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FTC Sues Regarding AndroGel Patent Settlement


Written by Gene Quinn
President & Founder of IPWatchdog, Inc.
Patent Attorney, Reg. No. 44,294
Zies, Widerman & Malek
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Posted: February 2, 2009 @ 9:33 pm
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The Federal Trade Commission has filed a complaint in federal district court challenging agreements in which Solvay Pharmaceuticals, Inc. paid generic drug makers Watson Pharmaceuticals, Inc. and Par Pharmaceutical Companies, Inc. to delay generic competition to Solvay’s branded testosterone-replacement drug AndroGel, a prescription pharmaceutical with annual sales of more than $400 million.

“At a time of escalating health care costs, these unlawful agreements deny patients the benefit of competition between branded and generic pharmaceuticals and ultimately cost consumers hundreds of millions of dollars a year,” said Acting FTC Bureau of Competition Director David P. Wales.

According to the Commission’s complaint, filed in the United States District Court for the Central District of California, Watson and Par, via its partner Paddock Laboratories, each sought regulatory approval from the FDA to market generic versions of AndroGel. In their FDA filings, both companies certified that their products did not infringe the only patent Solvay had relating to AndroGel, and that the patent was invalid. The complaint charges that Solvay agreed to pay the generic companies to abandon their patent challenges and agree not to bring a generic AndroGel product to market for nine years, until 2015.

“Today’s action reaffirms the Commission’s commitment to protect American consumers from artificially high prescription drug prices that result when branded and generic pharmaceutical companies decide to collude rather than compete,” Wales said. “The evidence in this case will show that Watson and Par agreed to defer their generic entry for nine years, not out of respect for Solvay’s patent, but due to the size of Solvay’s payments to them.”



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The court action seeks to promote competition between Solvay and generic drug makers that had sought to introduce generic versions of the branded prescription drug AndroGel. AndroGel, Solvay’s second highest selling pharmaceutical product, is a pharmaceutical gel containing synthetic testosterone. It is approved for testosterone replacement therapy in men with low testosterone levels, which often are associated with advancing age, certain cancers, and HIV/AIDS, among other conditions.

More than two decades ago, Congress passed the Hatch-Waxman Act to encourage generic manufacturers to challenge patents that either are invalid or narrow enough to be designed around. The legislation has worked. Studies have shown that generic manufacturers have prevailed in the majority of patent challenges. The resulting generic entry, which often occurs well before patent expiration, leads to significantly lower prices and huge savings for patients and the health care system.

In May 2003, Watson and Paddock, which partnered with Par, each filed applications for FDA approval to market generic versions of AndroGel. Solvay’s patent on Androgel had been issued in January 2003, with an expiration date of August 2020. By early 2006, Watson had received final approval to market its generic product. According to the complaint, it was well-known that if Watson or Par were to enter with cheaper generic versions of AndroGel, Solvay’s AndroGel sales would plummet and consumers would benefit from the lower prices.

The complaint alleges that Solvay, realizing the devastating effect generic entry would have on its AndroGel franchise, acted unlawfully to eliminate this threat: Solvay paid Watson and Par a share of its AndroGel profits to abandon their patent challenges and agree to delay generic entry until 2015. As a result, the complaint states that the defendants are cooperating on the sale of AndroGel and sharing the monopoly profits, rather than competing.

According to the Commission’s complaint, defendants’ agreements to eliminate generic AndroGel competition were, and continue to be, unfair methods of competition that violate Section 5(a) of the FTC Act. The Commission is seeking a final court judgment declaring that Solvay’s agreements with Watson and with Par and Paddock violate Section 5(a) of the FTC Act, and injunctive relief restoring competitive conditions and barring the defendants from engaging in similar or related conduct in the future.

The Commission vote approving the complaint was 4-0, with Commissioner Jon Leibowitz issuing a separate concurring statement. The complaint was filed under seal in the U.S. District Court for the Central District of California on January 28, 2009. It was filed jointly with the Office of the Attorney General of California.

In his separate statement, Commissioner Leibowitz said, “This is yet another example of pharmaceutical companies turning competition on its head. . . . Congress enacted the landmark 1984 Hatch-Waxman Act to encourage early generic entry and save consumers money, but these anticompetitive deals threaten to destroy that benefit and make crucial portions of the Hatch-Waxman Act extinct in all but name.”

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Posted in: Federal Trade Commission, Food & Drug Administration, IP News, IPWatchdog.com Articles, Patents, Pharmaceutical

About the Author

is a Patent Attorney and the founder of the popular blog IPWatchdog.com, which has for three of the last four years (i.e., 2010, 2012 and 2103) been recognized as the top intellectual property blog by the American Bar Association. He is also a principal lecturer in the PLI Patent Bar Review Course. As an electrical engineer with a computer engineering focus his specialty is electronic and computer devices, Internet applications, software and business methods.

 

6 comments
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  1. I take Androgel, a blend of synthetic testosterone and alcohol gel. I would guess a month’s supply probably costs Solvay $2.00 to produce and market. The retail price is about $290. Not surprising they would cheat to preserve their margin.

  2. We have been buying androgel for $247 each month for the past 4.5 years. We have been looking and hoping for the generic to come out soon as this is the most benificial testosterone replacement for him. It discusts me to see that the pharmaceutical companies are making such a large margin of profit on this drug and will PAY competitors to stay away from offering a generic. I hope and pray that this case is approved in the favor of the consumer.

  3. I have been lucky that my Pharmacy insurance coverage has paid for 80% of the Androgel for me but at the retail prices mentioned above, the out of pocket is still pretty stiff. Just went to pick up a new script after not refilling for the last year, mainly due to $$, and there is a new program that Androgel is pushing to save some money over a 6 month period of time. Check their website for details. It’s called the “Welcome Back to Androgel” program and I saved $20 today. Not a lot of dough but anything will help.

  4. Is a clear, colorless gel that comes in a carton containing 30 single-use packets.
    AndroGel contains the male hormone testosterone. This gel is prescribed as replacement hormone therapy for men who have abnormally low testosterone levels.
    Other forms of testosterone replacement include tablets, skin patches or intramuscular injections. The gel provides more consistent levels of testosterone compared to injections and causes less skin irritation than patches.

    In studies, the most common side effects reported for men using AndroGel were abnormal lab tests, acne, prostate disorders, skin irritation, gynecomastia (abnormally large breasts), and impaired urination.

    http://www.boost-your-low-testosterone.com/androgel-side-effects.html

  5. I recently retired and went on Medicare. I’ve been taking Androgel since it came out in 2000. I signed up with the AARP medicare RX plan, told them of the medications I was taking and now they tell me because of their “Formulary” changes they will not cover Androgel! Since I had to switch doctors, I moved from Houston to Memphis, I can’t get anybody to do anything! There questioning why I take it. I’m still arguing with them but It doesn’t look good! I can’t afford $300 a month. Does anybody know if the companies that have the generic drug for Androgel are goin to start producing it?

  6. i used androgel for 6 months and i wound up with prostate cancer ihave just had my prostate removed. i believe androgel is what caused my cancer. my doctor did not do the necessary blood work that androgel requires. please be very careful with this chemical. ihope none of you have to go through what i went through.