News & Analysis as of

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

Update on Mayo Myriad Patent Eligibility From USPTO BCP Partnership Meeting

On September 17, 2015, the USPTO held the first “bicoastal” Biotechnology/Chemical/Pharmaceutical Customer Partnership meeting, with live participation from the USPTO’s main campus in Alexandria, VA and from San Jose...more

Court Report -- Part III: September 2014

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Forest Laboratories LLC et al. v. Sigmapharm Laboratories LLC 1:14-cv-01119; filed September 3, 2014 in the District...more

Court Report -- Part II: September 2014

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Roxane Laboratories, Inc. v. Zydus Pharmaceuticals USA, Inc. 2:14-cv-05423; filed August 28, 2014 in the District Court...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

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

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

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

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

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

Court Report - June 2014 #5

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Novartis Pharmaceuticals Corp. et al. v. Mylan Inc. et al. 1:14-cv-00777; filed June 19, 2014 in the District Court of...more

Massachusetts Enacts New Biosimilars Substitution Law

On June 23, 2014, Governor Deval Patrick signed into law House Bill 3734, “An Act Relative to the Substitution of Interchangeable Biosimilars” (now Chapter 143 of the Acts of 2014). The new Act authorizes pharmacists to...more

More of the Same: Recently Released FDA Social Media Guidance for the Life Sciences Industry

On June 17, 2014, the U.S. Food and Drug Administration ("FDA") continued to outline its expectations for pharmaceutical and medical device manufacturer use of social media platforms to promote manufacturers' products in two...more

2014 Roundtable Series, Mergers & Acquisitions

Market watchers view mergers and acquisitions as an economic yardstick. After several years of modest volumes, we've already seen substantial M&A activity in 2014 across industries including biotech, pharmaceuticals, and...more

Court Report - June 2014

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Amarin Pharma, Inc. et al v. Teva Pharmaceuticals USA, Inc. 3:14-cv-03558; filed June 4, 2014 in the District Court of...more

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