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Repros Patent Problems Began When Harry Met Joe

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.
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