Biotechnology Prescription Drugs

News & Analysis as of

Trans-Pacific Partnership agreement on term of data exclusivity for biological pharmaceuticals, not patent term

Five years of negotiations have culminated this week in the signing of the Trans-Pacific Partnership (the “TPP”) agreement by 12 countries from the Pacific-rim region, including the US and Australia. While the partnership...more

Alert: Second Circuit Rules that "Product Hopping" May Constitute Unlawful Monopolization; Pharmaceutical Companies are Likely...

Recent antitrust challenges to pharmaceutical companies' efforts to transition patients from drugs nearing the end of their patent life to next-generation drugs have increased the risk of pursuing such "product hopping"...more

Court Report - February 2015 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Novartis AG et al. v. Ezra Ventures LLC. 1:15-cv-00150; filed February 11, 2015 in the District Court of Delaware. •...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

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 - 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

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

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

Nanotech Drug Formulations Drive Dealmaking

Some of the most commercially successful products to arise out of nanotechnology in terms of sheer size of revenues generated are nanotech drug formulations. This area continues to be hot in the wake of two recent deals, both...more

GEN and FiercePharma Compile Lists of Top Selling Drugs for 2013

Earlier this month, Genetic Engineering & Biotechnology News released its list of the top 25 best-selling drugs worldwide for 2013. GEN's list, which the journal released on March 3 (see "The Top 25 Best-Selling Drugs of...more

Japan Enacts Regenerative Medicine Law and Revisions to Pharmaceutical Affairs Law

On 20 November 2013, the Japanese Diet passed the Act regarding Ensuring of Safety of Regenerative Medicine (the "Regenerative Medicine Law") and the revisions to the Pharmaceutical Affairs Law (new PAL) as it applies to...more

MoFo BioMeter - Vol. 2, Issue 4, November 2013 - Q3 BioMeter Shows Strong Early Stage Deals

The average BioMeter value in the third quarter of 2013 was $30.4 million, an increase from the $22.2 million value in the second quarter. Like last quarter, Phase 1 and Phase 2 transactions showed very strong results, with...more

Tufts Report Shows Dramatic Shift from Small Molecule to Biologic Drugs

Last week, the Tufts Center for the Study of Drug Development (CSDD) at Tufts University released a report showing that the pharmaceutical industry has dramatically shifted its focus from a historical concentration on small...more

BIO Reiterates Support for 12-Year Data Exclusivity Period for Biologics

Last month, in a letter to the U.S. Trade Representative, Ambassador Michael Froman, Biotechnology Industry Organization (BIO) President and CEO James Greenwood expressed support for the efforts of the Obama Administration to...more

Healthcare Law -- Aug 19, 2013

As the Healthcare Landscape Shifts, Four Issues Are Critical to Build Effective Market Access Strategies - In this time of high growth and fast change for the healthcare industry, pharmaceutical, biotechnology and...more

BakerHostetler Patent Watch: Novozymes A/S v. DuPont Nutrition Biosciences APS

On July 22, 2013, in Novozymes A/S v. DuPont Nutrition Biosciences APS, the U.S. Court of Appeals for the Federal Circuit (Rader, Schall,* Bryson) affirmed the district court's judgment as a matter of law that U.S. Patent No....more

Court Report -- June 30, 2013

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Alpex Pharma S A et al. v. Zydus Pharmaceuticals USA Inc. et al. 1:13-cv-01143; filed June 26, 2013 in the District...more

Court Report -- June 17, 2013

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Fresenius Kabi USA, LLC v. Watson Laboratories Inc. et al. 1:13-cv-01015; filed June 6, 2013 in the District Court of...more

Court Report -- June 02, 2013

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Takeda Pharmaceutical Co. et al. v. Impax Laboratories, Inc. 3:13-cv-02416; filed May 29, 2013 in the Northern District...more

MoFo BioMeter - Volume 2, Issue 2: May 2013 - Flat BioMeter Value and Decline in Deal Volume are Hallmarks of Q1

The Morrison & Foerster BioMeter for the first quarter of 2013 shows a flat quarter for BioMeter value and a decline in dealmaking activity. A small number of large deals dominate an otherwise quiet quarter. In the...more

News from Abroad: UK Court of Appeal Upholds Invalidity of Enantiomer Patent

Originally published in WP Thompson & Co. on April 1, 2013. The "Obvious to Try" Test Is Overused in Assessing Obviousness - The UK Court of Appeal Decision in Novartis AG vs Generics (UK) Ltd (trading as United...more

Sharing an Umbrella

Big Pharma and academia cement big deals in the quest for bigger prizes - With the patents of many highly profitable blockbuster drugs expiring over the course of a few years, the search is on for new drugs to fill...more

GEN Compiles List of Top Biopharma R&D Spenders

Earlier this month, Genetic Engineering & Biotechnology News published its list of the top 20 best-selling prescription drugs worldwide for 2012 (see "GEN Compiles List of Top Selling Drugs for 2012"). The biotech...more

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