Testimony of Michael Gollin

MODDERN Cures Act Briefing
November 18, 2014
10:00 – 11:00 a.m.
2322 Rayburn House Office Building
Washington, DC 20515
Representative Leonard Lance (NJ-07)

Ready to Testify

Mr. Chairman and Guests:
My name is Michael Gollin.  Thank you for the opportunity to speak about medical innovation, using my machine voice.  Professionally, I am a patent attorney at the Venable law firm here in Washington, focusing on life sciences innovation, and I have taught business and law school classes on intellectual property strategy, and authored a book on the subject.  Personally, I am a husband, a father, and yes, a person with ALS, the lethal motor neuron disease named after Lou Gehrig. 
ALS has taken my ability to walk and talk, but not my will to advocate or my hope for a cure. I am here today to seek broad and active support in the battle against ALS.  Sympathy and buckets of ice are nice, but not enough.  Here are three ways Congress can help change the balance of risks to favor successful innovation. 
First, Congress should provide sustained substantial federal funding for ALS research, to avoid the risk that promising basic research will be dropped or postponed, and so young scientists will enter this field. 
Second, Congress should exercise oversight over the FDA and other federal agencies, to reduce the risk of delayed review and approval. There are promising initiatives to expedite drug approval for incurable terminal progressive diseases. Anyone with ALS will tell you we will tolerate much higher risk from therapy than the agencies, because the risk of inaction is a 100% certain decline into paralysis and eventual death.  So, for example, after completing two clinical trials, I volunteered for a third trial involving removing parts of my vertebrae and injecting stem cells into my spinal cord.  Ultimately I was rejected but dozens of other brave patients have gone ahead with that promising trial.   The FDA has moved too slowly on this and other trials. Congress should encourage the FDA to apply different risk standards where there is such a catastrophic unmet medical need.  By moving more quickly and creatively, FDA can encourage more private companies to invest
Third, and the main topic today, Congress should support the MODDERN Cures Act as a legislative framework to provide incentives to companies seeking new therapies for unmet needs.  In my experience obtaining patents for pharmaceutical companies, I have repeatedly observed that if strong patent protection is unavailable, management will remove funding from a promising drug candidate or diagnostic. I’ve seen this happen both with neurology and cancer drugs. 
Moreover, recent court decisions have gravely weakened patents for diagnostics and cutting edge genetic inventions, and I have seen clients defund research in those areas.
The Act would combat the risk of therapies lost because of weak patents.  It would create incentives for companies to invest in developing new drugs despite weak patent protection.  It would provide a new regulatory pathway with regulatory exclusivity for treatments and diagnostics to address unmet medical needs, like ALS.  The Act would build on the great promise of personalized medicine to allow earlier diagnosis and safer, more effective, treatments. 
The innovative genius of our economy is best realized when public initiatives stimulate privately funded research to solve unmet needs. The MODDERN Cures Act would harness this vital force to give pharmaceutical companies strong reasons to invest in promising therapies that would otherwise languish.
I ask you to use the enormous influence you have over appropriations, policy, and agency oversight and to adopt the MODERN Cures Act so that ALS and other incurable diseases are not forgotten.  I ask you to elevate the treatment of ALS on the list of our nation’s priorities as long as necessary to find a cure. 
One day we will win the battle with ALS.  One day a person with ALS will quote Lou Gehrig, saying “I’m the luckiest person on the face of the earth, because I have been cured of this terrible disease.”  Please join me and 30,000 other Americans with ALS, and a half million worldwide, and our families, in the fight to make that day come as soon as possible.
Thank you.