California's Stem Cell Bank and Its Fujifilm Moment

A CIRM slide from last week on the Cellular Dynamic stem cell bank project.

Remember the “Kodak Moment?” California’s $3 billion stem cell agency yesterday experienced a “Fujifilm Moment.”

It came when the Japanese firm announced it was buying Cellular Dynamics International (CDI) for $307 million. That doubled the price of the company stock overnight, probably leading to moments of ecstatic celebration in some circles. The stock closed at $16.43 today, well above its 52-week low of $4.72.

The purchase was part of what FierceBiotech today called a “fresh frenzy of biotech-related buyouts.”

Cellular Dynamics is a Wisconsin firm that has a $16 million grant from CIRM, as the stem cell agency is known, to create what could be the world’s largest bank of induced pluripotent stem cells (iPSCs). The firm was founded by noted University of Wisconsin researcher Jamie Thomson. The bank is located at the Buck Institute in Novato, north of San Francisco. The 155-employee CDI is also the prime subcontractor on a related $10 million award to the Coriell Institute.

At the CIRM board meeting last week, Uta Grieshammer, a science officer at the agency, gave an update on the $32 million project that directors approved in March 2013. From the tenor of her briefing, the effort seems to be on track. (Here is the CIRM-CDI contract dated Oct. 25, 2013.)

It is not entirely clear what, if anything, the Fujifilm purchase means for the CIRM contract with CDI.  Sometimes new owners have different views of previous business arrangements and seek modifications. The Fujifilm press release said CDI work will continue in California and Wisconsin. But the release also said Fujifilm will “seek synergies and efficiencies,” which can be industry-speak for cutbacks and layoffs.

The California Stem Cell Report yesterday queried the agency about its thoughts but no response has been forthcoming.

In June 2014, Kerry Grens of The Scientist magazine wrote about the stem cell banking business. The article said,

“The California Institute for Regenerative Medicine (CIRM) has the ambitious goal of creating the world’s largest iPSC bank. This will include cell lines from people with cardiomyopathy, blinding eye diseases, and Alzheimer’s, among other things. Michael Yaffe, the associate director for research activities at CIRM, said it was important not to duplicate the efforts of other iPSC banking initiatives. In planning the program, Yaffe explained, 'We wanted to make as many [cell lines] as possible. Then it became an economic argument: How many could we afford and how much could we push a deriver to handle?' 

“CIRM settled on a goal of 9,000 lines derived from 3,000 individuals. Yaffe said he anticipates that the first of these will be available for distribution by the end of the year or early 2015. What’s still unsettled, however, is the cost. It’s a tricky calculation, given that the utilization of the lines is unknown. 

“'If a few large pharmaceutical companies buy a complete set of all the lines, that would keep the bank established and running for many years,’ Yaffe said. ‘If academic researchers are going to buy a few lines at a time or a few lines each, it will create some challenges for the sustainability of the bank.’”

In December 2013, CIRM’s staff recommended a $2 million addition to the stem cell banking program. The CIRM governing board rejected the proposal after one board member called the plan dodgy. Jeff Sheehy, who serves on the grant review committee, said it needed to be peer reviewed and competitive.

The Fujifilm purchase attracted considerable news coverage but little mention of the CIRM connection. Here are links to some samples: Madison.com, ipscell.com, xconomy. Here is a link to CDI’s one-year progress report with CIRM.

California's Consumer Watchdog Loses U.S. Supreme Court Challege to WARF Stem Cell Patents

The U.S. Supreme Court yesterday appeared to have put an end to a California’s group nine-year effort to overturn patents on human embryonic stem cells held by the Wisconsin Alumni Research Foundation (WARF).

The court refused to hear the case that was brought by Consumer Watchdog of Santa Monica, Ca., and Jeanne Loring, head of the stem cell program at Scripps. The court issued its decision with no comment.

An article by Lisa Shuchman in The Litigation Daily said,

“The high court's denial leaves in place a ruling last year by the U.S. Court of Appeals for the Federal Circuit, which found that Consumer Watchdog lacked standing to appeal the findings of the PTO's (Patent and Trademark Office) administrative patent review board.” 

While today’s ruling involved relatively technical legal matters, the heart of the challenge to WARF’s patents involves who profits from stem cell research along with whether its patents have or will stifle scientific research.

Royalties from WARF patents in California alone generated an estimated $200 million in 2006 for the foundation. Executives of biotech firms in California have complained that WARF’s restrictions have posed a significant barrier to private investment. 

Asked for comment, Loring said,

"This doesn't mean they believe that human cells can or cannot be patented, but only that they decided that we had not been sufficiently harmed by the patent for them to become involved.

"Even without a Supreme Court decision, we have succeeded.  WARF wanted their patents to include iPS cells as well as ES cells, but they had to narrow their claims as a result of our challenge, and they cannot claim ownership of iPSCs."  

Doing the legal lifting in the WARF challenge was Dan Ravicher, executive director of the Public Patent Foundation of New York. Shuchman carried a comment from Ravicher on yesterday’s ruling. She wrote, 

“Ravicher said Monday that the Supreme Court's decision could impact many would-be patent challengers. ‘This case could have severe consequences for other third parties that challenge patents with IPRs or the other proceedings created under the America Invents Act,’ Ravicher said. ‘Now they will have no right to appeal an adverse decision.’

“But he also said the decision wouldn't preclude individuals who can claim direct harm, such as stem cell research scientists, from challenging WARF's patent—much the same way doctors successfully challenged the Myriad patents.

“Under the America Invents Act, third parties, such as nonprofits, public interest groups and industry organizations, have the right to challenge patents at the PTAB (Patent Trial and Appeal Board). But under the Federal Circuit’s ruling that now stands, they don't have the right to appeal a PTAB decision.”

Shuchman also recounted briefly some unusual history on the federal appellate ruling that declared Consumer Watchdog had no standing to sue. A more detailed account of that hearing can be found here.

The California Stem Cell Report has asked Consumer Watchdog and WARF for comments. We will carry them when we receive them. Here is the full text of what Loring had to say.

"Being involved for nearly 9 years in the challenge of WARF's patent on human ES cells has given me a fascinating glimpse into our legal system. I hoped that the Supreme Court would decide on the patentability of human embryonic stem cells. But ultimately, the Court decided not to take our case.  This doesn't mean they believe that human cells can or cannot be patented, but only that they decided that we had not been sufficiently harmed by the patent for them to become involved. Even without a Supreme Court decision, we have succeeded.  WARF wanted their patents to include iPS cells as well as ES cells, but they had to narrow their claims as a result of our challenge, and they cannot claim ownership of iPSCs.  

"I've learned that the law is every bit as complex as scientific research, and have gained great admiration for people like our attorney, Dan Ravicher, who relentlessly pursue the question of patent ethics - what should and should not be patented in the public interest.  Dan brought the issue of patenting the human genome to the Court, and won (the Myriad Genetics case).  Working on this challenge with Dan and John Simpson (of Consumer Watchdog) has been a joy, and if they ever want my help in the future, I'd agree in a second."

WARF, Oatmeal and the Patenting of Life

The battle over the WARF patent on human embryonic stem cells caught the attention of the Los Angeles Times last week, which added some oatmeal and history to the tale.

Michael Hiltzik, a business columnist with the largest circulation newspaper in the Golden State, reported on the challenge by Consumer Watchdog of Santa Monica, Ca., Jeanne Loring, head of the stem cell program at Scripps, and the Public Patent Foundation of New York.

The trio on Friday asked the U.S. Supreme Court to intervene and affirm their right to sue(See here and here.).  Hiltzik said, 

“The group has challenged the patent on two grounds: first, that the work covered wasn't novel or original, and second, that the Supreme Court has ruled that a ‘product of nature’ can't be patented.   

“All this is happening, researchers say, because WARF (Wisconsin Alumni Research Foundation) made exceptionally broad claims for its patent rights and exercised them very aggressively. This is, in fact, WARF's business; the nonprofit foundation was formed in the 1920s to exploit a patent issued to a University of Wisconsin professor on fortifying food with vitamin D, which it promptly licensed to Quaker Oats. By 1930, the deal was producing $1,000 a day. WARF also owns the rights to the drug Warfarin, which is named after the foundation.”

Hiltzik continued,

“The foundation demanded steep licensing fees of $5,000 a year from academic researchers and as much as $400,000 from commercial firms, plus royalties from product sales. 

“Eventually this backfired. When San Diego researcher Jeanne Loring was confronted by a demand for $75,000 a year from her start-up company—‘that's a lot, when your entire budget is $75,000,’ she told me--she looked closely at the patents only to conclude that they should never have been issued. 

“The key to (Wisconsin researcher Jamie) Thomson's success, she contends, was that he was able to get his hands on human embryos at a time when other researchers could not; the techniques he used had been applied to embryos of other species and shown to be effective. ‘Had I or any other stem cell scientist been given human embryos and sufficient funding, we could have made the same accomplishment, because the science...was obvious at the time,’ Loring says in a court declaration.  

“WARF disagrees. Thomson's success, it says in its own legal filings, ‘was anything but routine....He identified the critical steps needed to generate and culture these cells....No prior art reference taught these insights.’"

Judicial Activism, WARF and Embryonic Stem Cell Patents

The Corporate Counsel Web site/magazine today called up some interesting history involving an appellate court judge in the California-based challenge to an important patent on human embryonic stem cells.

The case involves WARF, the Wisconsin Alumni Research Foundation, which holds the patent on the work done by Jamie Thomson of the University of Wisconsin. Challenging the patent is Consumer Watchdog of Santa Monica, Ca., and Jeanne Loring, head of the stem cell program at Scripps, and Daniel Ravicher of Public Patent Foundation of New York.

Today they filed a petition with the U.S. Supreme Court to overturn an appellate court ruling that they had no standing to sue (see here and here). That ruling was written by Randall Rader, one of three judges on the appellate panel.  

Lisa Shuchman, a reporter for Corporate Counsel, wrote,

“It was one of the last decisions written by then-Chief Judge Rader before he resigned (as head judge) amid an ethics controversy.”

She continued,

“WARF did not raise the issue of standing in its Federal Circuit briefs. But about 20 seconds into Ravicher’s oral argument before the court, Rader interrupted, asking him, ‘Do you have standing to be here?’ That question eventually led the panel to rule against the advocacy group.

“On Twitter, Ravicher on Friday called that ruling ‘judicial activism at its finest.’

“'Statutes expressly say non profit groups like @ConsumerWD can challenge patents in court. Fed Cir decision judicial activism at its finest.— Daniel B. Ravicher (@danravicher) October 31, 2014’ 

“A year before the Federal Circuit’s June decision, the Supreme Court reversed the Federal Circuit in Association for Molecular Pathology v. Myriad Genetics Inc., ruling that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.

“'Under Myriad, there’s no way WARF’s patent would survive,’ Ravicher said. ‘Rader was on the record saying he thought the Supreme Court got Myriad wrong, and he looked for a way to avoid hearing this case on the merits because he didn’t want to further enforce the Myriad rule.’”

'Wipe This Thing Off the Books:' More Coverage of WARF Patent Challenge

The San Diego U-T is carrying a story on today’s filing with the United States Supreme Court on the California-based challenge to the WARF patent on human embryonic stem cells.

Bradley Fikes quoted one of the parties in the matter, Jeanne Loring, head of the stem cell program at Scripps, as saying,

“We think that now embryonic stem cells really are showing their worth in clinical studies, it's very important to just wipe this thing off the books, so nobody can either shut down trials or require huge licensing fees for successful efforts.”

Here is a link to the petition to the high court, which deals with a standing to sue issue – not the heart of the dispute. Here is a link to the press release from Consumer Watchdog of Santa Monica, Ca., another party in the matter. Here is a link to the earlier story on the California Stem Cell Report.

U.S. Supreme Court Action Being Sought in Major Human Embryonic Stem Cell Patent Case

The California-based  challenge to WARF’s patent on human embryonic stem cells is headed for the United States Supreme Court.

The nation’s highest court is expected to be asked Friday to overturn an earlier appellate court decision and allow two public interest groups to seek to cancel the patent held by WARF, the Wisconsin Alumni Research Foundation.

The specific issue is whether the California parties have the right to sue. But at the heart of the matter is the question of who profits from stem cell research along with whether the Wisconsin patents stifle scientific research.

As far back as 2006, executives of biotech firms in California complained that the Wisconsin patents were onerous and posed a significant obstacle to private investment.  That year the royalties from California alone generated an estimated $200 million for WARF.

Consumer Watchdog of Santa Monica, Ca., and Jeanne Loring, head of the stem cell program at Scripps, are pushing the eight-year-old case along with the Public Patent Foundation of New York, which is doing the legal lifting.  In 2013, the patent foundation won the famous Myriad case in which the Supreme Court ruled that genes cannot be patented because they occur naturally in nature. 

In a statement about Friday’s appeal to the high court, Dan Ravicher, executive director of the

Dan Ravicher and Jeanne Loring at Post Office when
they made the first filing in the WARF case in 2006.

foundation, said,

“The Court of Appeals’ refusal to allow Consumer Watchdog to appeal the (Patent and Trademark Office’s) faulty decision to uphold a patent on human embryonic stem cells is a clear violation of the express language of statutes passed by Congress and signed by the President to empower the public to seek revocation of invalid patents.”

John M. Simpson, stem cell project director for Consumer Watchdog, said,

“The patent should clearly be rejected because it covers ineligible subject matter and was obvious in view of earlier research.”

Loring said,

“This is an important battle. Human embryonic stem cells hold great promise for advancing human health, and no one has the ethical right to own them,”

Others who have filed affidavits supporting the challenge include Douglas Melton and Chad Cowan of Harvard and Alan Trounson, who was then with Monash University. He later became president of the $3 billion California stem cell agency but left that organization earlier this year to return to Australia.

The research that led to the patents was performed by Jamie Thomson at the University of Wisconsin. Thomson has a lab at UC Santa Barbara as well, where he is also a professor.

Coincidentally the Supreme Court filing comes during the week when Jonas Salk, who developed the polio vaccine, would have turned 100. He famously commented in 1955 about patenting the vaccine.

In a televised interview, Salk was asked who owns the patent on the vaccine. Salk replied,

"Well, the people, I would say. There is no patent. Could you patent the sun?"

That statement has led to a range of interpretations about what Salk meant. Michael Hiltzik, a Pulitzer Prize-winning columnist for the Los Angeles Times, wrote earlier this weekabout the issue. 

He quoted from a 2005 book on the vaccine that reported that Salk dissuaded his backers from seeking a patent because his techniques weren’t novel. He said his work was based on years of prior work by others.

The patent attorney looking into the matter for Salk and the backers said,

"If there were any patentable novelty to be found in this phase, it would lie within an extremely narrow scope and would be of doubtful value."

That is not much different than the argument being made by Loring, Consumer Watchdog and the Public Patent Foundation.

WARF Triumphs in Latest Chapter of hESC Patent Challenge

A California-based effort to ease patent restrictions on the research use of human embryonic stem cells last week suffered a severe blow when a federal court of appeals ruled in favor of a Wisconsin organization known as WARF.

At the heart of the matter is the question of who profits from stem cell research along with whether the patents stifle scientific research.

The ruling came Wednesday in a legal action brought by Consumer Watchdog of Santa Monica. The effort was supported by the former president of California stem cell agency, Alan Trounson, and Jeanne Loring, head of the stem cell program at Scripps in La Jolla, Ca. Doug Melton and Chad Cowan, both of Harvard, also backed the challenge.

The lawsuit was filed in a case involving the Wisconsin Alumni Research Foundation (WARF) and involved work by Jamie Thomson of the University of Wisconsin and of UC Santa Barbara. Consumer Watchdog said that Thomson deserved credit for being first to isolate and maintain human embryonic stem cells. But the organization said that “his achievement was not the result of his having created a patentable invention.” Consumer Watchdog's brief said that the work involved was “obvious.” One of the main reasons for Thomson’s achievement, the organization said was that “he had access to human embryos and financial support that other researchers did not have.”

A federal court of appeals in Washington, D.C., said Consumer Watchdog had no standing to sue to overturn WARF patents.

The court said that because Consumer Watchdog “has not identified a particularized, concrete interest in the patentability" of the work or shown “any injury in fact...it lacks standing to appeal” earlier decisions in favor of WARF.

It is unclear what the next step is in the eight-year-old dispute. John M. Simpson, the stem cell spokesman for the Consumer Watchdog, said,

"We are reviewing the decision and considering our options.  It's important to remember that because of our challenge WARF's claims were substantially narrowed as the patent went through the PTO (patent office) process."

WARF has not responded to a request for comment from the California Stem Cell Report.

Consumer Watchdog is represented in the matter by the Public Patent Foundation of New York, which successfully argued before the U.S. Supreme Court last year that genes cannot be patented because they occur naturally in nature.  

Here is a link to legal documents and other material in the case.  Last week's decision can be found below. 

  Appellate Court Decision Involving Consumer Watchdog and WARF

Bloomberg Reports on the WARF hESC Patent Challenge

The California-based challenge to the WARF patents involving hESC research drew national media coverage this week on Bloomberg News.

Susan Decker of Bloomberg described the heart of the matter as a dispute over who profits from stem cell research. She wrote,

“'What we’re asking the government to do is say WARF has no right' to the patent, said Dan Ravicher, executive director Public Patent Foundation in New York, which is handling the challenge for Consumer Watchdog(of Santa Monica, Ca.) 'It’s like the government sent a check to WARF they didn’t deserve.'”

Dan Ravicher and Jeanne Loring at Post Office
when they filed the patent challenge July 17,
2006.  The photo was taken by an anonymous
 woman at the Post Office with Loring's camera. 

The challenge to the patents was filed by Consumer Watchdog and researcher Jeanne Loring of Scripps seven years ago. They contend that the patents are “too similar to earlier research” to be valid and that they hinder scientific research. They also contend that the Myriad decision by the U.S. Supreme Court that limits the right of ownership of human genes should also apply to stem cells. Ravicher successfully argued the Myriad case before the high court.

Decker said the issue is no small matter and involves major developments in medicine. She reported,

“'The next paradigm shift in medicine will be advances in cell therapy -- it’s under way,' said Jason Kolbert, senior biotechnology analyst with Maxim Group LLC in New York. He said pharmaceutical makers such as Teva Pharmaceutical Industries Ltd. (TEVA) of Petach Tikva, Israel, and Pfizer (PFE) Inc. of New York are working with stem-cell researchers on new therapies.”

Decker reported that written arguments from the U.S. Patent Office are scheduled to be delivered Jan. 17 to the federal district court of appeals in Washington, D.C.

WARF Stem Cell Challenge: Appeal Says Patent Involves Cells Not 'Markedly Different' Than Found in Human Body

The battle over whether excessive protection of stem cell IP stifles research that can lead to cures was engaged once more today with a broadside against the powerful Wisconsin Alumni Research Foundation(WARF).

The attack came from California’s Consumer Watchdog organization and New York’s Public Patent Foundation which have been tussling with WARF for seven years. The dispute over intellectual property (IP) centers on a patent on human embryonic stem cells held by WARF and which the other organizations are challenging in a federal appellate court in Washington, D.C.

More specifically, the patent involves research by Jamie Thomson of the University of Wisconsin, and now also of UC Santa Barbara, in which he isolated human embryonic stem cells.

Consumer Watchdog of Santa Monica, Ca., this morning issued a news release concerning the organizations’ appellate brief that was filed last week. It cited the U.S. Supreme Court ruling earlier this year that said genes cannot be patented because they exist in nature.  The lead attorney in that successful case, Dan Ravicher of the Public Patent Foundation, is also handling the challenge to WARF.

The news release said that Thomson deserved credit for being first to isolate and maintain human embryonic stem cells, but “his achievement was not the result of his having created a patentable invention.” The brief said that the work involved was “obvious.” One of the main reasons for Thomson’s achievement, the news release said, was that “he had access to human embryos and financial support that other researchers did not have.”

The brief said,

“The claims at issue here cover human embryonic stem (hES) cells that are not markedly different from those in our bodies. Thus, the claims are invalid under 35 U.S.C. § 101 for covering ineligible subject matter, an issue the Court may and, as a matter of judicial economy and public policy, should address.”

The challenge to the WARF patent has drawn impressive support in the scientific community, including  Jeanne Loring, now director of the Center for Regenerative Medicine at The Scripps Research Institute, who was involved from the start. In 2007, Loring wrote in Nature that she became involved in the case because “scientists have an obligation not only to perform research but to make sure that our research can benefit the society that supports it.”

The news release said,

“Later in the case Dr. Alan Trounson, then of Australia’s Monash University and now president of the California Institute for Regenerative Medicine, Dr. Douglas Melton of Harvard and Dr. Chad Cowan of Harvard filed affidavits supporting the challenge.”

Here is a link to legal documents and other material in the case.

Challenge to WARF hESC Patents Cites Recent U.S. Supreme Court Decision

Patents on human embryonic stem cells are being challenged in a new legal filing that cites the recent U.S. Supreme Court decision that barred the patenting of human genes.

The stem cell case involves the Wisconsin Alumni Research Foundation (WARF), which holds the patents on the much-heralded work performed by Jamie Thomson  at the University of Wisconsin. The lawsuit was filed by the Public Patent Foundation of New York City on behalf of Consumer Watchdog, a nonprofit group in Santa Monica, Ca. Jeanne Loring, director of the Center for Regenerative Medicine at the Scripps Research Institute, is also involved along with Alan Trounson, president of the California stem cell agency. The agency itself is not a party.

This week's filing follows the so-called Myriad decision last month by the nation's highest court which said,

“Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.”

This week's stem cell suit said,

"WARF did not create or alter the properties inherent in stem cells any more than Myriad created or altered the genetic information encoded in the DNA it claimed.” 

The legal filing came in an appeal of an earlier decision by the U.S. Patent Office. The Public Patent Foundation, which was a successful party in the Myriad case, did the earlier legal work on the challenge to the WARF patents as well as this week's appeal.

The appeal, prepared by Dan Ravicher, said the WARF patents have "put a severe burden on taxpayer-funded research in California.”

Trounson released a statement saying,

“We don't want to do anything that gets in the way of finding treatments for some of the biggest killers today, so we feel that all patients with all kinds of diseases deserve to have access to these kinds of cells.”

Loring was quoted in a Consumer Watchdog press release as saying,

"Human embryonic stem cells hold great promise for advancing human health, and no one has the ethical right to own them.”

John M. Simpson of Consumer Watchdog said,

 “The best course if WARF truly cares about scientific advancement would be to simply abandon these over-reaching patent claims.”

A story by Bradley Fikes in the San Diego U-T cited intellectual property attorney Lisa Haile of DLA Piper as saying,

“A successful use of the Myriad case as a precedent for throwing out the foundation’s patent would open the door to similar challenges in just about any biotech product using material derived from life.”

WARF made no immediate comment.

Other stories on the WARF challenge appeared in the Milwaukee Journal, Genomeweb and the LaCross Tribune. 

WARF hESC Patent Update: Seven Years and Challenge Still Underway

Last week UC Davis stem cell researcher Paul Knoepfler and Scripps researcher Jeanne Loring engaged in an online Q&A that touched on patents and how they can stifle research and discourage development of therapies.

Loring did not mention it in the Q&A but she is the key figure in the ongoing challenge to the WARF (Wisconsin Alumni Research Foundation) patents on human embryonic stem cells. Her effort began in 2006 but has dropped out of the news. We asked her for an update on the case.

Here is the text of what she replied,

“Dan Ravicher is the lawyer behind several big patent cases, including the recent Supreme Court case challenging human gene patenting (Myriad), and a challenge to Monsanto's restrictive enforcement of its patents on genetically modified seeds. 

“I'm lucky that he is also the lawyer working with John M. Simpson (of Consumer Watchdog) and me to challenge the WARF patents.  Currently, we are getting ready for another year of appeals and counter-appeals on the third of WARF's three patents that give them control over all human embryonic stem cells.

“This is Dan's summary of the current situation:

"'We filed challenges at the Patent Office to all three of WARF's hESC patents. During those challenges, WARF agreed to narrow all three of the patents, and they also loosened their licensing requirements. But, even though the patents were narrowed, we still think they're invalid, and thus disagree with the Patent Office's decision to re-issue them in the narrowed forms. Unfortunately, due to the age of the patents and changes in the law, we were only allowed to appeal one of the three decisions, and that appeal is now pending at the Court of Appeals in Washington. But, we expect the decision in our appeal will affect the validity of the other two patents, since they're all basically on the same technology." 

“The 'narrowing' of the patents has had an unexpected consequence.  Before the narrowing, WARF's patents would have covered iPSCs as well as hESCs. After the narrowing, they can only claim hESCs.”

In the Q&A on Knoepfler's blog, which also involved an interesting discussion of IPS research, Loring said,

“Patents on fundamental things -- genes, human embryonic stem cells, iPS cells -- allow the patent holder to have a monopoly, preventing anyone else from using whatever they’ve patented.

“Patents are supposed to stimulate investment in development.  Why, as Justice Scalia said last week, would anyone have the incentive to study a gene and, for example, develop diagnostic tests, if they couldn’t prevent everyone else from working on that gene?

“But patents also stifle competition and the advances that come from having many different groups studying the genes or cells.  One of the main reasons I returned to academia was so I could have freedom to study human ES cells without worrying about getting threatening letters from a patent holder, demanding that I either stop working on the cells or pay a steep licensing fee.

“There will inevitably be problems commercializing iPSC-based therapies and assays, because at least three institutions own patents on aspects of iPSCs.  I’m paying attention to the patent 'landscape,' but have decided to deal with those problems when they arise, and hope that the iPSC patent holders realize that the potential of these cells is too great to keep to themselves.  It would be better for all of us if the issue of stem cell patents never has to be decided in the Supreme Court.”

WARF Loses Latest Round on Challenge to hESC Patents

Two watchdog groups said today they have scored a “major victory for unfettered scientific research” in a case involving a WARF patent on human embryonic stem cells.

Consumer Watchdog of Santa Monica, Ca., and the Public Patent Foundation of New York City filed the challenges to the WARF patents on work by Jamie Thomson of the University of Wisconsin.

The groups said in a news release that federal patent regulators have “agreed with the groups that the creation of human embryonic stem cell lines was obvious in the light of work that had been done in other species. In order to obtain a patent, work must be both new and non-obvious.”

WARF, which can appeal the decision, released the following statement.

“WARF has been invited by the Board of Patent Appeals to continue prosecution of this application and plans to do so and vigorously pursue these claims with the patent office. This decision regarding ‘913 does not affect the patent office’s 2008 decision to reaffirm WARF’s two most important base stem cell patents for primate and human embryonic stem cells, ‘780 and ‘806. These reaffirmed patents are not eligible for further appeal in this reexamination process.”

Geron Corp., of Menlo Park, Ca., which holds a license on the patent, said the decision will not “impact” the firm's “dominant human embryonic stem cell patent position.”

The 2006 challenge to the WARF patents was supported by Alan Trounson, then connected to Monash University but now president of the California stem cell agency, Douglas Melton and Chad Cowan of Harvard and Jeanne Loring, director of the Center for Regenerative Medicine at Scripps.

Loring said,

“This is great news for medical research. Human embryonic stem cells hold great promise for advancing human health, and no one has the ethical right to own them.”

The challenge involved three patents. Federal officials originally ruled unfavorably.

The Consumer Watchdog news release said,

“Under current patent law only one of the three (earfier) patent rulings could be appealed by the two groups.  That was the patent rejected by the Board of Appeals and Interferences. However, said the groups, the latest ruling by the Board of Appeals is a strong decision that could set a precedent leading to the revocation of the other two patents as well.

“The two public interest groups noted that the original three patent challenges  had already improved the situation for stem cell researchers; shortly after the PTO launched its initial re-examinations in 2006 at the groups’ request,  WARF announced a substantial easing of its licensing requirements.

“'WARF executives were acting like arrogant bullies blinded by dollar signs,' said (John M.)  Simpson (of Consumer Watchdog). 'Our challenges prompted a more co-operative stance towards the stem cell research community on their part.'”

“Both Consumer Watchdog and the Public Patent Foundation stressed that while University of Wisconsin researcher James Thomson deserved acclaim for his research that isolated human stem cells, important scientific accomplishments are not necessarily patentable.  They said one of the main reasons he was able to derive a human stem cell line was because he had access to human embryos and financial support that other researchers did not have.”

Geron issued a news release on the decision. The company said,

"'This is not a final rejection of the patent claims,' noted David J. Earp, J.D., Ph.D., Geron's chief patent counsel and senior vice president of business development. 'We are confident that WARF will make a strong case in support of the patentability of these claims in continued examination.'"

Fresh Comment

"Anonymous" has a fairly detailed comment on the "warf" item below about the "true overcome" of the latest action in the stem cell patent dispute.

AP Story on WARF Patent Matter

Re the WARF patent fight(see item below), here is a link to The Associated Press Story, which has been now carried on the San Jose Mercury News website.

Stem Cell Patent Fight Enters Another Round

Players in the ongoing saga of stem cells, WARF, California and patents rolled out another chapter today with folks on both sides finding something to make them happy.

WARF apparently fired out the first news release, declaring it was "pleased by the United States Patent and Trademark Office’s decision to uphold the claims of a key stem cell patent."

The opposing side, the Foundation for Taxpayer and Consumer Rights of Santa Monica, Ca., and the Public Patent Foundation, said the decision showed the following gains for researchers.

"The original broad patent was abandoned showing it was underserved and new amended claims have been narrowed.

"The original patent covered all embryonic stem cells no matter how they are derived, but the amended 'non-final' ruling, while permitting the patent, narrowed the claim only to stems cells derived from pre-implantation embryos.

"The newest stem cell research technology — Induced Pluripotent Stem Cells (IPS cells) — would clearly not be covered by the narrowed patent.

" Stem cells derived from fetal tissue could have been claimed under the old patent, but now cannot be."

FTCR and the patent group have been personally supported by CIRM President Alan Trounson in their challenge to the WARF patents.

The Wall Street Journal picked up on the story in its health blog, quoting Ken Taymor(see photo), a longtime follower of California stem cell affairs and executive director of the Center for Law, Business at UC Berkeley.

"It’ll be several years before the patent fight shakes out, according to Taymor, who co-authored a recent article on the subject in the journal Cell Stem Cell. 'In the mean time, there is all this other patenting activity that’s going on — patenting activity that’s not being challenged,' he said.

'Those are essential steps for commercialization.'

"What’s more, Geron and WARF hold a lot of the newer stem cell patents. 'So the more interesting question,' Taymor said, 'is what patents do they hold and what’s the scope of the claims that they have downstream in commercialization?' Taymor and his colleagues are looking into that now, and plan to publish their findings."

The story received a fair amount of attention in Wisconsin. At the time of this writing, only one newspaper in California, which is the leading biotech state in the nation, had carried a story. That publication is the San Jose Business Journal, and it wrote based on a Geron press release.

Here is a link to the story in The Scientist.

A Look Behind the WARF Patent Announcement

The folks who challenged the WARF stem cell patents and triggered a fresh wave of negative publicity for one of Wisconsin's more sacrosanct institutions deserve credit for this week's surprising announcement concerning more liberal access to the critical keys for ESC research.

That credit is deserved despite WARF's predictable assertion that the organization really has not changed its position. Additionally, part of the backdrop to its announcement seems to involve the abrupt departure last year of WARF's longtime counsel, Beth Donley.

Previously WARF had taken a hardline position on its ESC cell patents, serving notice that it would defend them aggressively. Donley was in the forefront of that position, which is where an attorney should be when her job is to defend an organization's IP. But the ultimate question for WARF really was whether it wanted to appear to be standing in the way of research that could benefit millions of ailing persons all because WARF was grubbing for dollars. We suspect that was a position that made WARF's directors uncomfortable.

Nonetheless, Andrew Cohn, government relations manager for WARF, in response to questions from the California Stem Cell Report, said:

"Our position has not changed. People completely overreacted to comments made (last spring) by a WARF staff person (Donley) in response to a question. They did not report the second sentence of her response which was WARF has no intention of interfering with the CIRM grant process. The policy announced this week was just a clarification on a policy that was misunderstood many people."

Of course, if WARF wanted to clarify its position it could have made its announcement concerning its patents last spring instead of this week.

Following Donley's statement last year, John M. Simpson, stem cell project director of the Foundation for Taxpayer and Consumers Rights in Santa Monica, Ca.; Jeanne Loring, a stem cell scientist with the Burnham Institute in La Jolla, Ca., and the Public Patent Foundation legally challenged the WARF patents, triggering a spate of articles that did not portray WARF as a benign non-profit.

The Simpson alliance is still not satisfied with WARF's position and plans to continue their efforts.

The Sacramento Bee said that Simpson, Loring and the Patent Foundation deserve credit for WARF's "change." It also noted, in an editorial, the benefits of having a friendly critic (Simpson et.al.):

"The California Institute for Regenerative Medicine -- apparently unwilling to pick a fight with WARF -- hasn't joined the patent challenge. Now, ironically, it may benefit from the activism of Simpson and Loring."

In addition to Simpson's coalition, others do not think WARF went far enough. Writing in The Scientist, Alison McCook said,

"Jonathan Auerbach, president of GlobalStem, Inc., agreed that the patents remain a significant 'roadblock' for research. The changes to the licensing terms don't affect in-house industry research, and if GlobalStem receives, for example, an NIH small business grant of $100,000 for human ES cell research, the company would still have to turn over a sizeable proportion -- perhaps in the range of $75,000 -- to WARF in licensing fees, Auerbach noted. Loosening the restrictions 'is progress, but it's not enough,' he told The Scientist. "

Aaron Lorenzo of Bioworld Today additionally reported:

"Some industry sources told BioWorld Today that the new policy doesn't go far enough - WARF said companies still will need a license when they want to conduct internal research, which potentially is debatable given recent Supreme Court rulings on patent law, or develop a product for the market. But those same critics nonetheless feel that the overall bent of the change in attitude represents a positive step."

As for Donley's role in all this, scuttlebutt is floating around in the stem cell world that one of the reasons for her departure from WARF involved a re-examination of the foundation's position on stem cell patents. One report has it that she gave only three days notice.

Whatever the reasons for its announcement, WARF is doing the right thing, and it should receive credit for moving in the right direction. So should Simpson and company for lighting the way.

Ebert on WARF and the Patent Challenge

Lawrence Ebert, a patent attorney in New Jersey, has a different take on WARF and the stem cell patent matter. Among other things, he faults The Sacramento Bee and challenges the challenge to the patents:

"Patent claims are not invalidated because earlier researchers paved the way for later researchers. PubPat's anticipation argument for human embryonic stem cells is based on a prior reference which is not enabled as to human embryonic stem cells. To look in a different area, the work of Galileo (and others) may have paved the way for the Wright Brothers, but no one achieved three dimensional flight control before the Wright Brothers, or taught how three dimensional flight control could be achieved. PubPat's obviousness argument is based on the assertion: recipe for mouse embryonic stem cells renders obvious recipe for human embryonic stem cells. If this were true, it probably would not have taken 15 years between mouse and human."

CIRM on WARF

The California stem cell agency, until now, has been nearly deathly silent on the WARF patent flap.

But the agency released the following statement in the wake of WARF's change of heart.

"The announcement today by the Wisconsin Alumni Research Foundation (WARF) appears to be a major step forward in facilitating the sharing and accessibility of materials that will move stem cell research closer to therapies and cures. We are interested to hear more details and to review the new licensing policies."

WARF Softens Stem Cell Patent Position, Critics Not Satisfied

In a surprising move, WARF says it is making changes in its embryonic stem cell patent program that should have a "positive" impact on the California stem cell research effort and others as well.

WARF previously had taken an aggressively combative position in relation to California and challenges to its ESC patents. Its move, however, did not satisfy opponents, who said the changes do not go far enough.

WARF said:

"Industry-sponsored stem cell research will be facilitated by a new WARF policy that will enable companies to sponsor research at an academic or non-profit institution without a license, regardless of location and regardless of intellectual property rights passing from the research institution to the company. This will enable companies to get started with stem cell research in a low-cost, visible manner and increase funding of stem cell research by for-profit companies. Companies will still need a license when they want to bring the research into their company laboratories or when they want to develop a product for the market."

WARF continued:

"Second, while ensuring provisions related to informed consent for embryo donations are communicated and honored, WARF is changing the cell transfer provisions in its academic and commercial licensing. The new policy will allow easier and simpler, cost-free cell transfers among researchers. This will facilitate collaborations within the human embryonic stem cell research community and thus advance the field."

WARF added:

"WARF is also clarifying its position with regards to the California Institute for Regenerative Medicine (CIRM). As a not-for-profit, grant-making organization, CIRM does not require any license or agreement from WARF to pursue its grant making policies. Further, WARF does not expect CIRM to remit to WARF or WiCell any portion of payment that CIRM receives from its grantees. WARF has been and will continue to be supportive of CIRM’s efforts to fund human embryonic stem cell research and move the technology forward."

John M. Simpson, stem cell project director for the Foundation of Taxpayer and Consumers Rights of Santa Monica, Ca., which is challenging WARF´s patents, said:

"WARF’s action demonstrates that their previous stance was indeed detrimental to stem cell research in the United States. While I welcome this step forward, the best thing would be for WARF to abandon its claims to these over-reaching patents that are recognized nowhere else in the world."

Jeanne Loring, a stem cell scientist at the Burnham Institute in La Jolla, Ca., said,

"This change in policy is a step in the right direction and academic scientists will be pleased that they can collaborate with other scientists without interference from WARF. But a change in licensing policy of the human ES cell patents doesn't solve the fundamental problem that the patents should not have been issued in the first place."

CIRM did not have an immediate reaction to the news from WARF but the California Stem Cell Report has queried the agency.

Stem Cell Snippets: Donley, Lomax and Reed

Items of some interest involving California stem cell matters.

Inside a Grant Review Session – Longtime patient advocate Don Reed, on his blog stemcellbattles.com, has a heartfelt look inside a session that reviewed grant applications for spinal research. Reed sits on the review committee. Reed also writes in opposition to more public disclosure in the CIRM grant process.

Whither Donley? -- Beth Donley, the longtime counsel for WARF, has resurfaced in a stem cell start-up. Donley, who served notice last spring that California would have to pay its stem cell dues to WARF, is the CEO of Stemina Biomarker Discovery Inc., which aims to use stem cells to develop tests for diseases. Reporter David Wahlberg of the Wisconsin State Journal has more here.

Nonproliferation -- The California stem cell agency received some attention at a chemical and biological weapons nonproliferation program in Monterey. Geoffrey Lomax, senior officer for medical and ethical standards at CIRM, spoke at the program, and the Monterey Herald covered the talk. The report by Kevin Howe can be found here. Lomax did not blow the dome off the Capitol, so to speak.