The Patent Trial and Appeal Board issued seven decisions in TC 1600 during the week of June 11-15, 2018, including four decisions denying institution of inter partes review and three final written decisions.  Summaries of the decisions follow:

Initiative for Medicines, Access & Knowledge (“I-MAK”), Inc. v. Gilead Pharmasset LLC (“Gilead”), IPR2018-00123 (Decision Denying Institution Entered June 13, 2018).

I-MAK filed six inter partes review petitions against patents owned by Gilead.  The technology of the current case, U.S. Patent No. 8,735,372 (“the ’372 patent”), is directed to a method of treating a human infected by hepatitis C virus by administering an NS5a inhibitor and a prodrug of a nucleoside derivative.  In its petition, I-MAK challenged claims 1 and 2 of the ’372 patent as obvious over the combination of Sofia (a conference poster), Congiatu (non-patent literature), and Serrano-Wu (US 2006/0276511).

The Board disagreed with I-MAK and held that I-MAK failed to meet its initial burden of establishing that Sofia qualified as a printed publication.  The Board found no evidence that Sofia was published in print or electronic form beyond it being presented as a poster.  In addition, the Board noted that I-MAK provided no information regarding (i) how long Sofia was posted, (ii) whether it was sufficiently publicized to, or placed in front of a sufficient number of, those interested in the subject matter, or (iii) the freedom of those viewing the poster to take notes or to copy the poster.  Without Sofia available as prior art, I-MAK’s obviousness arguments were undermined because Sofia was the only reference that taught the prodrug.

Accordingly, the Board declined to institute an inter partes review, finding that I-MAK had failed to show a reasonable likelihood that it would prevail with establishing the unpatentability of the challenged claims.

Initiative for Medicines, Access & Knowledge (“I-MAK”), Inc. v. Gilead Pharmasset LLC (“Gilead”), IPR2018-00103 (Decision Denying Institution Entered June 13, 2018).

In a second I-MAK v. Gilead case, I-MAK challenged certain claims of U.S. Patent No. 7,429,572 (“the ’572 patent”) on anticipation and obviousness grounds.  The ’572 patent is directed to compounds for the treatment of a host infected with a virus belonging to the Flaviviridae family, including hepatitis C virus, West Nile virus, and yellow fever virus.  Claims 1-16 were challenged as anticipated by Klecker, claims 1-19 were challenged as anticipated by Sommadossi, and claims 1-19 were challenged as obvious over Sommadossi and Klecker.  Gilead filed a preliminary response.

The Board agreed with Gilead that I-MAK selectively chose teachings of the Klecker reference to arrive at compounds encompassed by the genus of the claim.  The Board determined that I-MAK had not pointed to any teaching, other than the broad disclosure, to direct the skilled artisan to select the specific elements and in the claimed position within the sugar ring of the compounds.  As such, the Board found that I-MAK had failed to establish a reasonable likelihood that the claims were anticipated by Klecker.

As to Sommadossi, the Board further agreed with Gilead and found that I-MAK had attempted to make obviousness arguments over Sommadossi in the anticipation argument and that any inherency argument would also fail.  As such, the Board found that I-MAK had not established a reasonable likelihood that the claims were anticipated by Sommadossi.

Regarding the obviousness challenge, in the patent owner’s response Gilead contended that the petition completely ignored the Board’s decisions and Federal Circuit’s opinion in a prior interference proceeding involving the ’572 patent, which found that the prior art did not teach or suggest fluoridation of tertiary alcohols to produce the claimed compounds, and that arriving at the presently claimed compound would require extensive experimentation to achieve correct synthesis.  Accordingly, the Board declined to institute an inter partes review because I-MAK had failed to show a reasonable likelihood that it would prevail with establishing the unpatentability of the challenged claims.

Mylan Technologies, Inc. (“Mylan”) v. Noven Pharmaceuticals, Inc. (“Noven”), IPR2018-00174 and Mylan v. Noven, IPR2018-00173 (Decisions Denying Institution Entered June 12, 2018).

In these two cases, the Board denied institution of inter partes review.  In IPR2018-00174, Mylan requested review of claims 1-23 of U.S. Patent No. 9,730,900 (“the ’900 patent”) relating to transdermal drug delivery systems for administering estrogens.  In its petition, Mylan challenged claims 1, 2, 8, 10-16, and 18-23 as anticipated by Mueller.  Mylan further challenged claims: (i) 1, 2, 8-23 as obvious in view of Mueller and Vivelle-Dot Label, (ii) 3-7 as obvious in view of Mueller, Vivelle-Dot Label, and Kanios, and (iii)1-23 as obvious in view of Mueller, Vivelle-Dot Label, Kanios, and Chien.

In IPR2018-00173, Mylan requested review of claims 1-15 of U.S. Patent No. 9,724,310 (“the ’310 patent”), which also relates to transdermal drug delivery systems for administering estrogens.  In its petition, Mylan challenged claims 1, 2, 8, 10-15 as anticipated by Mueller.  Mylan further challenged claims: (i) 1, 2, 8-15 as obvious in view of Mueller and Vivelle-Dot Label, (ii) 3-7 as obvious in view of Mueller, Vivelle-Dot Label, and Kanios, and (iii) 1-15 as obvious in view of Mueller, Vivelle-Dot Label, Kanios, and Chien.  Noven filed a preliminary response in both proceedings.

As a threshold matter, the Board determined the meanings of the terms “about” and “flux.”  The Board agreed with the parties that the specification provided an express definition of the term “about” to mean “up to plus or minus 10% of a particular term.”  The Board also agreed with the parties that the specification provided an express definition of the term “flux” and found no reason to deviate from this definition.

The Board agreed with Noven that Mylan failed to establish that Mueller taught a transdermal therapeutic system having the claimed estradiol flux ranges.  For similar reasons, the Board also was not persuaded that Mylan established a reasonable likelihood of prevailing on each of its obviousness challenges.  Accordingly, the Board declined to institute an inter partes review in both cases.

Merck Sharp & Dohme Corp. (“Merck”) v. Wyeth LLC (“Wyeth”), IPR2017-00378 (Final Written Decision Entered June 8, 2018).

In its petition, Merck challenged claims 1-6, 10, 11, 14 and 17-20 of U.S. Patent No. 8,562,999 (“the ’999 patent”) on obviousness grounds.  The ’999 patent relates to formulations comprising an immunogen in the form of a polysaccharide-protein conjugate, a pH buffered saline solution, and an aluminum salt.  In particular, the specification discloses surfactants that act to stabilize and inhibit aggregation of an immunogenic composition.

The Board’s obviousness analysis focused on whether the combined disclosures of Chiron, Smith, and Elan taught or suggested placing a formulation in a siliconized container means, and inhibiting aggregation induced by the siliconized container means, as claimed in independent claim 1.  The Board agreed with Merck and determined that a preponderance of the evidence supported Merck’s contention that a person of skill in the art would have found it obvious at the time of the invention to store the formulation disclosed in Chiron in a siliconized container means.  In addition, the Board also agreed with Merck’s contention that a person of ordinary skill in the art would have appreciated that Chiron’s formulation inhibited aggregation induced by a siliconized container means.  The Board disagreed with Wyeth that one of skill in the art would not look to combine the teachings of Chiron and Elan, in part after concluding that Wyeth’s teaching away argument as to Elan was misplaced.

The Board did agree with Wyeth regarding the patentability of claim 18, which recites a 13-valent conjugate having different polysaccharide from S. pneumoniae serotypes.  In particular, Wyeth argued that Merck used impermissible hindsight as a blueprint to piece together prior art.  The Board concluded that Merck had not established by a preponderance of the evidence that a person of skill in the art would have found it obvious to modify the formulations disclosed in Chiron to reach the 13-valent conjugate recited in claim 18.

Merck also argued obviousness over the combined disclosures of Chiron, Smith, Elan, and Peña.  Peña discloses two available vaccines to prevent invasive pneumococcal illness.  The Board agreed with Merck as to the obviousness of the 7-valent conjugate (claim 17), but not as to the 13-valent conjugate (claim 18), over the combined prior art.

Accordingly, in its Final Written Decision, the Board determined that Merck had shown by preponderance of the evidence that claims 1-6, 10, 11, 14, 17, 19, and 20 are unpatentable as obvious.

Merck v. Wyeth, IPR2017-00380 (Final Written Decision Entered June 8, 2018).

Claims 1-6, 10, 11, 14 and 17-20 of U.S. Patent No. 8,562,999 (“the ’999 patent”), discussed above, were further challenged in a second inter partes review filed by Merck.

The Board’s obviousness analysis focused on whether the combined disclosures of Prevenar and Chiron, and optionally Peña, rendered the claims unpatentable as obvious.  The Board found that Wyeth’s contentions were inadequately supported by expert testimony or declarations and, by preponderance of the evidence, determined that one of ordinary skill in the art would have had a reason to add a histidine buffer to the Prevenar vaccine with a reasonable expectation of enhancing the stability of the formulation and, further, that the recited aggregation inhibition property of the formulation must be present in, or is the natural result of, the combination of elements disclosed by the prior art.  Accordingly, the Board determined the claims would have been obvious over the combination of Prevenar and Chiron.

Similar to the decision in IPR2017-00378, the Board agreed with Wyeth regarding the patentability of claim 18, which recites 13-valent conjugate having different polysaccharide from S. pneumoniae serotypes.  As such, claim 18 withstood the obviousness challenge.  Also, as in IPR2017-00378, Peña was cited as further evidence of obviousness.  The Board again agreed with Petitioner as to the obviousness of the 7-valent conjugate (claim 17), but not as to the 13-valent conjugate (claim 18), over the combined prior art.

Accordingly, in its Final Written Decision, the Board determined that Merck had shown by preponderance of the evidence that claims 1-6, 10, 11, 14, 17, 19, and 20 are unpatentable as obvious.

Merck v. Wyeth, IPR2017-00390 (Final Written Decision Entered June 8, 2018).

In a third challenge to claims of U.S. Patent No. 8,562,999 (“the ’999 patent”), the Board determined that claims 7-9, 12, 13, 15, 16, 21, and 22 of the ’999 patent are unpatentable as obvious.  As discussed above, the ’999 patent discloses formulations having an immunogen in the form of a polysaccharide-protein conjugate, a pH buffered saline solution, and aluminum salt.

The three obviousness grounds related to the combined teachings of: (i) Chiron, Smith, and Elan; (ii) Prevenar and Chiron; and (iii) WO 2011/100151 and U.S. Patent No. 7,935,787.

The Board agreed with Merck that a person of ordinary skill in the art would have placed Chiron’s formulation into a syringe and that Smith disclosed the common application of lubricating plastic syringe barrels and glass cartridges used as plungers to facilitate ease of use.  The Board disagreed with the evidence put forth by the Wyeth and its experts regarding, for example, that laboratories would specifically avoid using siliconized containers, substitute buffers, and use pH slightly below the preferred range.

On June 5, 2018, the Board issued an Order granting a Joint Motion to Limit the Petition.  As such, the obviousness challenge over WO 2011/100151 and U.S. Patent No. 7,935,787 was removed from the proceedings and the Board did not address the alleged unpatentability of claims 13 and 16.

Accordingly, in its Final Written Decision, the Board determined that Merck had shown by preponderance of the evidence that claims 7-9, 12, 13, 15, 16, 21, and 22 of the ’999 patent are unpatentable as obvious.