His tiny prenatal testing company has big plans after exacting legal revenge on lab giants

Ravinder Dhallan’s name is on key patents in noninvasive prenatal testing, a field that has reshaped screening for expectant mothers. But he was a minor figure in the $3.8 billion market.

Then, in 2020, his tiny company Ravgen filed litigation that accused rivals of copying its technology.

Over the last year, Ravgen has won settlements or lawsuits against some of the biggest names in testing. It was awarded $375.5 million from Laboratory Corporation of America, better known as Labcorp, after a jury verdict and a judge’s order for punitive damages. Other behemoths — Quest Diagnostics, PerkinElmer and Illumina — have settled for undisclosed sums. Litigation against Natera, Roche, Myriad and Biora is ongoing, though the defendants have argued that their methods were derived independently or with partners.

Depending on who you ask, Ravgen either serves as an inspiring David-versus-Goliath story or a cautionary tale for inventors on the cusp of commercialization. But outside legal experts agreed that Ravgen isn’t a patent troll that only exists to wring money from large companies.

Ravgen has sold diagnostics for more than a decade, and after winning cash from court victories, Dhallan plans to develop new tests. He now has another chance to make Ravgen relevant after the company’s initial batch of products never found a large market.

Ravgen and Dhallan declined interview requests. But the company’s legal saga was pieced together through a review of the litigation, statements to Endpoints News and interviews with one of Ravgen’s attorneys. The reporting also showed what it will take for Ravgen to go from legal victor to a commercial success.

Miscarriages and a better prenatal test

Before founding Ravgen in 2000, Dhallan was an emergency room physician with doctorates in medicine and biomedical engineering. During his residency at Massachusetts General Hospital, his wife suffered three miscarriages. Dhallan dedicated himself to developing a better prenatal diagnostic, Ravgen said in court filings.

The gold standard way to screen for genetic abnormalities was amniocentesis, a test that involves inserting a needle to withdraw amniotic fluid and that carries miscarriage risks. Ultrasounds are noninvasive but require follow-up invasive testing to reach a final diagnosis.

Dhallan wasn’t the only one working on an improved test. The challenge is that only a small amount of a baby’s DNA flows into blood samples taken from the mother. Dhallan and other researchers were on a quest to find a genetic needle in a haystack.

The company succeeded by using a method to preserve the fetal DNA in blood samples by adding a chemical that increased cells’ structural integrity, among its claimed breakthroughs. The techniques were published in the Journal of the American Medical Association in 2004 and The Lancet in 2007. Media outlets, including the Washington Post and CNN, covered the news as excitement built for noninvasive prenatal screening.

By 2012, Ravgen launched commercial prenatal tests to detect genetic disorders and chromosomal abnormalities, including Down syndrome. Around the same time, three other competitors launched noninvasive prenatal tests, representing at the time what the journal Prenatal Diagnosis called the dawn of an “extremely lucrative” industry.

Ravgen moved to partner with large diagnostics firms that didn’t already have tests on the market rather than build up its own manufacturing and commercialization infrastructure. But per Ravgen’s allegations, companies like Labcorp strung Dhallan along and later used his company’s foundational technology without a license.

“That is the reason for Ravgen’s inability to compete and gain significant market share — not any issues with the accuracy of Ravgen’s tests,” the company said in a statement.

Labcorp, which did not respond to a request for comment, in court filings said that its testing methods differed from Ravgen’s. Illumina challenged the validity of Ravgen’s patents, but in January, the intellectual property was upheld by the Patent Trial and Appeal Board, part of the US Patent and Trademark Office. Three months later, Illumina and Ravgen reached a confidential settlement.

Illumina declined to comment.

Ravgen is far from alone in suing companies over noninvasive prenatal tests. In 2021, Roche and Illumina settled a decades-long court fight over patents without disclosing the terms. But Ravgen’s lawsuits were different in that a smaller player took on so many behemoths, and all at once.

The litigation details meetings and communications between Ravgen and other companies, including Labcorp reaching out in 2011 after hearing from its intellectual property attorney about Ravgen’s patents. Those talks continued for a few years, but ultimately, Labcorp released its own tests.

Labcorp had claimed in court filings that its commercial partner Streck developed its testing methods and patented them in 1998.

A jury didn’t agree with Labcorp, and last fall, Ravgen was awarded $275.5 million, amounting to $100 per test that Labcorp sold with the infringing technology. In May, a federal judge ordered Labcorp to pay an additional $100 million in punitive damages. Labcorp did not respond to a request for comment.

Kerri-Ann Limbeek

“All of them just basically went ahead and used his technology,” said Kerri-Ann Limbeek, an attorney representing Ravgen. “These other companies have made hundreds of millions or billions of dollars off the inventions.”

Few observers had heard of Ravgen, a company with 20 employees that’s a blip in the testing market. The privately-held company declined to disclose financials.

Shawn Baker, a genomics consultant, said Ravgen cannot blame all its commercial woes on the defendants. Other testing startups managed to raise money and create a commercial infrastructure, while Ravgen waited on partnerships that never came.

“The idea that only huge companies were involved and he couldn’t compete is ridiculous,” Baker said. “It only reinforces my hunch that they were just absolutely inept.”

Jacob Sherkow

In response, Ravgen said in a statement that it wasn’t inept to think that “a company like Labcorp, with its established infrastructure, would be a better commercial play than attempting to recreate a duplicate infrastructure from scratch to compete with them.”

Jacob Sherkow, a law professor at the University of Illinois, said Ravgen serves as a cautionary tale for other inventors embarking on commercialization.

“I’ve got 20 bucks in my wallet that says we’re going to hear a relatively similar story in the AI space about 10 years from now,” Sherkow said.

Work to be done

The patents at issue in the lawsuits expired this spring, meaning Ravgen won’t see any money from tests sold afterward. But the legal payments are funding Dhallan’s next move: developing cancer tests.

Dhallan testified during the Labcorp trial that his sister and wife survived breast cancer after early diagnosis and that better cancer testing could lead to the same outcome for others. Legal victory, he said, “would allow me to continue to do the research that I’d like to do.”

Ravgen also wants to improve prenatal tests, a now-entrenched market that the FDA is moving to regulate.

“While it is true that the field is crowded, the prenatal field still needs innovation as the current approach to test processing can occasionally lead to false positives, and in the nascent field of liquid cancer biopsy, detection methods for many forms of cancer still need to be developed. So, there is good work still left to be done in both areas,” said Ravgen in a statement.

Baker said it would take a major technical breakthrough, as well as a superior sales channel, for Ravgen to become a force in the market.

Naomi Hawkins

“I wouldn’t hold my breath waiting for them to develop something amazing because, by all outward appearances, they haven’t yet done anything that has been commercially significant, apart from winning these cases,” Baker said.

Ravgen’s legal success, at first glance, might bring to mind a patent troll that extorts large companies. But the label doesn’t fit, said Naomi Hawkins, an intellectual property professor at the University of Sheffield.

“They’re a small player, but they’re actually trying to sell and develop tests,” Hawkins said.

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