Repros Patent Problems Began When Harry Met Joe Repros Patent Problems Began When Harry Met Joe - TheStreet
By Adam Feuerstein - 05/09/13 - 8:00 AM EDT
Tickers in this article: RPRX
THE WOODLANDS, Tex. (TheStreet) -- Investors who have read through Repros Therapeutics' regulatory filings know about the unresolved and worrisome patent conflict involving the company's testosterone
-boosting pill Androxal. Less known but more interesting are the events behind this patent fight, including allegations that Repros' CEO stole the idea for Androxal from a New York fertility doctor.
Call the story, "When Harry Met Joe." Except there's no fake orgasm over pastrami sandwiches at Katz's.
Harry is Dr. Harry Fisch, a New York urologist and fertility specialist. For male patients with low testosterone, particularly those who still want to have kids, Fisch has long prescribed clomiphene
, a decades-old hormone treatment normally used to boost fertility in women. In men, clomiphene
raises testosterone but also preserves sperm count.
In 2001, Fisch filed, and was granted, a U.S. patent covering the use of clomiphene to treat androgen testosterone deficiency in men.
Joe is, of course, Joe Podolski, the CEO of Repros. Back in 2001, Repros, then known as Zonagen, had run into trouble following the failure of an erectile dysfunction drug. With his largest shareholders considering a liquidation of the company, Podolski went in search of a new drug development project that might persuade investors to keep the company afloat.
At the same time, Fisch was looking for a company to develop and commercialize the idea of using clomiphene to treat men with "low T" based on his recently awarded U.S. patent. He knew Podolski and was aware of Zonagen's problems, so Fisch called Podolski and proposed a meeting in New York City to discuss a possible business idea. Before delving into the details, Fisch asked Podolski to sign a confidentiality agreement. Podolski agreed, signed the confidentiality agreement and traveled from his home in Texas to New York City to meet Fisch.
Fisch and Podolski met in New York, with Fisch sharing his clomiphene "low T" patent with Podolski and explaining his desire to partner with someone to turn the idea into a business.
In separate interviews, neither Podolski nor Fisch dispute the version of events up to this point in 2001. In particular, Podolski admits to signing Fisch's confidentiality agreement and gaining access to Fisch's patent. But here's where their stories diverge and the conflict begins.
According to Fisch, the meeting with Podolski didn't really go anywhere. "Joe told me he wasn't interested in the program," says Fisch. The two men parted ways.
"I thought more about starting a company to commercialize my concept, but I gave up. I'm not a biopharma expert and didn't think I was qualified to be a biotech CEO. Plus, I had a full-time job already," says Fisch.
Podolski remembers the meeting with Fisch differently. He liked the idea of using an oral drug like clomiphene to raise testosterone levels in men without reducing sperm counts, but Fisch's patent was weak, he says.
"I did a quick literature search and literally found 30 or 40 published pieces of prior art which made Harry's clomiphene patent un-enforceable... I told Harry his idea was not patentable," Podolski says. "But if you could isolate an isomer of clomiphene, you might have a better treatment. That would be interesting."
And that's what Podolksi, working with some consultants, set out to do. The result was Androxal, which is an isomer of clomiphene. The two drugs have the same molecular makeup but Androxal's chemical structure was changed slightly to improve its function. Just as importantly, Podolski believed Androxal, unlike clomiphene, could be patented for the treatment of low testosterone in men.
Podolski filed a patent for Androxal in July 2002, just over a year after Fisch's clomiphene patent was filed in October 2001. In that same year, Zonagen (now known as Repros) began clinical trials with Androxal.
And then the "When Harry Met Joe" story turns ugly.
"He stole my idea," says Fisch of Podolski, adding that Androxal only came into existence because Podolski violated his confidentiality agreement.
"I didn't steal anything from Harry," answers Podolski. Yes, the idea for Androxal may have germinated with the Fisch meeting in New York City, Podolski adds, but Fisch's confidentiality agreement was null and void because the information it contained was already in the public domain.
That Zonagen (now Repros) has now pushed Androxal into phase III studies and intends to seek U.S. approval next year, while Fisch has taken no steps to develop his clomiphene idea into a viable business further supports his case, says Podolski.
"If my patent is nothing to worry about, then why has Repros asked the U.S. patent office to re-examine my patent twice and lost both times," Fisch asks. "And why does Repros warn investors in its SEC filings that the company is potentially in violation of my patent?"
Fisch's clomiphene patent has withstood two challenges, including an appeal before a federal judge. But Wall Street has generally sided with Repros in the ongoing patent dispute, believing the company will eventually reach a financial settlement with Fisch. The doctor will be paid and he'll go away, is the operating assumption made by many investors.
"They're wrong," says Fisch. "They figured I wouldn't last this long, but this is personal for me. I plan on winning in the way I want to win and that will include an apology."
"Harry is going to sue us. I guarantee that, but our lawyers believe we have freedom to operate with our patent," says Podolski.
"I don't care what he believes," says Fisch of Podolski. "We're not talking theology here."
And what is Fisch's next step? He won't say exactly but he did offer a clue.
"Joe wouldn't have come up with the idea for Androxal without having met me... He has a very weak patent. There's a 90% likelihood that the Repros patent will be challenged and will not survive. My patent, however, will survive."