Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC
Opinion
Jazz Pharmaceuticals, Inc. ("Jazz") appeals from six inter partes review ("IPR") decisions of the United States Patent and Trademark Office Patent Trial and Appeal Board (the "Board"). 1 Collectively, the decisions held certain claims of Jazz's U.S. Patents 7,668,730 ("'730 patent"), 7,765,106, 7,765,107, 7,895,059, 8,589,182, 8,457,988 ("'988 patent"), and 8,731,963 ("'963 patent") (together, the "patents in suit") invalid as obvious. Because the Board did not err in its conclusions of obviousness, we affirm.
BACKGROUND
The patents in suit are members of a family of patents owned by Jazz relating to a drug distribution system for tracking prescriptions of a "sensitive drug." '730 patent Abstract. 2 "A sensitive drug is one which can be abused, or has addiction properties or other properties that render the drug sensitive." '730 patent col. 3 ll. 14-16.
One such sensitive drug is Xyrem
®
. Jazz exclusively markets Xyrem
®
, which the U.S. Food and Drug Administration ("FDA") has approved to treat symptoms associated with narcolepsy. However, the active ingredient in Xyrem
®
, gamma-hydroxybutyrate
*1351
("GHB"), may also be illicitly used as a "date-rape drug."
See
Hillory J. Farias and Samantha Reid Date-Rape Drug Prohibition Act of 2000, Pub. L. No. 106-172,
During the regulatory review process for Xyrem
®
, the FDA scheduled an advisory committee meeting for June 6, 2001. The meeting was announced in a May 14, 2001 Federal Register Notice, which stated that the meeting was open to the public and that "[a] main focus of the deliberations will be on risk management issues" associated with Xyrem
®
. Meeting Notice,
I
The claimed invention of the patents in suit involves tracking prescriptions of a sensitive drug through a database. '730 patent Abstract. Claim 1 of the '730 patent is illustrative, and recites:
1. A computerized method of distributing a prescription drug under exclusive control of an exclusive central pharmacy, the method comprising:
receiving in a computer processor all prescription requests, for any and all patients being prescribed the prescription drug, only at the exclusive central pharmacy from any and all medical doctors allowed to prescribe the prescription drug, the prescription requests containing information identifying patients, the prescription drug, and various credentials of the any and all medical doctors ;
requiring entering of the information into an exclusive computer database associated with the exclusive central pharmacy for analysis of potential abuse situations, such that all prescriptions for the prescription drug are processed only by the exclusive central pharmacy using only the exclusive computer database;
checking with the computer processor the credentials of the any and all doctors to determine the eligibility of the doctors to prescribe the prescription drug;
confirming with a patient that educational material has been read prior to shipping the prescription drug;
checking the exclusive computer database for potential abuse of the prescription drug;
mailing the prescription drug to the patient only if no potential abuse is found by the patient to whom the prescription drug is prescribed and the doctor prescribing the prescription drug;
confirming receipt by the patient of the prescription drug; and
generating with the computer processor periodic reports via the exclusive computer database to evaluate potential diversion patterns .
Of particular relevance to this appeal are the "exclusive computer database,"
*1352
"information identifying," and "periodic reports" terms, italicized above. The specification describes an "exclusive central database" as including all data relevant to distribution of a sensitive drug, "including patient, physician and prescription information."
Reports may be run against information in the database to "reveal potential abuse of the sensitive drug, such as early refills."
II
Amneal Pharmaceuticals, LLC ("Amneal") petitioned for IPR of the seven patents in suit. 3 The Board instituted review of all petitioned claims for each patent except for the '963 patent, where the Board partially instituted review of a subset of the petitioned claims, see Amneal Pharm., LLC v. Jazz Pharm., Inc. , IPR2015-01903, slip op. at 2 (P.T.A.B. Mar. 25, 2016), Paper No. 10. Also, in several of its institution decisions, the Board instituted review on fewer than all grounds raised in the petition. E.g. , Amneal Pharm., LLC v. Jazz Pharm., Inc. , IPR2015-00551, IPR2015-00554, slip op. at 42 (P.T.A.B. July 28, 2015), Paper No. 20.
The Board issued six final written decisions regarding the patents in suit.
4
The parties' current dispute centers on the Board's determination that the ACA materials were publicly accessible. The ACA materials consist of four documents associated with the public meeting held by the Xyrem
®
advisory committee: (1) the FDA advisory committee meeting transcript and slides; (2) an FDA preliminary clinical safety review of Xyrem
®
; (3) a Xyrem
®
briefing booklet; and (4) a video and transcript regarding a proposed distribution system for Xyrem
®
.
'730/'988 Decision
,
*1353 Next, the Board turned to whether a person of ordinary skill exercising reasonable diligence would have been able to locate the ACA materials. Id. at *14-16. It found that a person of ordinary skill in the art was a pharmacist or computer scientist having familiarity with computerized drug distribution procedures. Id. at *4-5. Furthermore, the Board agreed with Amneal that a person of ordinary skill "would have been familiar with the Federal Register and motivated to look for notices related to drug distribution, safety, or abuse prevention," and that a skilled artisan would have known that Xyrem ® contained an active ingredient susceptible to abuse. Id. ; see also id. at *15. According to the Board, this provided a person of ordinary skill with "sufficient motivation to have located the Federal Register Notice and FDA website for Xyrem." Id. at *15. Given that motivation, the Board found that a person of ordinary skill would have been capable of locating the Notice, as the Notice expressly stated that a "main focus of the deliberations will be on risk management issues" related to Xyrem ® , and the basic purpose of the Federal Register is to provide "notice to interested individuals of the actions of federal agencies." Id. (internal quotation marks omitted).
The parties also dispute two of the Board's claim constructions and its obviousness analysis. First, the Board construed "periodic reports" to "refer to reports that are generated at regular intervals or intermittently," id. at *8, rejecting Jazz's argument that the term only included reports generated at regular frequencies, id. at *7. Second, the Board construed "information identifying patients" as "information identifying a patient," and not limited to the information listed in the specification or requiring all listed types of information. Id. at *8. Similarly, the Board construed "information identifying ... various credentials of the any and all medical doctors" as "information identifying various credentials, i.e., at least two different types of credentials, of the prescribing doctor," and not limited to the information listed in the specification or requiring all listed types of information. Id. at *9.
Applying the above constructions, the Board held all instituted claims of the patents in suit unpatentable as obvious over the ACA materials alone or in combination with Robert R. Korfhage,
Information Storage and Retrieval
(1997) ("Korfhage"). The Board found that a person of ordinary skill would have been motivated to combine the ACA materials,
id.
at *16, and that the ACA materials collectively taught or suggested all limitations of the claims,
e.g.
,
id.
at *22, except for claims 2 and 10 of the '988 patent and claims 24, 26, and 27 of the '963 patent. The Board held those latter five claims obvious over the ACA materials and Korfhage.
Id.
at *25 ;
'963 Decision
,
Claims 2 and 10 of the '988 patent depend from independent claims 1 and 9, respectively, and recite an exclusive central database "distributed over multiple computers, and wherein a query operates over all data in all the distributed databases relating to the prescriptions, the doctors, and the narcoleptic patients." '988 patent col. 9 ll. 14-16. The Board found that Korfhage disclosed a database that can be distributed over multiple computers for cost and efficiency reasons, and that a person of ordinary skill "would have been motivated to modify the [ACA] distribution system to include multiple computers in a distributed database system for reasons of cost, efficiency, and the anticipated volume of prescription-related information to be received, entered, and queried."
'730/'988 Decision
,
The Board conducted a similar obviousness analysis with respect to claims 24, 26, and 27 of the '963 patent. These claims also recite a "central computer database being distributed over multiple computers." '963 patent col. 11 ll. 19-20;
Jazz appealed, challenging the Board's holding that the ACA materials are prior art and its claim constructions and obviousness analysis. We consider each issue in turn.
DISCUSSION
I. Jurisdiction
We must first address whether we have jurisdiction over the entirety of Jazz's appeal. The Supreme Court recently decided that
We recently addressed a similar scenario in
PGS
. In
PGS
, the Board had instituted IPR of only some of the claims and grounds raised by the petitioner.
Confronted with indistinguishable partially instituted IPRs and a lack of any request by either party for
SAS
-based action, we conclude that
PGS
controls this case. Under
PGS
, we have jurisdiction over Jazz's appeal under
II. Public Accessibility of the ACA Materials
Having concluded that we have jurisdiction over Jazz's appeal, we turn to the merits. We review the Board's legal determinations
de novo
,
In re Elsner
,
Jazz principally argues on appeal that the ACA materials are not prior art, so all of the Board's decisions relying on the ACA materials should be reversed. According to Jazz, the Board erred in concluding otherwise "by equating the constructive notice provided by the Federal Register with the law governing public accessibility of prior art." Appellant Br. 17. Emphasizing the substantial length of the annual Federal Register, Jazz asserts that the Board failed to make the requisite finding that a person of ordinary skill exercising reasonable diligence could have located the ACA materials.
Amneal responds that the ACA materials were widely disseminated, and that substantial evidence supports the Board's finding that a person of ordinary skill would have been motivated to find the ACA materials. Amneal further argues that neither indexing nor searchability is required under relevant case law.
This court and its predecessor have interpreted the "printed publication" provision of
*1356
Wyer
,
Whether a reference qualifies as a "printed publication" under § 102(b) is a legal conclusion based on underlying factual findings.
E.g.
,
Suffolk Techs., LLC v. AOL Inc.
,
We agree with Amneal that substantial evidence supports the Board's finding that the ACA materials were publicly accessible. At the outset, we note that whether a reference is a "printed publication" is a "case-by-case inquiry into the facts and circumstances surrounding the reference's disclosure to members of the public."
In re Klopfenstein
,
On May 14, 2001, the FDA announced a meeting of the Peripheral and Central Nervous System Drugs Advisory Committee through the Notice in the Federal Register. Notice,
The Notice also included a hyperlink to an FDA website where background material from the drug sponsor and the FDA would be posted before the meeting, and the meeting minutes, transcript, and slides would be posted after the meeting.
This is not the first time we have considered whether materials disclosed in association with meetings or conferences were "printed publications." In
Massachusetts Institute of Technology v. AB Fortia (
"
MIT
"
)
, the reference at issue was a paper orally presented at a scientific conference attended by between 50 and 500 cell culturists.
Similarly, in
Klopfenstein
, several researchers presented slides at two scientific meetings for a total of approximately three days.
In
Cordis Corp. v. Boston Scientific Corp.
, a medical resident presented a scientific monograph to several physicians and other colleagues, and gave copies of the paper to approximately six of his teachers.
Most recently, in Medtronic we considered whether distribution of a video and slides at several scientific meetings on spinal surgery were prior art printed publications. Medtronic , 891 F.3d at 1379. A CD containing the video was distributed at three meetings, and the slides at two of those meetings. Id. As in Klopfenstein , there was no evidence that either the video or the slides were stored for public access after the meetings. Id. at 1381. The first meeting was limited to members of a certain professional organization, but the second and third meetings were open to other surgeons. Id. at 1379. Roughly 20 and 55 surgeons attended the second and third meetings, respectively. Id. The Board had held that the video and slides were not prior art, but neither distinguished the limited from the open meetings, nor addressed whether the video and slides were distributed with a reasonable expectation that they would remain confidential. Id. at 1382. As "the size and nature of the meetings[,] ... whether they are open to people interested in the subject matter[,]" and "whether there is an expectation of confidentiality between the distributor and the recipients of the materials" are important factors in assessing public accessibility, we vacated the Board's finding that the video and slides were not prior art and remanded for further considerations. Id. at 1382-83.
Comparing the facts of this case to those in MIT , Klopfenstein , and Medtronic confirms that the ACA materials were disseminated more broadly and for a longer duration to persons of ordinary skill than the materials disclosed at individual meetings in those cases. In addition, unlike in Cordis , disclosure through public domain sources such as the Federal Register and a public federal agency website plainly indicates that there was no reasonable expectation that the ACA materials would remain confidential. As we explain below, each of these factors supports the Board's finding that the ACA materials were publicly accessible printed publications.
First, the breadth of the dissemination here to persons of ordinary skill is significant. "[A] printed publication need not be easily searchable after publication if it was sufficiently disseminated at the time of its publication."
Suffolk
,
Whether the disseminated material is addressed to or of interest to persons of ordinary skill is also relevant to the public accessibility inquiry.
See, e.g.
,
Klopfenstein
,
Second, the ACA materials were available online for a substantial time before the critical date of the patents in suit. "[T]he longer a reference is displayed, the more likely it is to be considered a 'printed publication.' "
Klopfenstein
,
Third, the ACA materials were distributed via public domain sources with no possible expectation that the materials would remain confidential or not be copied. We have consistently emphasized the importance of such expectations in determining whether a reference is publicly accessible.
See
Medtronic
, 891 F.3d at 1382 ;
Cordis
,
In sum, after considering the relevant factors identified in our public accessibility cases, the record here demonstrates that the ACA materials were widely disseminated to persons of ordinary skill for a substantial time with no reasonable expectation of confidentiality. They were "in the possession of the public,"
Wyer
,
Jazz asserts that the Board's finding of public accessibility must be reversed because evidence of "searchability or indexing [is] required to conclude that the ACA [m]aterials are prior art," Reply Br. 10, and Amneal did not submit such evidence. Because neither indexing nor searchability was required, we reject Jazz's argument.
We have consistently held that indexing or searchability is unnecessary for a reference to be a printed publication under § 102(b).
Medtronic
, 891 F.3d at 1381 ("We have stated that a printed publication 'need not be easily searchable after publication if it was sufficiently disseminated at the time of its publication.' " (quoting
Suffolk
,
Moreover, even assuming that indexing is relevant to this case, the Federal Register was meaningfully indexed.
7
The Notice was published on May 14, 2001, in issue 93 of the 66th annual volume of the Federal Register. 66 Fed. Reg., No. 93 (May 14, 2001). Consistent with its governing regulation,
Accepting the Board's unchallenged findings that a person of ordinary skill has a degree in either pharmacy or computer science, "was interested in drug distribution, safety, and abuse," and "would have had reason to look to the Federal Register and FDA Advisory Committee meeting notices,"
'730/'988 Decision
,
*1360
Jazz also argues that the Board erred by "equating the constructive notice provided by the Federal Register with the legal standard for prior art." Appellant Br. 21. We disagree. In response to Jazz's argument that a person of ordinary skill would have been incapable of finding the Notice, the Board observed that "[t]he Federal Register provides notice to interested individuals of the actions of federal agencies," and that a skilled artisan would have been motivated to seek out FDA meeting notices regarding drug abuse.
'730/'988 Decision
,
However, we do reiterate that "[i]f accessibility is proved, there is no requirement to show that particular members of the public actually received the information."
Constant v. Advanced Micro-Devices, Inc.
,
For the foregoing reasons, we hold that substantial evidence supports the Board's finding that the ACA materials were publicly accessible to persons of ordinary skill exercising reasonable diligence before the critical date of the patents in suit. Hence, they qualify as printed publications under § 102(b).
III. Claim Construction
We now turn to Jazz's claim construction arguments. Claim construction is a question of law that may involve underlying factual inquiries.
Teva Pharm. USA, Inc. v. Sandoz, Inc.
, --- U.S. ----,
A. "periodic reports"
Jazz asserts that the Board erred in construing "periodic reports," as recited in claim 1 of the '730 patent, among others. According to Jazz, "periodic" as used in the claims means at regular frequencies, Appellant Br. 18, and the Board's construction renders the word superfluous.
Amneal responds that the Board properly construed "periodic reports" as including reports generated at irregular frequencies, and Jazz's proposed construction *1361 improperly adds limitations without support in the intrinsic or extrinsic evidence.
We agree with Amneal that the Board did not err in construing "periodic reports" to encompass reports generated at both regular and irregular intervals.
'730/'988 Decision
,
We also look to the specification in interpreting the claims. The disclosure of the patents in suit further supports the Board's construction. The specification discloses two types of reports: reports made in response to a specific event that may occur at irregular intervals, such as early refill requests, '730 patent fig. 4B; id. col. 2 ll. 14-15; id. col. 6 ll. 33-37, and reports generated at regular frequencies, id. col. 6 ll. 12-13. Jazz argues that "periodic reports" refers only to the latter, and that the former reports are unclaimed embodiments. Appellant Br. 34. But Jazz provides no persuasive support in either the plain meaning of "periodic" or in the written description to exclude an embodiment repeatedly highlighted in the specification.
In addition, the prosecution history supports the Board's construction. During prosecution, the patent applicant pointed to several parts of the specification as providing written description support for the claim limitation "generating periodic reports via the exclusive computer database to evaluate potential diversion patterns." J.A. 14966. The cited disclosures referred specifically to early refill reports, J.A. 14993, and to the procedure for early refill requests, J.A. 15000, but not to reports generated at regular intervals. By indicating that the specification's disclosure of early refill reports provides written description support for the "periodic reports" term, the prosecution history lends further support to the Board's construction that does not exclude reports generated at irregular frequencies from the scope of the claims.
Because the totality of the evidence supports the Board's construction of "periodic reports" but not Jazz's, we affirm the Board's construction.
B. "information identifying"
Jazz also argues that the Board erred in construing the various terms reciting "information identifying" patients and physicians, as recited in claim 1 of the '730 patent, among others. Contrary to the Board's construction, Jazz contends that the specification identified examples of such information, and those examples set forth the minimum content needed to satisfy the "information identifying" term because the specification uses the words "contains" and "includes." Appellant Br. 43.
Amneal responds that the Board properly construed the "information identifying" claim terms as potentially including the types of information listed in the specification, but not limited to those types of information and not requiring all types of that information. Again, Amneal argues that Jazz's construction improperly imports limitations from the specification into the claims.
We agree with Amneal that the Board did not err in rejecting Jazz's request to *1362 read into the claims a minimum set of identifying information. The claim language simply refers to "prescription requests containing information identifying patients, the prescription drug, and various credentials of the any and all medical doctors." E.g. , '730 patent col. 8 ll. 45-48 (emphasis added). It recites no specific types of identifying information. The specification does list various kinds of identifying information in discussing figure 2, id. col. 4 ll. 18-25, but never indicates that such information must be included in the claimed "information identifying" a patient or physician. We decline to read such limitations into the broad claim language based on the specification's use of the word "contains" or "includes" in the context of describing a certain embodiment. Jazz cites no authority persuading us to do so. Thus, we affirm the Board's constructions of the claim terms reciting "information identifying."
IV. Obviousness
We finally consider Jazz's challenge to the Board's obviousness analysis. Obviousness is a question of law with underlying factual issues, including the scope and content of the prior art, differences between the prior art and the claims at issue, the level of ordinary skill, and relevant evidence of secondary considerations.
Graham v. John Deere Co.
,
Jazz argues that the Board's finding that a person of ordinary skill would have been motivated to modify the ACA materials with the distributed system disclosed in Korfhage lacks substantial evidence with respect to claims 2 and 10 of the '988 patent and claims 24, 26, and 27 of the '963 patent. First, Jazz argues that the Board's decisions regarding the '963 and '988 patents are contradictory, so both cannot be right. Appellant Br. 47-48. Second, Jazz asserts that the Supreme Court's decision in
KSR International Co. v. Teleflex Inc.
,
Amneal responds that the Board's decisions are not contradictory, and that Jazz's reading of
KSR
would impose "the exact sort of 'rigid preventative [rule] that [denies] factfinders recourse to common sense' the Court rejected." Appellee Br. 41 (alteration in original) (quoting
KSR
,
We agree with Amneal that the Board's decisions are consistent. The Board made the same essential finding in both decisions that a person of ordinary skill would have been motivated to run the ACA materials' distribution system over multiple computers, as taught in Korfhage.
Compare
'730/'988 Decision
,
We also agree with Amneal that Jazz misinterprets both the Supreme Court's decision in
KSR
and this court's obviousness precedent.
KSR
did not impose a rigid requirement to identify both a problem to be solved in the art and a finite universe of potential options. Rather, the Supreme Court rejected the teaching, suggestion, or motivation test, because the Court considered that the test was a "[r]igid, preventative rule[ ] that den[ies] factfinders recourse to common sense."
KSR
,
KSR
did state that "[w]hen there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp."
KSR
,
CONCLUSION
We have considered Jazz's remaining arguments, and find them unpersuasive. For the foregoing reasons, we affirm the Board's decisions.
AFFIRMED
Amneal Pharm., LLC v. Jazz Pharm., Inc.
, No. IPR2015-01903,
As the patents in suit share a substantially identical specification, for ease of reference we cite only the '730 patent.
Amneal filed several of its petitions for IPR jointly with Par Pharmaceutical, Inc. ("Par"). Jazz and Par reached a settlement during the pendency of this appeal, and accordingly Par is no longer a party. See Jazz Pharm., Inc. v. Amneal Pharm., LLC , No. 17-1671 (Fed. Cir. Jan. 19, 2018), ECF No. 51. In discussing the proceedings before the Board, we refer to the petitioners collectively as "Amneal."
For simplicity, unless otherwise noted we cite only the Board's final written decision concerning the '730 and '988 patents, which is representative of the other decisions on appeal. See Appellant Br. 9 n.5.
Because the applications for each of the patents in suit were filed before March 16, 2013, the pre-Leahy-Smith America Invents Act version of § 102 applies.
See
Pub L. No. 112-29,
The record in this case lacks any details regarding the FDA meeting itself-who attended and whether they were persons of ordinary skill, how long the meeting lasted, and whether copies of the ACA materials were distributed. Consequently, the Board did not address whether any potential distribution of the ACA materials at the meeting alone satisfied the "public accessibility" standard, and we do not address that possibility here in the first instance.
"The contents of the Federal Register shall be judicially noticed ...."
Reference
- Full Case Name
- JAZZ PHARMACEUTICALS, INC., Appellant v. AMNEAL PHARMACEUTICALS, LLC, Appellee
- Cited By
- 22 cases
- Status
- Published