Biotechnology

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Court Report -- Part II: November 2014

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Par Pharmaceutical, Inc. v. Glaxosmithkline LLC et al. 2:14-cv-06627; filed November 19, 2014 in the Eastern District of...more

Patent Update for IT and Biotech Companies: New Pieces to the Patent Puzzle

In This Presentation: - PATENT ELIGIBLE SUBJECT MATTER: LIFE IN SOFTWARE/IT AFTER ALICE CORPORATION V. CLS BANK (AND OTHER RECENT 101 DECISIONS) - A Brief History with respect to Software and Biz...more

Election's Impact On Bioeconomy Discussed, Hottest Companies Revealed At ABLCNext

Many of the top policymakers, leaders, and stakeholders in the bioeconomy gathered in San Francisco this week for ABLCNext. The Biobased and Renewable Products Advocacy Group's (BRAG®) Executive Director Kathleen Roberts...more

DOE Announces New Grant Topics To Help Small Businesses Develop Clean Energy Technologies

DOE's Office of Energy Efficiency and Renewable Energy (EERE) recently announced three new subtopics related to bioenergy under its SBIR and Small Business Technology Transfer (STTR) programs...more

BIO IPCC Panel Discusses Impact of Myriad-Mayo Guidance

Yesterday, we reported on a session of the Biotechnology Industry Organization (BIO) Intellectual Property Counsel's Committee fall conference, which took place earlier this week in Nashville, TN, in which the U.S. Patent and...more

USPTO Provides Update on Status of Revised Myriad-Mayo Guidance

During a session of the Biotechnology Industry Organization (BIO) Intellectual Property Counsels Committee (IPCC) fall conference, which took place this week in Nashville, TN, the U.S. Patent and Trademark Office provided a...more

Back in the game: The rise of US M&A

US M&A is bouncing back - After a tough few years, acquisitions in the United States have seen a remarkable resurgence - The first half of 2014 saw a great dealmaking revival in the United States. Deal values...more

President and Fellows of Harvard College v. Lee (Fed. Cir. 2014)

One of the most iconic inventions of the biotechnology era is the "Harvard Oncomouse" invented by Philip Leder and Timothy Stewart in the early 1980's. One of the first transgenic mice transformed with DNA encoding something...more

Examination of Myriad-Mayo Guidance Comments -- University Community Joint Comment

On March 4, the U.S. Patent and Trademark Office issued a guidance memorandum, entitled "Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural...more

MoFo BioMeter, Volume 3, Issue 4

Q3 BioMeter Shows Reemergence of Late Stage Deals - The average BioMeter value in the third quarter of 2014 was $43.7 million, an increase from the $30.4 million value in the same quarter in 2013, and a slight increase...more

Examination of Myriad-Mayo Guidance Comments -- BIO Joint Comment

On March 4, the U.S. Patent and Trademark Office issued a guidance memorandum, entitled "Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural...more

IMDRF Releases International Framework for Regulating Device Software

On October 14, 2014, the International Medical Device Regulators Forum (IMDRF) issued a final version of “Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations” (“the...more

Introducing a New Drug Into the Marketplace in the Lifecycle of a Pre-Sales Revenue Biotechnology Venture Destined for IPO Success

Mindful that this series of articles describes biotech ventures that are ripe for initial public offerings even before launching an income-producing drug product into the commercial market, the paramount objective for all...more

Success Protecting Intellectual Property in the Lifecycle of a Pre-Sales Revenue Biotechnology Venture Destined for IPO

For a drug discovery start-up, patent protection of the intellectual property underlying the commercialization pursuit is critically important. If the company is a university or research institution spin-out that obtained...more

The FDA Drug Approval Process in the Lifecycle of a Pre-Sales Revenue Biotechnology Venture Destined for IPO Success

The U.S. Food & Drug Administration regulates new drug approvals in a process that is extremely thorough, lengthy and expensive. Regulations apply to a drug candidate’s product development phase, the approval process and...more

Tech Transfers in the Lifecycle of a Pre-Sales Revenue Biotechnology Venture Destined for IPO Success

Many biotech ventures begin life as an invention conceived by a scientist/professor working in a laboratory at a federally-funded university or scientific institute. The intellectual property underlying such inventions is...more

Sherry Knowles Addresses Real World Impact of Myriad-Mayo Guidance at BIO Symposium

Last month, at the Biotechnology Industry Organization (BIO) IP & Diagnostics Symposium in Alexandria, VA, Sherry Knowles of Knowles IP Strategies addressed the impact of the U.S. Patent and Trademark Office's Myriad-Mayo...more

“Why Biobased?” Report Released by USDA

On October 7, 2014, the U.S. Department of Agriculture (USDA) released "Why Biobased?," a report that comprehensively synthesizes findings from the existing government, academia, and non-governmental organizations on...more

DuPont And P&G Announce Plans To Use Cellulosic Ethanol In Tide® Detergent

On October 6, 2014, DuPont and Proctor & Gamble announced their joint plan to replace currently used corn-based ethanol with cellulosic ethanol in North American Tide® laundry detergent. According to DuPont's press release on...more

Dutch Ministry Of Economic Affairs Releases Biobased Packaging Catalogue

The Dutch Ministry of Economic Affairs (DMEA) has launched the first edition of a Biobased Packaging catalogue that was compiled by Wageningen UR Food & Biobased Research. The catalogue came about as a result of companies...more

CMS Publishes Open Payments Data Detailing Payments and Transfers of Value Provided by Life Sciences Manufacturers to Physicians...

On September 30, 2014, CMS published data regarding payments and transfers of value that pharmaceutical, biologic, and medical device manufacturers provided to U.S. physicians and teaching hospitals during the period August 1...more

Amgen Poised to Enter Biosimilars Market

As reported in Fierce Biotech earlier today, Amgen announced the results of a Phase III clinical trial of its biosimilar drug (designated ABP 501) for moderate-to-sever plaque psoriasis conducted in comparison with adalimumab...more

Guest Post: Nature's Indelible Marker - Naturally abundant, stable isotopes have already protected the identity and origin of $1.5...

The pharmaceutical industry is an important segment of the world economy. In 2013, worldwide sales of prescription drugs were over $830 billion. If one adds in over-the-counter medicines and other health-related products...more

Malama Composites Wins "Most Innovative Technology" Award From PortTech For Biobased Rigid Urethane Foams

On September 25, 2014, Biobased and Renewable Products Advocacy Group (BRAG®) member Malama Composites, Inc. (Malama) announced that its biobased rigid urethane foams won the PortTech Los Angeles Entrepreneur Pitch...more

The Revitalize American Manufacturing And Innovation Act Passes House Of Representatives

On September 15, 2014, the U.S. House of Representatives passed H.R. 2996, the Revitalize American Manufacturing and Innovation (RAMI) Act. The Act "earmarks up to $300 million in federal funding -- $30 million annually for...more

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