This blog has previously reported on several PTAB and Federal Circuit decisions concerning what does and does not qualify as prior art:
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Petitioner Failed to Show That Patent Owner’s Drug Product Package Insert Was a Printed Publication
On February 9, 2018, the PTAB denied Sandoz Inc.’s petition for inter partes review of U.S. Patent No. 9,512,216, a patent owned by AbbVie Biotechnology Ltd. The patent recites methods for treating moderate-to-severe chronic plaque psoriasis with adalimumab, a human anti-tumor necrosis factor α (TNFα) antibody. The methods of the claimed invention involve subcutaneously administering to a patient an initial dose of 80 mg of adalimumab, followed by 40 mg of adalimumab every other week starting one week after the initial dose. The patent is one of several patents AbbVie owns that relate to its blockbuster autoimmune drug Humira.
Continue Reading Petitioner Failed to Show That Patent Owner’s Drug Product Package Insert Was a Printed Publication
CAFC Hears IPR Appeal From Parties That Were Time-Barred From Filing Petition
Research Corporation Technologies, Inc. (RCT) sued Mylan Pharmaceuticals, Inc. (Mylan), Breckenridge Pharmaceutical, Inc. (Breckinridge), and Alembic Pharmaceuticals Ltd. (Alembic), in federal district court, accusing them of infringing United States Reissued Patent No. RE38,551. The patent claims pharmaceutical compositions useful in the treatment of epilepsy and other central nervous system disorders. Within one year of being served with the infringement complaint, Breckenridge alone petitioned the PTAB to institute inter partes review of the patent, but the PTAB denied the petition on its merits.
Continue Reading CAFC Hears IPR Appeal From Parties That Were Time-Barred From Filing Petition
Kyle Bass Gets Fresenius’ Diprivan Claims Canceled in IPR
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
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
Your Supplemental Evidence is Timely, but is it Relevant to a Claim at Issue? PTAB Will Decide.
Once a trial has been instituted at the PTAB, a party seeking consideration of supplemental evidence may file a motion in accordance with the following requirements: (1) the request for the authorization to file a motion to submit supplemental information must be made within one month of the date the trial was instituted; and (2) the supplemental information must be relevant to a claim for which the trial was instituted. 37 C.F.R. § 42.123(a). Mere satisfaction of these requirements for filing a motion may not, however, be sufficient to convince the PTAB to grant the motion. Instead, in deciding the motion, the PTAB will use its broad discretion to determine if the proffered supplemental evidence will assist the PTAB in “ensur[ing] efficient administration of the Office and the ability of the Office to complete [trial] proceedings in a timely manner.” See Redline Detection, LLC v. Star Envirotech, Inc., 811 F.3d 435, 445 (Fed. Cir. 2015), and our discussions here and here.
Continue Reading Your Supplemental Evidence is Timely, but is it Relevant to a Claim at Issue? PTAB Will Decide.
Federal Circuit to PTAB (Again) – Explain Yourself!!
The Federal Circuit has once again vacated and remanded a PTAB final written decision on the basis that the PTAB did not adequately explain its reasons for finding a claimed invention obvious. In In re Nuvasive, Appeal No. 15-1670 (Fed. Cir. Dec. 7, 2016), the Federal Circuit reviewed the PTAB’s final written decision in IPR2013-00506 that concluded various claims of NuVasive, Inc’s U.S. Patent No. 8,361,156 were invalid as obvious over a combination of prior art references. The patent claims spinal fusion implants, and were challenged by Medtronic Inc.
Continue Reading Federal Circuit to PTAB (Again) – Explain Yourself!!
Prior Art Made Available at Members Only Gatherings May Not Satisfy “Publically Accessible” Requirement
On July 27, 2018, the Federal Circuit issued an opinion vacating the GoPro, Inc. decision discussed in the post below.
On June 11, 2018, the Federal Circuit issued a decision vacating and remanding the Medtronic decision discussed in the post below.
An updated discussion of the Medtronic decision is available here:
PTAB Failed to Properly Apply Test for Printed Publication
Two recent PTAB decisions highlight important developments in qualifying a publication as a reference, available as prior art. In one case, the PTAB concluded that a printed catalog did not qualify as a printed publication prior art because it was distributed only at a private tradeshow to persons not necessarily skilled in the art. In the other case, the PTAB concluded that a video and associated slide presentation did not qualify as printed publications because these materials were distributed only to experts at a private, invitation-only conference. These decisions interpret precedents from the Federal Circuit and offer simple examples of what type of publications may not qualify as prior art.
Continue Reading Prior Art Made Available at Members Only Gatherings May Not Satisfy “Publically Accessible” Requirement
IPR Institution Denied Because Petitioner Used Hindsight Bias to Formulate Arguments
On August 23, 2016, the PTAB denied Mylan Laboratories Limited’s (Mylan) petition for IPR (IPR2016-00627) against a patent owned by Aventis Pharma S.A. (Aventis). In doing so, the PTAB offered guidance regarding what is required to successfully make out a claim of obviousness regarding a new chemical compound. In particular, the PTAB’s decision offers insight into the threshold a petitioner will need to meet in order to establish that a person of ordinary skill in the art would have recognized a prior art reference as “promising to modify.”
Continue Reading IPR Institution Denied Because Petitioner Used Hindsight Bias to Formulate Arguments