IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`)
`) MDL No. 22-MD-3038 (CFC)
`) ANDA CASE
`)
`)
`)
`
`))
`
`
`)
`)
`) C.A. No. 22-cv-294 (CFC)
`) CONSOLIDATED
`ANDA CASE
`
`)))
`
`
`)
`)
`)
`)
`
`))
`
`
`)
`) C.A. No. 22-1040 (CFC)
`) ANDA CASE
`)
`
`)))
`
`
`)
`
`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
`
`
`
`CONFIDENTIAL INFORMATION - SUBJECT TO PROTECTIVE ORDERCONFIDENTIAL INFORMATION SUBJECT TO PROTECTIVE ORDER
`
`1
`
`Novo Nordisk Exhibit 2007
`Mylan Pharms. Inc.v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`

`

`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
`
`FDA-approved once daily dosage of liraglutide was 1.2-1.8 mg. Therefore, a person of ordinary
`
`skill would likely expect a weekly therapeutic dose for semaglutide to be greater than the daily
`
`dose of liraglutide. The data disclosed in the ’462 patent demonstrate the surprising result that a
`
`therapeutically effective once weekly dosage of semaglutide is actually lower than the approved
`
`daily liraglutide dose and achieved adequate reduction in HbA1c with substantial weight loss.
`
`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
`
`remotely suggested this would be so. Thus, it was unexpected that 1.0 mg of semaglutide once
`
`weekly would effectively treat type 2 diabetes.
`
`The administration of 1.0 mg once weekly of semaglutide has been commercially
`
`successful, even beyond Novo Nordisk’s expectations, and at least six different generic companies
`
`are seeking to market generic versions of Ozempic®, which includes prescribing information
`
`encouraging doctors and patients to administer semaglutide in an amount of 1.0 mg once weekly.
`
`Copying is further objective indicia of nonobviousness.
`
`The magnitude of weight loss seen with semaglutide in the claimed methods was
`
`particularly unexpected, in view of weight loss effects shown by other GLP-1 drugs, such as
`
`liraglutide. This finding led to semaglutide being approved by the FDA as an anti-obesity
`
`treatment, Wegovy®, in addition to its use as a diabetes treatment (i.e., Ozempic®). Semaglutide’s
`
`216
`
`
`CONFIDENTIAL INFORMATION - SUBJECT TO PROTECTIVE ORDERCONFIDENTIAL INFORMATION SUBJECT TO PROTECTIVE ORDER
`
`
`
`Novo Nordisk Exhibit 2007
`Mylan Pharms. Inc.v. Novo Nordisk A/S
`IPR2023-00724
`Page 00002
`
`

`

`exceptional weight loss effects have received considerable praise and have helped satisfy a long-
`
`felt need for an improved anti-obesity therapeutic. The magnitude of these clinical anti-obesity
`
`benefits was first discovered by the inventor of the ’462 patent.
`
`Defendants have not identified what they contend is the closest prior art to the asserted
`
`claims of the ’462 patent. Plaintiffs reserve their right to address unexpected results over such
`
`prior art upon identification by Defendants.
`
`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
`
`the specification “provides no support” for the claimed dosage of 1.0 mg semaglutide once weekly.
`
`Defendants’ Invalidity Contentions at 220. Defendants’ argument sounds in the written
`
`description requirement, not enablement. A specification need not “provide[ ] support” for the
`
`claimed dosage in the specification to meet the enablement requirement. Rather, the enablement
`
`requirement is satisfied if a skilled artisan is enabled to make and use the invention without undue
`
`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
`
`administering (parenterally or subcutaneously) 1.0 mg semaglutide once weekly without undue
`
`experimentation. Accordingly, Defendants have not offered clear and convincing evidence of
`
`nonenablement of claims 1-3.
`
`
`
`217
`
`
`CONFIDENTIAL INFORMATION - SUBJECT TO PROTECTIVE ORDERCONFIDENTIAL INFORMATION SUBJECT TO PROTECTIVE ORDER
`
`
`
`Novo Nordisk Exhibit 2007
`Mylan Pharms. Inc.v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
`
`