facebook-pixel

How BYU scientists struck pharmaceutical gold — and the fight over who keeps the money

For the past decade, scientists have been fighting over the proceeds from the massive settlement with Pfizer

(Illustration by Christopher Cherrington | The Salt Lake Tribune)

Editor’s note • This story is available to Salt Lake Tribune subscribers only. Thank you for supporting local journalism.

One day in 2012, Weilin Xie got a call out of the blue telling him he had $1 million coming his way.

No, Xie had not won a lottery. His former professor, Brigham Young University biochemist Daniel Simmons, had called to tell him the money was for Xie’s participation 20 years earlier in research that led to the development of blockbuster anti-inflammatory drug Celebrex.

Xie did not know what to say, he would later testify in court filings, except to express gratitude for the financial recognition of his hard work in Simmons’ lab at BYU.

Xie would later learn to his dismay that Simmons hadn’t shared the full picture with him.

BYU had set aside nearly $130.5 million from a successful lawsuit for the scientists who invented the technology, and nearly all of it was going to Simmons. Xie’s proposed payment was a tiny slice. And BYU had allocated nothing to Donald Robertson, who was Xie’s boss at that time, and chairman of its biochemistry department’s graduate section.

That division sparked litigation that continues today, highlighting how disputes often arise when university research using federal grants and donations leads to lucrative discoveries. Cutting-edge science is nearly always a team effort, but cash and accolades are often reserved for the team captains, while behind-the-scenes contributors like Robertson can go unrecognized.

A month before Simmons’s call to Xie, BYU had won $450 million in a lawsuit over the creation of Pfizer’s nonsteroidal painkiller, which has brought relief to millions of arthritis sufferers and enriched Pfizer stockholders and executives.

Xie turned down the money and forced BYU back into court. He would ultimately settle for an undisclosed amount.

(Christopher Cherrington | The Salt Lake Tribune)

Like Xie, Robertson had left BYU years earlier. Robertson had come out as gay following a divorce and moved to San Diego, where he taught at a community college and lived with his new partner, according to his obituary. His lawsuit seeking compensation, filed in 2014, did not claim any connection between his orientation and BYU’s decision to exclude him from the Celebrex settlement.

But by then, Robertson was terminally ill with cancer. In the latest legal development, the 10th Circuit Court of Appeals this month ruled his estate can go forward with its breach-of-contract claim against BYU.

A lab discovery worth billions

Simmons, who retired in 2016 and now lives in Heber, is one of BYU’s most decorated professors. The Simmons Center of Cancer Research, which had received money from the Pfizer settlement, was named in his honor when he stepped down as its director in 2014. BYU materials inevitably refer to Simmons as the discoverer of COX-2, the enzyme critical to the development of Celebrex.

When Simmons joined BYU from Harvard Medical School in 1989, he was already deep into research into one of the human genes that produces an enzyme called cyclooxygenase, which is linked to inflammation, according to a 2003 profile published in BYU’s alumni magazine. Ultimately, Simmons would discover cyclooxygenase was two enzymes, and one of them, COX-2, could be selectively blocked, creating a whole new class of drugs.

COX-2 inhibitors were worth billions. There’s no question that Simmons was the face of the COX-2 discovery, but how much of the final reward he deserves is in dispute.

Robertson, who had joined BYU’s faculty in 1980, would claim in court that his lab featured critical pieces of the COX-2 discovery: equipment, cell lines, chemicals, grant funding and, most importantly, Xie, who was working for Robertson as a graduate student.

Simmons “borrowed” Xie from Robertson, according to the profile in the alumni magazine, and went to work sequencing the DNA of a genetic segment that turned out to produce COX-2.

The team published its pivotal findings in the April 1991 issue of Proceedings of the National Academy of Sciences. The research was supported by grants from the Salt Lake City-based Bireley Foundation and the National Institutes of Health.

Simmons is listed as the senior author on the paper; Xie was the lead author and Robertson the third. Three months later, BYU and Simmons formalized an agreement with Monsanto, the company that would later become Pfizer, to develop a painkilling drug based on the discovery.

The drugmaker cancelled the agreement the next year and moved forward with the development of the drug.

In the meantime, Robertson, a father of four, left BYU and came out as gay.

In the 1990s, BYU was not known as a welcoming place for gay students and faculty. Although BYU last year removed the section from its strict Honor Code that prohibited “all forms of physical intimacy that give expression to homosexual feelings,” it later reaffirmed that same-sex relationships were still “not compatible” with its rules.

Pharmacological gold mine

Celebrex turned out to be one of the most profitable drugs of all time. Released in the late 1990s, it was an instant hit among arthritis patients, garnering billions in sales. It also prompted a lawsuit from a competitor, Merck, who released another COX-2 drug, Vioxx, the following year.

While reviewing that case as an expert witness for Merck, Simmons discovered the drug’s development relied on his research and intellectual property owned by BYU. Teamed up as co-plaintiffs, Simmons and BYU sued Pfizer in 2006, claiming they had been cheated out of billions in profits that Celebrex reaped. Xie and Robertson both testified as expert and fact witnesses on BYU’s behalf. Shortly before the case was to go to trial in 2012, Pfizer settled for a whopping $450 million. Then came the hard part: What to do with the money.

Legal fees and expenses skimmed $160 million off the top, leaving $290 million to be apportioned under BYU’s policies governing intellectual property developed on campus. Under the university’s policies that were in effect when the discoveries were made, 1989 to 1992, the university would own any intellectual property arising from any research it sponsored. But 45% of any proceeds would go to the IP’s developers. That translated into $130.5 million for Simmons and anyone else determined to be a developer.

The university’s share of $159.5 million was to be divided equally between the College of Physical and Mathematical Sciences and the Technology Transfer Office. BYU ultimately invested the money in endowments to support research, scholarships and student academic projects, according to university spokeswoman Carri Jenkins.

The remaining money would go to “individuals or groups of individuals who make a significant original, creative contribution to the conception and/or commercialization of a technology or work.” The policy also said that “others who are directed in the performance of their work, utilizing the skills expected of their position, are not developers.”

A secret committee picks who gets millions

On June 6, 2012, BYU convened a committee to determine who qualified as a COX-2 developer and how much of the $130.5 million each should receive. The committee heard only from Simmons — Xie and Robertson were not even informed of its existence, much less invited to provide input or make a claim.

(Brigham Young University) Daniel Simmons

In his legal filings, Simmons affirmed his conviction that he was the technology’s sole developer. Xie’s participation in the lab was helpful, he said, but he played a supporting role in line with what was expected of him as a BYU grad student.

Simmons “took his methods to BYU, where he eventually taught them to Xie (and others). Dr. Simmons could have taught his sequencing method to any competent student or laboratory technician in order to complete the research of which he had conceived,” his lawyers wrote.

The filings contend it was Simmons who recognized the pharmacological significance of the research; the others were just doing their jobs.

After hearing from Simmons, the committee concluded he was the sole developer and awarded him all the money, save $1 million for others who might come forward with a valid claim.

Simmons insisted some of the Pfizer money go to Xie and another former graduate student named Jeffrey Chipman. The committee said yes for Xie, even though it didn’t believe he qualified as a developer.

Simmons called up Xie with the news the following day, but left out the crucial details, according to Xie’s declaration. Xie was later instructed by BYU’s lawyer, Leo Beus, to accept the $1 million as “a gift.” Simmons allegedly left a voicemail, asking Xie to take the money and sign a release so Simmons “could start my new life.” Xie declined.

Xie’s expert witness makes his own claim

After turning down the money, Xie went to BYU’s law firm asking for a larger share and credit as a COX-2 co-developer.

Xie earned his doctorate in 1991 and also moved to San Diego, where he became senior principal investigator with Celgene Corp., a major biotech firm recently acquired by Bristol-Meyers Squibb.

“I was shocked by the difference in allocation considering how significant my role was in the discovery of COX-2 and in the development of technologies to discover the COX-2 selective inhibitor drug,” Xie wrote in a declaration filed in January 2013. “While this work was the result of a collaborative effort between Dr. Simmons and me, I specifically conceived of, and successfully designed and executed key experiments independent of Dr. Simmons that were critical to our discovery of COX-2.”

To review Xie’s claim, BYU once again convened the same committee to figure out credit.

Xie would ultimately take a settlement, but in the process, he tapped Robertson to offer statements in support for his claim. Through his participation, Robertson would learn that he too had a valid claim as a developer, according to his court filings.

Robertson filed his own claim with the court in 2014, asking the court for half of the money BYU had for the drug’s developers. But by then he was terminally ill with cancer.

After his death in August 2014, his trust hired new counsel, who asserted a new claim of breach of contract against BYU.

“Robertson not only supervised, but also designed Xie’s experiments,” his lawyers wrote. “When Xie had questions or needed help solving problems in the lab, he turned to Robertson for help and creative input. All of Xie’s DNA sequence experiments and analysis were done in Robertson’s lab.”

Judge Robert Shelby rejected that claim, ruling that Robertson had no contract with BYU when it came to the COX-2 research. The 10th Circuit overturned Shelby’s ruling, keeping the lawsuit alive.

The appellate judges said BYU’s intellectual property policies amounted to an “implied” contract with Robertson, and Robertson’s trust had alleged sufficient facts to plausibly claim BYU breached it by not considering his potential role as a COX-2 developer.

A spokesperson for BYU refused to comment on the claims brought by Robertson because they are the subject of pending litigation, except to say, “BYU has worked to follow its policies in regard to the distribution to developers.”

So now the case returns to Shelby’s Salt Lake City courtroom where the next chapter in the 30-year saga will soon play out.

At stake are riches that few could ever spend in a normal lifetime.


Comments:  (0)