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Novartis Gene Therapies, Inc. v. Genzyme Corporation

Docket IPR2023-00608, Patent Trial and Appeal Board (Feb. 22, 2023)
James Tartal, Jeffrey Fredman, Sheridan Snedden, presiding
Case TypeInter Partes Review
Patent9051542
Patent Owner Genzyme Corporation
Petitioner Novartis Gene Therapies, Inc.
Assignee AVIGEN INC
...
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Novartis Gene Therapies, Inc. v. Genzyme Corporation

Docket IPR2023-00609, Patent Trial and Appeal Board (Feb. 22, 2023)
James Tartal, Jeffrey Fredman, Sheridan Snedden, presiding
Case TypeInter Partes Review
Patent9051542
Patent Owner Genzyme Corporation
Petitioner Novartis Gene Therapies, Inc.
Assignee AVIGEN INC
...
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Mylan Technologies, Inc. v. Noven Pharmaceuticals, Inc.

Docket IPR2018-01119, Patent Trial and Appeal Board (May 18, 2018)
Kristi Sawert, Susan Mitchell, Zhenyu Yang, presiding
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Mylan Technologies, Inc. v. Noven Pharmaceuticals, Inc.

Docket IPR2018-00174, Patent Trial and Appeal Board (Dec. 4, 2017)
James Moore, Kristi Sawert, Susan Mitchell, presiding
Case TypeInter Partes Review
Patent9730900
Orange Book Patent9730900
Patent Owner Noven Pharmaceuticals, Inc.
Petitioner Mylan Technologies, Inc.
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Mylan Technologies, Inc. v. Noven Pharmaceuticals, Inc.

Docket IPR2018-00173, Patent Trial and Appeal Board (Dec. 4, 2017)
James Moore, Kristi Sawert, Susan Mitchell, presiding
Case TypeInter Partes Review
Patent9724310
Orange Book Patent9724310
Patent Owner Noven Pharmaceuticals, Inc.
Petitioner Mylan Technologies, Inc.
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24 Notice refund approved: Notice refund approved

Document IPR2023-00609, No. 24 Notice refund approved - Notice refund approved (P.T.A.B. Oct. 11, 2023)
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22 Notice refund approved: Notice refund approved

Document IPR2023-00608, No. 22 Notice refund approved - Notice refund approved (P.T.A.B. Oct. 6, 2023)
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20 Institution Decision Deny: Denying Institution of Inter Partes Review 35 USC § 314

Document IPR2023-00608, No. 20 Institution Decision Deny - Denying Institution of Inter Partes Review 35 USC § 314 (P.T.A.B. Aug. 30, 2023)
Evans explains that “[a]n ongoing challenge in the field of gene therapy and vaccine research is to generate liquid virus formulations which are stable for longer periods of time within a useful temperature range.” Id. at 1:16– 19, 28–30.
Indeed, “no signs of settling or precipitation” were observed for prior art adenovirus compositions stored in a high ionic strength buffer over a 7-day period (Ex.1009, [00369]), and a POSA would have understood that AAV “is significantly more stable than the adenovirus” used in Liu (Ex.1013, 1283); Ex.1025, ¶¶197-198.
Patent Owner contends that [Petitioner] fails to establish that the POSA would have been motivated to develop a composition comprising an rAAV “concentration exceeding 1x1013 vg/ml,” “one or more multivalent ions selected from … citrate, sulfate, magnesium, and phosphate,” with an ionic strength “greater than 200mM.” [Ex. 2004] ¶¶ 75–79.
To prove inherency in the context of obviousness “[a] party must ... meet a high standard ... the limitation at issue necessarily must be present, or the natural result of the combination of elements explicitly disclosed by the prior art.” PAR Pharm., Inc. v. TWI Pharms., Inc., 773 F.3d 1186, 1195– 96 (Fed. Cir. 2014).
Petitioner fails to submit any evidence that the particle radius and product recovery elements of claims 5 and 6, respectively, would necessarily be present, or the natural result of the combination of teachings explicitly disclosed by Evans, Huang, and Mingozzi.
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