Tuesday, April 14, the House Judiciary Committee convened to discuss H.R. 9, the “Innovation Act,” which was introduced in February 2015 by the Committee’s Chairman, Rep. Bob Goodlatte (R-VA). The hearing came a day after the Federal Circuit Bar Association sent a letter to Rep. Goodlatte that questioned the need for a bill creating a presumption of fee-shifting, given the marked increase in fee awards in patent cases since the Supreme Court’s 2014 opinion in Octane Fitness LLC v. Icon Health & Fitness Inc. In its letter, the FCBA also warned that the fee-shifting provision could pose a significant obstacle to legitimate enforcement efforts. Continue Reading
In a decision released on March 25, 2015, FDA denied a Citizen’s Petition that would have effectively made the information and patent exchange described in § 262 of the Biologics Price Competition and Innovation Act (“BPCIA”) a precondition for approval. The Petition, which had been filed by Amgen, requested that FDA require biosimilar applicants to certify to FDA that they had provided the reference product sponsor a copy of their biosimilar application as well as “information that describes the process(es) used to manufacture the biosimilar product that is the subject of that application.” FDA Response at 1. FDA denied the Petition, finding that the language of the BPCIA did not require FDA to act and explaining that that FDA would not exercise its discretion to force biosimilar applicants to comply with a provision the interpretation of which is currently the subject of ongoing litigation.
Under Secretary of Commerce for Intellectual Property and USPTO Director, Michelle Lee, announced on Friday that a series of actual and proposed rulemakings aimed at improving post-grant proceedings before the PTAB will be forthcoming—some effective immediately and others rolling out over the summer and beyond.
According to Lee, at least some of the changes have been spurred by comments received from industry, academic and legal commentators in response to a notice of proposed rulemaking (“Request for Comments on Trial Proceedings Under the America Invents Act Before the Patent Trial and Appeal Board”) published by the Patent Office in the Federal Register in June 2014.
Three-Phase Plan: Lee explained that the Office is currently planning to implement some of its changes to the post-grant proceeding rules in three stages.
Fifty years ago, the Supreme Court held in Brulotte v. Thys Co., 379 U.S. 29 (1964) that a license agreement requiring royalty payments for use of a patented invention after expiration of the patent term is unlawful per se. On March 31, in Kimble v. Marvel Enterprises, Inc., No. 13-720, the Supreme Court will consider whether economics, the parallel antitrust law, and marketplace realities are such that Brulotte should be overturned.
Kimble arose out a licensing dispute over a patent settlement involving a glove that allows its wearer to mimic the comic-book hero Spider-Man by shooting pressurized foam string from the palm. While expressing some reservation regarding whether the Brulotte rule continued to make sense, the Ninth Circuit held that the settlement royalty provision was unenforceable after the patent’s expiration.
The thrust of Kimble’s argument is that Brulotte was based on antitrust principles regarding the inherent market power of a patent and antitrust per se rules—principles that have been widely rejected. Kimble advocates instead that Brulotte-type agreements be analyzed on a case-by-case basis under the antitrust rule of reason and only be invalidated if the patentee is actually shown to have market power.
The case has attracted over a dozen amicus briefs on all sides of the issues, including from the American Intellectual Property Law Association, the Licensing Executives Society, and Intellectual Property Owners Association.
Most notably, the Solicitor General has submitted a brief defending the Brulotte rule and has been granted the right also to present oral argument. The SG argues that the rule is based on sound patent law principles of free public access to unpatented and formerly-patented inventions and that antitrust considerations do not justify overruling Brulotte’s rule of patent policy. The SG further contends that principles of stare decisis apply with particular force to statutory-interpretations decisions such as this one.
We will be monitoring the Supreme Court oral argument next week and will report further.
In a recent decision, the International Trade Commission rejected a petitioner’s attempt to use allegations of unfair competition and unfair acts as a possible way of working around the Federal Circuit’s bar on claims of induced infringement.
The Commission issued its Notice of Investigation in Certain Audio Processing Hardware and Software and Products Containing Same, ITC Inv. No. 337-TA-949 on March 12, 2015. The complaint filed by Andrea Electronics Corporation alleges that Respondents Acer, ASUSTek, Dell, Hewlett Packard, Lenovo, Toshiba, and Realtek Semiconductor unlawfully import into the United States and sell to end users certain microphone products, audio codecs, audio processing software, and personal computers (including laptops, desktops, notebooks, and tablets) that induce infringement of Andrea’s patents. Certain Audio Processing Hardware and Software and Products Containing Same, ITC Inv. No. 337-TA-949, Complaint (Feb. 9, 2015).
Filing an appeal brief with the Patent Trial and Appeal Board (PTAB) can be an effective way to advance prosecution and secure allowable claims. Last November, we summarized Tips for Writing Effective PTAB Briefs to help propel applicants to PTAB victory. The U.S. Patent and Trademark Office (USPTO) published guidance on March 11, 2015 about claim grouping in appeal briefs, “Effective Use of Claim Grouping in Appeals to the Patent Trial and Appeal Board.” We now summarize the guidance and provide further tips in view of it to help make the organization of your brief effective. Perhaps the most important tip of all is to remember that, as emphasized in the PTAB guidance’s concluding paragraph, every situation is different. Carefully considering the issues in your particular case will help ensure that your appeal brief is organized as effectively as possible.
In an order released on March 19, 2015, U.S. District Court Judge Richard Seeborg of the Northern District of California denied Amgen’s motion for judgment on the pleadings as well as its request for a preliminary injunction to prevent Sandoz from marketing its drug Zarxio®. Amgen v. Sandoz, No. 14-cv-04741-RS (N.D. Cal. Mar. 19, 2015). The ruling was consistent with the judge’s earlier statements regarding Amgen’s motions during a hearing held on March 13, 2015.
On March 6, 2015, the U.S. Food and Drug Administration (FDA) granted approval for Zarxio®, making the pharmaceutical company Sandoz the first company to win approval of a “biosimilar” product. Zarxio® is biosimilar to Amgen’s Neupogen® (filgrastim), which was originally approved for use in 1991 to stimulate the proliferation and differentiation of white blood cells. On July 24, 2014, Sandoz announced that the FDA had accepted its Biologics License Application (BLA) for filgrastim, an application which was filed under the new biosimilar pathway created in the Biologics Price Competition and Innovation Act of 2009 (BPCIA).
The U.S.I.T.C. instituted its first investigation under its 100-day pilot program for early determination of a specific potentially case-dispositive issue.
On March 12, 2015, the Commission issued its Notice of Investigation in Certain Audio Processing Hardware and Software and Products Containing Same, ITC Inv. No. 337-TA-949. The complaint filed by Andrea Electronics Corporation alleges that the Respondents unlawfully import into the United States certain microphone inputs, microphones and microphone arrays, audio codecs, audio processing software, and personal computers (including laptops, desktops, notebooks, and tablets). The named Respondents include Acer, ASUSTek, Dell, Hewlett Packard, Lenovo, Toshiba, and Realtek Semiconductor. Certain Audio Processing Hardware and Software and Products Containing Same, ITC Inv. No. 337-TA-949, Complaint (Feb. 9, 2015).
As the March Madness season kicks into full gear, organizations throughout the country will be seeking to capitalize upon the energy created by college basketball to host events and promotions. In doing so, however, it is important to remember that the phrase “March Madness” is a federally registered trademark owned by the NCAA. For full details on NCAA’s ownership of the trademark and how to avoid getting into a sticky situation regarding this phrase, please see our post on our Copyright & Trademark Matters blog.
Applicants identified upon a U.S. patent application’s filing can impact the ownership rights to the patent application throughout prosecution. Prior to implementation of relevant aspects of the America Invents Act (AIA) on September 16, 2012, patent application Applicants could only be Inventors. Conversely, applications filed on or after September 16, 2012 can have Inventors or Assignees as Applicants. The choice of Applicant – Inventors or Assignees – upon filing in post-AIA applications affects how Power of Attorney can be properly established before the U.S. Patent and Trademark Office (USPTO).
Pre-AIA patent applications filed before September 16, 2012 can have Power of Attorney granted by Inventors or Assignees under Rule 32, provided that the requirements of Rule 3.73 are satisfied. In contrast, post-AIA applications filed on or after September 16, 2012 can be filed with Inventors or Assignees as the Applicant, with Rule 32 requiring a Power of Attorney to be signed by either the “Applicant” or “Patent Owner.” However, an Assignee only becomes the patent owner after the application issues as a patent. Thus, in order to take over prosecution in a post-AIA application, the Assignee must either initially be listed as or later formally established to be the Applicant for Power of Attorney to be granted on behalf of the Assignee.