The following OpEd comes from the CEOs of Amicus Therapeutics and Nkarta Therapeutics who argue against the Federal Circuit’s “blocking patent” decision in Acorda and in support of Acorda’s petition for writ of certiorari. – DC
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“If I have seen further than others, it is by standing upon the shoulders of giants.” Sir Isaac Newton’s observation has never been more true than in the development of medicines.
Scientific advances have brought us to the verge of a golden age of medicine. In the years ahead we have the opportunity to alleviate enormous human suffering: more and more cancers will be cured; gene therapies and precision medicines will turn fatal genetic diseases in children into diseases that kill no more; seniors and the families who care for them will no longer be afflicted by Alzheimer’s. To help ensure that we will benefit from such advances, our policies and laws must be aligned with the interests of patients.
A patent issue pending before the United States Supreme Court, if left unaddressed, could have serious consequences for us all: slowing medical innovation by deterring researchers from improving upon existing medicines. This should alarm every patient who needs a new medicine today and every person who may need one tomorrow.
Rarely, if ever, can scientists deliver a cure for a disease at the beginning of their research. Biology is complex and magic bullets for diseases are extraordinarily rare. In practice, scientists build new therapies brick by brick. Each incremental step can be meaningful on the way to a cure: by buying time – time with better quality of life, and time until the next advance can provide even more benefit.
To develop these advances requires hundreds of millions – and often billions – of dollars of investment, over periods that average more than a decade. The average failure rate is about 90% for those drugs that actually make it to patient trials. Any addition to these enormous hurdles slows investment in medical innovation and deprives patients of new and more effective medicines.
We understand this in very personal ways. One of us, John Crowley, has two children with a rare and serious neuro-muscular disorder, Pompe disease. They were not supposed to live to see kindergarten. Today those children are now in their early 20s and thriving despite their disability because of a novel medicine that has improved and significantly prolonged their lives, though it has not cured them. It has, however, given our family the chance to see birthdays and graduations that otherwise never would have been. It has also given us time to build on this progress to experiment on potentially better ways to treat our children’s devastating diseases.
Paul Hastings was diagnosed with Crohn’s disease as an adolescent – long before any of the innovations over the last twenty years to treat this condition; as a result, he lost his colon at age 13. Had today’s medicines been developed then, he likely would not have had to.
We have each devoted our lives and our careers to the development of innovative medical treatments. We have seen first-hand the thought, dedication and the enormous investment of human and financial capital that goes into the approval of even one new drug. We have seen that even an incremental improvement over existing treatments can result in substantial quality of life enhancements for those living with disease and disability.
A critical case has now put the backbone of this progress – improvements to earlier innovation – under threat. In Acorda Therapeutics v. Roxane Laboratories, a lower federal court ignored 50 years of Supreme Court precedent to nullify patents that were integral to Acorda’s work in turning a failed compound into a first-of-its kind, FDA- approved medicine that improves walking in patients suffering the debilitating effects of multiple sclerosis.
The legal issue in the case revolves around the lower court’s dramatic expansion of the so-called “blocking patent” doctrine, which weakens protections for patents for medicines, like the Acorda patents, that improve upon prior patents.
The U.S. Supreme Court will decide next month whether to hear the case. We are deeply concerned that leaving the lower court’s ruling intact will deter investment in science and medicine needed to improve upon existing treatments. In so doing, it would deprive patients of cutting-edge medicines that can dramatically enhance the quality and length of their lives.
The Founders authorized Congress to grant patent protections to “promote the Progress of Science.” More than two hundred years later, we are in an age of unprecedented medical innovation, but patent law is moving ominously in the other direction. Let’s not turn the clock back on the progress we all need.
John F. Crowley is the Chairman and Chief Executive Officer of Amicus Therapeutics
Paul Hastings is the President and CEO of Nkarta Therapeutics