Archive for November, 2009

Effects Of Biosimilars Legislation On Patent Litigation

October 07, 2009
Bruce S. Manheim and Denise L. Loring

Intellectual property protection may not immediately come to mind when one considers health care reform, but it should.

Those interested in patent protection should pay special attention to provisions in this pending legislation that would authorize the Food and Drug Administration to approve follow-on versions of biotech medical products (“biosimilars”).[1]

These provisions would establish a complex dispute resolution scheme for biotech medicine patents that departs significantly from the rules of civil litigation.

If enacted, the legislation threatens to convert the U.S. patent system into a two-tiered regime in which biotech medicine patent holders would have fewer rights to enforce their patents. This could diminish the value of biotech patents.


Bipartisan Agreement Found in Biosimilars

September 25, 2009
Connecticut Record Journal
By Jim Greenwood

For too long, the health care debate has focused on issues that divide the political parties, undermining meaningful reform. Many lawmakers have, however, been able to find common ground on one issue in this massive debate: the approval of biosimilars. Biosimilars, often erroneously referred to as biogenerics, are medicines that are similar to, but not the same as breakthrough biologic medicines.

Biologics represent the cutting edge of medicine, providing advanced therapies and drugs that are saving and extending the lives of patients living with debilitating diseases including cancer, Multiple Sclerosis and HIV/AIDS. Continued advancements hold the promise of improved medicines and, one day, cures. By allowing biosimilars to enter the marketplace, Congress can increase patient access to life-saving medicines, reduce costs and provide a foundation for continued biomedical innovation.


Roll Call Authors Unite Against Current Follow Biologics Legislation

September 20, 2009
Patent Docs
By Donald Zuhn

Earlier this month, James Love and James Glassman, writing in the Congressional newspaper Roll Call, expressed “alarm” regarding recent Congressional action concerning the establishment of a follow-in biologics (FOB) regulatory pathway (“Don’t Kill Competition for High-Tech Drugs”).  That action included the recent passage by the House Committee on Energy and Commerce of a health care reform bill containing a licensure pathway for biosimilar biological products that would prevent the FDA from approving a biosimilar application until 12 years after the date on which the reference product (i.e., the innovator biologic) was first licensed (see “House Committee Approves Health Care Reform Bill Calling for 12-Year Exclusivity Period”), and prior approval by the Senate Health, Education, Labor and Pensions (HELP) Committee of an amendment providing a 12-year data exclusivity period for biologic drug makers (see “Senators Champion 12-Year Data Exclusivity in Senate”).

 James Love, the director of the public interest advocacy group Knowledge Ecology International, and James Glassman the former under secretary of State for public diplomacy and public affairs in the George W. Bush administration and editor of Roll Call from 1988-93, contend that passage of FOB provisions by the House Energy and Commerce and Senate HELP Committees would “make it difficult, if not impossible, for generic drugs to compete with biologics, even after patents have expired.”  The authors add that these provisions, if reconciled and passed into law, have “the potential to harm millions of sick people, in the United States and beyond.”


FDA Should Get New Power Over ‘Biosimilar’ Treatments

September 21, 2009
The Hill
By Francis B. Palumbo

President Barack Obama is keenly interested in holding down the cost of healthcare while increasing access for tens of millions of Americans and has strongly advocated for a public option. And while Congress is consumed with debating this major change in our healthcare system, it is also debating another controversial issue, also intended to improve access and contain costs — the issue of “follow-on biologics” or “biosimilars.”

These are injected biologicals used to treat many truly dreaded diseases such as cancer and multiple sclerosis, as well as other serious illnesses. They are made from organic sources such as animal cells, microorganisms and yeast, and have given new hope and new life to many people with crippling illness.


WA Leaders Shape Health Care Reform Legislation

October 8, 2009
Seattle Post-Intelligencer
By Jim Greenwood

Washington state has long been a home for innovative thinkers. From Boeing to Microsoft to, companies based in Washington have pushed the envelope on what’s possible. Senator Patty Murray (D, WA) and Representative Jay Inslee (D, WA-1) have followed suit with their leadership on legislation that would enable biotech companies in Washington and across the nation to continue their quest for innovative cures and therapies to address unmet medical needs.

The most promising medical innovations are coming from biotechnology companies in Washington and across the United States. Among the most advanced innovations are biologics – complex proteins produced by living cells that have been custom designed using our newly acquired understanding of human genetics and DNA. Biologics have added major therapeutic options for the treatment of debilitating diseases (such as cancer, HIV/AIDS, Alzheimer’s, multiple sclerosis and many rare diseases) including some for which no effective therapies were available and others for which previously existing therapies were clearly inadequate.