Iovate Health Sciences, Inc. is the exclusive license holder of U.S. Patent No. 6,100,287 (the “’287 Patent”), owned by the University of Florida Research Foundation, Inc. The patent claimed a method for enhancing muscle performance or recovery from fatigue involving certain kinds of ketoacids and amino acids.  Iovate and the Foundation sued Bio-Engineered Supplements & Nutrition, Inc. (“BSN”) for infringing certain claims of the ‘287 patent.  BSN countered that the patent claims were invalid because the Flex ad was published before the critical date and was detailed enough to teach a “person skilled in the art” how to practice the method claimed in the patent.  The judge agreed, invalidating those patent claims.

Iovate argued on appeal that someone skilled in the art of nutritional supplements would not rely on an ad in a muscle magazine because of “the lack of scientific testing and the existence of false advertising in the industry.”  However, the Court agreed with BSN that the ad disclosed every limitation found in the patent claims on which Iovate relied , as well as how to administer the product to humans to enhance muscle performance or recovery from fatigue.  It was not necessary for the ad to disclose a specific dosage or an effective amount because the patent claims did not contain any required dosage amount.  A person skilled in the art could practice the invention by purchasing the ingredients listed in the ad, mixing them together and giving them to a person for the purposes described in the ad.  If necessary, anyone skilled in the art could figure out how much of each ingredient to include by reading publications listed in the patent that revealed acceptable clinical dosages of the two important ingredients.  No undue experimentation would have been required to make the method work.

This case shows that an invalidating “printed publication” does not have to be a scholarly article, Ph.D. thesis or issued patent.  Even an ad in a muscle magazine can do the trick.

Source:  Iovate Health Sciences, Inc. v. Bio-Engineered Supplements & Nutrition, Inc., U.S. Ct. Apps. Fed. Cir., No. 2009-1018 (11/19/2009)

Judith L. Grubner, Esq. is a partner in the law firm of Arnstein & Lehr and Intellectual Property Practice Group Leader.  Thanks to Judy for her excellent post!

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The Food & Drug Administration issued on May 1 a consumer warning to stop using Hydroxycut, the heavily marketed weight-loss product. The agency said that “some Hydroxycut products are associated with a number of serious liver injuries” and announced that the maker was recalling all products.

Did the FDA properly react? The warning cited 23 serious health problems, including jaundice, liver damage, seizures and cardiovascular disorders. One person has died from liver failure since 2002 when the Center for Food Safety and Applied Nutrition first received reports about liver damage associated with intake of Hydroxycut.

Some people — for reasons not totally understood — had adverse reactions to Hydroxycut, according to a research report cited in the FDA warning. Sometimes the individuals required serious treatment for liver damage. Other times, the people regained normal health when they stopped taking the product.

Until 2004, Hydroxycut contained ephedra, a substance that the FDA banned after a study found more than 16,000 adverse events associated with its use in dietary supplements. According to a recent label, the main ingredients in Hydroxycut are now the minerals calcium, chromium and potassium, plus what the company calls Hydroxagen Plus and HydroxyTea. The former contains leaf and rind extracts and the latter is a combination of tea and ginger extracts.

None are banned substances. And the  health hazard evaluation board acknowledged in its report that it “does not know what ingredient(s) of Hydroxycut are responsible for producing liver toxicity. In addition, there is insufficient information to determine whether there is a dose-response effect between Hydroxycut ingestion and liver disease or whether its effects are cumulative over time.”

The board concluded, “Three lines of evidence derived from multiple disparate sources suggest it is very likely that exposure to Hydroxycut can cause idiosyncratic hepatotoxicity.”

Some definitions are in order. According to a 2007 article in Toxicological Sciences, “Idiosyncratic hepatotoxicity is a rare and unpredictable event of liver injury affecting generally less than 1 in 10,000 patients treated with certain drugs. However, it is a serious clinical problem as it accounts for 10% of all drug-induced liver failure cases.”

And citing a study published in May 2005 in the Nature Reviews Drug Discovery, the article said, “Idiosyncratic hepatotoxicities are currently the main cause for Food and Drug Administration-mandated warnings, restrictions of use or even withdrawals of drugs from the market.”

So, the FDA puts great weight on idiosyncratic hepatoxicity even though it is uncommon and difficult to predict in a population. Given the level of uncertainty, did the FDA have other options? After conducting a risk-benefit analysis, could the agency have told the makers of Hydroxycut to add a warning to immediately discontinue use and seek medical attention if certain symptoms present themselves? Why did an average of three cases per year — none this year and only three last year — justify a ban and recall?

Here’s a clue from the report, which references the Center for Food Safety and Applied Nutrition as CFSAN:  “In discussions in March and April of 2009 with hepatologists Tse-Ling Fong, M.D. of the University of Southern California and William Lee, M.D. of the University of Texas Southwestern Medical Center, CFSAN has become aware of these physicians’ case series of patients with severe liver disease associated with the use of Hydroxycut. Two cases from this series, representing additional cases to the ones reported to CFSAN, underwent liver transplantation following acute liver failure.”

Were the doctors two of the three sources? And were their case series the underlying reason for such swift and final FDA action? The answers are not here, but they are needed.

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The FDA has just announced a massive recall of the popular weight loss supplement, Hydroxycut.

According to the FDA press release dated today, FDA has received 23 reports of serious health problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant. One death due to liver failure has been reported to the FDA. Other health problems reported include seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.

Hydroxycut is manufactured and distributed by Iovate Health Sciences.  As of this writing, both the hydroxycut.com and iovate.com websites are effectively “down” with all information having been stripped from their home pages.  Expect recall notices to be posted there shortly.

A long list of products are included in the recall.  They are:

• Hydroxycut Regular Rapid Release Caplets
• Hydroxycut Caffeine-Free Rapid Release Caplets
• Hydroxycut Hardcore Liquid Caplets
• Hydroxycut Max Liquid Caplets
• Hydroxycut Regular Drink Packets
• Hydroxycut Caffeine-Free Drink Packets
• Hydroxycut Hardcore Drink Packets (Ignition Stix)
• Hydroxycut Max Drink Packets
• Hydroxycut Liquid Shots
• Hydroxycut Hardcore RTDs (Ready-to-Drink)
• Hydroxycut Max Aqua Shed
• Hydroxycut 24
• Hydroxycut Carb Control
• Hydroxycut Natural

According to FDA, one death due to liver failure has been reported.   If there is real causation behind this announcement then this could be one of the largest supplement liability issues ever.

Stay tuned for more news as we receive it.

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