Recommendations for NextGen Health IT Infrastructure

Health care information technology (health IT) facilitates the delivery of personalized medicine by providing and supporting the infrastructure for patients, consumers and health care providers to communicate and distribute information. The Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC) (collectively, the Office) acknowledge the importance of the technology and the risks to the public if this infrastructure is not adequately maintained. In its report “FDASIA Health IT Report: Proposed Strategy and Recommendations for a Risk-Based Framework” (Report), the Office has proposed a strategy and offered recommendations to maintain the integrity of health IT while supporting innovation. The proposed strategy and recommendations are based on the premise that risk and corresponding controls should focus on health IT functionality and not the platform(s) on which such functionality resides or the product name/description of which it is a part. Embedded within the Report are several points that may be relevant to those involved with the development of products and services that support the delivery of personalized health care information that clinical decisions. Continue reading this entry

USPTO Releases Examiner Post-"Myriad" Training Slides – Points to Ponder

The United States Patent and Trademark Office (USPTO) published its examiner training materials (Training Materials) for applying ”2014 Procedures For Subject Matter Eligibility Analysis Of Claims Reciting Or Involving Laws of Nature/Natural Principles, Natural Phenomena, And/Or Natural Products” (Guidance), that advised U.S. patent examiners and the public of the factors for determining whether a patent claim satisfies the U.S. Supreme Court’s interpretation of 35 U.S.C. §101, as applied to products and processes that might fall under one of the judicial exceptions to patentable subject matter (see my prior posts of March 5th and March 7th for a review of the Guidance). A few points raised in the Training Materials bear close attention. Continue reading this entry

USPTO Issues Guidance for Examining Process Patents

On March 4th, 2014, the U.S. Patent and Trademark Office (USPTO) issued “2014 Procedures For Subject Matter Eligibility Analysis Of Claims Reciting Or Involving Laws of Nature/Natural Principles, Natural Phenomena, And/Or Natural Products” Guidance, advising examiners and the public of the factors for determining whether an invention satisfies the U.S. Supreme Court’s interpretation of 35 U.S.C. §101, as applied to patent-eligibility. See Assn. for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __, 133 S. Ct. 2107 (2013) (“Myriad“) and Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. __, 132 S. Ct. 1289 (2012) (“Prometheus“). The Guidance advises examiners to apply the Myriad and Prometheus holdings to any subject matter that could be characterized as a judicial exception to patent-eligibility: a law of nature; a natural principle; a natural phenomena, or a natural product. If the claimed subject matter could fall within one of the judicial exceptions to patent-eligibility, examiners are instructed to evaluate the claimed subject matter, using the following factors, to determine if the claim recites something significantly different than the judicial exception(s). My March 5th post reviews the Guidance’s analysis of patent claims that could fall under the natural product exception to patent-eligibility. This post will review the Guidance’s review of patent claims that could fall relate to a law of nature exception to patent-eligibility. Claims directed to abstract ideas are not analyzed using the principals of the Guidance. Examiners are directed to MPEP 2106(II) for analysis of claims involving abstract ideas. Continue reading this entry

USPTO to Apply Myriad Beyond Isolated DNA

On March 4th, 2014, the United States Patent and Trademark Office (“USPTO”)  issued a Guidance, advising examiners and the public of the factors for determining whether an invention satisfies the U.S. Supreme Court’s interpretation of 35 U.S.C. §101, as applied to patent-eligibility. See Assn. for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __, 133 S. Ct. 2107 (2013) (“Myriad“) and Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. __, 132 S. Ct. 1289 (2012) (“Prometheus“). The Guidance supersedes the USPTO’s one page document issued the day the U.S. Supreme Court held that isolated DNA that is structurally no different from DNA in the human body, other than it is isolated from the human body, is not patent-eligible. (See the prior post of June 13, 2013.) In the Guidance, the USPTO advises examiners to apply the Myriad and Prometheus holdings to any subject matter that could be characterized as a judicial exception to patent-eligibility: a law of nature; a natural principle; a natural phenomena, or a natural product. If the claimed subject matter could fall within one of the judicial exceptions to patent-eligibility, examiners are instructed to evaluate the claimed subject matter, using the following factors, to determine if the claim recites something significantly different than the judicial exception(s). Continue reading this entry

Genentech's Distribution of Prescribing Information to Physicians is Alleged to Infringe Method Patent

On January 31, 2014, Phigenix, Inc.  (“Phigenix”) filed a lawsuit in federal district court in Georgia alleging that the sale and use of the drug Kadcyla by Genentech, Inc. (“Genentech”) infringed U.S. Patent No. 8,080,534B2, assigned to Phigenix, under 35 U.S.C. Section 271. Particularly, Phigenix alleges that Genentech’s distribution of prescribing information to healthcare professionals such as physicians throughout the United States, infringes the patent.

U.S. Patent No. 8,080,534B2

U.S. Patent No. 8,080,534B2, (“the ’534 Patent”) issued on December 20, 2011, to Carlton D. Donald and is titled Targeting PAX2 for the Treatment of Breast Cancer . The ‘534 Patent relates to the treatment of breast cancer by administering a composition that inhibits PAX2 expression or PAX2 activity to the patient. The relevant claims of the ’534 Patent recite: Continue reading this entry