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Guest Column
Don't sacrifice American innovation with 'march-in'
By Niels Reimers
Guest columnist
A DC-based advocacy group has just petitioned the government to seize the patent covering the prostate cancer drug Xtandi so generic manufacturers can copy the medication.
The group behind this petition has issued similar calls in the past. But both Democratic and Republican admin- istrations have rejected such petitions on the grounds that they misconstrue current law, as the current ad- ministration should likewise recognize.
The government contributed approximately $500,000 to research at UCLA that served as the foundation for Xtandi. The university's findings were eventually li- censed by Astellas — which, after more than $1.4 billion of investments and years of research and development, created the medication.
Since the government funded early-stage research underpinning Xtandi, the petitioners argue, federal of- ficials should forcefully lower its price by licensing the medication to generic manufacturers. Of course, that's not warranted by the law that took the medication from bench to bedside: the Bayh-Dole Act.
Prior to 1980, America had an innovation problem. The government funded basic research at university and non-profit labs and retained the patents resulting from the research. Inventors had no incentive to move their discoveries from the laboratory into the marketplace. It was up to the government to license these patents for commercial development.
The process was a mess. Twenty-six different licens- ing policies governed the federal agencies funding re- search.The government often offered only non-exclusive licenses. Private companies were loath to invest their time and money in such a dysfunctional system.
As a result, fewer than 5 percent of federally funded discoveries were licensed for commercial development. More than 28,000 taxpayer-funded insights languished. Not a single new drug was developed from federally funded R&D.
The Bayh-Dole Act broke that gridlock by allowing university research labs to retain their patents and li- cense them to private firms in exchange for royalties.
The result opened a floodgate of American innova- tion. The law has helped grow the U.S. economy by up to $1.7 trillion. Over the past 25 years, U.S. universities and research institutions have been granted more than 80,000 patents, and some 70 percent of university inno- vations have been licensed to small companies.
The Bayh-Dole Act contains a "march-in" clause, which allows the government to require the patent owner to license additional companies if efforts are not being made to develop the technology.
Some organizations have long sought to use the gov- ernment's march-in authority as a mechanism to impose price controls, especially on pharmaceuticals. Admin- istrations since have rejected all such petitions. The Obama-Biden Administration dismissed more of these off-base petitions than any other.
This petition grossly distorts the Bayh-Dole Act. If it were adopted, innovators would know that anyone could ask the government to "march in" to allow copiers to undercut them in the marketplace.
No one would make investments under such condi- tions. Once again, taxpayer-funded discoveries — like the one that led to the prostate cancer drug the petition concerns — would languish in labs.
Protecting innovation isn't a partisan issue. The Biden administration can prevent a catastrophic drop in pri- vate-sector research and development investment by rejecting this latest march-in petition.
Niels Reimers is the founder and former executive director of Stanford University’s Office of Technology Li- censing. This piece originally ran in the San Jose Mer- cury News.
SHS Hall of Fame dinner to honor some of school's greatest achievers
Fred Hall — Publisher Emeritus Jon Earnest — Editor
Dick Sheppard — Editor Emeritus
Thursday, May 5, 2022 | A4 | Mid Valley TiMes Editorial & Opinions
QUOTE
“There are only two kinds of people who are really fascinat- ing: people who know absolutely everything, and people who know absolutely nothing.”
— Oscar Wilde (1854-1900)
Perhaps the most popular Sanger athletic achievement of the past half-century will take its place in Sanger High School's prestigious Athletic Hall of Fame this Saturday night.
The 1976 Sanger High foot- ball team – a 12-1 juggernaut that steamrolled its way to the Yosemite Division "Valley" championship — is the team inductee for the 2022 ceremo- ny, which begins at 5:30 p.m. Saturday, May 7 at the Sanger Community Center. Also being inducted at the event are Rick Bubenik (the longtime "Voice of the Apaches"), celebrated mid 1950s football-track coach Ray Newman, Class of 1940 star athlete Ed Dittenbir and later 1990s water polo-swim star Colleen Santos.
I well remember the '76 Apaches football champions — it was my senior year at Fresno's Bullard High (yes, I'm an old guy) and I watched the Knights get overpow- ered by three touchdowns at Tom Flores Stadium (pretty sure it had yet to be named for Sanger's favorite football
son). Bruising running back Ted Torosian, option quarter- back Craig Lawley and a stout defense remain etched in my memory.
It was also back in the day when ruling the section (we all called it "Valley" back in the day) was limited to large (Yo- semite), mediums (Sequoia) and small (Sierra) school divi- sions. Sanger not only played with — they went on to domi- nate — the "big boys" that sea- son.
Congratulations in advance to a great Apaches team, and the other SHS athletic giants all worthy of their honor.
•••
One other quick prep sports
note, and it's a big one. Reedley High senior Morgan Gates on May 2 was named the presti- gious Central Section Female Scholar Athlete of the Year. The water polo-swim standout already was the North Yosem- ite League's Scholar Athlete re- cipient, and beat out all others from Madera to Kern County to join male winner Louis Di- Modica of Nipomo High.
In addition to her athletic
exploits, Mor- gan carries a dazzling 4.22 grade point av- erage.
We'll report more on this in our next is- sue. Well done, Morgan!
Jon Earnest
•••
Once again, credit goes out
to the Greater Reedley Cham- ber of Commerce and the spon- sors who helped make the re- turn of the May 1 Street Faire & Car Show a big success. Crowds may not have been at peak years, but was still very strong for the first Street Faire since 2019 because of COVID.
There's more community activities this Friday and Sat- urday, May 6-7, as the Dinuba Cinco De Mayo celebration takes places at Rose Ann Vuich Park. There will be plenty of music both days (5-10 p.m. Fri- day, 1-10 p.m. Saturday), and a parade on Saturday at 10 a.m.
Jon Earnest is news-sports editor for The Times.
Protect IP to keep American tech at the top
By Paul R. Michel
Guest columnist
America can't outcompete low-wage countries when it comes to manufacturing cheap, mass-produced widgets.
But we can, and historically have, outcompeted every other nation when it comes to creat- ing superior technology, from semiconductors and smart- phone operating systems to ad- vanced medicines.
Unfortunately, this advan- tage is disappearing. Com- petitor nations have greatly improved their policies which enable technological break- throughs.
America is heading in the opposite direction. Our leaders are actively weakening the pat- ents, trademarks, copyrights, and other intellectual property protections that incentivize companies to make investments in new technologies.
Until recently, the U.S. pat- ent system was the global "gold standard." It was imitated by other nations, particularly archrival China. Over the past few years, China has upgraded its system to the point that, in many respects, it now surpass- es our own. Patents are more rapidly granted, remedies to prevent IP theft are more com- mon, and the laws are modern-
ized almost annually. The list goes on.
Meanwhile, the United States has been weakening its patent system. In 2011, Con- gress over-reacted to exagger- ated complaints by Big Tech companies about "patent trolls," — firms that buy up patents and sue reputable companies for infringement — and instituted a powerful tribunal inside the U.S. Patent and Trademark Of- fice that usually invalidates pat- ents challenged there.
The Supreme Court has also made challenging patents easier, made injunctions to stop infringement generally unavail- able, and shrank the scope of in- ventions eligible for patenting. Today, many important inven- tions held ineligible for patent- ing here are eligible throughout Europe and in China.
This represents a huge fail- ure of U.S. leadership.
Fortunately, leaders are emerging in the U.S. Senate who are focused on reviving patents to invigorate economic growth and job creation: Sena- tors Coons, Tillis, Hirono, and Cotton. They are leading ef- forts to make more inventions eligible for patenting.
Separately, Senators Schum- er and Young are proposing to increase federal funding for technology by sponsoring the
American Innovation and Com- petition Act.
This effort is vital to U.S. recovery in economy and tech- nology because public funding, which helps spur private sector innovation, has been shrinking for decades -- as has private in- vestment. Venture capital firms insist on their clients obtaining ownership rights before com- mitting the needed funds. So, prospects for our future pros- perity rise or fall in line with the strength of IP protections.
However, Big Tech has con- vinced many of their colleagues to leave matters alone. Their le- gions of lobbyists swarm Capi- tol Hill, suggesting that patent revival is not necessary. Only a few members, such as those named above, understand the link between robust patents and economic revival.
Economic progress requires fixing our ailing patent system. Andwemustdososoon—be- fore China replaces us as the world's leader in the advanced technologies that will dominate the 21st Century.
Paul R. Michel served on the United States Court of Ap- peals for the Federal Circuit for 22 years, and as its chief judge from 2004 until his retirement in 2010. This piece originally ran in VentureBeat.