Posts Tagged: "Patentability"

‘Substantially Equivalent’ Disclosure May Satisfy Written Description Requirement Under Certain Circumstances

The Federal Circuit recently affirmed in part and reversed in part a district court decision holding that Actavis Laboratories FL, Inc.’s (“Actavis’s”) generic Abbreviated New Drug Application (“ANDA”) product infringed claims of patents owned by Nalpropion Pharmaceuticals (“Nalpropion”) and that the asserted claims were not invalid. The Court found that the district court did not err in finding that Nalpropion’s U.S. Patent No. 8,916,195 (“the ’195 patent”) was not invalid for lack of written description, but that the district court did err in finding that the asserted claims of U.S. Patent Nos. 7,375,111 (“the ’111 patent”) and 7,462,626 (“the ’626 patent”) were not obvious in view of the prior art.

Alice: Benevolent Despot or Tyrant? Analyzing Five Years of Case Law Since Alice v. CLS Bank: Part I

It’s been five years since the Supreme Court remade the law of patent eligibility in Alice Corp Pty Ltd v. CLS Bank Int’l. As we all know, in Alice the Supreme Court dictated that patent-eligible subject matter is determined based on a two-step test. The application of this test under Queen Alice’s reign has drastically altered the patent landscape. Over 1,000 patents have been invalidated by the federal courts and the U.S. Patent and Trademark Office’s (USPTO’s) Patent Trial and Appeal Board (PTAB), while over 60,000 patent applications have been abandoned before the USPTO following rejections for patent ineligible subject matter. Patents and portfolios in many fields – particularly software and biotechnology – have declined in value or simply become unsaleable at any price. Defenders of Queen Alice and her critics go back and forth endlessly, driven by differing permutations of ideology, technology, judicial philosophy and business goals. I have contributed my share to those discussions, no doubt. But today, let’s get down to data and see what has really happened under Queen Alice’s rule.

Latest Federal Circuit Ruling on 101 Strikes Down Mallinckrodt Method of Treatment Claims; Newman Dissents

In the most recent exploration of Section 101 by the Federal Circuit, Chief Judge Sharon Prost authored a non-precedential opinion holding the claims of a patent for a method of administering inhaled nitric oxide (iNO) ineligible for patent protection under the Alice/Mayo framework. The ruling paves the way for industrial gas company Praxair Distribution to move forward with its abbreviated new drug application (ANDA) for a nitric oxide delivery system. Judge Pauline Newman dissented in part, stating that the “method that is described and claimed does not exist in nature” and “was designed by and is administered by humans,” so should be patent eligible.

Damage to Our Patent System by Failure to Honor the U.S. Legal Framework: Double Patenting

As the summer winds down, it is time again to focus on how to fix the U.S. patent system. In June, the Senate Judiciary’s IP Subcommittee held unprecedented hearings on patent eligibility. They are now back in closed door sessions with selected stakeholders to further consider language to amend Section 101, having received extensive feedback. My testimony in part addressed the unconstitutionality of the U.S. Supreme Court’s cases on patent eligibility, which have created judicial exceptions that arrogantly ignore the plain wording of Congress’ statute (“invention or discovery” in the disjunctive in Sections 100(a), (f) and (g) and Section 101) and its legislative history, and despite the fact that the U.S. Constitution gives Congress the sole power to create patent law. The doctrine of judicially-created non-statutory obviousness-type double patenting is the flip side of the coin of the patent eligibility issues.  A rejection for “non-statutory obviousness-type” double patenting is based on a “judicially-created doctrine” grounded in public policy and which is primarily intended to prevent prolongation of the patent term by prohibiting claims in a second patent not patentably distinct from claims in a first patent. This is problematic for at least the following reasons.

PTAB Institutes Series of IPRs Brought by Pfizer Against Sanofi Patents

During the week of August 12 – 16, the Patent Trial and Appeal Board (PTAB), issued 26 institution-phase decisions in inter partes review (IPR) proceedings. Nine IPR petitions were denied institution while 17 were instituted; nine of the instituted IPRs were joined to other proceedings that are already ongoing at the agency. Pfizer saw a lot of success last week in having seven IPRs instituted against Sanofi-Aventis, challenging four injectable insulin treatment patents that are at the center of district court infringement litigation between the two parties. The PTAB also instituted IPRs on a series of three LifeNet patents covering tissue graft technologies, which have been asserted against RTI Surgical, including one patent which helped LifeNet earn a multimillion-dollar award for patent infringement in district court.