Posts Tagged: "biologics"

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, and numerous similar effective variants. This comprehensive protection is critical given the investment and risk associated with biologics. Estimates are that the pre-approval cost of developing a biologic approaches $1.2 billion and that the time needed to recover the pre-approval R&D costs be between 12.9 and 16.2 years. In the United States, the Biologics Price Competition and Innovation Act of 2009 (“Biologics Act”) provides for 12 years of exclusivity for the drugs. Through this, Congress endeavored to fill the void left by patents and trade secrets in the protection of biologics.

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 was a treat to chat with Jim Greenwood. Our conversation lasted about 35 minutes, and we talked about his decision to leave Congress to take over at BIO, exciting new technologies BIO companies are working on, healthcare reform, the importance of patents to start-up companies and capital investment requirements. We also learn that he is an avid bird watcher and has started to become a bit of a gym rat.

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 Property, will be a featured speaker at the Intellectual Property Super Session taking place during the 2010 BIO International Convention. The May 3 event, entitled “Leveraging IP to Spur Global Biotechnology Innovation, Investment and Jobs,” will examine the role that intellectual property systems play in attracting biotech investment and how some countries are successfully leveraging their patent policies to foster economic growth.

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 Protection and Affordable Care Act of 2009: The health care reform bill passed today by the Senate includes many provisions which serve as early Christmas presents for patients living with debilitating…

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 actually working, yes Senators working on a weekend, as the contentious debate continues. Even a relatively rare Presidential visit to Capitol Hill is scheduled for later this afternoon, presumably so President Obama can…

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) urges Congress and the White House to revisit pending biogenerics legislation that would grant biotech companies an a 12-year exclusivity period for biologics. The press release explains that the experts, who are Harvard…

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 most profound debates the patent and innovation industry has seen in a very long time, and perhaps the most profound debate that has occurred since Thomas Jefferson and James Madison argued whether the fledgling…

Earlier today James Love and James Glassman published what can only be described as an intellectually dishonest op-ed piece on RollCall.com.  The two James either simply do not understand patent law, the biologics legislation they detest or have an agenda that requires lying and obscuring the truth using scare tactics and falsehoods.  I don’t really know whether they are as…

On Thursday morning, August 13, 2009, CNBC aired a segment titled Fixing America’s Health Care System on Squawk Box, which is CNBC’s longest running program.  Appearing on the program were Dr. Scott Gottlieb, who is a former FDA deputy commissioner, Tommy Thompson, former Health & Human Services Secretary and Wisconsin Governor and Jim Greenwood, a former Republican Congressman who is…

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 attorney to a top spot in the Department of Justice, asked for study of open source initiatives for the federal government and has complained about counterfeiting and copyright infringement abroad.  On patent matters…