Photo of Eric M. Brusca, Ph.D.

For clients producing biotech advancements in biologics and vaccines, Eric M. Brusca, Ph.D. secures patents internationally through prosecution and related proceedings. Clients rely on his legal experience from handling a wide variety of these technologies. They also gain sure and insightful assessments of their patentable products and processes, all rooted in his graduate training and research in microbiology, biochemistry and molecular biology. A teacher as well, he communicates effectively with his clients and successfully represents their interests. Read full bio here.

Update: On November 1, 2018, the CAFC issued a modified opinion and an order denying Contour’s petition for rehearing en banc.  The modified opinion is consistent with the original petition, discussed below, insofar as the PTAB decision was vacated and remanded, but adds the following statement at page 8: “When direct availability to an ordinarily skilled artisan is no longer viewed as dispositive, the undisputed record evidence compels a conclusion that the GoPro Catalog is a printed publication as a matter of law.”  The modified opinion also deleted the following statements, parts of which were quoted in the blog, below: “Contrary to the Board’s conclusion, the attendees attracted to the show were likely more sophisticated and involved in the extreme action vehicle space than an average consumer. Thus, it is more likely than not that persons ordinarily skilled and interested in POV action cameras were in attendance or at least knew about the trade show and expected to find action sports cameras at the show. While the Board found that GoPro did not provide any evidence as to what products the companies at the trade show make, GoPro was not the only manufacturer of POV action cameras. The vendor list provided with Mr. Jones’s declaration listed a number of vendors who likely sell, produce and/or have a professional interest in digital video cameras.”

In a previous blog post, we reported that in a final written decision on October 26, 2016, the PTAB concluded that GoPro, Inc. (GoPro) failed to demonstrate that the challenged claims in a patent owned by Contour IP Holding LLC (Contour) were unpatentable. IPR (IPR2015-01080; “the GoPro IPR”)  GoPro asserted that the challenged claims were unpatentable in view of, among other references, a GoPro product catalog that included information for a digital video camera.Continue Reading Tradeshow Catalog Qualifies as Prior Art

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

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

In Ultratec, Inc. v. CaptionCall, LLC, No. 2016-1706 (Fed. Cir. Aug. 28, 2017), the Federal Circuit vacated and remanded multiple IPR decisions where the PTAB failed to consider material evidence and failed to explain its decisions to exclude the evidence.

Ultratec and CaptionCall are currently litigating in both district court and before the PTAB.  Ultratec sued CaptionCall for infringement in the Western District of Wisconsin where a jury found the patents infringed and not invalid. 
Continue Reading CAFC: PTAB Abused Its Discretion When It Refused to Admit Expert’s Trial Testimony

Cancelled in RedOn 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

Merging concept illustrated by two different jigsaw piece a silver and a gold one.

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

Red boxing gloves with the glow of flashes in the background.

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

Work in progressOnce 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.

businessman between a rock and a hard space

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!!