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May 29, 2007
Twist in the patent wars
I recently ran in to this interesting twist in the patent war -- how patents and FDA approval can work to knock out the competition. The story involves Adams Respiratory Therapeutics. They make the cold medicine Mucinex - and run the ads featuring Mr. and Mrs. Mucus who take up housekeeping in your nasal passages.
As SmartMoney relates:
Adams has patented the ability of Mucinex to deliver that 600mg dose over a 12-hour period, and relied on favorable regulatory rulings to push the product's growth. After the company gained Food & Drug Administration approval for its extended-release guaifenesin product in 2002, the agency ordered all competing drugs off the market. Now, however, the U.S. patent office is reexamining one of Adams' patents, an action requested by an undisclosed third party.
Yes, you read that right, once Mucinex was given FDA approval, all other competitors became illegal. The Adams 2006 SEC 10-K report goes into further detail:
In 2002, the FDA approved our 505(b)(2) application for Mucinex SE as an OTC long-acting guaifenesin product. Prior to our 505(b)(2) application for Mucinex SE, only short-acting guaifenesin products had been marketed OTC, while long-acting guaifenesin products were marketed as prescription drugs, despite their lack of formal approval by the FDA. Under the Durham Humphrey Act of 1951, the FDA established that no drug may simultaneously be sold as a non-prescription product and as a prescription product at the same dose for the same indication. Any products that violate this rule are subject to FDA regulatory action and removal from the market.
On October 11, 2002, the FDA issued warning letters to 66 manufacturers, distributors, marketers, and retailers of single-ingredient guaifenesin extended-release products. The letters stated that such prescription products require FDA approval, and without FDA approval, they could no longer be marketed legally. A number of the manufacturers and distributors that received a warning letter from the FDA filed a “Citizens Petition,” which is similar to an appeal, with the FDA requesting that the agency either elect not to enforce existing regulatory policies requiring removal of the drugs from the market or delay such enforcement. On February 25, 2003, the FDA issued a letter in response to the Citizens Petition to the 66 recipients of the original warning letter, reiterating that following the FDA’s approval of Mucinex SE in July 2002, all other single-ingredient guaifenesin extended-release drug products may no longer be marketed legally. The FDA decided, however, to allow a grace period for the manufacturers and distributors to remove such drugs from the market as follows:
• the FDA required that the warning letter recipients cease manufacturing unapproved single-ingredient guaifenesin extended-release products no later than May 21, 2003;
• no distribution (including distribution by secondary wholesalers or other distributors) could occur after October 23, 2003; and
• no retail sales could occur after November 30, 2003.
Historically, long-acting prescription guaifenesin products and, according to the FDA, several thousand other drugs were marketed without FDA approval. Resource limitations prevented FDA enforcement actions against many unapproved prescription and OTC drugs. In October 2003, the FDA published a draft compliance policy guide articulating its existing informal policy regarding drugs marketed in the United States that do not have required FDA approval. In June 2006, the FDA announced that it had finalized its policy, under which the FDA will exercise its discretion in taking enforcement action against unapproved drugs once the FDA has approved a similar drug, whether the similar drug is prescription or OTC. In publishing the policy guide, the FDA publicly affirmed the actions it took relating to long-acting, single-ingredient guaifenesin products. As of this date, however, the FDA has only taken regulatory action to remove from the market single-ingredient, extended-release guaifenesin. The FDA approved Mucinex DM and our maximum strength, long-acting guaifenesin and dextromethorphan combination product, as well as Mucinex D and our maximum strength, long-acting guaifenesin and pseudoephedrine combination product, pursuant to Section 505(b)(2) NDAs. We are hopeful the FDA will take similar action on extended-release guaifenesin combination products. However, we can offer no assurance that the FDA will do so or when any such action may take place.
The company's November 2006 SEC 10-Q filing had this to say about the result:
The FDA’s removal of competitive long-acting, single-ingredient guaifenesin prescription products in November 2003. This removal resulted in Mucinex SE being the only long-acting, single-ingredient guaifenesin product available in the United States. Based on data from IMS Health—NPA TM , we estimate that, for the 12 months ended June 30, 2003, there were approximately 10.5 million prescriptions filled for long-acting, single-ingredient guaifenesin products. After November 2003, we believe that a majority of prescriptions written for long-acting, single-ingredient guaifenesin resulted in OTC sales of our Mucinex SE product. Humibid SE is now also available to meet this demand in a maximum strength formulation.
But, the saga isn't over. As the SmartMoney story pointed out, the patents are in re-examination. And the company points out in its SEC filings, another company is seeking FDA approval for a similar drug.
All in all, as I said, an interesting twist. It is also an interesting insight into the competitive nature of businesses built around intangibles and intellectual property.
Posted by Ken Jarboe at May 29, 2007 10:12 AM
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