Greenblum & Bernstein, P.L.C.
REEXAMINATION AND POST-GRANT
PRACTICE GROUP NEWSLETTER
keePing TABs No. 18
In This Issue
· Ongoing Tally of Filed IPR and CBM Petitions
· Federal Circuit Decisions
· Final Written Decisions
· USPTO Institutes IPR
Ongoing Tally of Filed IPR and CBM Petitions
St. Jude Medical, Cardiology Division, Inc., v. Volcano Corporation, April 24, 2014
St. Jude filed in IPR petition of a patent owned by Volcano Corp. The petition was denied because it was filed more than one year after Volcano filed a counterclaim of infringement of the patent against St. Jude. St. Jude appealed the decision to the Federal Circuit, Volcano and the USPTO moved to dismiss, and the Federal Circuit granted their motion to dismiss.
The Court explained that §314(d), entitled “No Appeal,” states: “The determination by the Director whether to institute an inter partes review under this section shall be final and nonappealable.” Further, IPR is a two-step process, (1) the decision to institute or not, and if instituted, (2) the Board’s proceeding and decision. “The statute provides for an appeal to this court only of the Board’s decision at the second step, not the Director’s decision at the first step.”
In Re Dominion Dealer Solutions, LLC., April 24, 2014
After being served a complaint for infringement by AutoAlert, Inc., Dominion Dealer Solutions, LLC, timely petitioned for inter partes review of the five patents in question. The petition was denied as was a request for rehearing. In October 2013 Dominion sued the PTO in district court and in November, filed a petition for a writ of mandamus in the CAFC asking to vacate the non-institution and institute the IPRs.
The “remedy of mandamus is a drastic one, to be invoked only in extraordinary situations” where the following three requirements are met: (1) a clear and indisputable right to relief, (2) a lack of adequate alternative means to obtain relief, and (3) “the issuing court, in exercise of its discretion, must be satisfied that the writ is appropriate under the circumstances.” The Court concluded that there was no “clear and indisputable” right to challenge the decision not to institute IPR. The Court noted that the district court recently held that the statute precludes judicial review of the PTO decision. The CAFC did not decide that issue, but denied Dominion’s petition.
In Re The Procter & Gamble Company, April 24, 2014
P&G petitioned the Federal Circuit to issue a writ of mandamus directing the PTO to
withdraw the orders instituting inter partes reviews of three P&G patents. The Court references the above cases, stating:
In today’s decision in St. Jude Medical, Cardiology Div., Inc. v. Volcano Corp., No. 2014-1183, we describe the statutory scheme governing inter partes reviews, 35 U.S.C. §§ 311-319, and conclude that a decision by the Director not to institute an inter partes review may not be appealed to this court. In In re Dominion Dealer Solutions, LLC, No. 2014-109, also issued today, we conclude that a non-institution decision may not be directly reviewed by this court through the extraordinary means of mandamus. The present case involves a decision by the Director to institute an inter partes review. We conclude that immediate review of such a decision is not available in this court. We therefore deny P&G’s petition for mandamus relief.
Thus the Federal Circuit has stated that is will not review PTO decisions to institute or not to institute inter partes review by appeal or by writ of mandamus.
Selected PTAB Final Written Decision:
Corning v. DSM , IPR2013-00043 and IPR2013-00044 (May 1, 2014);(McKelvey, Karaffa, Obermann, Bisk, Kamholz, and Yang)
The USPTO denied DSM IP Assets’ motion to exclude portions of Corning’s expert witness declarations in IPR2013-00043 and IPR2013-00044. The motion was denied with respect to the items the PTAB did not rely on in deciding the case.
DSM argued that Item 3 should be excluded because the witness failed to consider other causes for differences in cure doses; and that Item 6 should be excluded as it did not disclose the underlying facts on which it was based. The PTAB notes that these arguments do not go to exclusion of the evidence, but to the weight that should be accorded and these types of arguments “should be presented in a patent owner’s response.”
On the same day, the PTAB entered its Final Written Decision upholding the claims of the patents and dismissing as moot DSM’s motions to amend claims. The claims were directed to obtaining 95% of the maximum attainable modulus at a cure dose of less than 0.65J/cm2. The prior art did not explicitly show this, but Corning tried to show that it was inherently in the prior art with an expert witness who testified about tests by two Corning scientists measuring the cure dose to attain 95% in the prior art. The testimony did not include test data or related documents. Through additional discovery, DSM obtained some laboratory documents from these tests and challenged the accuracy of the tests and the analysis, duplicating the efforts with differing results.
The PTAB did not question the good faith of the scientist on either side, but, if in conflict, the PTAB credited the testimony of DSM’s experts over Corning’s because it was more detailed and supported by the underlying data. Corning failed to show that the prior art inherently met the limitations of the claims and DSM failed to show that it did not. As Corning had the burden of proof, it necessarily lost.
PTAB Institutes Inter Partes Review:
Orange Book Patents set for Inter Partes Review IPR2014-00651, IPR 2014-00652, IPR2014-00653, IPR2014-00654, IPR2014-00655, IPR2014-00377, IPR2014-00378, IPR2014-00379
The USPTO initiated several IPRs on three Depomed patents this year. These patents relate to the Acuform drug delivery technology, a delayed release system included in the FDA Orange Book. In 2011-2012 Depomed filed claims against five pharmaceutical companies on this group of patents and against three more in 2013, including Purdue Pharma L.P. in January 2013 and Endo Pharmaceuticals Inc. in April 2013. The Purdue product in question is Oxycotin, and the Endo product is Opana ER (oxymorphone hydrochloride extended-release).
Purdue and Endo filed their IPR petitions in January 2014 and April 2014, respectively, within the one year requirement under the AIA. These appear to be among the first Orange Book patents attacked in an inter partes review.