Posts Tagged: "follow on biologics"

The Myth of ‘Trivial’ Drug Patents

Critics of drug patents often claim that when initial drug patents expire, drug companies stuff their patent portfolios with “trivial” patents that unjustifiably extend their patent monopoly to keep the prices up.  This argument perpetuates common myths and misunderstandings that fail on several levels… In the last decade, large molecule biological drugs have come to the fore. They provide dramatic new treatments for some conditions but can be very expensive. It is difficult to develop inexpensive generic-type versions for biological drugs.

SCOTUS says OK to give notice of commercial marketing before FDA license under Biologics Price Competition and Innovation Act

42 U.S.C. § 262(l) of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) regulates “biosimilars,” biological products that are highly similar to FDA-approved biological products. Section 262(l) has two notification requirements that are important to this case… The second question addressed by the Court was whether the applicant must provide notice after the FDA licenses its biosimilar, or if it may provide notice before the FDA licenses its biosimilar. The Court concluded that an applicant might, but does not have to, provide notice to the manufacturer of the biologic before obtaining a license from the FDA.

Industry Reaction to SCOTUS decision in Sandoz v. Amgen

The Court’s Sandoz v. Amgen decision gutted a statute that had been carefully crafted to facilitate timely resolution of patent disputes and avoid delaying market entry of biosimilar products. In holding that a biosimilar applicant cannot be compelled through federal law to engage in the patent dance, the Court effectively gave biosimilar applicants a license to hide the ball. Given the complexity of biologics and biosimilars, it can be very difficult for an innovator company to reasonably determine which of its patents might be infringed by the biosimilar. Now, potentially meritorious patent infringement questions could be kicked far down the road. This could lead to delayed launch of the biosimilar product, possibly through a decision not to launch at risk or possibly by way of injunctive relief outside the BPCIA.

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 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.

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 unquestionably good. This is not the type of deal where residents of Nebraska get the rest of us to pay for them, or where seniors in Florida get to keep prescription coverage courtesy of the federal government while seniors everywhere else lose. The provisions favorable to the biotech community will spur innovation, lead to new cures and undoubtedly prolong life. If only Congress could have passed these provisions and scrapped the rest.

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 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.

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 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…

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) 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…

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 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…

Dishonest Roll Call Editorial on Follow on Biologics

Earlier today James Love and James Glassman published what can only be described as an intellectually dishonest op-ed piece on  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…

Fixing America’s Health Care System

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…

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 in an Op-ed piece published by It is not surprising that Dean, who is a Medical Doctor and politician, would attempt to let his positions on health reform be known.…