On June 7, 2017, the PTAB issued a final written decision in IPR 2016-00254 canceling claims in a Fresenius Kabi USA, LLC (Fresenius) patent covering Diprivan®. The PTAB instituted the IPR in response to a petition filed by hedge fund manager Kyle Bass and his colleague Erich Spangenberg. Diprivan® is the commercial name for propofol, an intravenous anesthetic agent used during surgery and other medical procedures.Continue Reading Kyle Bass Gets Fresenius’ Diprivan Claims Canceled in IPR
One-Year Time Bar Does Not Apply to a Request for Joinder of IPR Proceedings
Teva Pharmaceuticals USA, Inc. (“Teva”) filed a Petition, seeking an IPR of claims 1–20 of Allergan’s U.S. Patent No. 8,642,556. [IPR2017-00579, Paper No. 9] Along with the Petition, Teva filed a Motion for Joinder to join Mylan Pharmaceuticals Inc. v. Allergan, Inc., IPR2016-01129. This blog has previously reported on the topic of joinder in IPR Petitions here and here.
Teva’s Petition was not timely, having been filed more than one year after Allergan filed a complaint alleging infringement of the ‘556 patent against Teva. Teva’s Motion for Joinder, however, was filed within one month of the date that the Board instituted review in response to Mylan’s Petition. Under 37 C.F.R. § 42.122(b), Teva’s Motion for Joinder with Mylan’s Petition was timely.
Continue Reading One-Year Time Bar Does Not Apply to a Request for Joinder of IPR Proceedings
Supreme Court to Decide Whether IPRs Violate Article III and the Seventh Amendment
An updated discussion of this issue is available here: The Supreme Court Finds IPR Proceedings Constitutional
The Supreme Court issued an order on June 12, 2017, indicating it will review the Federal Circuit’s judgment in Oil States Energy Services, LLC v. Green’s Energy Group, LLC, 639 Fed. Appx. 639 (Fed. Cir. 2016) (link). The petition presented three questions, of which the Court will address only one:
Whether inter partes review—an adversarial process used by the Patent and Trademark Office (PTO) to analyze the validity of existing patents—violates the Constitution by extinguishing private property rights through a non-Article III forum without a jury.
Continue Reading Supreme Court to Decide Whether IPRs Violate Article III and the Seventh Amendment
AIA Estoppel – 7 Things We Know So Far
When the America Invents Act was enacted, one of the biggest questions facing petitioners was the scope of the estoppel set forth in 35 U.S.C. § 315(e). While IPR was expected to provide a cheaper, more efficient method of challenging the validity of a patent, what would the challenger be giving up?
The statute provides that for any patent claim addressed in a final written IPR decision the petitioner (or real party in interest), may not request, maintain, or assert that any such claim is invalid on a ground that the petitioner “raised or reasonably could have raised” during the IPR in any proceeding before the patent office, or in any action in the district courts or the ITC. 35 U.S.C. § 315(e). The legislative history of the statute suggests that Congress intended a broad application of estoppel. See, e.g., 157 Cong. Rec. S1375, 1358 (Daily Ed. March 8, 2011) (Statement of Senator Grassley) (indicating that inter partes review “will completely substitute for at least the patents-and-printed publications portion of the civil litigation”).Continue Reading AIA Estoppel – 7 Things We Know So Far
Supreme Court to Decide Whether PTAB May Institute/Decide AIA Trials on Fewer than All Challenged Claims
An updated discussion of this issue is available here: Supreme Court Decides that IPR Final Decisions Must Address All Challenged Claims
The Supreme Court issued an order on May 22, 2017, granting SAS Institute’s petition for a writ of certiorari to review the Federal Circuit’s judgment in SAS Institute, Inc. v. ComplementSoft, LLC, 825 F.3d 1341 (Fed. Cir.), reh’g en banc denied, 842 F.3d 1223 (Fed. Cir. 2016) (order).Continue Reading Supreme Court to Decide Whether PTAB May Institute/Decide AIA Trials on Fewer than All Challenged Claims
Presentation Not Qualified as a Printed Publication Because Audience Lacked Expertise
In a recent final written decision (Trustees of the University of Pennsylvania v. Coalition for Affordable Drugs VIII, LLC, IPR2015-01835, Paper No. 56 (PTAB Mar. 6, 2017)), the Board determined that the Coalition for Affordable Drugs (“Petitioner”) failed to demonstrate that claims 1-10 of U.S. Patent No. 8,618,135 (“the ’135 patent) were obvious. The claims recite methods of treating a subject suffering from a disorder associated with hyperlipidemia and/or hypercholesterolemia. Petitioner asserted these claims were obvious because the alleged prior art taught applying step-wise escalating doses of a microsomal triglyceride transfer protein (MTP) inhibitor to treat hyperlipidemia and hypercholesterolemia. As in cases we have previously discussed here and here, the Petitioner failed to satisfy its burden of proof because it did not show that the alleged prior art qualified as a “printed publication.”
Continue Reading Presentation Not Qualified as a Printed Publication Because Audience Lacked Expertise
Coalition for Affordable Drugs Fails to Knock Out Biogen’s Tecfidera® Patent
On March 21, 2017, the PTAB refused to cancel claims of a Biogen MA Inc. (Biogen) patent covering multiple sclerosis drug Tecfidera® during IPR2015-01993, which was instituted in response to a petition filed by the Coalition for Affordable Drugs V LLC (CFAD), a group started by hedge fund manager Kyle Bass.
Biogen’s U.S. Pat. No. 8,399,514 claims methods of treating patients for multiple sclerosis (MS). Each claim requires the administration of a dose of about 480 milligrams (mg) per day of dimethyl fumarate (DMF), monomethyl fumarate (MMF), or their combination. CFAD argued that a combination of several prior art references renders obvious all claims of Biogen’s patent. Generally, this combination of prior art describes results from administering 120, 360 and 720 mg/day of DMF to MS patients, but do not disclose the claimed dose. The 720 mg/day dose was reported to reduce brain lesions in a dose-dependent manner, while the 120 and 360 mg/day dose did not show statistically significant results versus placebo. CFAD nevertheless argued that a person of ordinary skill in the art would have been motivated to conduct routine experiments to optimize the effective dose and ultimately arrive at the dose recited in the claims.Continue Reading Coalition for Affordable Drugs Fails to Knock Out Biogen’s Tecfidera® Patent
Tech Industry Debates AIA Proceedings at Inaugural PTAB Conference
Introduction of Panelists and summary of Session
Early March 2017 kicked off the PTAB Bar Association’s Inaugural Conference in Washington, D.C. I had the privilege of attending several sessions, one of which was “View from the Tech Industry,” which included panelists from the Tech Industry who commonly practice before the PTAB in either petitioner or patent owner roles. Representatives of Google and Microsoft presented petitioner views. Representatives from Personalized Media Communications, LLC, and Trading Technologies International, Inc., presented patent owner views.
The Tech Industry panelists debated the current state of AIA proceedings, expressing their views on AIA jurisprudence, mechanics of AIA proceedings, and strategies vis-à-vis co-pending district court litigation.
Continue Reading Tech Industry Debates AIA Proceedings at Inaugural PTAB Conference
Pending Bill Would Deliver More Judicial Scrutiny to USPTO and FDA Rules
The House of Representatives recently sent to the Senate its bill (H.R.5) that combines six previous regulatory reform bills, including, as Title II of the bill, the “Separation of Powers Restoration Act.” Section 202 of the bill effectively removes the option for courts to apply Chevron deference to agency rulemaking and interpretations. Thus, rather than deciding whether a regulation is permissible as reasonably related to the purposes of the enabling legislation, by amending 5 U.S.C. § 706, the bill will require a reviewing court to “decide de novo all relevant questions of law, including the interpretation of constitutional and statutory provisions, and rules made by agencies.” To eliminate any doubt about its intent, the amendment specifically states that the court shall not interpret any gap or ambiguity in a statue or regulatory provision as an implicit delegation of legislative rulemaking authority to an agency, and the court shall not defer to an agency’s interpretation on a question of law. As a result, rather than simply deciding whether an agency’s construction of silent or ambiguous statutory provisions are permissible as a matter of statutory interpretation, the reviewing court must make its own, independent interpretation. The change in the statute would mean that prior court approvals of agency rules, applying Chevron deference, will not dictate the outcome of future challenges under the doctrine of stare decisis.
Continue Reading Pending Bill Would Deliver More Judicial Scrutiny to USPTO and FDA Rules
PTAB Bar Association Conference Kicks Off with Keynote Address
The PTAB Bar Association held its first conference in Washington DC March 1-3, 2017 with more than 400 attendees and a wait list of interested individuals. PTAB Chief Judge David Ruschke gave the keynote address.
Chief Judge Ruschke began by acknowledging why we are now at a point where there is an interest in having a PTAB Bar Association. Specifically, he noted that the PTAB has become a vital component of the patent system. We have seen that reflected in an incredible rise in appeals to the Federal Circuit from the PTAB and also that post-grant proceedings are now an important tool for every patent litigator.
Continue Reading PTAB Bar Association Conference Kicks Off with Keynote Address