Life Sciences

News & Analysis as of

Post-Grant Review Roils Patent Litigation Waters

The America Invents Act (AIA) has had a profound impact on patent litigation, particularly surrounding inter partes and other post-grant proceedings. Below, Manish K. Mehta, who handles patent litigation across an array of...more

Smith & Nephew Sells Its Gynecology Business for $350 Million

Smith & Nephew recently announced that it will sell its gynecology business to Medtronic for $350 million. As part of the sale, Medtronic will obtain Smith & Nephew’s key gynecological surgical solution, called the TRUCLEAR...more

BIO Publishes Study on Capital Raising for Emerging Therapeutic Companies

On May 24, 2016, the Biotechnology Innovation Organization (BIO) published a study, “Emerging Therapeutic Company Investment and Deal Trends,” which collects ten years of data to identify trends affecting “emerging...more

UPDATE: Subject Matter Eligibility under 35 U.S.C. § 101 – Life Sciences

The United States Patent And Trademark Office (USPTO) issued a memorandum on May 4, 2016 (May 2016 Memo) to the Patent Examining Corps to provide further Examiner instructions relating to subject matter eligibility under 35...more

U.S. Trade Representative Issues 2016 Special 301 Report

On April 27th, Ambassador Michael B.G. Froman, U.S. Trade Representative (USTR), issued the 2016 Special 301 Report. According to the USTR website, "[i]ntellectual property is a critical source of economic growth and...more

FDA Issues “Leapfrog” Draft Guidance for 3D Printing of Medical Devices

3D printing raises significant technical considerations for device manufacturers. In response to the increasing use of 3D printing in the medical device arena, on May 10, the US Food and Drug Administration (FDA or...more

MoFo BioMeter, Volume 5, Issue 1

The full-year 2015 BioMeter paints the picture of a strong year for biotechnology, but deeper analysis shows a cautionary trend. The average BioMeter value for the entire year across all transactions reporting up-front...more

Q1 2016 IPO Market Review

The first quarter of 2016 produced a meager eight IPOs with gross proceeds of $667 million. Only once over the prior 12 years has the first quarter produced a lower tally—there were only two new offerings in the glum...more

U.S. Patent Office Updates Subject Matter Eligibility Guidance, Including Life Science Examples

In view of the U.S. Supreme Court’s decisions in Alice, Myriad, and Mayo, the United States Patent and Trademark Office (USPTO) has issued a series of guidance documents on patent subject matter eligibility under 35 U.S.C. §...more

The Government Whittles Away at Life Sciences Patents

The current U.S. Supreme Court has been noted for its hostility to patent holders in general, but the Supreme Court has been especially hostile to any sort of life sciences or software invention. The Court has attempted to...more

USPTO Updates Alice Guidance with Examiner Instructions, More Work Needed

On May 4, the USPTO issued a new memorandum for patent examiners, “Formulating a Subject Matter Eligibility Rejection and Evaluating the Applicant's Response to a Subject Matter Eligibility Rejection” (“Examiner...more

Top Takeaways from Fenwick’s Fifth Annual Digital Health Investor Summit

Fenwick’s fifth annual Digital Health Investor Summit brought together investors who are active in the digital health space to discuss the evolving digital health sector and their investment outlook for the year...more

Subject Matter Eligibility Guidance -- Example on Diagnosing and Treating Julitis

Last week, the U.S. Patent and Trademark Office issued further guidance for determining subject matter eligibility under 35 U.S.C. § 101. In addition to a memorandum on subject matter eligibility determinations that was...more

With a Focus on Life Sciences Claims, USPTO Issues 2016 Guidance on Patentable Subject Matter

Earlier this month, the U.S. Patent & Trademark Office (“USPTO”) issued updated guidance to its examining corps concerning subject matter eligibility rejections and responses under 35 U.S.C. § 101. The 2016 Guidance,...more

USPTO Issues New Subject Matter Eligibility Examples for Life Sciences

The United States Patent and Trademark Office (USPTO) recently provided updated guidance regarding the patent eligibility of subject matter related to natural products. The updated guidance may be of interest to companies...more

U.S. Patent Office Issues New Examples of Patent Eligibility Analysis of Life Sciences Claims

On May 4, 2016, the United States Patent Office published a subject matter eligibility update for determining patent eligibility under 35 U.S.C. § 101. The Update supplements the previous guidelines and includes additional...more

Patentable Subject Matter in the Life Sciences: New USPTO Guidance Impacts Diagnostic Methods and Natural Products

The United States Patent and Trademark Office issued on May 6, 2016, updated guidance to its patent Examiners that would have an impact on patent applications covering diagnostic methods and natural products. The new...more

USPTO Releases Patent Eligibility Update

On May 4, 2016, the USPTO released a “May 2016 Subject Matter Eligibility Update” (“Update”) providing guidance to patent examiners on formulating a subject matter eligibility rejection and evaluating an applicant’s response...more

USPTO Issues Update to Subject Matter Eligibility Guidance

In a notice published in the Federal Register (88 Fed. Reg. 27381) on Friday, the U.S. Patent and Trademark Office issued further guidance for determining subject matter eligibility under 35 U.S.C. § 101. The notice,...more

Silicon Valley Venture Capital Survey - First Quarter 2016

Background - We analyzed the terms of 148 venture financings closed in the first quarter of 2016 by companies headquartered in Silicon Valley. Overview of Results - The weakening in valuations that began in...more

USPTO Issues Subject Matter Eligibility Update

On May 5, 2016, the USPTO published a Memorandum to the Patent Examining Corps titled “Formulating a Subject Matter Eligibility Rejection and Evaluating the Applicant’s Response to a Subject Matter Eligibility Rejection.” The...more

New (and Improved?) PTO Guidelines on Biotech Patent-Eligibility

The PTO has released a new set of life sciences’ examples to teach Examiners how and when to reject claims and, hopefully, teach the patent bar how to write allowable claims. (A copy if found at the end of this...more

USPTO Releases Next Iteration of Examiner Guidance on Patent Subject Matter Eligibility

On May 5, 2016, the USPTO released an update to its examiner guidance on patent subject matter eligibility. The update includes a new set of life science examples, a memorandum to the patent examining corps with instructions...more

May 2016 Update to Examiner Guidance on Patent Subject Matter Eligibility

A Federal Register notice is scheduled to publish on May 6, 2016 updating the 2014 interim guidance on patent subject matter eligibility and the July 2015 update on subject matter eligibility. On May 4, 2016, a related...more

Healthcare & Life Sciences Private Equity Deal Tracker: Warburg Pincus Acquires DocuTAP

DocuTAP has announced that it has been acquired by Warburg Pincus. DocuTAP, based in Sioux Falls, S.D., is a provider of urgent care technology, including software for electronic medical records, practice management and...more

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