IP Law Bulletin

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.

Following close on the heels of last week’s controversial decision in Mayo Collaborative Services v. Prometheus Laboratories, the United States Supreme Court sent another hotly contested biotech case back down for further consideration by a lower federal court. In Association for Molecular Pathology v. Myriad Genetics, the Supreme Court granted certiorari to the parties in the Myriad case, vacated the decision of the Court of Appeals for the Federal Circuit, and then promptly remanded the case to the Federal Circuit for reconsideration in accordance with the Supreme Court’s March 20th decision in the Mayo case, which held that a diagnostic method claim that simply recites a law of nature is unpatentable subject matter under 35 U.S.C. §101.

On March 20, 2012, the United States Supreme Court unanimously reversed the Federal Circuit in a long-awaited decision that may have broad-reaching effects on diagnostic method patents, as well as personalized medicine patents. At issue in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. ___ (2012) was whether the correlation between blood levels and optimal dosages of a drug was a patentable process or an unpatentable law of nature. The Court held that Prometheus' claim, which had been twice upheld by the Federal Circuit, was an unpatentable law of nature.

A previous edition of Nutter’s IP Bulletin included an article analyzing U.S. post-grant review proceedings established by the Leahy-Smith America Invents Act (AIA) in view of European opposition proceedings. As a follow up, our readers may be interested in a cost comparison of the AIA’s post-grant review and European opposition proceedings recently presented by Director David Kappos on the USPTO’s website. Director Kappos indicates that the AIA’s post-grant review procedures are more costly than European opposition proceedings primarily because the AIA’s post-grant review procedures are more akin to litigation (e.g., conducted by patent judges, allow substantial discovery, and create estoppel) while European oppositions proceedings are akin to patent examination (e.g., conducted by examiners, no discovery, and no estoppel).

The Federal Circuit recently addressed the patentability of ranges. In ClearValue, Inc. v. Pearl River Polymers, Inc., decided on February 17, 2012, the court reversed a denial of Judgment as a Matter of Law (JMOL) seeking a ruling of anticipation and found the claimed invention, which recites a clarification process for “water of raw alkalinity less than or equal to 50 ppm” by using a blend of a high molecular weight polymer and an aluminum polymer, to be anticipated by a reference that disclosed the same blend for clarifying water of “up to 150 ppm.”