It\u2019s daggers out at the\u00a0Federal Trade Commission<\/strong>\u00a0in its fight against anticompetitive practices in health care.<\/p>\n

This past year, it has issued more stringent\u00a0guidelines<\/u><\/a>\u00a0to block and discourage hospital mergers, and it\u00a0investigated<\/u><\/a>\u00a0practices by middlemen in the drug supply chain.<\/p>\n

Now drug manufacturers themselves are in the agency\u2019s crosshairs<\/strong>. In November, the FTC challenged the validity of more than 100 drug patents in the Food and Drug Administration\u2019s \u201cOrange Book.\u201d It\u2019s a novel attack on drug prices.<\/p>\n

The Orange Book is where drug companies list patents, which they argue protect their products from competition.<\/p>\n

Generic drugmakers seeking to make a copycat version of a branded drug generally have to first\u00a0challenge<\/u><\/a>\u00a0its patents in court. But listing a patent in the Orange Book can trigger a 2\u00bd-year delay of FDA approval for a generic competitor.\u00a0<\/p>\n

Though there has long been a procedure to dispute the validity of Orange Book-listed patents, it\u2019s seldom used. November\u2019s action marks the first time the FTC has deployed this weapon, said\u00a0Hannah Garden-Monheit<\/strong>, director of the FTC\u2019s\u00a0Office of Policy Planning<\/strong>.<\/p>\n

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\u201cWe are using all the tools we have to bring down drug prices and reduce barriers to generic competition,\u201d she said in an interview.<\/li>\n<\/ul>\n
In what Garden-Monheit described as \u201ca first salvo,\u201d the agency sent letters to 10 drugmakers challenging patents that covered delivery devices for certain drugs. The FTC argues that patent law protects active ingredients in medicines, not delivery methods.<\/p>\n
Inhalers for asthma and chronic obstructive pulmonary disease as well as EpiPens were among the targeted products.<\/p>\n
\u201cWe thought, \u2018How are these products still hundreds of dollars after all these years?\u2019\u201d<\/strong>\u00a0Garden-Monheit said.<\/p>\n
After an Orange Book challenge, companies\u00a0have 30 days<\/u><\/a>\u00a0to withdraw or amend the patent, or prove it is valid.<\/p>\n
The move is critically important because drugmakers frequently extend the 20-year patent protection for a drug by changing its delivery device or method.\u00a0Instead of a pill, they develop a capsule. Instead of a dose every six hours, they create a longer-acting version. Sometimes they alter the process by which the drug is made \u2014 a \u201cprocess patent.\u201d<\/strong>\u00a0<\/p>\n
Each tweak gets a new patent in the Orange Book.<\/p>\n
While a\u00a0single patent once would cover a single active medicine<\/u><\/a>, many drugs are now protected by over half a dozen patents or more \u2014 \u201cpatent thickets\u201d \u2014 which pose obstacles to cheaper generics seeking to enter the market.<\/p>\n
The pharmaceutical industry, naturally, is chafing at the FTC\u2019s decision, saying drug companies are acting legally in listing these patents in the Orange Book, according to their interpretation of law. (It is already battling the Biden administration\u2019s plan to negotiate prices of some drugs for Medicare patients.)<\/p>\n
\u201cThe underlying statute is not clear about listing certain types of drug-delivery device patents, and the industry has long asked for the FDA to provide guidance,\u201d\u00a0Megan Van Etten<\/strong>, a spokesperson for\u00a0PhRMA<\/strong>, the industry trade group, said in an email. \u201cWe\u2019re disappointed that the FTC has characterized companies as acting inappropriately rather than help seek the clarity industry needs to ensure compliance.\u201d<\/p>\n
The agency\u2019s letters have already produced\u00a0some wins<\/u><\/a>. After an FTC challenge, drugmaker\u00a0GSK\u00a0<\/strong>withdrew all patents on two popular inhalers for asthma, Advair and Flovent. Both delivered old off-patent medicines, yet nonetheless cost hundreds of dollars.<\/p>\n
About 30 percent of the first round of warning letters resulted in companies voluntarily delisting patents from the FDA\u2019s book<\/strong>, according to an FTC spokesperson. The FTC is considering how to go after those that ignored the letters and\u00a0said in a November statement<\/u><\/a>\u00a0that it could \u201ctake any further action as needed in the public interest, which includes investigating the manufacturers\u2019 conduct as a violation of FTC laws.\u201d<\/p>\n
But it\u2019s a big job clearing out patent thickets. The Orange Book\u00a0contains tens of thousands<\/u><\/a>\u00a0of listings. While the FTC has targeted delivery patents, it may next go after other types of patents that it feels are unjustified.<\/p>\n
\u201cWe are taking a close and active look at this,\u201d Garden-Monheit said.\u00a0\u201cCompanies who haven\u2019t received a letter from us challenging a patent shouldn\u2019t think they\u2019re off the hook.\u201d<\/strong><\/p>\n
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This article is not available for syndication due to republishing restrictions. If you have questions about the availability of this or other content for republication, please contact NewsWeb@kff.org<\/a>.<\/em><\/p>\n
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