Posts Tagged: "NIH"

This week in Other Barks & Bites: the Trump Administration sues Gilead for infringement over HIVE PrEP treatment patents; Senators Inhofe and Wicker ask President Trump to show no leniency on Chinese IP theft; the Supreme Court hears the Allen v. Cooper copyright appeal; the Federal Circuit issues precedential opinions on PTAB evidence admissibility and limitation in patent claim preamble; the Copyright Office says that its digital recordation pilot project is on track for Spring 2020; the PTAB Precedential Opinion Panel (POP) will review the Board’s rejection of substitute patent claims in a motion to amend; “This Is Spinal Tap” creators settle copyright suit; and T-Mobile announces December launch for nationwide 5G network.

This week in the U.S. capital, the Senate will hold committee hearings on antitrust issues in digital platforms and real-time payment systems, a sector of fintech that will also be explored by the House Task Force on Financial Technology. Elsewhere in the House of Representatives, there will be hearings on Veterans’ Affairs scheduling technology, clean industrial innovations and medical research funding at the NIH. The week kicks off at the Information Technology and Innovation Foundation with a look at small business innovation funding programs. The Brookings Institution will also host events on Army modernization efforts and issues in disaggregating health data for improved policy-making.

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 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.

Once we go down a path of government price controls and compulsory licensing we will have foregone opportunities for other, more rational policy choices and will soon find ourselves in a race to the bottom. Of course, making prescription drugs more affordable must be an important, shared goal. But the solutions we pursue cannot risk choking off America’s innovative ecosystem that leads the world in discovering new cures and treatments. As Nobel laureate and NIH Director Harold Varmus said in 1995, one must first have a new drug to price before one can worry about how to price it.  Letting our federal government import foreign price controls and expropriate patents is not the way to go about it.

Rep. Lloyd Doggett (D-TX) recently introduced the Medicare Negotiation and Competitive Licensing Act of 2018. Lest the title confuse you, by “competitive licensing” Rep. Doggett means compulsory licensing anytime a company declines to sell their drug for whatever price the Secretary of Health and Human Services  cares to offer during “Medicare negotiations” where the government holds all the cards. Past attempts to impose artificial “reasonable pricing” requirements on developers of government supported inventions did not result in cheaper drugs. A study titled Compulsory Licensing Often Did Not Produce Lower Prices For Antiretrovirals Compared to International Procurement found that resulting drug prices were often higher than they would have been under a more cooperative approach.

NCATS is working with industry to de-risk promising therapies by helping to take them further down the development pipeline. But the key ingredient remains finding a private sector partner willing and able to assume the burden of commercial development, which dwarfs the amount of money the government spent on the underlying research. This investment can only be justified if the technology has strong patent protection… There’s a reason it’s called intellectual property. Ownership of inventions in the United States of America isn’t a gift from the king but the right of a free people to securely own what they create. That’s the driver of American entrepreneurs, who with proper support will astound centralized governments run by dictators for life with what they can do when turned loose. Restoring our patent system removes the leash holding them back. After that, watch out if you’re in their way.

Those who believe that patents aren’t important or that companies would undertake the rigors of commercial development with only non-exclusive licenses don’t understand the realities facing innovators like Inovio… Unfortunately, there’s good reason for anxiety. If they are successful their patents could be subjected to years of post-grant reviews by competitors and those who believe life science patents harm the public interest. Even if their IP holds up, they may face howls from critics and politicians demanding that the government step in to issue compulsory licenses so others here and abroad can copy the vaccine. For the 35 million living with HIV, the scientific barriers aren’t the only ones standing in the way of effective treatments.

The old arguments that patents inhibit innovation, and non-exclusivity with compulsory licensing leads to a brave new world are now in vogue. We’ve stood at this fork in the road before. It requires courage to reject the easy path downward and restore the system which created our prosperity. If we lack the will, we have no one else to blame as we plunge deeper into the mire. That’s the last place anyone wanting to drain the swamp while growing the economy should go.

Being an entrepreneur isn’t easy. While it is a tough road for anyone, it’s particularly tough if you’re in the public sector and threatened by politicians… Rather, the march in provision is intended to insure that good faith efforts are being made towards commercialization and that sufficient quantities of resulting products are available to meet public health or safety needs. If the government is ever pressured to misapply the law for price control, the bottom would fall out of our public technology transfer system. Such a change would not be restricted to drugs but to any product commercialized under Bayh-Dole. What company would commercialize a federally funded invention if an agency could retroactively apply a completely arbitrary standard of fair pricing to justify taking the technology away through compulsory licensing? The answer is easy to guess.

While those in the military are often thanked for their service, let’s also thank researchers like Dr. Rosenberg and his colleagues who spend their lives trying to alleviate human suffering. But that can only happen when their discoveries are commercialized– otherwise they are merely generating interesting research papers. Rather than deserved accolades, NCI and Kite Pharma got a pie in the face from the NY Times.

Earlier today, by a vote of 94 to 5, the United States Senate overwhelmingly passed the 21st Century Cures Act. Having passed in the House, the Cures Act now goes off to the White House for the President’s signature, where it will receive a warm reception. “I’ll sign it as soon as it reaches my desk, because like a lot of you I’ve lost people I’ve loved deeply to cancer,” President Obama said in his weekly address on December 3, 2016, as he called upon Congress to act swiftly to pass the legislation and send it to the White House.

The focus of the political advocates pushing march-in may be lower drug costs. But the long-term costs of ripping apart IP rights are far higher and more fundamental than advocates acknowledge. The long-term price of exercising these exceptional prerogatives could include creating a crisis in confidence over use of federally funded research discoveries, dried-up private investments where basic research has federally funded fingerprints, hesitation to commercialize university research, and a corresponding drop in start-ups, new products, economic development and technological advancements. March-in could effectively repeal Bayh-Dole.

At the time of an NIH study in 2011, algae-based biofuel production costs using conventional technologies were anywhere from $300 USD to $2,600 USD per barrel, much higher than the production costs of petroleum, which have since dropped dramatically in recent years. The economic disincentive associated with algae exploration when compared to petroleum is very real, but not the only challenge. Challenges preventing increased biofuel production from algae resources include the need to find more efficient algae harvesting techniques, more cost-effective oil extraction and effective use of land and water. Conquering these challenges should reduce the cost per barrel, but much research is still to be done. Despite the challenges that lie ahead, scientists and innovators remain optimistic.