IP Law Bulletin

Patent prosecutors drafting claims that recite open-ended ranges (e.g., at least 10%, greater than 5 units) were again warned of the perils of claiming more than has been disclosed. In a recent decision by the Federal Circuit, MagSil Corp. v. Hitachi Global Storage Tech., Inc., the Court affirmed the trial court’s determination that the asserted claims were invalid as a matter of law for lack of enablement. The Court found that the open-ended range recited in the independent claim was not enabled because the disclosure provided support for only a small portion of the claimed open-ended range, citing to the dual function of enablement for both ensuring there is adequate disclosure to support a claimed invention and preventing claims broader than the disclosed invention. Patent practitioners reciting open-ended ranges should consider taking one or more steps to better ensure validity of their claims, including reciting the structure that enables the recited range in the claim, adding dependent claims that close the open-ended range, and providing examples in the specification that support a wide spectrum of values, and in particular values that fall within the high end of the open-ended range.

On August 16, 2012, biotechnology patent owners breathed a short sigh of relief, as the US Court of Appeals for the Federal Circuit issued the highly anticipated decision in Association for Molecular Pathology v. Myriad Genetics, finding that DNA sequences are indeed eligible for patent protection. However, not all biotech innovators will be happy with the Myriad decision since certain diagnostic method claims were again struck down as ineligible for patent protection. Additionally, one of the three judges on the panel dissented on the patentability of isolated DNA, arguing, “extracting a gene is akin to snapping a leaf from a tree.” The final word on this subject may need to come from the Supreme Court.

The Federal Circuit in In re Baxter International upheld a reexamination decision by the Board of Patent Appeals and Interferences that conflicted with the Federal Circuit’s prior determination of validity of certain claims.  The Federal Circuit’s original decision was rendered on appeal from a request by Fresenius, a competitor of Baxter, to declare Baxter’s patent invalid.  Fresenius originally lost on certain claims in both the District Court and the Federal Circuit for failing to prove the patent’s invalidity by clear and convincing evidence.

In the wake of the Supreme Court’s recent decision in Prometheus v. Mayo, the Federal Circuit held in CLS Bank v. Alice Corp. in a 2-1 decision that it must be “manifestly evident” that a claim is directed to an abstract idea for the claim to be invalid for that reason under 35 U.S.C. § 101.  The court held that the single most reasonable conclusion must be that the “claim is directed to nothing more than a fundamental truth or disembodied concept, with no limitations in the claim attaching that idea to a specific application” for the claim to be invalid for claiming an abstract idea.  The court cautioned against “paraphrasing a claim in overly simplistic generalities” and emphasized that “[p]atent eligibility must be evaluated based on what the claims recite, not merely on the ideas upon which they are premised.”  The majority also noted that sections 102, 103, and 112 of 35 U.S.C. are equally as important as § 101, and that a district court is free to address invalidity issues in whatever order it chooses.

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.

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.

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.