IPR2023-00724
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`
`v.
`NOVO NORDISK A/S,
`Patent Owner
`______________________
`Case IPR2023-00724
`Patent 10,335,462
`______________________
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`PATENT OWNER’S RESPONSE
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`PROTECTIVE ORDER MATERIAL
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`PROTECTIVE ORDER MATERIAL
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`Novo Nordisk Exhibit 2014
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
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` U.S. Patent No. 10,335,462
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`
`v.
`NOVO NORDISK A/S,
`Patent Owner
`______________________
`Case IPR2023-00724
`Patent 10,335,462
`______________________
`
`
`
`PATENT OWNER’S RESPONSE
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`PROTECTIVE ORDER MATERIAL
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`PROTECTIVE ORDER MATERIAL
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`Novo Nordisk Exhibit 2014
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`IPR2023-00724
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`Exhibit Description
`EX2033 September 24, 2012 NN9535-3819 Clinical Trial Report (produced as NN-
`OZEM-000064989) [UNDER SEAL]
`EX2034 September 19, 2011 NN9535-3819 Safety Committee Meeting (produced
`as NN-OZEM-004435305) [UNDER SEAL]
`EX2035 September 18, 2011 email from Lisbeth Vesterg Jacobsen to Christine
`Jensen (produced as NN-OZEM-004435304) [UNDER SEAL]
`EX2036 NN9535-3819 CTR Workflow (produced as NN-OZEM-004437994)
`[UNDER SEAL]
`EX2037 --intentionally omitted--
`EX2038 March 11, 2010 email from Anne Flint to Nilas Ohrner, copying Christine
`Jensen (produced as NN-OZEM-004442969) [UNDER SEAL]
`EX2039 March 11, 2010 draft Semaglutide Dose selection for phase 3 presentation
`(produced as NN-OZEM-004442970) [UNDER SEAL]
`EX2040 November 26, 2010 draft Clinical Trial Protocol for NN9535-3819
`(produced as NN-OZEM-004434630) [UNDER SEAL]
`EX2041 November 26, 2010 email from Anne Flint to Christine Jensen et al
`(produced as NN-OZEM-004434628) [UNDER SEAL]
`EX2042 --intentionally omitted--
`EX2043 --intentionally omitted--
`EX2044 --intentionally omitted--
`EX2045 --intentionally omitted--
`EX2046 May 20, 2010 DPComm Summary Sheet (produced as NN-OZEM-
`004338873) [UNDER SEAL]
`EX2047 May 28, 2010 DPComm Clipping (produced as NN-OZEM-004338872)
`[UNDER SEAL]
`EX2048 Drug Product Semaglutide B, 1.34 mg/ml, Description and Composition of
`the Drug Product [UNDER SEAL]
`EX2049 Declaration of Devraj Chakravarty
`EX2050 Declaration of Christine B. Jensen, Ph.D. [UNDER SEAL AND
`REDACTED COPIES]
`EX2051 Declaration of Anne Flint [UNDER SEAL AND REDACTED COPIES]
`EX2052 Declaration of Chloe Jiang
`EX2053 Declaration of Smita Agarwal
`EX2054 Declaration of Robin S. Goland, M.D.
`EX2055 Declaration of Michael J. Blaha, M.D.
`EX2056 Declaration of Patrick J. Sinko, Ph.D. [UNDER SEAL AND REDACTED
`COPIES]
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`administration of the active compound to alleviate the symptoms or
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`complications….” EX1001, 5:16-27.6
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`VI. WO421 Is Not Prior Art to At Least ’462 Claims 1-3
`A. Legal Standards
`“[A] document is prior art only when published before the invention date.”
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`Mahurkar v. C.R. Bard, Inc., 79 F.3d 1572, 1576 (Fed. Cir. 1996).
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`6 At Institution, the Board found ’462’s claims do “not require any particular
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`degree of efficacy.” Inst.23. Petitioner and its experts, however, rely on numerous
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`efficacy assertions to argue criticality and obviousness. E.g., Pet.32, 34, 39-41, 46-
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`47; EX1003, ¶¶324-325, 329-330, 367-369; EX1005, ¶¶68-71, 225, 227, 232-234.
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`PO and its experts respond to those assertions. E.g., EX2010, ¶299 n.4.
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`would have been changed based on results received (and that would still need to be
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`analyzed) in the same month NCT773 began. EX2010, ¶414. Petitioner also
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`ignores that 1.0 mg was not disclosed in NCT657 or NCT773. EX2010, ¶415.
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`Instead, Petitioner “explains” that 1.0 mg was “directly between” the NCT773 0.8
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`and 1.2 mg doses. Pet.57. That is not how POSITA select doses (EX2010,
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`¶416)—it is hindsight.
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`Next, Petitioner repeats its Ground 4 “obvious to try” and dose optimization
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`arguments, again citing Copaxone (Pet.57), which is inapposite. §VIII.DVIII.D;
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`EX2010, ¶417.
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`Additionally, as to claim 3, Petitioner fails to identify any “solution”
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`teaching. §VIII.C; EX2010, ¶418. And as to claims 4-10, Petitioner relies on its
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`defective Ground 3 arguments without explaining whether and how POSITA
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`would have modified NCT657 and/or NCT773 using the ’424 publication, and
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`without providing motivation to combine or REOS explanations. Pet.58; EX2010,
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`¶419. For the reasons discussed regarding Ground 3, Petitioner fails to show
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`claims 2-10 are obvious. §VIII.C; EX2010, ¶420.
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`F.
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`Petitioner Fails to Address Objective Evidence of Non-
`Obviousness of Which Petitioner Is Aware
`Petitioner’s hand-waving at objective indicia—of which it and the rest of the
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`world is aware of—speaks volumes. Pet.58-59; EX2018, 129:8-131:14
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`(confirming Ozempic® practices claims 1-3); EX2056, §VI (Ozempic® practices
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`claims 1-10). ’462 covers Ozempic®, a remarkably-successful, world-renowned,
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`treatment. To the extent the Board finds Petitioner has made out a prima facie case
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`of obviousness, objective evidence of non-obviousness overcomes any such
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`showing. Leo, 726 F.3d at 1357-58 (“Objective indicia ‘can be the most probative
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`evidence of nonobviousness in the record, and enables the court to avert the trap of
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`hindsight.’”).
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`1.
`Nexus
`Nexus is presumed where, as here, “the patentee shows that the asserted
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`objective evidence is tied to a specific product and that product embodies the
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`claimed features, and is coextensive with them.” Fox Factory, Inc. v. SRAM, LLC,
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`944 F.3d 1366, 1373 (Fed. Cir. 2019); id. at 1374 (“perfect correspondence” not
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`required). Here, 1.0 mg Ozempic® is “essentially the claimed invention.” Id.; see
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`also EX2056, §VI (1.0 mg Ozempic® embodies claims 1-10 of ’462); EX2054,
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`¶¶39-46; EX2018, 129:8-131:14. And any unclaimed features are not, e.g.,
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`described as “critical.” Fox Factory, 944 F.3d at 1374-75. Thus, the presumption
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`applies.
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`Even if the Board were to disagree about the presumption, PO has “prove[n]
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`nexus by showing that the evidence of secondary considerations is the ‘direct result
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`of the unique characteristics of the claimed invention.’” Fox Factory, 944 F.3d at
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`1373-74. As demonstrated by the evidence cited for each of the factors below (see
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`also, e.g., EX2054, ¶¶ 46-59, 93), PO’s objective evidence here is tied to
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`Ozempic®’s unique characteristics claimed in the ’462: (1) administering
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`semaglutide (2) once-weekly at (3) 1.0 mg (4) to treat patients with T2D. Thus,
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`presumption or not, there is nexus.
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`2.
`Commercial Success
`Demonstrating an invention’s commercial value (“commercial success”),
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`weighs in favor of non-obviousness. WBIP, LLC v. Kohler Co., 829 F.3d 1317,
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`1337 (Fed. Cir. 2016). Ozempic® has enjoyed immense commercial success since
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`its 2018 launch, increasing each year and generating more than $19 billion in net
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`sales in the U.S. See EX2300, ¶74. Ozempic® attained “blockbuster” status—
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`more than $1 billion in annual sales—the first full year after launch. See id..
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`Specifically, prescriptions and dollar sales for the 1.0 mg dose of Ozempic® have
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`generated an estimated
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` prescriptions from launch to November 2023,
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`comprising have generated an estimated
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` of Ozempic®’s total sales and
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` of
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`Ozempic®’s total prescriptions for the same time period. Id. ¶¶85-87.Petitioner’s
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`experts confirm Ozempic®’s commercial success. EX2019, 131:21; EX2018,
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`123:12-124:3.
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`Ozempic®’s success is despite the T2D space being extremely crowded
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`when Ozempic® launched and being increasingly crowded as new drugs have been
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`introduced. See EX2300, ¶¶36-70 (describing drugs available in the T2D space).
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`As of Ozempic®’s launch, over 20 non-insulin drugs were approved to treat T2D,
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`and 6 more have been approved since. See id. Nevertheless, Ozempic®’s share of
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`total U.S. dollar sales among competitor treatments continues to rise. Id. ¶¶75-76.
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`This success has been driven in substantial part by ’462. Ozempic® ‘s
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`promotional materials emphasize ’462’s benefits: efficacy, safety/tolerability, and
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`convenience and compliance. See EX2300, ¶¶94-105; see also, e.g., EX2302,
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`EX2303, EX2306. The promotional efforts and expenditures for Ozempic® are
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` other T2D drugs that most directly compete with Ozempic® (i.e.,
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`GLP-1 agonists, DPP-4 inhibitors, and SGLT2 inhibitors) at similar points in their
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`lifecycles. EX2300, ¶¶106-10. Nor is Ozempic®’s commercial success due to the
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`success of other Novo Nordisk T2D products such that patients who formerly used
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`other Novo Nordisk products (e.g., Victoza®) newly began using Ozempic®. Id.
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`¶¶110-12; EX2323, 7-9; EX2315, 7-9. Finally, Ozempic®’s commercial success is
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`not due to pricing strategies. EX2300, ¶¶113-16. Novo Nordisk priced Ozempic®
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` competitor products
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` EX2334, 74-78, and offered
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`rebating that was
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`products, EX2300, ¶115
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`—other competitor
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`There is also no evidence that other patents served as “blocking” patents to
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`reduce marketplace incentives to develop the claimed inventions. See EX2300,
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`¶¶117-120. A so-called “blocking patent” is an earlier patent infringed by the
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`practicing of a later patent that “may deter non-owners and non-licensees from
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`investing the resources needed to make, develop, and market such a later,
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`‘blocked’ invention.” Acorda Therapeutics, Inc. v. Roxane Lab’ys, Inc., 903 F.3d
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`1310, 1337 (Fed. Cir. 2018). “[T]he mere existence …of blocking patents does
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`not, without more, ‘necessarily detract from evidence of commercial success….’”
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`Id. at 1338. Here, Petitioner may assert two patents covering the compound
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`semaglutide—’343 and ’122—are blocking patents. The ’343 issued only a few
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`short months before ’462’s latest priority date creating only a “small window of
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`time” that could potentially disincentivize innovation relative to the large time that
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`existed prior. EX2300, ¶120; EX2487, 1. The ’122, in turn, issued after ’462’s
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`latest priority date (July 1, 2012), so cannot have disincentivized innovation
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`leading to ’462. EX2300, ¶120; EX2488, 1. Accordingly, the’343’s and ’122’s
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`existence do not substantially diminish the significant commercial success
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`associated with ’462, embodied by Ozempic®.
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`3.
`Unexpected Results
`The significant reductions in HbA1c and weight loss in T2D patients using
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`Ozempic® is unexpected in comparison to previously-available medications for
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`treating T2D, including the closest prior art—other GLP-1 analogues (or, as
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`Petitioner seems to suggest, semaglutide but with no data). EX2054, ¶¶57-76.
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`Allgenesis Biotherapeutics, Inc. v. Cloudbreak Therapeutics LLC, IPR2020-01438,
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`Pap.29, 73-77 (Feb. 15, 2022) (comparative efficacy and safety data between
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`claimed and prior art methods demonstrated unexpected results). Once-weekly 1.0
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`mg Ozempic® provides superior HbA1c and weight loss as compared to once-daily
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`liraglutide at 1.2 or 1.8 mg.45 EX1001, Figs. 1, 5; EX2054, ¶¶61-63, 65, 76;
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`Amgen Inc. v. Sandoz Inc., 66 F.4th 952, 964 (Fed. Cir. 2023) Ozempic® was also
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`superior for glucose control and weight loss versus higher doses of other once-
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`weekly GLP-1 analogues—dulaglutide (0.75 and 1.5 mg) and exenatide ER (2.0
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`mg). EX2054, ¶¶65-73. POSITA would not have expected these superior
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`outcomes using ’462’s claimed method. Id. ¶¶74-78. Indeed, before ’462’s
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`invention POSITA would have expected these weight loss results to be possible
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`only with bariatric surgery. Id. ¶77. And Ozempic® was far superior in HbA1c
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`reduction versus other T2D treatments, including insulin, and weight loss—and
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`most other therapies caused weight gain. Id. ¶¶50-59, 64-65, 40-49.
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`In addition to the HbA1c reduction and weight loss results, treatment of
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`diabetes with 1.0 mg once-weekly semaglutide has also demonstrated both
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`unexpected kidney protective benefits and unexpected cardiovascular benefits—
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`45 These results were also surprising and unexpected for semaglutide, for which no
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`prior results were available. EX2011; EX2054, §§VIII.A, VIII.F.3.
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`neither of which were known prior to ’462. See EX2011, ¶¶44-46, 57; EX2055,
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`¶¶33, 39, 44; EX2056, §VII. These results would not have been expected as there
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`was no data regarding kidney protection or cardiovascular outcomes for
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`semaglutide at this dose and administration until well after any priority date for
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`’462.
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`Clinical trial data comparing 0.5 mg once-weekly semaglutide, 1.0 mg once-
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`weekly semaglutide, and 1.8 mg daily liraglutide in T2D patients revealed “the
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`largest magnitude of [kidney] protective effects [was] observed for semaglutide
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`1.0mg.” EX2015, 8; EX2011, ¶¶47-51; EX2056, §VII. Further trials evaluating
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`1.0 mg once-weekly semaglutide showed surprising results with impressive
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`reductions in several markers of chronic kidney disease. EX2011, ¶¶52-56. And
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`although some kidney disease markers likely improved via reduction in HbA1c,
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`body weight, and blood pressure, there is additional benefit from the claimed
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`method that “does not appear to be explained or accounted for by changes in these
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`parameters alone.” EX2013, 9; EX2011, ¶¶55-56. Most recently, Novo stopped a
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`Phase IIIb trial directed to effects of semaglutide on kidney outcomes due to the
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`superior efficacy of 1.0mg once-weekly semaglutide versus placebo. EX2011,
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`¶¶58-62; EX2056, §VII. The trial was stopped because patients receiving 1.0mg
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`once-weekly semaglutide had such unexpected improvements that it would have
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`been unethical to continue administering placebo to patients in the placebo arm.
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`Id. ¶¶62-63. Such stoppage is “very rare.” Id.
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`1.0 mg once-weekly semaglutide also remarkably demonstrated superiority
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`as compared to placebo on cardiovascular endpoints in a clinical trial designed
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`simply to show cardiovascular safety for 1.0mg once-weekly subcutaneous
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`semaglutide. EX2055, ¶¶34-36; EX2056, §VII. Once-weekly semaglutide showed
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`a 26% reduction in major adverse cardiovascular events (MACE), including a
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`statistically significant 39% decrease in nonfatal stroke. Id. (citing EX2101, 8-10).
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`For 1.0mg once-weekly semaglutide specifically, the MACE reduction was 29%
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`(p=0.06). Id. ¶37 (citing EX2102, 44). This MACE reduction was particularly
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`notable compared to the already-impressive 13% reduction in MACE seen with
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`1.8mg daily liraglutide, the allegedly closest prior art.46 Id. ¶38. Further, the
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`reduction in nonfatal stroke appears more robust (and clinically relevant) for
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`semaglutide. Id. ¶38 (citing EX2110, 2); see also id. ¶41. These results were also
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`surprising and unexpected in view of previously-completed research with DPP-4
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`inhibitors which had shown no benefit to reduction in MACE. Id. ¶43 (citing
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`EX2105, 2, 11).
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`46 See n.36.
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`The clinical trial data also trended towards greater benefit for 1.0mg once-
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`weekly semaglutide in the components of MACE. Most notably, the data show a
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`38% reduction in myocardial infarction with the claimed dose (p=0.09) versus a
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`12% reduction with 0.5 mg once-weekly semaglutide (p=0.62). Id. ¶37 (Blaha)
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`(citing EX2102, 45-47). The claimed dose also showed more benefit on other
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`intermediate cardiovascular outcomes that are highly important in everyday
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`clinical practice. Id. (citing EX2102, 101-04). The cardiovascular outcomes
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`benefits seen with the claimed dose are unlikely to be explained solely by
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`reduction in HbA1c, blood pressure, or weight, and were seen across essentially all
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`subgroups of patients—regardless of baseline BMI, gender, age, or cardiovascular
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`risk. Id. ¶¶40, 42; EX2110, 3-6; EX2111, 3; EX2100, 3, 9-10.
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`Thus, across HbA1c and weight loss, chronic kidney disease, and
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`cardiovascular outcomes, 1.0mg once-weekly semaglutide has demonstrated
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`surprising and unexpected results, underscoring nonobviousness.
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`4.
`Long-Felt Need
`Prior to ’462 and Ozempic® there was a long-felt need for a safe, effective,
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`and tolerable once-weekly T2D treatment that significantly reduced HbA1c and
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`caused significant weight loss, an important treatment component. EX2054, ¶¶79-
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`83, 40-58; see also EX1003, ¶323 (“semaglutide was an option that would be
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`provided as a once weekly injection, a significant improvement in the eyes of
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`patients”); EX1005, ¶¶ 80-81 (discussing “[f]urther research”; “once weekly
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`dosing for GLP-1 receptor agonists in development… could ‘improve compliance,
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`and… offer an improved throughout-the-day glycemic control compared with the
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`currently available GLP-1R agonists (exenatide and liraglutide)’” and “‘[n]ausea
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`may best be avoided by a long half-life…’”), 262 (“GLP-1-receptor agonists, such
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`as… liraglutide, produced gastrointestinal problems at higher doses.”). Many
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`available therapies were effective at lowering blood sugar but caused weight gain.
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`EX2054, ¶80. And the then-available GLP-1 analogues did not cause weight loss
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`that meaningful impacted T2D, and had, e.g., lack-of-adherence or insufficient
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`blood sugar management issues. Id. ¶¶81-82. Ozempic® satisfied this long-felt
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`need. Cyclobenzaprine, 676 F.3d at 1082-83; EX1003, ¶323 (“once weekly
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`injection [was] a significant improvement in the eyes of patients”); EX2018, 20:2-
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`21:14 (Bantle); EX2010, ¶¶178-191.
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`5.
`Industry Praise
`Ozempic® is now a household name. EX2080. It has been widely praised
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`by patients, clinicians, prominent medical journals, and the media—all of which
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`evidence nonobviousness. Lassen Therapeutics 1, Inc. v. Singapore Health Servs.
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`Pte Ltd., PGR2019-00053, Pap.10, 33-36 (Feb. 6, 2020). Ozempic®’s trial results
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`have been praised in numerous medical journals, including the Lancet Diabetes
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`Endocrinology. See EX2082; EX2083; EX2084; EX2085; EX2101; EX2054,
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`¶¶84-85, 62-74. And the New Yorker and NY Times published prominent articles
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`describing the impact Ozempic® has had on medicine. EX2080, 1; EX2081, 2;
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`EX2054, ¶¶86-87.
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`Bantle confirmed that he is aware of patients praising Ozempic®, yet did not
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`take this into account in forming his opinions. EX2018, 125:4-19.
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`Further, the impressive and unexpected cardiovascular outcomes discussed
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`above in §VIII.F.3 have brought a “paradigm shift” in treating and managing T2D.
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`EX2055, ¶¶45-46; EX2056, §VII. Clinical practice guidelines now recommend
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`using a small set of GLP-1 receptor agonists with demonstrated cardioprotective
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`benefits—namely semaglutide, liraglutide, and dulaglutide—in the treatment of
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`diabetes. Id. ¶¶47-51 (citing EX2090, 10, 26; EX2091, 11; EX2092, 11, 14, 16;
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`EX2087, 14 (guidelines)). The American College of Cardiology recognizes there
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`is a “potential for clinically relevant heterogeneity within the class” based on
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`different patient risks and concerns and specifically recommends that if a patient is
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`being treated with once-weekly semaglutide, that the 1.0mg dose be used for
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`cardiovascular benefit. Id. ¶48 (citing EX2092, 11, 14). And modeling suggests
`
`that semaglutide may provide a greater reduction in MACE among T2D patients
`
`than dulaglutide. Id. ¶52 (citing EX2095, 1, 5-6). This paradigm shift in treatment
`
`has been the driving force in the creation of cardiometabolic clinics staffed with
`PROTECTIVE ORDER MATERIAL
`
`89
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`Novo Nordisk Exhibit 2014
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00014
`
`
`
`
`cardiologists who have the expertise to treat both T2D and atherosclerotic
`
`IPR2023-00724
` U.S. Patent No. 10,335,462
`
`cardiovascular disease. Id. ¶53 (citing EX2088, EX2089, EX2093).
`
`6.
`Skepticism
`Industry skepticism weighs in favor of nonobviousness. Neptune Generics,
`
`LLC v. Eli Lilly & Co., 921 F.3d 1372, 1377-78 (Fed. Cir. 2019). In 2012 there
`
`were (and still are) few once-weekly GLP-1 analogues available to treat T2D and
`
`POSITA would have been skeptical others would be approved. EX2054, ¶88.
`
`Even after Ozempic® was approved, POSITA would have remained skeptical that
`
`the reported clinical trial results would be obtainable in practice. Id. ¶¶89-90.
`
`Ozempic® overcame this skepticism and far exceeded its clinical trial results. Id.
`
`¶¶89-92; see also §VIII.F.3. The industry’s skepticism was misplaced.
`
`IX. Conclusion
`Petitioner has failed to show that ’462 is anticipated or obvious. The
`
`patentability of ’462 should be confirmed.
`
`Dated: January 17, 2024
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`
`
`Respectfully submitted by:
`
`/J. Steven Baughman/
`J. Steven Baughman (Reg. No. 47,414)
`
`
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`PROTECTIVE ORDER MATERIAL
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`90
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`Novo Nordisk Exhibit 2014
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00015
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