IP Law Bulletin

About five years ago, the Federal Circuit in In re Seagate Technology set-out a two-prong test for proving a patent was willfully infringed: (1) patentee must show by clear-and-convincing evidence that the infringer acted despite an objectively high likelihood that its actions constituted infringement of a valid patent; and (2) patentee must also demonstrate that this objectively-defined risk was either known or so obvious that it should have been known to the accused infringer. In a recent decision Bard Peripheral v. W.L. Gore, the Federal Circuit provided further insight to this test by holding that the first prong, i.e., whether a defendant’s actions were objectively reckless, is a question of law to be determined by the judge. While the second prong and the ultimate determination of willful infringement remains a question for the jury to decide, it is anticipated that when a judge finds a defendant acted in an objectively reckless manner, a jury will find in favor of the second prong, and thus in favor of willful infringement. However, by putting the first question in the hands of the judge, it is also anticipated that there will be fewer findings of objective recklessness because many consider it more difficult to convince a judge than a jury that a defendant’s actions were objectively reckless. Of note to litigators is that the objective reckless determination is now subject to de novo review, i.e., without deference to the lower court’s decision, because the determination is a question of law.

On May 16, 2012, the United States Patent and Trademark Office (PTO) launched a new “Quick Path Information Disclosure Statement (QPIDS)” pilot program.  The program is intended to reduce application pendency and applicant costs when it becomes necessary to submit an information disclosure statement (IDS) after the issue fee is paid for a patent application.

On July 2, 2012, the PTO announced plans to open regional PTO offices in Denver, Colorado, Dallas, Texas, and San Jose, California. These three offices, along with the regional office that just opened this past week in Detroit, Michigan, will be used to work with entrepreneurs to process patent applications, reduce the backlog of unexamined patents and appeals of examiner rejections, and speed up the overall patent application process. The PTO plans to establish a timeline for opening the newly announced offices in the coming months. The PTO is also currently working on establishing a model for how the regional offices will be set-up and operate in conjunction with the main office in Alexandria, Virginia. This model will likely evolve based on lessons learned from the new Detroit office. We note that the Boston Patent Law Association (BPLA) spearheaded an effort to bring one of the regional offices to the New England region. While we are disappointed that the exceptional bid prepared by the BPLA was unsuccessful, the new offices will certainly help our clients even if they do not have offices in Detroit, Denver, Dallas, or San Jose as these regional offices continue to support the PTO’s efforts to expedite patent prosecution. Stay tuned to future updates from Nutter about the set-up and operation of the regional offices.

On July 5, 2012, the United States Patent and Trademark Office issued a memorandum to all patent examiners providing guidelines for examining process claims for patent eligibility in view of the Supreme Court decision Mayo v. Prometheus. Entitled “2012 Interim Procedure for Subject Matter Eligibility Analysis of Process Claims Involving Laws of Nature,” the much-anticipated guidance is intended to apply to process claims focused on a law of nature, natural phenomenon, or naturally occurring relation or correlation (“natural principle”). Although it is expected this guidance will predominantly impact claims examined in Technology Center 1600 (Biotechnology), the guidelines will be applicable to any process claim that refers to a natural principle. Process claims directed to abstract ideas, such as the claims in Bilski will continue to be examined using the previously issued guidance for determining subject matter eligibility under Bilski v. Kappos.

In our November 2010 and January 2010 issues, we reported on the Patent Office’s (PTO) then-new Green Technology Pilot Program (GTPP), which was one of several programs that allow an applicant to receive expedited prosecution of their application. The GTPP in particular allows an applicant to petition for his or her application to be examined more quickly if it pertains to the development of a renewable energy source, energy conservation, or the reduction of green house gas emissions. Earlier this year, the PTO officially closed the opportunity to file petitions under the GTPP because the number of granted petitions and pending applications reached the limit of 3,500 applications being accorded special status under the pilot program. Many applicants are now faced with the question of what to do to speed up prosecution of their applications, whether they are directed to “green tech” or not.

On March 9, 2012, the Indian Controller of Patents granted the first compulsory license to an Indian company to manufacture a patented drug. The decision could have wide-ranging implications for pharmaceutical companies holding patents in India, as well as in other countries throughout the world.

The Supreme Court issued a ruling in Kappos v. Hyatt on April 18, 2012, that clarifies the rules regarding the introduction of new evidence in a district court action challenging a rejection of a patent application by the Board of Patent Appeals and Interferences under 35 U.S.C. § 145. The Court affirmed a prior en banc Federal Circuit decision, holding there are no limitations on a patent applicant’s ability to introduce new evidence in a Section 145 proceeding beyond those present in the Federal Rules of Evidence and the Federal Rules of Civil Procedure. In so holding, the Court rejected the Patent Office’s (PTO) contention that new evidence should be admissible only if the applicants had no reasonable opportunity to present the evidence during prosecution. The Court was also not persuaded that the Administrative Procedure Act or any other precedent precluded the introduction of new evidence or required the use of a deferential standard of review. Instead, the Court held that any new evidence introduced is evaluated under a de novo standard of review, though the district court does have discretion to consider the findings of the PTO when evaluating the new evidence.

On March 16, 2013, the U.S. Patent Office will change from a first-to-invent to a first-to-file system. The Board of Patent Appeals and Interferences will be replaced by the Patent Trial and Appeal Board and interference practice will go by the way-side. Newly defined Derivation Proceedings will also begin at this time. The question for many in the scientific world is: does a well-kept laboratory notebook matter in this new race to the Patent Office?

The Federal Circuit recently issued a decision in In re Staats confirming that patentees can seek broadened reissue claims more than two years after a patent issues as long as they first sought a broader claim within the two year period. While filing a continuing application during the pendency of an original application is usually the preferred approach, the Staats panel confirmed that seeking a broadening reissue is another available option, even after the two year mark.

The Supreme Court issued two long-awaited decisions that are likely to have broad-reaching effects on diagnostic method patents, as well as personalized medicine patents. On March 20, 2012, the Supreme Court unanimously reversed the Federal Circuit in Mayo Collaborative Services v. Prometheus Laboratories, Inc., holding that Prometheus’ claim, which had been twice upheld by the Federal Circuit, was an unpatentable law of nature. Shortly thereafter, the Court granted certiorari in the hotly-contested biotech case of Association for Molecular Pathology v. Myriad Genetics, vacated the Federal Circuit’s opinion, and remanded the case to the Federal Circuit for further consideration in accordance with the Mayo decision.