In Amgen v. Sandoz, Fed. Cir., No. 15-1499 (July 21, 2015), a divided panel of the U.S. Court of Appeals for the Federal Circuit issued its first decision interpreting the Biologics Price Competition and Innovation Act (BPCIA), and did so in a manner that favors biosimilar applicants in one respect while favoring reference product sponsors (e.g., owners of original biologic products) in another. The result for Amgen and Sandoz is that Sandoz can start selling Zarxio™, its biosimilar version of Amgen’s Neupogen® (filgrastim) product, on September 2, 2015. The result for other biosimilar applicants is less clear, since the court’s decision leaves open more questions than it answers.
The Federal Circuit has issued its long-awaited decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc., but the decision is not good news for those seeking to obtain or enforce U.S. patents on diagnostic methods. The appeals court affirmed the district court’s finding that Sequenom’s claims are invalid under 35 USC § 101, applying the analytical framework set forth in the U.S. Supreme Court’s Mayo decision in a way that could have a ripple effect across the diagnostic and personalized medicine industry.
The Claims At Issue
The Sequenom patent at issue was U.S. Patent 6,258,540. The claimed technology relates to diagnostic methods for determining certain fetal characteristics such as [...]
The U.S. Court of Appeals for the Federal Circuit issued its remand decision in Akamai Technologies, Inc. v. Limelight Networks, Inc., and this time affirmed the district court decision that Limelight was not liable for infringement of Akamai’s patents because Limelight had not performed each step of the method claims and was not responsible for the actions of its customers. The decision sets a high bar for joint infringement of method claims, requiring a principal-agent relationship, contractual relationship, or joint enterprise to hold a party liable for the actions of another.
Liability For U.S. Patent Infringement
Liability for U.S. patent infringement is provided for in 35 [...]
On February 5, 2015, the USPTO announced the launch of an Enhanced Patent Quality Initiative and solicited public comments on certain proposals aimed at improving patent quality, which are due by May 5, 2015. With a few weeks left in the comment period, the Office of Inspector General of the U.S. Department of Commerce issued a report on its review of the USPTO’s quality assurance program. The report is eye-opening and underscores the problems the USPTO faces in measuring and improving patent quality.
USPTO Patent Quality Pillars and Initiatives
In the February 5 Federal Register Notice, the USPTO identified three patent quality pillars and six new patent quality initiatives [...]
Under U.S. patent laws, the 20-year term of a patent can be extended if the USPTO fails to meet certain timeliness benchmarks during the patent examination process. The statute provides for Patent Term Adjustment (PTA) equal to the number of days of USPTO delay, less the number of days of applicant delay. The statute defines taking more than three months to respond as one type of applicant delay, and delegates authority to the USPTO to define other circumstances that amount to applicant delay, which the USPTO has done in 37 CFR § 1.704. While many of the USPTO’s circumstances are not surprising, one category in particular can result in PTA deductions for actions made to advance prosecution.[...]
Last week, in In Re Roslin Institute, the U.S. Court of Appeals for the Federal Circuit held that cloned cattle, sheep, pigs and goats are non-patent eligible subject matter under 35 USC § 101. While the result that these cloned animals cannot be patented may not be surprising, the basis for the court’s finding–that the claimed subject matter was ineligible under the “product of nature” doctrine, has some scratching their heads. A more logical way to understand the decision is to read the court’s holding as finding that the cloned animals are non-patent eligible subject matter because they cannot be distinguished from naturally occurring animals.
The patent application at iss [...]