Posts Tagged: data exclusivity


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 …

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. …

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, …

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