During the week of December 10, 2018, the Board issued several Final Written Decisions and institution decisions in Technology Center 1600.  The decisions are summarized below:

Final Written Decisions

Mylan Pharmaceuticals Inc. v. Sanofi-Aventis Deutschland GmbH, IPR2017-01526 (Final Written Decision, December 12, 2018) and Mylan Pharmaceuticals Inc. v. Sanofi-Aventis Deutschland GmbH, IPR2017-01528 (Final Written Decision, December 12, 2018). Petitioner Mylan challenged the patentability of claims 1-25 of U.S. Patent No. 7,476,652 (the “’652 patent”) and claims 1-20 of U.S. Patent No. 7,713,930 (the “’930 patent”) as being obvious over various combinations of prior art references including the Lantus Label, Lougheed, Farmaceutiska Specialiteter I Sverige (“FASS”), Owens, and Grau.  IPR2017-01526 at 2-3, IPR2017-01528 at 2-3.  The ’930 patent issued from a continuation application to the application that issued as the ’652 patent.  IPR2017-01526 at 5.  The ’652 and ’930 patent claims are directed to pharmaceutical formulations with an acidic pH comprising insulin glargine (Gly(A21)-Arg(B31)-Arg(B32)-human insulin), at least one surfactant, at least one preservative, and water.  IPR2017-01526 at 5, IPR2017-01528 at 5.

Regarding the obviousness analysis, the parties’ main dispute was what skilled artisans would have expected as to aggregation of insulin glargine.  IPR2017-01526 at 16.[1]  The Board agreed with Petitioner that skilled artisans would have had reason to modify the prior art that taught that aggregation was a concern in developing insulin formulations to add a surfactant to the formulation to address that concern.  Id. at 31.  First, the Board found that skilled artisans would have been concerned about aggregation of insulin formulations disclosed in the prior art.  Id. at 31-34.  Further, the prior art taught that the rate of insulin aggregation increased in acidic solutions due to the presence of an increased number of monomers in solution that unfold causing exposure of hydrophobic surfaces.  Id. at 34.  Second, the Board disagreed with Patent Owner’s arguments that skilled artisans would not be concerned about insulin glargine aggregation because skilled artisans would have expected that insulin glargine is more hexameric than insulin and that insulin glargine formulations include zinc, which promotes hexameric formation.  Id. at 36.  The Board found that it was known that zinc does not bind insulin at an acidic pH and that even though prior art insulin formulations were believed to be hexameric at a neutral pH, they were still thought to aggregate.  Id.

The Board also agreed with Petitioner that skilled artisans would have had a reasonable expectation of success in adding surfactants to insulin glargine to prevent aggregation because the prior art was replete with examples of using nonionic surfactants to successfully stabilize insulins to prevent aggregation.  Id. at 37-40.  Thus, the Board found that “Mylan showed by preponderance of the evidence, a reason that one of ordinary skill in the art would have modified the insulin glargine formulations that Lantus Label and Owens teach by adding nonionic surfactants to achieve the claimed pharmaceutical formulations with a reasonable expectation of success.”  Id. at 40.

Patent Owner argued that objective evidence of the commercial success of its Lantus product supported nonobviousness of the challenged claims.  Id. at 42.  Although there was no dispute that the Lantus product was a commercial success, the Board credited Petitioner’s expert and found that Patent Owner’s blocking patents listed in the Orange Book as covering the Lantus product “may have precluded others from entering the market with their own insulin glargine formulation products.”  Id. at 43.  Thus, the Board found “because Patent Owner could have precluded others from market entry prior to the patents covering insulin glargine expiring, Patent Owner’s evidence of commercial success is insufficient to support the nonobviousness of the challenged claims.”  Id. at 43.

Accordingly, the Board determined that Petitioner showed by a preponderance of the evidence that the ’625 and ’930 patent claims at issue would have been obvious and are unpatentable.  Id. at 44, 47.

[1] Citations are to IPR2017-01526 because the Final Written Decisions for IPR2017-01526 and IPR2017-01528 are substantially the same.

Institution Decisions

Aquestive Therapeutics, Inc. v. ICOS Corp., IPR2018-01183 (Decision Denying Institution of Inter Partes Review, December 7, 2018). Petitioner Aquestive Therapeutics filed a petition requesting inter partes review of claims 1-12 of U.S. Patent No. 6,943,166 (“the ’166 patent”) as being obvious over various combinations of prior art references including Daugan, SNDA, the FDA Guideline, Ruberg, and Cutler.  IPR2018-01183 at 3.  The Board exercised its discretion to deny the petition under 35 U.S.C. § 314(a) and cited several factors weighing heavily in favor of denying institution.  Id. at 6.  First, the Board found that Petitioner had previously and unsuccessfully challenged the same claims in IPR2017-00412 under its former name, MonoSol.  Id. at 4.  At the time it filed the prior petition, MonoSol knew of at least four out of the five references asserted in IPR2018-01183, and should have known of the fifth, as it was published in 1995.  Id. at 5.  Second, because Petitioner had the benefit of the previous decision denying institution and the decision denying Petitioner’s rehearing request in IPR2017-00412, the Board agreed with Patent Owner that Petitioner “used those decisions as a roadmap to reformulate its argument.”  Id.  Petitioner also waited 18 months after filing its petition in IPR2017-00412 “without reasonable justification.”  Id.

ABS Global, Inc. v. XY, LLC, IPR2018-01224 (Decision Granting Institution of Inter Partes Review, December 10, 2018). Petitioner ABS Global, Inc. challenged claim 11 of U.S. Patent No. 9,365,822 (“the ’822 patent”) as obvious over the combination of Johnson, Salisbury, and Garcia.  IPR2018-01224 at 5.  The ’822 patent focuses on methods of sorting cells, such as sperm, via flow cytometry in which the cells are surrounded by sheath and collection fluids that include a citric acid to assist the cells with various stresses involved during sorting.  Id. at 2-4.  Claim 11 of the ’822 patent claims a method of producing at least one sexed embryo by producing and collecting sperm cells surrounded by sheath and collection fluids including a citric acid and fertilizing at least one egg with the collected sperm cells.  Id. at 5.

Petitioner asserted that Johnson discloses all the elements of the claimed invention, except that the sheath and collection fluids do not include a citric acid.  Id. at 11.  Petitioner further asserted it would have been obvious to use buffer solutions including a citric acid when sorting sperm because the prior art, such as Salisbury and Garcia, taught that such buffers produced better results for sperm.  Id. at 12.  The Board found that Petitioner had shown sufficiently for institution purposes that skilled artisans had a reason to use a citric acid in buffers with sperm.  Id. at 15-16.

The Board rejected Patent Owner’s argument that none of the references disclose a sheath or collector fluid that includes citric acid.  Id. at 14.  The Board explained that it is the combination of the references, not a single reference alone, that renders the claims obvious.  Id.  The Board also rejected Patent Owner’s argument that Johnson teaches away from the claimed method because Johnson knew about using buffers containing a citric acid but did not teach using buffers with citric acid.  Id. at 19.  The Board found that Patent Owner did not identify any specific teaching away in Johnson that discouraged the use of citric acid in sheath or collection fluids.  Id.  Finally, the Board rejected Patent Owner’s argument that unexpected results demonstrate that the claimed method is non-obvious because the Board found that skilled artisans would have expected that citric acid would have improved performance with respect to sperm.  Id. at 19.

As a result, the Board determined that Petitioner established a reasonable likelihood that it would prevail in showing the unpatentability of claim 11 of the ’822 patent based on Johnson, Salisbury, and Garcia and instituted inter partes review of claim 11.  Id. at 20.


Edited on 1/9/2019, to add the following case:

Reactive Surfaces Ltd. v. Toyota Motor Corp., IPR2018-01194 (Decision Denying Institution of Inter Partes Review, December 10, 2018). Petitioner Reactive Surfaces Ltd. challenged claims 1-5 of U.S. Patent No. 9,193,873 (“the ’873 patent”) on two grounds of obviousness based on (1) McDaniel and Selvig and (2) Schneider and Adams, and one ground of anticipation based on Schneider.  IPR2018-01194 at 6.  The ’873 patent is directed to protein-polymer composite materials for removing bioorganic stains from a surface, comprising one or more amylases dispersed in a two-component nonaqueous organic solvent-borne polymer resin. Id. at 3.

Patent Owner argued that the Board should deny institution under 35 U.S.C. § 325(d) because the Patent Office had already considered and denied the McDaniel and Selvig ground.  Id. at 7.  The Board decided it would be more efficient to resolve the decision based on the merits, rather than determining whether the arguments had been previously presented during prosecution.  Id. at 8.

The Board first found that Petitioner failed to show a reasonable likelihood that

it would prevail on obviousness over McDaniel and Selvig.  Id. at 20.  Although Petitioner provided a reason why skilled artisans would have combined McDaniel and Selvig to arrive at the claimed invention, the Board found that Petitioner merely pointed to disparate sections of McDaniel to identify different claimed components and processing steps without offering any rationale for why skilled artisans “would have picked and chosen among McDaniel’s teachings to combine them to arrive at the claimed invention.”  Id.

Regarding anticipation in view of Schneider, the Board found that Petitioner failed to show “where Schneider discloses each and every element in a challenged claim arranged as recited in that claim.”  Id. (emphasis in original).  The Board found that Petitioner’s picking and choosing from multiple, distinct teachings of Schneider “does not establish that one of skill in the art could take Schneider’s teachings in combination with his own knowledge of the particular art and be in possession of the invention.”  Id.

The Board similarly found that Petitioner failed to show a reasonable likelihood that the challenged claims were obvious over Schneider and Adams.  Id. at 23-24.  The Board found Petitioner relied on the same disparate teachings of Schneider and failed to provide any reason why a skilled artisan would have combined the teachings of Schneider and Adams to arrive at the claimed invention.  Id. at 24.