Latest Publications

Share:

Statements of Efficacy and Safety Material Claim Limitations

In Allergan Sales, LLC v. Sandoz, Inc., (Fed. Cir. 2018-2207, Aug. 29, 2019), the Federal Circuit held that “wherein” clauses in a patent claim were limitations because the “wherein” elements were material to patentability....more

The Era of Personalized Medicine Has Arrived - PMC’s Annual Progress and Outlook Report

The Personalized Medicine Coalition (PMC) released its annual “Personalized Medicine At FDA: A Progress & Outlook Report” (Report) that monitors current successes and challenges in bringing personalized therapies to market....more

PMC Releases "A Consumers Guide to Genetic Health Testing"

The Personalized Medicine Coalition, or the “PMC” is an organization of over 250 members that seeks to promote the understanding and adoption of personalized or precision medicine concepts, services, and products by health...more

Is 101 Relief in Sight?

Senators Thom Tillis (R-N.C.) and Chris Coons (D-Del.) released a plan to revise Section 101 of Title 35 of the U.S. Code relating to U.S. patent law, reports Alexis Kramer of Bloomberg Law. As reported by Ms. Kramer, the...more

New Guidance from Federal Circuit for Computer-Implemented Medical Methods

A patent claiming methods to integrate physiological treatment data remotely using a computer was held invalid under 35 U.S.C. § 101. University of Florida Research Foundation, Inc. v. General Electric Company, et al. (Fed....more

USPTO Releases 2019 Eligibility Update

On January 4, 2019, the US Patent and Trademark Office (USPTO) announced revised guidance for determining subject matter eligibility under 35 U.S.C. § 101 for computer-implemented inventions (Guidance). The Guidance takes...more

Medical Treatment Patent Claims Held Patentable Subject Matter Under the Alice/Mayo Section 101 Test

In Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals Int’l Ltd, Slip Op. (Nos. 2016-2707, 2016-2708, April 13, 2018) the U.S. Court of Appeals for the Federal Circuit provided useful guidance for patentees seeking to...more

Advancing Access to Precision Medicine Act - A Bipartisan Bill

On February 15, 2018, representatives Eric Swalwell (CA-15), John Shimkus (IL-15), Scott Peters (CA-52), Erik Paulson (MN-03), and Juan Vargas (CA-51), introduced the Advancing Access to Precision Medicine Act (H.R....more

FDA Releases Stem Cell Guidance Documents

Therapies that use autologous or allogeneic stem cells are examples of early personalized therapies. Removing cells from a patient and reintroducing them to the same or a matched patient, for example, as done in bone marrow...more

FDA Approves Companion Dx for PD-1 Inhibitor

According to the American Cancer Society (“ACS”), lung cancer (both small cell and non-small cell) is the second most common cancer in both men and women (not counting skin cancer). About 14% of all new cancers are lung...more

USPTO Update on Patent-Eligibility for Life Science Inventions

On August 2nd 2017, the USPTO hosted a Bicoastal Biotechnology/Chemical/Pharmaceutical Customer Partnership that focused on the USPTO’s current thinking on patent-eligibility. The meeting followed the USPTO’s June 25th, 2017...more

Why The Federal Circuit Revisited Written Description

In Stanford University v. The Chinese University of Hong Kong (Fed Cir. No 2015-2011, June 27, 2017), the Federal Circuit vacated and remanded interference decisions on the ground the Patent Trial and Appeal Board (“Board”)...more

USPTO Extends Cancer Immunotherapy Pilot Program

On June 29th, 2016, the USPTO announced the Cancer Immunotherapy Pilot Program to allow expedited examination of patent applications that pertain to cancer immunotherapy. Under the Program and after proper petition, the USPTO...more

NIH Begins Beta Test of Million Patient Cohort

The National Institutes of Health announced the enrollment of the first participants as beta testers of the “All of Us” research program. Initially branded as the “Precision Medicine Initiative®” Cohort Program, “All of Us”...more

Federal Circuit’s Primer on Equivalence Infringement of Chemical Process Patents

In an appeal characterized as “unusual,” the Federal Circuit affirmed the grant of a preliminary injunction, holding it likely that plaintiff patent holder would succeed on the merits its claim of infringement of a patent...more

Breaking Down Barriers Between Pre-clinical and Clinical Adoption of Personalized Medicine

Personalized medicine will change how health care is delivered and disease is prevented and treated. But first, how disease and health is defined, as well as the clinical development and adoption of new therapies must align...more

HHS and Medicare Asked to Expand Coverage for Genetic Tests

Fifteen members of Congress have asked the Department of Health and Human Services (HHS) and the Medicare Payment Advisory Commission (Medicare) to examine how the federal government can help improve patient access to genetic...more

One is Not Enough – Infringement Liability under § 271(f)(1)

In Life Technologies Corp. v. Promega Corp., Slip Op. 14-1538 (Feb. 22, 2017), the U.S. Supreme Court held that the supply of a single component of a multicomponent invention for manufacture abroad does not give rise to...more

Federal Circuit Knocks Out Patents After CBM Challenge

Apple successfully invalidated three patents for failure to recite patent eligible subject matter. Apple, Inc. v. Ameranth, Inc., 2015-1792, 2015-1793 (Fed. Cir. 2016). The patents relate to synchronous communication systems...more

FDA Hits “Pause” on Regulation of LDTs

On January 13, 2017, the U.S. Food and Drug Administration (FDA) issued a Discussion Paper on Laboratory Developed Tests (LDTs) (LDTs) (Discussion Paper). The Discussion Paper follows FDA’s late 2016 announcement that,...more

More Than 25% of New Molecular Entities Approved in 2016 Are Personalized Medicines

The Personalized Medicine Coalition (PMC) recently reported that for the third year in a row, personalized medicines accounted for more than 25% of all new molecular entities (NMEs) approved by the US Food & Drug...more

Precision Medicine - Obama’s Health Care Legacy

As we come to the end of President Obama’s administration, it is time to look back on the past eight years and the administration’s impact on the delivery of the nation’s health care. While the Affordable Care Act (signed...more

New Report Outlines 5 Year Plan to Achieve Cancer Moonshot

The Cancer Moonshot Task Force has just released its 5 year plan for implementing President Obama’s “Cancer Moonshot” program (“Report”). The initiative, announced during President Obama’s 2016 State of the Union Address, is...more

Inherent Disclosure Satisfied Written Description

In Yeda Research and Development Co., Ltd. v. Abbott GMBH & Co. KG, Slip Op. 2015-1662 (Fed. Cir. 2016), the Federal Circuit held that a claim to an isolated protein described by its partial amino acid sequence satisfies 35...more

Ariosa Loses Verinata Patent Challenge

Fetal diagnostic pioneer Ariosa Diagnostics lost its latest attempt to invalidate competitor Verinata Health’s U.S. Patent No. 8,318,430, “Methods of Fetal Abnormality Detection.” The USPTO’s Patent Trial and Appeal Board...more

148 Results
 / 
View per page
Page: of 6

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide