Posts Tagged: "Joseph Allen"

One of the few areas of bipartisan agreement in Washington is that it’s time to respond to Chinese economic and military aggression. The need is underscored by a sobering report from the Senate Homeland Security & Governmental Affairs Committee’s Permanent Subcommittee on Investigations titled “Threats to the U.S. Research Enterprise: China’s Talent Recruitment Plans.” The report documents how China exploits our culture encouraging the open exchange of science in order to achieve their commercial and military objectives. In its editorial, “China’s Bid on American Science,” The Wall Street Journal aptly summarizes the report:  “It found the U.S. government is funding research for hundreds of scientists at American universities and labs who are effectively under contract to turn over their findings to China.” No nation can allow others to steal its cutting-edge technologies. While we must effectively respond to China and others looking to do us harm, we must avoid inadvertently undermining the policies which made us the leader in turning government funded R&D into highly innovative products. Unfortunately, an initial agency response is not reassuring on that score.

Next year marks the 40th anniversary of the passage of the Bayh-Dole Act. With election day looming, 2020 is likely to be the most politically contentious year of our lifetime. The country is divided right down the middle on many fundamental issues. Rather than debate, the opposing sides often descend into personal attacks, even questioning one another’s patriotism. This isn’t the time you want issues you care about dragged into the public arena, but patent rights and the Bayh-Dole Act have been summoned into the gladiator pit. Happy birthday, indeed.

Trying to rationally address hot button issues in an election year is always a dangerous proposition. That’s particularly true as we approach what promises to be one of the nastiest political years in history. Because so much time will be taken up campaigning, for legislation to pass it needs to get moving soon. It shouldn’t be long before we know whether anything meaningful will happen with attempts to reduce the costs of drugs, where intellectual property rights are in the crosshairs. Let’s keep our fingers crossed that, if action is taken, it’s based on careful consideration of all the related issues rather than raw emotion. While this may be wishful thinking, several thoughtful new articles contain important warnings against jumping down some of the beckoning gopher holes. Critics of the Bayh-Dole Act, which provides the incentives of the patent ownership to commercialize federally funded inventions, claim that the government is developing drugs from its R&D and giving them to companies that then make “obscene profits.”Despite numerous rebuttals, this red herring is continually deployed as the justification for the government setting the price of drugs coming out of public/private sector partnerships.

Perhaps the report on China’s strategy for eclipsing the U.S. lead in biopharma from the Information Technology & Innovation Foundation (ITIF) resonated so strongly with me because of several articles in The Wall Street Journal. Taken together, they present a sobering picture of what we’re up against. The first was a book review of “Leadership and the Rise of Great Powers” by Yan Xuetong, a prominent Chinese professor. Characterized as “a window into Chinese elite thinking about the world; it is as much a political manual as an international-relations text book.”  The thesis is the inevitable rise of China as the world’s dominant power at the expense of the United States.

I recently visited Egypt as part of a team led by the Departments of State and Agriculture, supported by the good folks at the AUTM Foundation. Egypt, like many countries, is looking at our model for integrating research universities into their economy. I was asked to speak about the Bayh-Dole Act and thought it was important to emphasize that there were many factors required beyond enacting a law to reverse an entrenched national policy. On returning, I was struck by Gene Quinn’s article “It May Be Time to Abolish the Federal Circuit.” After leaving the Senate staff, I became Executive Director of the Intellectual Property Owners Association (IPO). Our highest priority was creating the Court of Appeals for the Federal Circuit (CAFC) to restore confidence in the U.S. patent system. Framed in my office is a very gracious thank you note from Judge Howard Markey, who inspired this effort and went on to become the first Chief Judge of the new court. Judge Markey was the only person I ever met with an unending supply of funny patent jokes, but that’s another story. Unlike Bayh-Dole, that effort appears to have gone off track. So why did one change stick and one not?

On Wednesday, March 14, we lost Senator Birch Bayh.  We knew for several months that this day wasn’t far off, as his health rapidly declined.  I wanted to let him know one more time how grateful I am for having had the privilege of working for him. Yesterday, I spoke with a reporter from the Indianapolis Star who wanted to know what it was like working for Sen. Bayh.  I said that he was the same person in private that you saw in public.  He came to Congress to get things done and had no problem working across party lines. It was a rare Senator who didn’t like Birch Bayh.

Just as the drug pricing debate on Capitol Hill is heating up, an important new study, “The Bayh-Dole Act’s Vital Importance to the U.S. Life-Sciences Innovation System,” published by the Information Technology & Innovation Foundation (ITIF), underscores the law’s contribution to the United States’ lead in the life sciences. The report warns that attempts to misuse the march-in rights provision of the law to control drug prices would have serious consequences to our competitiveness and our health. Predictably, the critics condemned the report as “A lot of myth and propaganda.” Despite being repeatedly rebuffed, they continue to argue the law authorizes the government to license competitors if a resulting product isn’t “reasonably priced.” That debate spilled over to the Capitol Hill unveiling of the study, in which I participated. What happened there sheds a lot of light on the nature of the argument.

I recently delivered a keynote address at a special session of the AUTM Annual Meeting, where the Advanced Medical Technology Association (AdvaMed) released its new University Technology Transfer Best Practices Guide. Following is a transcript of that speech.

The opening salvo in what promises to be one of the hottest debates in the new Congress was fired January 29 during a day-long hearing in the House Committee on Oversight and Reform—how to lower the price of prescription drugs. And it didn’t take long to make it clear that patents are right in the middle of the scrum. The role of patents was a prominent part of the House hearing. While cursory nods were made to the importance of encouraging innovation, the witnesses discussed how patent exclusivity, thickets, and evergreening drove up prices while promoting the greater use of Patent Trial and Appeal Board (PTAB) reviews against drug patents. The Committee was assured that curtailing patents wouldn’t harm innovation because the National Institutes of Health (NIH) is such an important funder of life science R&D.

Hopefully, you’ve been fortunate enough—at least once in your life—to work for someone you really admired. That happened to me as a Senate Judiciary Committee staffer for Senator Birch Bayh (D-IN), who gave me the opportunity that changed my life. He turns 91 today… Bayh-Dole not only cut through the bureaucratic red tape strangling the development of federally-funded R&D; it marked a turning point in how patents were viewed in Congress. When I first joined the Committee, patents were considered tools for big business to stifle competition. Intellectual property fell under the jurisdiction of the Subcommittee on Antitrust and Monopolies. The Senate Small Business Committee was a hot bed of anti-patent sentiment.