Biotechnology

News & Analysis as of

The Return of Biotech IPOs

Biotech IPO market activity has recently returned to levels not seen since before the financial crisis. This has been brought about in part by the accommodations afforded issuers under the Jumpstart Our Business Startup Act...more

Court Report - August 2014 #4

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Aptalis Pharmatech Inc. et al. v. Apotex Inc. et al. 1:14-cv-01038; filed August 11, 2014 in the District Court of...more

Court Report - August 2014 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Unimed Pharmaceuticals LLC et al. v. Perrigo Co. et al. 1:14-cv-01004; filed July 31, 2014 in the District Court of...more

FDA Releases Another Prospective Guidance

On August 5th, the U.S. Food and Drug Administration issued a "Guidance for Industry" entitled "Reference Product Exclusivity for Biological Products file under Section 351(a) of the PHS Act." Before setting forth the first...more

Examination of Myriad-Mayo Guidance Comments -- International Bioindustry Associations

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

Court Report - August 2014 #2

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Glycobiosciences Inc. v. Dara Biosciences, Inc. et al. 1:14-cv-01281; filed July 28, 2014 in the District Court of the...more

MoFo BioMeter - Vol. 3, Issue 3, August 2014 - Q2 Biometer Shows Strong Value In Drug Discovery Platforms

The average BioMeter value in the second quarter of 2014 jumped significantly to $143.4 million, an increase from the $15.9 million value in the first quarter. This included two blockbuster deals, the $1 billion up front paid...more

Court Report -- Part II: August 2014

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Medicines Company v. Accord Healthcare, Inc. et al. 1:14-cv-00626; filed July 24, 2014 in the Middle District of North...more

Examination of Myriad-Mayo Guidance Comments -- ACLU

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

Court Report - August 2014

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Roche Molecular Systems, Inc. v. Cepheid 3:14-cv-03228; filed July 16, 2014 in the Northern District of...more

BIO Industry Group Comments on JOBS Act

The Biotechnology Industry Organization (BIO) issued a press release with the below infographic noted that this week marks a JOBS Act milestone with the 100th company to have gone public since the Act was passed. ...more

Settlement Highlights Need for Compliance with U.S. Export Control Rules When Sponsoring Foreign Workers

The U.S. Department of Commerce’s Bureau of Industry and Security recently reached a $115,000 civil settlement agreement with a California-based global technology company on the basis that it violated several export control...more

Court Report -- Part III

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Cubist Pharmaceuticals Inc. v. Fresenius Kabi USA LLC 1:14-cv-00914; filed July 11, 2014 in the District Court of...more

Court Report -- Part II - July 2014 #2

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Acorda Therapeutics Inc. v. Actavis Laboratories FL Inc. 1:14-cv-00882; filed July 7, 2014 in the District Court of...more

Biobased Companies Among Recipients Of EPA Funding

On July 14, 2014, EPA announced recipients of funding to develop and commercialize innovative, sustainable technologies to address current environmental issues. Among the recipients were the following companies pursuing...more

BioPharma Patents Quick Tips and News - May/June 2014

QUICK TIPS - 35 U.S.C. 112 Tips: 1) Does your U.S. Examiner assert that not enough representative species are described in the specification? MPEP Section 2163 II.A.3(a)(ii) says that “(t)he written...more

EU Launches € 50 Million Public-Private Biobased Industries Partnership

In a July 9, 2014, press release, the European Union (EU) announced the launch of seven public-private partnerships, established under the EU's new research funding program Horizon 2020. They represent a total investment of €...more

Software Sector Leads Pack in 2Q Venture Funding and Biotech Sector Finishes Second

Last week, the National Venture Capital Association (NVCA), a trade association representing the U.S. venture capital industry, released the results of its MoneyTree Report on venture funding for the second quarter of 2014. ...more

Federal Circuit Holds That Even Functional Claims Require Structural Fence Posts

In AbbVie Deutschland Gmbh v. Janssen Biotech, Inc., the Federal Circuit affirmed the district court decision that found AbbVie’s patents directed to anti-IL-12 antibodies invalid for lack of adequate written description. As...more

AbbVie Deutschland GmbH v. Janssen Biotech, Inc. (Fed. Cir. 2014) - Absent Description of Representative Species to Support Entire...

Last week, in AbbVie Deutschland GmbH v. Janssen Biotech, Inc., the Federal Circuit affirmed judgments by the District Court for the District of Massachusetts in infringement and interference actions involving AbbVie...more

Court Report -- Part II - July 2014

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Otsuka Pharmaceutical Co. Ltd. v. Par Pharmaceutical Inc. 1:14-cv-00789; filed June 20, 2014 in the District Court of...more

An Unsuccessful Reach for the STELARA, Written description of generic biomolecule claims

AbbVie owns US 6,914,128 (’128), which covers a variety of anti-IL12 monoclonal antibodies. AbbVie markets an anti-IL12 monoclonal (viz. Humira®) as a treatment for a variety of auto-immune disorders, including psoriasis....more

Court Report - July 2014 #2

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Eli Lilly and Company et al. v. Panacea Biotec, Ltd. 1:14-cv-01064; filed June 26, 2014 in the Southern District of...more

NNI Publishes Progress Review of 2011 EHS Research Strategy

On June 25, 2014, the National Nanotechnology Initiative (NNI) posted Progress Review on the Coordinated Implementation of the National Nanotechnology Initiative 2011 Environmental, Health, and Safety Research Strategy, which...more

Docs @ BIO: BNA Issues Report on PTO's Patent Eligibility Guidance

Sounding an appropriately alarmist note, the Bureau of National Affairs (BNA) Life Sciences Law and Industry Report issues the results of a study on how the U.S. Patent and Trademark Office is administering its March 4, 2014...more

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