Administrative Agency Civil Procedure

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Federal Circuit Affirms Tygacil Formulation Patent

In Apotex, Inc. v. Wyeth LLC, the Federal Circuit affirmed the decision of the USPTO Patent Trial and Appeal Board (PTAB) finding that Apotex had failed to show that claims directed to a specific formulation of tigecycline...more

And Now There Are Two: The Ninth Circuit Strikes Class Arbitration Waivers Joining the Seventh Circuit on Finding that these...

Seyfarth Synopsis: The Ninth Circuit joined the Seventh Circuit and the NLRB in finding that mandatory arbitration agreements that require all claims to be brought by employees on an individual basis violate the NLRA. On...more

D.C. District Court Invalidates CMS’s “Protest” Requirement

On August 19, 2016, the United States District Court for the District of Columbia granted a group of hospitals’ motion for summary judgment against HHS in a challenge of the Provider Reimbursement Review Board’s (PRRB) denial...more

Chevron Deference In California

In mid July, the House of Representatives passed the Separation of Powers Restoration Act of 2016, H.R. 4768 (SOPRA). If enacted, the SOPRA would amend the federal Administrative Procedure Act to require a reviewing court to...more

Litigating Against the Government? Recent Decision Regarding Claim Certification Dispute Proves That Forrest Gump's Mama Was Right...

Forrest Gump’s mama was a brilliant woman. As anyone who watched the 1994 Academy Award-winning classic can confirm, Mrs. Gump’s advice to her son provided an indispensable well of wisdom from which Forrest often drew to...more

August 2016: Circuit Courts Align to Shield SEC Administrative Proceedings from Collateral Constitutional Attack

In response to the financial crisis of the late 2000s, Congress passed the Dodd-Frank Wall Street Reform and Consumer Protection Act (“Dodd-Frank”) in 2010. Previously the SEC could pursue civil penalties only against...more

Is Final Really Final? Alternative Patent Prosecution Routes after a Final Office Action

The prosecution of a patent application before the U.S. Patent and Trademark Office (USPTO) can be a prolonged and costly process. The patent prosecution process can include the issuance of an Office Action by the USPTO and...more

Federal Circuit Grants En Banc Review of PTAB Amendment Practice

On August 12, 2016, the U.S. Court of Appeals for the Federal Circuit granted rehearing en banc to appellants in In re Aqua Products, Inc to consider the procedures used by the USPTO Patent Trial and Appeal Board (PTAB) to...more

PTAB Misapplied Common Sense in Finding Claims Obvious

In Arendi S.A.R.L. v. Apple Inc., [2015-2073] (August 10, 2016) the Federal Circuit reversed the PTAB Final Written Decision that claims 1-2, 8, 14-17, 20-21, 23-24, 30, 36-39, and 42-43 of U.S. Patent No. 7,917,843 were...more

Apotex Inc. v. Wyeth LLC (Fed. Cir. 2016)

Perhaps the most significant Supreme Court decision in the past quarter century for the working patent practitioner is Dickinson v. Zurko, which strictly speaking is less a patent case than an administrative law decision. ...more

“Substantial Evidence” Hurdle is Substantially Difficult to Overcome

One of the less appreciated hurdles to a successful appeal of a Final Written Decision in an IPR proceeding is the “substantial evidence” standard of review the Federal Circuit applies to the Graham factors that underlie a...more

Federal Circuit Vacates and Remands PTAB Obviousness Determination Not Supported by Adequate Reasoned Explanation

In In re Warsaw Orthopedic, Inc., 2015-1050, 2015-1058 (August 9, 2016), the Federal Circuit affirmed in part, vacated in part, and remanded the PTAB’s decision in IPR2013-00206 and IPR2013-00208 that claims 1–8 and 17–23 of...more

Real Estate and Land Use - August 2016

Court of Appeal Holds EIR Inadequately Analyzed Energy Impacts - Ukiah Citizens for Safety First v. City of Ukiah et al. (248 Cal.App.4th 256) (partially published) - Why It Matters: The California Court of Appeal...more

USPTO Updates Accelerated Examination Program – Program Still Creates a Record That Could Be Cited Against Patent Owners in...

Yesterday, the USPTO published a notice updating the accelerated examination program and noting that the USPTO plans to publish a request for comments to seek public input on whether there is value in retaining the program....more

HHS Proposes Administrative Dispute Resolution Process for 340B-Related Claims

On August 12, 2016, the US Department of Health and Human Services (HHS) Health Resources and Services Administration issued a notice of proposed rulemaking that establishes an administrative dispute resolution process for...more

Wisconsin District Court Follows 5th Circuit: Internal Tipsters Are Not Considered “Whistleblowers” Under Dodd-Frank

On August 12, 2016, the U.S. District Court for the Eastern District of Wisconsin in Lamb v. Rockwell Automation Inc., No. 15-CV-1415-JPS (E.D. Wis. Aug. 12, 2016) held that the Dodd-Frank whistleblower protection provision...more

In re Aqua Products, Inc. -- CAFC Grants Rehearing En Banc to Consider PTAB Motions to Amend

On Friday, August 13, 2016, the Federal Circuit granted a petition for rehearing en banc filed in the In re Aqua Products, Inc. case to consider two questions related to the PTAB's treatment of Motions to Amend in IPR...more

En Banc Federal Circuit To Review Standards for Amending Claims During AIA Proceedings

In a rare grant of a petition for rehearing en banc, the court decided that an appeal “warrants en banc consideration” of who bears what burden when amending in an IPR. In re: Aqua Products, No. 15-1177, slip op. at 2 (Fed....more

BRI Does Not Apply if Patent Expires Any Time During Reexamination Proceeding

In In Re CSB-System International, Inc., [2015-1832] (August 9, 2016), the Federal Circuit held that the PTAB erred in applying a broadest reasonable interpretation claim construction, instead of a Phillips claim...more

Federal Circuit To Review IPR Claim Amendment Rules En Banc

The Federal Circuit will rehear en banc the appeal In re: Aqua Products, Inc., No. 2015-1177 to address whether the PTAB’s rules requiring the Patent Owner to demonstrate the patentability of proposed amended claims are...more

A Favorable, New Climate for Challenging Medicare Appeals

Over the past decade, health care providers seeking to challenge Medicare claim denials have faced increasing delays in reaching what many consider the most important step in the Medicare appeals process - a hearing before an...more

In re Magnum Oil Tools Int'l, Ltd. (Fed. Cir. 2016)

McClinton Energy Group filed an inter partes review (IPR) petition against all claims of U.S. Patent No. 8,079,413, owned by Magnum Oil Tools International, Ltd. The USPTO's Patent Trial and Appeal Board (PTAB) instituted...more

CMS Audit Practices: How false can you get?

Caring Hearts Personal Home Care Services provided physical therapy and skilled nursing services to homebound Medicare patients. During an audit, CMS determined that Caring Hearts provided services to patients who didn’t...more

Settlement Reached in Temple-Inland; Delaware Internally Reviewing Unclaimed Property Audit Practices

The court case challenging Delaware’s unclaimed property audit methodologies has settled following an opinion brutalizing Delaware’s position. This settlement leaves the US District Court for the District of Delaware...more

The Social Cost of Carbon Passes Its First Judicial Test

Earlier this week, the 7th Circuit affirmed the Department of Energy’s new energy efficiency requirements for commercial refrigeration equipment. This is a big deal in its own right, simply because the numbers are really...more

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