Intellectual Property Science, Computers & Technology Administrative Agency

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FDA's 'Active Moiety' Interpretation of the Three-Year Clinical Investigation Exclusivity

The court found that a different interpretation could result in marketing exclusivity for the original innovator drug in perpetuity. In Otsuka Pharmaceutical Co. v. Burwell, the U.S. District Court for the District of...more

When Can Common Sense be Relied Upon to Find an Invention Obvious?

All patent practitioners recognize that a single prior art reference can be used to reject claims in an obviousness rejection. However, the issue is whether the Patent Office must provide additional evidence, above and beyond...more

Of Technical Tools and Problems: Going Beyond the Two-Prong Alice Test

It is abundantly clear that the Supreme Court's 2014 Alice Corp. v. CLS Bank decision has significantly changed the patent-eligibility landscape for business methods and some types of software inventions. For instance, in...more

Will the Supreme Court Review Whether FDA-Mandated Bioequivalence Testing to Maintain Approval Falls Within the § 271(e)(1) Safe...

The Supreme Court has been asked to review whether the safe harbor established by 35 U.S.C. § 271(e)(1) encompasses a generic drug manufacturer’s bioequivalence testing performed only as a condition of maintaining FDA...more

Accountability and Transition in ICANN’s New gTLD Program

Bringing accountability to the Internet Corporation for Assigned Names and Numbers (ICANN), the little known yet hugely significant global regulator of the Internet domain name system, is always a significant victory. ICANN...more

A legal look at Patent Trial and Appeal Board decisions and trends: PTAB Statistics - Then and Now

The Inter Partes Review (IPR) and Covered Business Method (CBM) procedures were enacted on September 16, 2012. Since then, the PTAB has released data on a monthly basis to illustrate the trends in the various petitions and...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

Apotex Files Petition for IPR On Amgen’s Neulasta Patent

On August 5, Apotex filed a petition for an IPR on Patent No. 8,952,138, owned by Amgen. The ’138 patent is the same patent that is being challenged in the District Court for the Southern District of Florida, in a case in...more

The Specter of Alice Looms Large Even in PGRs

On August 3, 2016, the Patent Trial and Appeal Board issued a post-grant review decision that bears one striking similarity to its previous post-grant review decisions, namely invalidation of claims under Alice Corp. Pty. v....more

PTAB Reversed–Common Sense Improperly Used to Supply Missing Limitation in Obviousness Inquiry

In a rare rebuke of the PTAB’s discretion, the Federal Circuit has outright reversed a finding of obviousness based on the Board’s misapplication of the law on the permissible use of “common sense” in an obviousness analysis....more

Winning an Alice Challenge Requires Specificity

In light of Enfish and DDR Holdings, software patent owners are quick to point out how their inventions improve the functioning of the computer itself. However, it is well understood that simply improving the functioning of...more

AbbVie v. Amgen: The Litigation Phase for a HUMIRA® Biosimilar Begins

To date, Amgen has been the reference product sponsor for many biosimilar applications. Correspondingly, Amgen has been the Plaintiff in many of the litigations that have been based on the provisions of the Biosimilar Price...more

USPTO Launches Patents 4 Patients

To support the National Cancer Moonshot initiative, the USPTO has launched the Patents 4 Patients program, also known as the Cancer Immunotherapy Pilot Program. Under this program, applicants can obtain expedited examination...more

CBM Decisions Show Limits of Enfish

Recent covered business method (CBM) review decisions by the Patent Trial and Appeal Board (PTAB or Board) demonstrate that the US Court of Appeals for the Federal Circuit’s Enfish decision (IP Update, Vol. 19, No. 6) will...more

No Rehearing on Dual Use PTAB Panels

Confirming that the same panel of judges at the Patent Trial and Appeal Board (PTAB or Board) has the authority to institute America Invents Act (AIA) reviews and make a final determination on the merits, the US Court of...more

Life Technologies Corporation v. Unisone Strategic IP, Inc. (PTAB 2016)

Life Technologies Corp. filed a petition requesting covered business method (CBM) patent review of a number of claims of U.S. Patent No. 6,996,538. The PTAB determined that the claims are unpatentable under 35 U.S.C. § 101...more

Opportunity for Response when Claim Construction Changes

Addressing claim construction and procedural issues during an inter partes review (IPR), the US Court of Appeals for the Federal Circuit vacated a Patent Trial and Appeal Board (PTAB or Board) patentability determination for...more

Genzyme Therapeutic Products Ltd. v. Biomarin Pharmaceutical Inc. (Fed. Cir. 2016)

The Federal Circuit affirmed the decision by the Patent Trial and Appeals Board (PTAB) in an inter partes review (IPR) that the claims of Genzyme's U.S Patent Nos. 7,351,410 and 7,655,226 were obvious, in Genzyme Therapeutic...more

PTAB Institution Decision Does Not Shift Burden from the Patent Challenger to the Patentee

The Federal Circuit previously clarified that a petitioner’s burden to prove unpatentability never shifts to the patent owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc. On July 25, 2016, the Federal Circuit’s In re...more

PTO Cannot Raise & Decide Unpatentability Theories Never Presented by the Petitioner

In In re Magnum Tools International, Ltd., [2015-1300] (July 25, 2016) the Federal Circuit reversed the PTAB’s determination that the challenged claims U.S. Patent No. 8,079,413 were invalid for obviousness. The Federal...more

Shortridge v. Foundation Construction Payroll Service, LLC (Fed. Cir. 2016)

Douglas M. Shortridge, the named inventor of U.S. Patent No. 8,744,933, sued Foundation Construction Payroll Service, LLC ("Foundation") for infringement thereof in the U.S. District Court for the Northern District of...more

Can FDA Implement The BPCIA As The CAFC Suggested?

In Amgen v. Apotex, the Federal Circuit held that under the Biologics Price Competition and Innovation Act (“BPCIA”), “an applicant must provide a reference product sponsor with 180 days’ post-licensure notice before...more

Federal Circuit Patent Updates - July 2016 #2

WBIP, LLC v. Kohler Co. (No. 2015-1038, -1044, 7/19/16) (Moore, O'Malley, Chen) - Moore, J. Affirming denial of JMOL that patent was invalid as obvious and lacked an adequate written description, affirming finding of...more

HP Inc. v. Big Baboon, Inc. (PTAB 2016) - Business Method Patent Not Invalid under 35 U.S.C. § 101

HP Inc. and SAP America, Inc. filed a Petition seeking a covered business method (CBM) patent review of claims 15 and 20–34 of U.S. Patent No. 6,343,275 owned by Big Baboon, Inc. The PTAB, however, determined that the...more

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