Posts Tagged: biologics


Biologics Applicant Must Give Post-Approval Notice to Reference Product Sponsor

The Federal Circuit held that there was no statutory language that made section (8)(A) non-mandatory. Further, Amgen v. Sandoz disposed of Apotex’s argument that (8)(A) would …

The Amgen Quagmire: Federal Circuit Rules Patent Dance Does Not Excuse Biosimilar Applicants from Providing Notice of Intent to Market

The Supreme Court is currently considering whether to review Amgen Inc. v. Sandoz Inc., the Federal Circuit’s first decision regarding the Biologics Price Competition and Innovation …

Clinical Trials and Tribulations: Why IP Protection is Critical to the Future of Biologic Medicine

Given the importance of intellectual property rights to economic growth and technological development, as well as the wider benefits of biopharmaceutical research, the provisions found in the …

IP Protection for Biologics in the TPP: Trading Away Future Treatments and Cures

Globally there are approximately 7,000 medicines in development to treat and cure a wide variety of diseases. Of these, more than 5,000 are in development in the United States. …

Trans-Pacific Partnership – What do IP practitioners need to know?

Trade partners negotiating the Tans-Pacific Partnership trade deal have reached an agreement. The agreement details have not been released, and likely will not be submitted to Congress …
By Gene Quinn
4 years ago 4

Obama Administration Caves on Data Exclusivity in Historic TPP Trade Deal

In order to reach an agreement the United States granted a key concession relating to biologics, which are advanced medicines made from living organisms. Presently the United …
By Gene Quinn
4 years ago 3

The Need for Regulatory Data Protection in the TPP: Why Australia’s Got it All Wrong

While patents protect innovations that are novel, nonobvious and useful, data exclusivity protects the extensive preclinical and clinical trial data required to establish new therapies as safe …

When Patents Aren’t Enough: The Case for Data Exclusivity for Biologic Medicines

Although complementary, patents and data exclusivity protection incentivize innovation in different ways and serve distinct purposes. Patents provide protection for innovations that meet the standards of patentability …

Protecting Data Exclusivity, Protecting the Future of Medicine

Traditionally, “small molecule” drugs are patent protected for a twenty-year term. Biologic medicines, however, are more difficult to comprehensively protect with patents due to their size, complexity, …

Exclusive Interview: Jim Greenwood, President & CEO of BIO

On Wednesday, April 21, 2010, I had the pleasure of conducting an exclusive, on the record interview with Jim Greenwood, former Congressman and current President & CEO of BIO. It …
By Gene Quinn
9 years ago 0

BIO Gearing Up for Big Spring 2010, Headlined by Kappos

The Biotechnology Industry Organization (BIO) has just announced that David Kappos, Director of the U.S. Patent and Trademark Office and Under Secretary of Commerce for Intellectual …
By Gene Quinn
10 years ago 0

Biotech Provisions in Senate Health Care Bill Promotes Innovation

WASHINGTON, DC (December 24, 2009) – Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood released the following statement on today’s vote by the Senate to pass The Patient …
By Press Releases
10 years ago 2

Fact vs. Fiction: The Truth on Biologics and Biosimilars

For many months we have been hearing about the government attempts to “reform” health care in the United States, and this weekend the United States Senate is …
By Gene Quinn
10 years ago 6

Anti-Innovation Chorus Continues Over Biologics

A press release issued earlier today by the Pharmaceutical Care Management Association (PCMA) explained that a new article published in the New England Journal of Medicine (NEJM) …
By Gene Quinn
10 years ago 7

Why a Global Patent System is a Bad Idea

A little over a week ago, in a blog post written by Microsoft’s Deputy General Counsel Horacio Gutierrez started what will certainly become one of the …
By Gene Quinn
10 years ago 30