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
By all means, let’s “nothingburger” this piece and quickly get it out of the spotlight before anyone notices anything amiss with Pharma patents in general….
Oops. Too late. See posts starting at 1 below.
Clearly the best course of action in response to bad tr 0llinh behavior is to give Big Pharma a huge handout in the form of patent protection for “new” corrrlations. What could go wrong?
The problem with this op-ed is that it appeals to the heartstrings of the reader and not to the law. That may make a decent piece for policymaker consideration, but it’s kind of out-of-place on a patent law blog as a commentary on a pending Supreme Court case. Even if you don’t want to dig deeply into the case at hand, at the very least, boil the question down to a simplified fact pattern and make a legal argument in favor of your preferred outcome based on that.
More self-serving vapid advertisements from the cr appy attorneys at Paul Hastings who apparently wake up and deeply inhale their own supply every morning.
Like adults can see right through this silliness?
dcl comment at 2 nailed this. These guys are tr 0lling an obvious patent. That’s the reality. They want to eliminate consideration of certain facts from the 103 analysis because … it’s all about them and they lost which needs to be corrected, somehow.
Gross people. Shall we check the political associations? Hmm?
Spell check messed me up. Shoulda said “like adults can’t see…”
I keep waiting for the transition from rhetorical preface to substantive argument, and it just never comes. Defendants have the evergreening metaphor, and plaintiffs apparently have the “bricks, not magic bullets” slogan, plus the idea that children will die if any pharmaceutical patent is ever successfully challenged in court.
Based on this op-ed, one might get the impression that the Federal Circuit ruled that improvements are categorically unpatentable. As far as I can tell from the opinion, this is really about a tertiary issue, deep in the weeds of secondary considerations (which are rarely dispositive), where the district court finds as a factual matter that the absence of competition, followed by the later success of the patented drug is better explained by the deterrent effect of the patentee’s earlier patents than by the nonobviousness of the patent. This seems like a commonsense inference that a factfinder could or couldn’t draw in a particular case depending on things like the breadth of the earlier patents and whether there was or wasn’t testimony that competing researchers were actually deterred.
I get that it’s a somewhat common argument from generics–you were alone in the field because your earlier patents locked it up, not because you were innovative–but it seems like it’s maybe true in some cases, false in others, and is only about secondary considerations in any event.
But who cares about any of this, right? Think of the children?
Based on this op-ed, one might get the impression that the Federal Circuit ruled that improvements are categorically unpatentable… [T]his is really about a tertiary issue, deep in the weeds of secondary considerations (which are rarely dispositive)…
Exactly. This issue is a big nothingburger. The (so-called) “blocking patent doctrine” does not mean that subsequent improvements are not patentable over the original drug discovery. It merely means that one sort of evidence (commercial success evidence) is not relevant for evaluating obviousness during the term that the earlier patents keep competition off the market.
Commercial success is (empirically speaking) the weakest form of objective evidence (one can count on one hand the number of precedential cases in which the commercial success evidence was outcome determinative). Discounting such evidence in light of the “blocking patent doctrine” will not keep even a single new drug off the market. If the improvement is really non-obvious, it will be possible to show as much quite regardless of the (largely meaningless in any event) “commercial success” evidence.
The above op-ed looks like a river of crocodile tears to me.
Maybe the Acorda decision is wrong, and maybe if one looks at the whole corpus of pharma patent litigation, the “blocking patents” argument comes up in practice in a way that swallows secondary considerations in pharma cases and puts pharma patentees at an unfair disadvantage defending their patents. And maybe, if that’s true, it’s a reason for courts to refine secondary-considerations or for Congress to step in. Or maybe none of that’s true. I don’t know, and the op-ed authors don’t seem to know either. I’m not even 100% sure the op-ed authors know what secondary considerations are or what happened in Acorda.
I guess what has me so annoyed is that the op-ed seems like a weird way of addressing readers of this blog on a legal issue. The posts here are generally good at getting to the heart of complex legal issues in an accessible way, and for all the warts of the comments section, the commenters seem to understand basic patent law and policy, can get some good discussions going when they choose to. Against that baseline, this post just feels very much out of place.
ReasonTV’s “People Will Die” video seems appropriate here. link to youtube.com
“The average failure rate is about 90% for those drugs that actually make it to patient trials.”
Maybe THAT should be the focus of innovation…
(also, think about what a 90% failure rate means for patents actually possessing claimed utility, given that the failure point is perhaps years after the filing date of patents that must include these massive number of failures)
I’m pretty sure that “potential life saving drug” qualifies as a “utlility” to which the compound is put.
Potential does not cut it when it is shown that there is a 90%
F
A
I
L
rate.
I think they evaluate that on an art by art basis brusinzky.
6,
Oh, I “get” that Person of Ordinary Skill In The Art is applied as a function of “art by art” basis, but I know of NO such parallel to possession.
One either possesses something at the time of filing or one does not.
The elephant in the room here is the admission that 90% of the time, Pharma people do NOT actually possess a claimed utility at the time of filing.
I’m sure if they could then they would herp anon.
I am sure that they DON’T, 6.
You want to know why?
sure
Most ALL other industries are economically punished if they permit themselves to have inefficient development processes.
Underlying MOST ALL Pharma arguments about how they can justify charging prices extremely out of line with actual costs (and I have insider information on just how extreme, but am under an obligation to not divulge) is because “they have to make up for all the failures of their other development efforts that do not pan out.”
In a very real sense, P00R development is subsidized and removed from ANY competitive effects that would — and should — place a priority on changing.
We (the Royal “we”) coddle the industry because human lives are directly effected. But this type of coddling runs AGAINST the critical thinking that would show that having the typical competitive driver would be beneficial overall and in the long run — and ironically, is the SAME critical thinking as to ONE OF the reasons (and I hasten to note NOT the only reason) why patents and a patent system — in and of themselves — are desirable.
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