Posts Tagged: "Bayh-Dole"

The new Presidential Administration has hardly settled in before being confronted with a stark choice: will they continue policies that foster public/private sector R&D partnerships or be diverted down a path that’s been a dead-end? President Biden faces two herculean tasks: getting the COVID-19 pandemic under control while reviving the economy. The problems are intertwined and require continuous innovation to overcome, which means tapping the best minds in our public and private sectors. We’ve just witnessed a modern miracle, as such partnerships seamlessly came together to create effective COVID-19 vaccines and therapies in record time. But the policies these collaborations depend on are now being questioned.

It may seem odd, as unprecedented public/private sector R&D alliances work to discover and develop therapies to counter COVID-19, that some are trying to punish the companies trying to get us out of this mess. For example, House “Progressive” leaders unveiled the  “three protections”  they will try to insert in the next Congressional aid package, beginning with this: “NO EXCLUSIVITY: Pharmaceutical manufacturers should not be granted exclusivity for any COVID-19 vaccine, drug, or other therapeutic-whether it has been developed with U.S. taxpayer dollars and publicly funded, or not.” Consider the last phrase. They would take away rights to technologies developed entirely with private funding without evidence of any public need for doing so.

The world is teetering on the brink of a public health and economic catastrophe, depending on emergency partnerships between our public and private sectors to develop a successful treatment for the coronavirus. If there was ever a time to be thankful that we have policies in place making that possible, it’s now. But there are those who want to use this crisis to return to the failed policies of the past. Here’s the bottom line: the Bayh-Dole Act works. It allows the private sector to collaborate with universities and federal laboratories, like the National Institutes of Health, knowing that intellectual property they bring into such partnerships will be protected. It also allows academic institutions and federal labs to determine what type of license is best suited to promptly commercialize their inventions.

Almost a third of the recently signed $8.3 billion bill to fund the United States response to the coronavirus outbreak is devoted directly to vaccine research and development. And while the realities of drug development and FDA approval mean it is unlikely any vaccine will be available before next year, the government has numerous tools at its disposal in seeking to reduce the strain on the nation’s health care system. As many as nine different pharmaceutical companies worldwide are rushing to develop a safe and effective vaccine. Some are using traditional vaccine methods, including testing previously developed vaccines for other viruses. Others are using new technology to address the outbreak. The rush to find and deploy a coronavirus vaccine raises several interesting legal and regulatory issues, including balancing speed with efficacy, understanding ownership, and vaccine costs.

It’s highly appropriate that the 40th anniversary of the Bayh-Dole Act occurs in a year as politically contentious as that in which it passed. In 1980, many predicted that our best years were behind us and that the United States would soon lose its place as the world’s economic superpower. Experts proclaimed the best remedy was to adopt the “Japan, Inc.” model,  where the government  bureaucracy orchestrated a coalition of dominant companies boldly plotting the future (that idea was particularly popular with many in Washington, D.C.). The patent system was under constant attack for being unfair, the U.S. suffered from double digit unemployment and inflation (dubbed “the misery index”) and energy costs skyrocketed. Congress discovered that despite billions of dollars invested annually in federally funded R&D, few inventions were being brought to the marketplace where they could benefit the American people. It felt like the bottom had fallen out from under the feet of our nation. To remind us how far we’ve come—and prevent us from sliding back into the morass—stakeholders across the innovation spectrum have come together to form Bayh-Dole 40. This coalition of industry, academic, policy organizations, venture capital and others (including IP Watchdog) will host a series of events, briefings, papers and other activities explaining the importance of the incentives and authorities of our intellectual property system as embodied in the Bayh-Dole Act, to our prosperity and continued well being.

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.

In late August, the U.S. International Trade Commission published a notice of institution of a Section 337 investigation on behalf of the Regents of the University of California, which is now underway. The University filed a complaint in July alleging that a series of major retailers including Amazon.com, Bed Bath & Beyond, IKEA, Target and Walmart have infringed patents through the importation of certain filament light-emitting diodes (LEDs) and products containing the same. The ITC action is part of an enforcement campaign that is being hailed by the firm representing the university as a “first-of-its-kind university-led effort” to vindicate patent rights owned by the institution.

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.

A just-released study co-sponsored by the Biotechnology Innovation Organization (BIO) and AUTM provides new evidence of the significant contribution academic patent licensing makes to the U.S. economy. The report is the most recent in a series, and the numbers are astounding. This couldn’t come at a better time. Renewed efforts are underway to subvert Bayh-Dole from an engine driving innovation into a weapon for government price controls. Even though the Bush, Obama and Trump Administrations wisely rejected their theories, the critics keep banging the drum, and some in Congress are dancing to their tune.

Based on the age of many of us in the room, President Reagan was probably the first president many of us remember. And I mention this because we need another President Reagan—another person like that, who sees the power of the patent system. Upon taking Office, President Reagan told the then leaders at the patent office that the backlog of unexamined patent applications was unacceptable and he wanted it brought down to 18 months in his first term. The leaders at the patent office told him that that was simply not possible. That’s how bad the backlog was then. And then President Reagan and his advisors asked whether it would be possible to reduce the backlog to an average pendency of 18 months within two terms, assuming he would be given two terms. And they said, “yes, we think we can do that within two terms.”  And they didn’t quite get it done, but they got really, really close. They got to around 18.2 or 18.3 months average pendency by the end of President Reagan’s second term. And it was because President Reagan invested in the patent office.

On May 12, Frederick Reinhart published an article titled “Knowledge Ecology International Letter Misleads on March-In Rights.” Reinhart is a past president of the Association of University Technology Managers (AUTM), and his views echo those expressed by many in the university technology transfer field, including a frustration that not everyone acknowledges and appreciates the considerable investments and risks undertaken by the for-profit companies that license patents to inventions funded by the federal government. Knowledge Ecology International (KEI) recognizes the importance of the private sector in bringing therapies to the market, even when federal funding of R&D has played a role, and also that robust returns on those investments have a positive impact on innovation.

The National Institute of Standards and Technology recently indicated in its “Return on Investment Initiative draft green paper” that it would issue regulations effectively ending attempts to misuse march-in rights to assert government price controls over successfully commercialized federally-funded inventions. Such an announcement was bound to elicit a reaction. That it came in The Washington Post shouldn’t be a surprise. The paper’s April 18 article, “A rare deterrent to limitless drug price increases may die under Trump” gives coverage to both sides, but the takeaway is that something nefarious is underway: “As drug prices have soared, lawmakers and patient advocates have pushed the federal government to deploy for the first time a powerful deterrent: a legal provision that allows it to suspend a drugmaker’s patent and license someone else to produce the drug. Now, responding to industry alarm over those demands, the Trump administration is proposing to strictly limit the little-known power,” said the article. There’s a reason why this “little-known power” has never been used—it doesn’t exist.

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 success of a life science product, and thereby the company, rests heavily upon a combination of patent protection, regulatory exclusivity and product life cycle management. A company’s ability to formulate and articulate an integrated strategy is critical to obtaining investments, strategic partnerships and market success. In this two-part series, we will discuss recent judicial developments that affect life science companies’ IP strategies and also outline the four basic principles of an integrated IP strategy on which a company’s intellectual property audit and preparation for third-party diligence should focus. These are: (1) patent prosecution and strategy, (2) rights and ownership, (3) interplay of patent and regulatory exclusivity, and (4) freedom to operate and competitors. Part one will focus on patent prosecution and strategy, as well as rights and ownership.

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.