{"id":13379,"date":"2024-11-18T09:24:32","date_gmt":"2024-11-18T14:24:32","guid":{"rendered":"https:\/\/cip2.gmu.edu\/?p=13379"},"modified":"2026-02-03T20:00:04","modified_gmt":"2026-02-03T20:00:04","slug":"what-the-ftc-gets-wrong-about-the-fdas-orange-book","status":"publish","type":"post","link":"https:\/\/blogs.uakron.edu\/ualawip\/2024\/11\/18\/what-the-ftc-gets-wrong-about-the-fdas-orange-book\/","title":{"rendered":"[Archived Post] What the FTC Gets Wrong About the FDA\u2019s Orange Book"},"content":{"rendered":"

By Emily Michiko Morris<\/a> & Douglas Park<\/a><\/em><\/p>\n

\"\"The high cost of some pharmaceuticals is a complex issue, but the Federal Trade Commission\u2019s (FTC\u2019s) most recent criticism of pharmaceutical patents’ role is misguided. The FTC has criticized the listing<\/a> of drug product device patents in the FDA’s \u201cOrange Book<\/a>,\u201d a listing of patents related to various FDA-approved drug products. The FTC claims that listing these device patents serves merely to delay generic market entry, but they overlook key legal and practical details of how generic drugs enter the market and how listing in the Orange Book actually promotes generic competition by informing manufacturers of which patents cover branded drugs. Here’s a breakdown of where the FTC\u2019s reasoning falls short.<\/p>\n

30-Month Stays Do Not Delay Generic Market Entry <\/strong><\/h5>\n

One of the FTC’s main concerns is the 30-month stay provision under the Drug Price Competition and Patent Term Restoration Act of 1984 (better known as the Hatch-Waxman Act), which temporarily halts FDA approval of a generic drug when a brand-name company sues the generic for patent infringement. The stay applies only to infringement suits over patents listed in the Orange Book. The FTC therefore argues that brand-name companies list device patents in the Orange Book simply to use this stay to delay generic entry into the market. However, this interpretation is outdated and inaccurate.<\/p>\n

First, the FTC\u2019s objection to these device patents appears to be based on a 22-year-old FTC study that has since been made obsolete by 2003 changes to the Hatch-Waxman Act. Prior to 2003, brand-name pharmaceutical patent owners could secure a 30-month stay for each patent that they added to their infringement suit. The 2003 modifications to Hatch-Waxman now allow patentees only a single stay.<\/p>\n

Second, although even a single 30-month stay could delay generic market entry, the Hatch-Waxman Act already protects against this by expressly giving federal district courts discretion to lengthen or shorten the stay, thus allowing courts to curtail the stay if patent is invalid or clearly not infringed. This likewise curtails a patentee\u2019s ability to abuse the 30-month stay by listing in the Orange Book patents that actually do not cover the drug product for which they are listed.<\/p>\n

Third, recent research shows that the 30-month stay has little to no effect in delaying generic market entry. A study by Kannapan et<\/a> al. found that generics usually take years to enter the market \u2013 long after the 30-month stay expired \u2013 due \u00a0least in small part to the fact that FDA final approval itself on average takes more than 30 months. (Hatch-Waxman\u2019s 30-month stay prevents only final<\/em> FDA approval, such that the FDA can proceed with review of a generic\u2019s application even during the stay.) Moreover, as the Kannapan study notes, almost 40% of brand-name patentees decline to file suit within that 45-day period, thus failing to trigger any 30-month stay.<\/p>\n

Listing Patents in the Orange Book Facilitates Generic Patent Challenges<\/strong><\/h5>\n

Perhaps more importantly, the FTC\u2019s focus on the 30-month stay also misses the value of the Orange Book in providing not only a risk-free but often lucrative legal framework for generic drug manufacturers to challenge patents.<\/p>\n

First, listing patents in the Orange Book also saves generics the often large costs of searching for and identifying any patents their drug products might infringe. Some commentators <\/a>lament the fact that biosimilar manufacturers do not have a similar list of patents to help them plan their marketing strategy.<\/p>\n

Second, while applying for FDA approval, generic manufacturers can file what are known as Paragraph IV certifications claiming that any patents listed in the Orange Book for the drug product at issue are invalid or uninfringed. These certifications constitute patent \u201cinfringement,\u201d allowing brand-name manufacturers to sue the generics. This saves the generic from the risks of damages and other losses they otherwise might incur.<\/p>\n

In addition, as an incentive to challenge patents, this system also grants the first successful generic challenger 180 days of market exclusivity as the only generic on the market. These exclusivity periods in some cases can be worth billions of dollars, making Paragraph IV challenges potentially quite lucrative. Not surprisingly, Paragraph IV certifications \u2013 even when not sued upon by brand-name patentees \u2013 appear to be quite successful<\/a> in clearing the way generic market entry.<\/p>\n

For patents not listed in the Orange Book, however, generics who challenge brand-name drug patents enjoy none of these benefits. When a patent is not listed in the Orange Book listings, a generic loses this risk-free opportunity to challenge patents, making generic entry more dangerous than many can afford. Even if a patent related to a drug product is not listed in the Orange Book, brand-name patentees can sue generic manufacturers for infringement and can do so even after the FDA has approved the generic for marketing. The generic is therefore at risk of liability for not only potentially millions of dollars of infringement damages but also loss of their investments in manufacturing and marketing the drugs at issue.<\/p>\n

De-listing device patents would thus deprive potential generic manufacturers not only of notice but also of the protections of Paragraph IV certifications.<\/p>\n

Device Patents Are Critical for Drug-Device Products But Are Difficult to Copy<\/strong><\/h5>\n

The FTC nonetheless seems to believe that the targeted device patents are merely peripheral in importance and therefore should not be listed. For drug-device products like inhalers or auto-injectors, however, the device is crucial to efficacy and even safety.<\/p>\n

For inhalers, for example, some devices are designed for children, while others are suitable only for adults. Some designs are specific to the condition being treated and the area of the throat that they target. Some designs are easier to use than others and therefore more likely to yield consistently sufficient dosages. Some designs also vaporize drugs into smaller particles that travel further and are more easily absorbed, making them more effective for some indications.<\/p>\n

Similarly, the auto-injector device design is critical to the safety and operation of the oft-criticized EpiPen. Even small design changes can lead to large differences in safety \u2013 indeed, part of the reason why the EpiPen auto-injector device has multiple patents on it is that the design itself has been modified many times to address various safety concerns<\/a>.<\/p>\n

Because small differences in structure can lead to large changes in efficacy and safety, trying to create generic versions of EpiPen or other such complex drug-device products can be immensely difficult<\/a>, leading to significant delays in market entry. For example, even though Teva had Mylan\u2019s permission to create a generic version of EpiPen, Teva still had difficulty in doing so and received FDA approval only after multiple attempts and a two-year delay<\/a>. For this reason, the FDA has developed guidelines specifically for generics trying to develop generic epinephrine autoinjectors<\/a>, as well as specific guidelines for albuterol inhalers<\/a> and other such drug-device products.\u00a0<\/strong><\/p>\n

The FTC\u2019s Strategy Could Backfire<\/strong><\/h5>\n

Far from stifling competition, listing patents in the Orange Book helps generic manufacturers challenge patents by reducing the risks of entering the market. Removing these patents would reduce generics\u2019 ability to compete, ultimately harming consumers.<\/p>\n","protected":false},"excerpt":{"rendered":"

By Emily Michiko Morris & Douglas Park The high cost of some pharmaceuticals is a complex issue, but the Federal Trade Commission\u2019s (FTC\u2019s) most recent criticism of pharmaceutical patents’ role is misguided. The FTC has criticized the listing of drug product device patents in the FDA’s \u201cOrange Book,\u201d a listing of patents related to various […]<\/p>\n","protected":false},"author":3627,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[5,20,26,35,40,41],"tags":[],"class_list":["post-13379","post","type-post","status-publish","format-standard","hentry","category-biotech","category-healthcare","category-innovation-2","category-patent-law","category-patents","category-pharma"],"jetpack_featured_media_url":"","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/blogs.uakron.edu\/ualawip\/wp-json\/wp\/v2\/posts\/13379","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.uakron.edu\/ualawip\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.uakron.edu\/ualawip\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.uakron.edu\/ualawip\/wp-json\/wp\/v2\/users\/3627"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.uakron.edu\/ualawip\/wp-json\/wp\/v2\/comments?post=13379"}],"version-history":[{"count":2,"href":"https:\/\/blogs.uakron.edu\/ualawip\/wp-json\/wp\/v2\/posts\/13379\/revisions"}],"predecessor-version":[{"id":15579,"href":"https:\/\/blogs.uakron.edu\/ualawip\/wp-json\/wp\/v2\/posts\/13379\/revisions\/15579"}],"wp:attachment":[{"href":"https:\/\/blogs.uakron.edu\/ualawip\/wp-json\/wp\/v2\/media?parent=13379"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.uakron.edu\/ualawip\/wp-json\/wp\/v2\/categories?post=13379"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.uakron.edu\/ualawip\/wp-json\/wp\/v2\/tags?post=13379"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}