs' subsequent petition for
a writ of certiorari before the United States Supreme Court was denied on November 14, 2016.
(D.I. 33; D.I. 51)
C.

The Chapman Application

The low-ABUK patents and the '933 patent are continuations of the Chapman
application, which was filed on March 29, 2006. In re OxyContin, 994 F. Supp. 2d at 388. The
Chapman application recited a "process for preparing oxycodone hydrochloride having less than
25 ppm [14-hydroxy]." Id. During an interference proceeding on April 19, 2007 involving
claims 96-188 of the Chapman application, the Board of Patent Appeals and Interferences (the

5

"BPAI") 5 declared an interference between the Chapman application and U.S. Patent No.
7,153,966 ("Casner"). On March 18, 2008, the BPAI found that independent claim 96 of the
Chapman application and the dependent claims thereof were invalid as obvious in view of U.S.
Patent No. 7,153,966 ("Casner"), and the Federal Circuit affirmed. See Chapman v. Casner,
C.A. No. 08-1427, 315 F. App'x 294, 295 (Fed. Cir. Mar. 11, 2009); (D.I. 25, Ex. 10, 3/13/08
Order). The adjudicated Chapman application claims related to a method for making oxycodone
API using a hydrogenation step to remove 14-hydroxy, but they did not require that some of the
remaining 14-hydroxy be derived from the 8a isomer. Teva, 811 F.3d at 1349. In holding that
the claims at issue were unpatentable under § 103, the BPAI relied on the lack of any reference
in the claims to 8a as the source of the 14-hydroxy, noting that "[b]ecause the claims did not
specify the source of the 14-hydroxy, any prior art reference that disclosed conditions under
which either 8a or 8P converted to 14-hydroxy would render the claim obvious." Id (citing

Chapman, 315 F. App'x at 297). Because the prior art references disclosed conditions under
which 8P converts to 14-hydroxy, the BPAI determined that the Chapman application claims
were obvious in view of the prior art. Id

III.

LEGAL STANDARD
Rule 12(b)(6) permits a party to move to dismiss a complaint for failure to state a claim

upon which relief can be granted. Fed. R. Ci v. P. 12(b)( 6). When considering a Rule 12(b)( 6)
motion to dismiss, the court must accept as true all factual allegations in the complaint and view
them in the light most favorable to the plaintiff. Umland v. Planco Fin. Servs., 542 F.3d 59, 64
(3d Cir. 2008).
5

Pursuant to the America Invents Act of 2011, the BP AI subsequently changed its name to the
Patent Trial and Appeal Board ("PTAB") when the legislation went into effect on September 16,
2012.
6

To state a claim upon which relief can be granted pursuant to Rule 12(b)(6), a complaint
must contain a "short and plain statement of the claim showing that the pleader is entitled to
relief." Fed. R. Civ. P. 8(a)(2). Although detailed factual allegations are not required, the
complaint must set forth sufficient factual matter, accepted as true, to "state a claim to relief that
is plausible on its face." Bell At/. Corp. v. Twombly, 550 U.S. 544, 570 (2007); see also Ashcroft

v. Iqbal, 556 U.S. 662, 663 (2009). A claim is facially plausible when the factual allegations
allow the court to draw the reasonable inference that the defendant is liable for the misconduct
alleged. Iqbal, 556 U.S. at 663; Twombly, 550 U.S. at 555-56.
When determining whether dismissal is appropriate, the court must take three steps. 6 See

Santiago v. Warminster Twp., 629 F.3d 121, 130 (3d Cir. 2010). First, the court must identify
the elements of the claim. Iqbal, 556 U.S. at 675. Second, the court must identify and reject
conclusory allegations. Id. at 678. Third, the court should assume the veracity of the wellpleaded factual allegations identified under the first prong of the analysis, and determine whether
they are sufficiently alleged to state a claim for relief. Id.; see also Malleus v. George, 641 F.3d
560, 563 (3d Cir. 2011). The third prong presents a context-specific inquiry that "draw[s] on
[the court's] experience and common sense." Id. at 663-64; see also Fowler v. UPMC

Shadyside, 578 F.3d 203, 210 (3d Cir. 2009). As the Supreme Court instructed in Iqbal, "where
the well-pleaded facts do not permit the court to infer more than the mere possibility of
misconduct, the complaint has alleged - but it has not 'show[n]' - 'that the pleader is entitled to
relief."' Iqbal, 556 U.S. at 679 (quoting Fed. R. Civ. P. 8(a)(2)).
6

Although Iqbal describes the analysis as a "two-pronged approach," the Supreme Court
observed that it is often necessary to "begin by taking note of the elements a plaintiff must plead
to state a claim." 556 U.S. at 675, 679. For this reason, the Third Circuit has adopted a threepronged approach. See Santiago v. Warminster Twp., 629 F.3d 121, 130 n.7 (3d Cir. 2010);
Malleus v. George, 641 F.3d 560, 563 (3d Cir. 2011).
7

IV.

DISCUSSION
In support of their motion to dismiss, defendants contend that collateral estoppel bars

plaintiffs from relitigating the previously-adjudicated issue of the invalidity of claims requiring
oxycodone products with low levels of 14-hydroxy. (D.I. 24 at 8-18) In response, plaintiffs
allege that the '933 patent has never been adjudicated and includes limitations that have never
been addressed in previous litigations. (D.I. 28 at 8) Moreover, plaintiffs argue that applying
collateral estoppel to different patent claims from those previously adjudicated requires an
intense factual analysis that would be premature at this stage of the litigation. (Id at 11)
As a preliminary matter, the court notes that collateral estoppel may be decided on a
motion to dismiss under Rule 12(b)(6). M & M Stone Co. v. Pennsylvania, 388 F. App'x 156,
162 (3d Cir. 2010). In considering the motion, the court "may consider 'matters incorporated by
reference integral to the claim, items subject to judicial notice, matters of public record, orders
[and] items appearing in the record of the case."' Thibault v. Del. Tech. & Cmty. Coll., C.A. No.
11-1080-MPT, 2012 WL 2073847, at *2 (D. Del. June 8, 2012) (quoting Buck v. Hampton Twp.
Sch. Dist., 452 F.3d 256, 260 (3d Cir. 2006)). Matters of public record may include prior judicial
opinions and patent prosecution histories, among other things. See M & M Stone, 388 F. App'x
at 162; Genetic Techs Ltd. v. Bristol-Myers Squibb Co., 72 F. Supp. 3d 521 , 526 (D. Del. 2014).
In Blonder-Tongue Laboratories, Inc. v. University of Illinois Foundation, 402 U.S. 313
(1971), the Supreme Court held that defensive collateral estoppel may be used in the patent
context ifthe accused infringer shows: "(1) that a patent was found invalid in a prior case that
had proceeded through final judgment and in which all procedural opportunities were available
to the patentee; (2) that the issues litigated were identical; and (3) that the party against whom
estoppel is applied had a full and fair opportunity to litigate." Abbott Labs. v. Andrx Pharma. ,
8

Inc., 473 F.3d 1196, 1203 (Fed. Cir. 2007). Regional circuit law controls the determination of
whether prior findings invoke collateral estoppel pursuant to these guidelines. Id. at 1202-03. In
this regard, the Third Circuit has held that collateral estoppel applies when "(1) the identical
issue was previously adjudicated; (2) the issue was actually litigated; (3) the previous
determination was necessary to the decision; and (4) the party being precluded from relitigating
the issue was fully represented in the prior action." Jean Alexander Cosmetics, Inc. v. L 'Orea!

USA, Inc., 458 F.3d 244, 249 (3d Cir. 2006) (citations omitted). Although collateral estoppel
may apply even when the previously-litigated patent claims are not identical to the claims at
issue in the patent-in-suit, "the differences between the unadjudicated patent claims and
adjudicated patent claims" cannot "materially alter the question of invalidity." Ohio Willow

Wood Co. v. Alps South, LLC, 735 F.3d 1333, 1342 (Fed. Cir. 2013).
For the reasons set forth below, I recommend that the court deny the pending motion to
dismiss. At this stage of the proceedings, defendants have failed to establish that the invalid
claims of the previously-litigated low-ABUK patents are sufficiently identical to the disputed
claims of the '933 patent. The claims of the '933 patent contain limitations not set forth in the
low-ABUK patents, but whether these limitations are material to the patentability of the '933
patent is a question of fact to be reserved for a later stage of the proceedings.

A.

Product Claims 1 & 16 of the '933 Patent
1.

Sa limitation

The inclusion of the 8a limitation as a required element in claims 1 and 16 of the '933
patent distinguishes those claims from the claims of the low-ABUK patents and the Chapman
application. Specifically, independent claims 1 and 16 of the '933 patent claim "[a]n oxycodone
hydrochloride composition," which "comprises ... 8a, 14-dihydroxy-7, 8-dihydrocodeinone."
9

The "well understood" definition of "comprising" is "including but not limited to." Exergen
Corp. v. Wal-Mart Stores, Inc., 575F.3d1312, 1319 (Fed. Cir. 2009); see also Glaxo Group
LTD v. Teva Pharms. USA, Inc., 2009 WL 1220544, at *2 (D. Del. Apr. 30, 2009) (Comprising
"is a term of art used in claim language which means that the named elements are essential, but
other elements may be added and still form a construct within the scope of the claim.") (internal
quotations omitted).
In contrast, the product-by-process claim language of the low-ABUK patents does not
necessarily require the Sa required by the '933 patent product claims. The '072 patent claims
" [a]n oxycodone hydrochloride active pharmaceutical ingredient having less than 25 ppm 14hydroxycodeinone, wherein at least a portion of the 14-hydroxycodeinone is derived from Sa,
14-dihydroxy-7, S-dihydrocodeinone." ('072 patent, col. 34:57-60) Claim 1 of the '799 patent
claims "[a]n oral dosage form comprising particles ... wherein at least a portion of the 14hydroxycodeinone is derived from Sa, 14-dihydroxy-7, S-dihydrocodeinone." (' 799 patent, col.
34:54-59) Claim 3S of the ' SOO patent claims " [a]n oxycodone hydrochloride composition
having less than 25 ppm 14-hydroxycodeinone ... wherein at least a portion of the 14hydroxycodeinone in the composition having more than 100 ppm 14-hydroxycodeinone was
derived from the 8a, 14-dihydroxy-7, 8-dihydrocodeinone component during the conversion of
the oxycodone free base to the oxycodone salt." ('800 patent, col. 36:1-21) The "derived from
Sa" language of the low-ABUK product-by-process patent claims does not transform Sa into a
required claim limitation, unlike the "comprises" language in the '933 patent product claims.
Whether the Sa limitation in the '933 patent renders claims 1 and 16 patentably distinct from the
invalid low-ABUK claims is a question of fact not properly resolved at this stage of the
proceedings.
10

The Federal Circuit and district court decisions in the Teva litigation illustrate why the
invalidity determination regarding the low-ABUK patents is insufficient to have collateral
estoppel effect on the validity of the '933 patent at this stage of the proceedings. In Teva, the
Federal Circuit concluded that determining the source of 14-hydroxy in the end product did not
need to be resolved to arrive at the claimed invention, which was an oxycodone API with lowABUK levels. Teva, 811 F.3d at 1352. The Federal Circuit also held that identification of the
source of the remaining 14-hydroxy as being 8a had no effect on the structure or nature of the
low-ABUK oxycodone product. Id. ; see also In re OxyContin, 994 F. Supp. 2d at 405. The
Federal Circuit' s reasoning was based on the fact that the "derived from 8a" limitation in the
low-ABUK patents was a process limitation in a product-by-process claim that was thus
immaterial to the obviousness analysis. Id. at 1353-54 ("Because the source of the 14-hydroxy
has no effect on its structure or its removal through hydrogenation, the limitation that it be
' derived from 8a' cannot be a structural limitation.").
"A product-by-process claim is ' one in which the product is defined at least in part in
terms of the method or process by which it is made."' SmithKline Beecham Corp. v. Apotex

Corp., 439 F.3d 1312, 1315 (Fed. Cir. 2006) (quoting Bonito Boats, Inc. v. Thunder Craft Boats,
Inc., 489 U.S. 141 , 158 n. (1989)). "In determining validity of a product-by-process claim, the
focus is on the product and not the process of making it" because "an old product is not
patentable even if it is made by a new process." Greenliant Sys. , Inc. v. Xicor LLC, 692 F.3d
1261 , 1268 (Fed. Cir. 2012) (quoting Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340,
1369 (Fed. Cir. 2009)) (internal quotation marks omitted); see also SmithKline, 439 F.3d at 1317.
As a result, "[i]f the product in a product-by-process claim is the same as or obvious from a
product of the prior art, the claim is unpatentable even though the prior product was made by a
11

different process." In re Thorpe, 777 F.2d 695, 697 (Fed. Cir. 1985). However, ifthe process
limitations impart "structural and functional differences" to the product, converting the product
into something that is actually "new," the structural and functional differences are relevant to the
analysis even when they are "not explicitly part of the claim[s]." Amgen, 580 F.3d at 1367,
1370.
Unlike the product-by-process claims of the low-ABUK patents, claims 1 and 16 of the
'933 patent are product claims with a mandatory 8a limitation. Although the "derived from 8a"
limitation in the low-ABUK patents had no bearing on the invalidity determination because the
8a process was immaterial to the obviousness analysis, the 8a limitation present in the '933
patent claims must be evaluated to determine the validity of the claims. The 8a limitation in the
'933 patent could therefore be material to patentability, and it would be premature to grant the
motion to dismiss before a factual analysis ofthis issue occurs. The prosecution history of the
'933 patent also confirms the significance of the 8a limitations in the claims of the '933 patent,
as plaintiffs overcame the Chapman application by demonstrating that "[t]he claims at issue in
the interference proceedings ... did not recite" 8a. ('933 patent, 3/4/14 Applicant Arguments I
Remarks Made in an Amendment at 5; 3/23/15 Notice of Allowance at ii 4)
Defendants refer to the PTO's double patenting rejection of the '933 patent and plaintiffs'
terminal disclaimers of the low-AB UK patents in response thereto in support of their contention
that the validity issues for the '933 patent are substantially identical to the validity issues that
rendered the low-ABUK patents invalid. (D.I. 24 at 9-10) A double patenting rejection is issued
when a continuation application, 7 defined as "a second application for the same invention

7

Continuation applications allow inventors to file new patent applications based on the
disclosures of previous applications, without having the previous applications treated as
12

claimed in a prior nonprovisional application," MPEP § 201.07 (9th ed. 2014), is not patentably
distinct from the parent, In re Berg, 140 F.3d 1428, 1432 (Fed. Cir. 1998). "Uniformly, unlike
examination for obviousness based on prior art, the issue of obviousness-type double patenting is
directed to whether the invention claimed in a later patent is an obvious variant of the invention
claimed in an earlier patent." Sun Pharm. Indus., Ltd. v. Eli Lilly & Co. , 625 F.3d 719, 722 (Fed.
Cir. 2010). As such, "the disclosure of a patent cited in support of a double patenting rejection
cannot be used as though it were prior art, even where the disclosure is found in the claims."

Gen. Foods Corp. v. Studiengesellschaft Kohle mbH, 972 F.2d 1272, 1277 (Fed. Cir. 1992); see
also In re Kaplan, 789 F.2d 1574, 1579 (Fed. Cir. 1986) ("In considering the question [of
obviousness-type double patenting], the patent disclosure may not be used as prior art.").
The purpose of the judicially-created doctrine of obviousness-type double patenting is "to
prevent improper timewise extension of the patent right by prohibiting the issuance of claims in a
second patent which are not 'patentably distinct' from the claims of a first patent." In re Braat,
937 F.2d 589, 592 (Fed. Cir. 1991). The filing of a terminal disclaimer overcomes an
obviousness-type double patenting rejection by "foregoing that portion of the term of the second
patent that extends beyond the term of the first." In re Berg, 140 F.3d at 1432 (citing In re

Goodman, 11 F.3d 1046, 1052 (Fed. Cir. 1993)). As a result, the "filing of a terminal disclaimer
simply serves the statutory function of removing the rejection of double patenting, and raises
neither presumption nor estoppel on the merits of the rejection." Quad Envtl. Techs. Corp. v.

Union Sanitary Dist., 946 F.2d 870, 874 (Fed. Cir. 1991) (concluding that a terminal disclaimer
"is not an admission of obviousness of the later-filed claimed invention in light of the earlier-

invalidating prior art. Word to Info, Inc. v. Google Inc., 140 F. Supp. 3d 986, 991 (N.D. Cal.
2015).
13

filed disclosure, for that is not the basis of the disclaimer."); see also Edwards Lifesciences Corp.

v. St. Jude Med., Inc., 2003 WL 25784357, at *11 n.19 (C.D. Cal. Aug. 29, 2003) ("[A]n
obviousness-type double-patenting rejection is issued when the PTO considers pending claims
obvious in view of another patent by the same inventor; such rejection does not mean that the
respective claims are considered the same.").
In the present matter, defendants filed terminal disclaimers, but expressly stated that
"[t]hese terminal disclaimers are being submitted solely for the purpose of removing the double
patenting rejections. The filing of these terminal disclaimers is neither an admission of the
propriety of the rejections nor an admission that the inventions claimed in present claims 71-90
are not ' independent and distinct' from the inventions of' the low-ABUK patents. (D.I. 25, Ex.
8 at 10/1/14 Response at 13) The filing of the terminal disclaimers does not constitute
acquiescence to the merits of the rejection. See Quad Envtl., 946 F.2d at 874; Edwards

Lifesciences, 2003 WL 25784357, at *11 n.19. Thus, the only practical effect of the terminal
disclaimers was to limit the term of the ' 933 patent to the full statutory term of the low-ABUK
patents. The foregoing analysis of the claim language of the '933 patent compared to the lowABUK patents further demonstrates that the '933 patent contains additional limitations not
required by the low-ABUK patents, and it is premature for the court determine with certainty that
these limitations do not render the claims patentably distinct from the low-ABUK patents.
Defendants also rely on the doctrine of inherency in support of their argument that the
' 933 patent should be invalidated based on its similarities to the invalid low-ABUK patents.
(D.I. 24 at 13-14; D.I. 31at3-7) Pursuant to the doctrine ofinherency, "the discovery of a
previously unappreciated property of a prior art composition, or of a scientific explanation for

14

the prior art's functioning, does not render the old composition patentably new to the
discoverer." Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347 (Fed. Cir. 1999).
As a result, "[t]he express, implicit, and inherent disclosures of a prior art reference may be
relied upon in the rejection of claims under 35 U.S.C. §§ 102 or 103." MPEP § 2112. "[A] prior
art reference may anticipate without disclosing a feature of the claimed invention if that missing
characteristic is necessarily present, or inherent, in the single anticipating reference." Schering
Corp. v. Geneva Pharms., Inc., 339 F.3d 1373, 1377 (Fed. Cir. 2003).
Inherency, however, may not be established by probabilities or possibilities. The
mere fact that a certain thing may result from a given set of circumstances is not
sufficient. If, however, the disclosure is sufficient to show that the natural result
flowing from the operation as taught would result in the performance of the
questioned function, it seems to be well settled that the disclosure should be
regarded as 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)). A party must meet a high standard to rely on inherency in establishing the
existence of a claim limitation in the prior art in an obviousness analysis. Par Pharm. Inc. v. Twi
Pharms. , Inc., 773 F.3d 1186, 1195-96 (Fed. Cir. 2014). "Whether a claim limitation is inherent
in a prior art reference ... is also a question of fact." Finnigan Corp. v. Int 'l Trade Comm 'n,
180 F.3d 1354, 1362 (Fed. Cir. 1999); see also S.O.ITec Silicon On Insulator Techs., S.A . v.
MEMC Elec. Materials, Inc. , 745 F. Supp. 2d 489, 513 (D. Del. 2010) ("Inherency is a factual
issue."); Continental Can Co. USA, Inc. v. Monsanto Co., 948 F.2d 1264, 1268-69 (Fed. Cir.
1991).
The inherency doctrine does not apply under the facts presently before the court. As
previously discussed in conjunction with the obviousness-type double patenting analysis, the
low-ABUK patents are not prior art references in relation to the '933 patent because the '933
15

patent is a continuation of the low-ABUK patents. Gen. Foods Corp., 972 F.2d at 1277.
Defendants cite the Southern District of New York's decision inAbbvie Inc. v. Kennedy Trust for

Rheumatology Research, 2014 WL 3360722, at *6-7 (S.D.N.Y. July 9, 2014), to support the
application of the inherency doctrine to non-prior art references to establish collateral estoppel.
In Abbvie, the court granted summary judgment, invalidating the patent claims on grounds of
collateral estoppel based on an obviousness-type double patenting rejection. Id The court
discussed inherency without acknowledging that the previously-litigated patents were not prior
art. Id This case contradicts the Federal Circuit's decision in Quad Environmental

Technologies, which held that the filing of a terminal disclaimer did not raise estoppel issues on
the merits of the double patenting rejection. 946 F.2d at 874. It is also inconsistent with the
decision in Bourns, Inc. v. United States, which observed that "[a] domino approach in which
each successively narrower claim is compared with the one before it, not with the prior art, is
inappropriate since it improperly gives prior-art effect to the subject matter of an invalid claim."
537 F.2d at 493. In this instance, I recommend that the court follow Federal Circuit precedent
over the Southern District of New York's unpublished decision inAbbvie.
Even if the court were to credit defendants' authority, courts have routinely held that the
inherent teaching of a prior art reference is a question of fact. See Toro Co. v. Deere & Co., 355
F.3d 1313, 1320-21 (Fed. Cir. 2004); In re Napier, 55 F.3d 610, 613 (Fed. Cir. 1995). As
previously stated, fact-based inquiries are premature for resolution at this stage of the
proceedings. This is particularly true where, as here, the case authorities relied upon by the
defendants represent decisions on summary judgment or thereafter. See Abbvie, 2014 WL
3360722, at *6-7 (decided on summary judgment). None of defendants' authority was decided
on a motion to dismiss, and a question of fact remains in the present case regarding whether the
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differences between the unadjudicated patent claims and the adjudicated claims materially alter
the question of validity. See Soverain Software LLC v. Victoria 's Secret Direct Brand Mgmt.,

LLC, 778 F.3d 1311 (Fed. Cir. 2015) (post-verdict judgment as a matter oflaw); Ohio Willow
Wood Co. v. Alps South, LLC, 735 F.3d 1333 (Fed. Cir. 2013) (summary judgment); Alcon
Research, Ltd. v. Apotex Inc., 687 F.3d 1362 (Fed. Cir. 2012) (post-trial appeal of final
judgment); Santarus, Inc. v. Par Pharm., Inc., 694 F.3d 1344 (Fed. Cir. 2012) (post-trial appeal
of final judgment); In re Kao , 639 F.3d 1057 (Fed. Cir. 2011) (review ofBPAI decision
assessing whether obviousness determinations were based on substantial evidence); Bourns Inc.

v. U S. , 537 F.2d 486 (Ct. Cl. 1976) (summary judgment); Westwood Chem., Inc. v. US. , 525
F.2d 1367 (Ct. Cl. 1975) (summary judgment). As such, resolution at this stage of the
proceedings would be premature.

2.

95% limitation

The low-ABUK patent claims do not recite any percentage of oxycodone hydrochloride,
whereas claims 1 and 16 of the '933 patent specify that the composition must comprise at least
95% oxycodone hydrochloride. ('933 patent, col. 6:3-8; ' 072 patent, col. 5:65-6:3) Defendants
refer to the low-ABUK patent specification, which indicates that the composition "preferably"
contains at least 95% oxycodone hydrochloride or higher, as evidence that plaintiffs did not
intend to exclude this limitation from the low-ABUK patent claims. (D.I. 24 at 12-13)
However, the claims of the low-ABUK patents do not recite the 95% limitation. To the extent
that the 95% limitation is identified in the patent specifications of the low-AB UK patents, the
court notes that patent claims are evaluated for invalidity. Although the claims must be analyzed
in view of the specification, preferred embodiments identified in the specification cannot be

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improperly imported into the language of the claims themselves. See Phillips v. A WH Corp., 415
F.3d 1303, 1323-24 (Fed. Cir. 2005).
As previously explained in connection with the 8a limitation, whether a product
containing 95% oxycodone is novel over the low-ABUK patents is a question of fact not
properly resolved on a Rule 12(b)(6) motion to dismiss. The Teva decision does not discuss the
percentages of oxycodone in the prior art. Therefore, it would be inappropriate at this stage of
the proceedings for the court to conclusively rule that the 95% limitation does not materially
affect the patentability of the '933 patent.

3.

5 ppm limitation

Claim 16 of the '933 patent contains another limitation requiring that the composition
"comprises ... less than 5 ppm of codeinone." This limitation was not present in the low-ABUK
patent claims, and codeinone was not discussed in the course of the Teva litigation or the
Chapman interference proceedings. Whether the limitation represents only a slight difference
that does not render claim 16 patentably distinct from the adjudicated low-ABUK claims is an
issue of fact not properly resolved on a motion to dismiss. The fact that the low-AB UK patent
specification states that the present invention may reduce other ABUKs, such as codeinone, does
not establish that codeinone is necessarily present in the specific 5 ppm quantity in the
adjudicated claims. See Phillips, 415 F.3d at 1323-24. Moreover, the 5 ppm limitation of claim
16 is narrower than the low-AB UK claims, which have limits of 25 ppm, and the adjudicated
low-ABUK claims therefore cover oxycodone hydrochloride that is less pure than the recitation
of oxycodone hydrochloride with less than 5 ppm of 14-hydroxy in claim 16 of the '933 patent.

See Bourns, 537 F.2d at 493 ("A domino approach in which each successively narrower claim is
compared with the one before it, not with the prior art, is inappropriate since it improperly gives
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prior-art effect to the subject matter of an invalid claim."). Because the Teva litigation did not
address the narrower 5 ppm limitation, and the question of whether the difference in claim
language materially alters the patentability of claim 16 is fact-intensive, the court cannot rule at
this stage of the proceedings that collateral estoppel should apply to invalidate claim 16 of the
' 933 patent.

B.

Process Claim 10 of the '933 Patent

The claimed processes in claim 10 of the '933 patent require the step of removing 8a
from an oxycodone base composition. (' 933 patent, col. 34:27-35:27) In contrast, the Federal
Circuit in Teva declined to consider process limitations in concluding that the disputed productby-process claims were invalid. See Teva, 811 F.3d at 1354 ("We also conclude that, because
' derived from 8a[]' is a process limitation, the district court did not err in disregarding the
limitation in its obviousness analysis."). Questions regarding whether hydrogenation was wellknown in the art and whether the process of removing 8a from an oxycodone base composition
is material to the patentability of the '933 patent claims are factual in nature and are not properly
resolved on a motion to dismiss. Moreover, the process claims at issue in the Chapman
interference proceedings did not recite an 8a limitation.
A petition for rehearing en bane before the Federal Circuit in the Teva litigation was
denied on May 4, 2016. (D.I. 33 , Ex. 1) On November 14, 2016, the United States Supreme
Court denied the petitions for writ of certiorari. Purdue Pharma L.P., et al. v. Epic Pharma,

LLC, et al. , 137 S. Ct. 475 (2016); Grunenthal GmbH v. Teva Pharms. USA, Inc. , et al. , 137 S.
Ct. 476 (2016).

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V.

CONCLUSION
For the foregoing reasons, I recommend that the court deny defendants' motion to

dismiss pursuant to Rule 12(b)(6). (D.I. 23)
This Report and Recommendation is filed pursuant to 28 U.S.C. § 636(b)(l)(B), Fed. R.
Civ. P. 72(b)(l), and D. Del. LR 72.1. The parties may serve and file specific written objections
within fourteen (14) days after being served with a copy of this Report and Recommendation.
Fed. R. Civ. P. 72(b)(2). The objections and responses to the objections are limited to ten (10)
pages each. The failure of a party to object to legal conclusions may result in the loss of the right
to de novo review in the District Court. See Sincavage v. Barnhart, 171 F. App'x 924, 925 n.1
(3d Cir. 2006); Henderson v. Carlson, 812 F.2d 874, 878-79 (3d Cir. 1987).
The parties are directed to the court's Standing Order For Objections Filed Under Fed. R.
Civ. P. 72, dated October 9, 2013, a copy of which is available on the court's website,
http://www.ded.uscourts.gov.

Dated: March 1, 2017

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