Tag: Pharma and BioPharma Litigation

1
Sandoz v. Amgen—Biosimilars at the Supreme Court—Oral Argument
2
Markush Madness: Watson Avoids Infringement by Adding an Element to a Formulation
3
Humira® Update: Big Guns Take Aim at Top-Selling Biologic

Sandoz v. Amgen—Biosimilars at the Supreme Court—Oral Argument

All nine U.S. Supreme Court justices heard argument on Wednesday April 26th, in Sandoz Inc., v. Amgen Inc.  The Supreme Court is reviewing interpretations of the Biologics Price Competition and Innovation Act (BPCIA) made by the U.S. Court of Appeals for the Federal Circuit. Wednesday’s arguments focused on four main issues:

  1. whether the FDA could preliminarily grant licensure prior to the expiration of the 12 year statutory period;
  2. whether the notice of commercial marketing requires official licensure to be made;
  3. whether the “patent dance” was required by the BPCIA; and
  4. whether state law could be used to enforce compliance with the “patent dance” elements of the BPCIA.

Industry watchers hope that the Supreme Court will streamline the process for getting biosimilars to market by providing increased certainty.

To read the full alert, click here.

By: Theodore J. Angelis, Peter Giunta, Kenneth C. Liao, Margaux L. Nair and Jenna Bruce

Markush Madness: Watson Avoids Infringement by Adding an Element to a Formulation

On February 1, 2017, in Shire Development, LLC v. Watson Pharmaceuticals, Inc., the U.S. Court of Appeals for the Federal Circuit held that Watson’s proposed generic version of Shire’s LIALDA® did not infringe claims 1 and 3 of Shire’s U.S. Patent No. 6,773,720 (the “’720 patent”).[1]  In reversing the district court, the Federal Circuit determined that Shire’s claim to an outer layer “consisting of” a list of specific elements closes the universe of elements for infringement purposes, and Watson’s addition of an ingredient (“magnesium stearate”) to the outer layer of its accused product created non-infringement because it was outside the claimed list of elements.[2]  The Federal Circuit’s opinion rests on a strict reading of the Markush groups within the ’720 patent and a rejection of the district court’s broad reading of the Federal Circuit’s opinion in Norian Corp. v. Stryker Corp.[3]

Background
A Markush-type claim (also known as a Markush group) allows a patent drafter to capture independent, related claim elements in a single limitation.  The claim is characterized by the form “selected from the group consisting of A, B and C.”[4]  The “consisting of” language closes the group from including other members, such as “D.”  “Consisting of” limits an element to only the named members of the group, and an element selected from outside that group will not be covered by the claim.  In contrast, patent drafters frequently use an alternative preamble “comprising” to keep the claims open to additional, unrecited elements.[5]

Here, Shire sued Watson for infringing claims 1 and 3 of the ’720 patent by filing an Abbreviated New Drug Application (“ANDA”) with the Food and Drug Administration seeking to market a generic version of Shire’s drug LIALDA®.  The ’720 patent is directed to a controlled-release oral composition of mesalamine (5-amino-salicylic acid) used to treat Crohn’s disease and ulcerative colitis.  The claimed composition includes the mesalamine active ingredient; an inner, lipophilic matrix that “resists dissolving in water”; an outer, hydrophilic matrix that “readily dissolves in” water; and other optional excipients.

To read the full alert, click here.

By: Kenneth C. Liao and Peter Giunta

Humira® Update: Big Guns Take Aim at Top-Selling Biologic

AbbVie Inc.’s Humira® (adalimumab) was the top selling drug in 2015.  Unsurprisingly, it is the focus of biosimilar applicants and patent challengers aiming to get into the market.  We provide this update on three events regarding Humira® that took place over the past two months: (1) Amgen Inc., which is pursuing a biosimilar version of Humira®, received a recommendation toward approval from the U.S. Food and Drug Administration (“FDA”); (2) AbbVie sued Amgen for patent infringement in the U.S. District Court for the District of Delaware, alleging that Amgen infringed several of its patents by seeking FDA approval of its biosimilar version of Humira®; and (3) the U.S. Patent and Trademark Office instituted inter partes review (“IPR”) of a Humira® patent at the request of Boehringer Ingelheim.

Please click here to view the alert.

By: Margaux L. Nair, Trevor M. Gates, Peter Giunta, Theodore J. Angelis

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