Posts Tagged: biosimilars


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 …

The Sticking Point that Shouldn’t Be: The Role of Pharmaceutical Patents in the TPP Negotiations

The controversy swirling around the Trans-Pacific Partnership (TPP) Trade Agreement sheds light on two critically important but divisive issues: international trade and intellectual property protection for pharmaceuticals. …

Biosimilars at the Federal Circuit – Will this be the Last Dance?

This statute tried to mirror the Hatch-Waxman statute for small molecules, including both an abbreviated drug approval process and a mechanism to address any patent claims during …

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, …

Bio-Pharma at the U.S. Supreme Court

Since my last article here on IPWatchdog.com, the pharmaceutical industry has been simply overflowing with interesting developments, including the US Supreme Court hearing arguments concerning three …
By Ed Silverman
7 years ago 1

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
10 years ago 0

Health Care Bill Good for BIO According to Greenwood

Notwithstanding the above, I am conflicted in my feelings. It seems that one of the deals included in the Health Care Bill, provisions aimed at biotechnology, are …
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

Howard Dean Supports Strong Protection for Biologics

Last week, on July 8, 2009, former Presidential Candidate, former Vermont Governor and former Chair of the Democratic National Committee, Howard Dean stepped into the health reform debate, discussing …
By Gene Quinn
10 years ago 5

Obama Administration Wants Short Biologic Exclusivity

Until recently the Obama Administration had not taken any particularly strong or controversial stances with respect to intellectual property protection.  Sure, President Obama appointed a former RIAA …
By Gene Quinn
10 years ago 7