IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`)
`) MDL No. 22-MD-3038 (CFC)
`) ANDA CASE
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`) C.A. No. 22-cv-294 (CFC)
`) CONSOLIDATED
`ANDA CASE
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`) C.A. No. 22-1040 (CFC)
`) ANDA CASE
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`IN RE: OZEMPIC (SEMAGLUTIDE)
`PATENT LITIGATION
`
`_____________________________________
`NOVO NORDISK INC. and
`NOVO NORDISK A/S,
`
`Plaintiffs,
`
`v.
`
`RIO BIOPHARMACEUTICALS INC., et al.,
`
`Defendants.
`
`_____________________________________
`NOVO NORDISK INC. and
`NOVO NORDISK A/S,
`
`Plaintiffs,
`
`v.
`
`MYLAN PHARMACEUTICALS INC.,
`
`Defendant.
`
`NOVO NORDISK’S INITIAL RESPONSES TO DEFENDANTS’ INITIAL
`INVALIDITY CONTENTIONS REGARDING U.S. PATENT NOS. 8,129,343; 8,536,122;
`8,114,833; 8,920,383; 9,775,953; 9,457,154; and 10,335,462
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`
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`CONFIDENTIAL INFORMATION - SUBJECT TO PROTECTIVE ORDERCONFIDENTIAL INFORMATION SUBJECT TO PROTECTIVE ORDER
`
`1
`
`Novo Nordisk Exhibit 2015
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00001
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`B.
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`THE REFERENCES CITED BY DEFENDANTS .............................................160
`
`1.
`
`2.
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`3.
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`4.
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`5.
`
`6.
`
`7.
`
`U.S. Patent No. 6,221,046 (Burroughs ’046) ...........................................160
`
`U.S. Patent Publication No. 2004/0097883 (’883 Publication) ...............162
`
`U.S. Patent No. 5,938,642 (Burroughs ’642) ...........................................164
`
`U.S. Patent No. 5,391,157 (Harris ’157)..................................................166
`
`U.S. Patent No. 5,584,815 (Pawelka) ......................................................168
`
`U.S. Patent No. 6,235,004 (Steenfeldt-Jensen) ........................................169
`
`Other Alleged Prior Art References Identified by Defendants ................171
`
`C.
`
`THE REFERENCES CITED BY DEFENDANTS, ALONE OR IN
`COMBINATION, DO NOT RENDER THE CLAIMS OF THE ’154 PATENT
`INVALID .............................................................................................................172
`
`1.
`
`2.
`
`The Level of Ordinary Skill in the Art.....................................................172
`
`The Claims of the ’154 Patent Are Not Anticipated by Any Prior Art
`Reference .................................................................................................173
`
`a.
`
`b.
`
`c.
`
`Burroughs ’046 Does Not Anticipate the Claims of the ’154
`Patent............................................................................................173
`
`The ’883 Publication Does Not Anticipate the Claims of the
`’154 Patent ...................................................................................175
`
`Burroughs ’642 Does Not Anticipate the Claims of the ’154
`Patent............................................................................................176
`
`3.
`
`The References Cited by Defendants, Alone or in Combination, Do Not
`Render the Claims of the ’154 Patent Invalid for Obviousness ...............178
`
`4.
`
`Objective Indicia Support a Finding of Non-Obviousness ......................179
`
`D.
`
`THE ASSERTED CLAIMS OF THE ’154 PATENT ARE NOT INVALID
`FOR INDEFINITENESS .....................................................................................179
`
`VIII. THE ’462 PATENT .........................................................................................................180
`
`A.
`
`B.
`
`THE SPECIFICATION, CLAIMS, AND PROSECUTION ...............................181
`
`INVENTION OF THE ’462 PATENT ................................................................182
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`
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`CONFIDENTIAL INFORMATION - SUBJECT TO PROTECTIVE ORDER
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`vii
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`Novo Nordisk Exhibit 2015
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00002
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`C.
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`THE REFERENCES CITED BY DEFENDANTS
`
`
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`The references Defendants cite in their Contentions, either alone or in combination, do not
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`render any of claims 1-10 of the ’462 patent invalid. While each of Defendants’ cited references
`
`is discussed below, some are not prior art and others are not relevant to the claimed inventions of
`
`the ’462 patent.
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`1. WO 2011/138421 (“WO ’421”)
`
`International PCT Publication WO 2011/138421 (“WO ’421”), entitled “Combination
`
`Therapy” was published on November 10, 2011. Defendants identify WO ’421 as prior art, and
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`also include it in combinations of prior art asserted against claims of the ’462 patent. Defendants
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`allege that WO ’421 is prior art to the ’462 patent “under § 102(b).” Defendants’ Invalidity
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`Contentions at 98. However, WO ’421 was not published more than one year before the ’462
`
`patent’s foreign and U.S. provisional priority filings and was not published before the ’462 patent’s
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`invention date; therefore, it is not prior art under 35 U.S.C. § 102(b). In any event, WO ’421 does
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`
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`CONFIDENTIAL INFORMATION - SUBJECT TO PROTECTIVE ORDER
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`183
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`Novo Nordisk Exhibit 2015
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00003
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`

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`4.
`
`Objective Indicia Support a Finding of Non-Obviousness
`
`Objective indicia support a conclusion that the claims of the ’462 patent are non-obvious.
`
`First, as explained above, the determination that a 1.0 mg once weekly dose would be effective in
`
`treating type 2 diabetes was unexpected. A person of ordinary skill in the art would expect that a
`
`minimum therapeutically effective dose for semaglutide would be higher, including because the
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`FDA-approved once daily dosage of liraglutide was 1.2-1.8 mg. Therefore, a person of ordinary
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`skill would likely expect a weekly therapeutic dose for semaglutide to be greater than the daily
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`dose of liraglutide. The data disclosed in the ’462 patent demonstrate the surprising result that a
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`therapeutically effective once weekly dosage of semaglutide is actually lower than the approved
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`daily liraglutide dose and achieved adequate reduction in HbA1c with substantial weight loss.
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`Indeed, dosages of 0.8 mg once weekly and greater showed even better treatment of type 2 diabetes
`
`and weight loss than 1.2 and 1.6 mg once daily doses of liraglutide. Nothing in the prior art
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`remotely suggested this would be so. Thus, it was unexpected that 1.0 mg of semaglutide once
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`weekly would effectively treat type 2 diabetes.
`
`The administration of 1.0 mg once weekly of semaglutide has been commercially
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`successful, even beyond Novo Nordisk’s expectations, and at least six different generic companies
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`are seeking to market generic versions of Ozempic®, which includes prescribing information
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`encouraging doctors and patients to administer semaglutide in an amount of 1.0 mg once weekly.
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`Copying is further objective indicia of nonobviousness.
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`The magnitude of weight loss seen with semaglutide in the claimed methods was
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`particularly unexpected, in view of weight loss effects shown by other GLP-1 drugs, such as
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`liraglutide. This finding led to semaglutide being approved by the FDA as an anti-obesity
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`treatment, Wegovy®, in addition to its use as a diabetes treatment (i.e., Ozempic®). Semaglutide’s
`
`216
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`CONFIDENTIAL INFORMATION - SUBJECT TO PROTECTIVE ORDERCONFIDENTIAL INFORMATION SUBJECT TO PROTECTIVE ORDER
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`Novo Nordisk Exhibit 2015
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00004
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`exceptional weight loss effects have received considerable praise and have helped satisfy a long-
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`felt need for an improved anti-obesity therapeutic. The magnitude of these clinical anti-obesity
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`benefits was first discovered by the inventor of the ’462 patent.
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`Defendants have not identified what they contend is the closest prior art to the asserted
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`claims of the ’462 patent. Plaintiffs reserve their right to address unexpected results over such
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`prior art upon identification by Defendants.
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`E.
`
`THE ASSERTED CLAIMS ARE ENABLED AND SUPPORTED BY
`SUFFICIENT WRITTEN DESCRIPTION
`
`1.
`
`The Claims Are Not Invalid for Lack of Enablement
`
`Defendants argue that the ’462 patent’s claims are invalid for lack of enablement because
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`the specification “provides no support” for the claimed dosage of 1.0 mg semaglutide once weekly.
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`Defendants’ Invalidity Contentions at 220. Defendants’ argument sounds in the written
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`description requirement, not enablement. A specification need not “provide[ ] support” for the
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`claimed dosage in the specification to meet the enablement requirement. Rather, the enablement
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`requirement is satisfied if a skilled artisan is enabled to make and use the invention without undue
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`experimentation. Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1334 (Fed. Cir.
`
`2003).
`
`Defendants have not explained why a person of ordinary skill—with the benefit of the ’462
`
`patent’s disclosure—would be unable to carry out a method of treating type 2 diabetes by
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`administering (parenterally or subcutaneously) 1.0 mg semaglutide once weekly without undue
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`experimentation. Accordingly, Defendants have not offered clear and convincing evidence of
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`nonenablement of claims 1-3.
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`
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`217
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`CONFIDENTIAL INFORMATION - SUBJECT TO PROTECTIVE ORDERCONFIDENTIAL INFORMATION SUBJECT TO PROTECTIVE ORDER
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`Novo Nordisk Exhibit 2015
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00005
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`

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`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`
`By: /s/ Erica R. Sutter
`
`Jack B. Blumenfeld (#1014)
`Brian P. Egan (#6227)
`Travis J. Murray (#6882)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@morrisnichols.com
`began@morrisnichols.com
`tmurray@morrisnichols.com
`
`Attorneys for Novo Nordisk Inc.
`and Novo Nordisk A/S
`
`
`
`
`
`
`OF COUNSEL:
`
`Jeffrey J. Oelke
`Ryan P. Johnson
`Robert E. Counihan
`Laura T. Moran
`Erica R. Sutter
`Olivia L. Wheeling
`FENWICK & WEST LLP
`902 Broadway, Suite 14
`New York, NY 10010-6035
`(212) 430-2600
`
`December 21, 2022
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`CONFIDENTIAL INFORMATION - SUBJECT TO PROTECTIVE ORDER
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`221
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`Novo Nordisk Exhibit 2015
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00006
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