Posts Tagged: "orange book"

The Hatch-Waxman Act (“the Act”) was designed to strike a delicate balance between pharmaceutical innovation and faster access to affordable drugs. However, one aspect of the Act, the patent listing process, when used improperly, can knock this balance out of whack. Unfortunately, in the present environment, the potential for improper patent listing is high, and current remedies are insufficient.

The U.S. Patent and Trademark Office Patent Trial and Appeal Board (PTAB) recently released an update to its Orange Book patent and biologic patent study, examining post-grant petitions filed against Orange Book patents and biologic patents between September 16, 2012, and June 30, 2021. The PTAB classified a petition as challenging an Orange Book-listed patent by comparing the petition’s filing date with data from the U.S. Food and Drug Administration’s (FDA’s) electronic Orange Book indicating when the patent was listed. The PTAB manually identified biologic patents as any patent potentially covering a Purple Book-listed product and any non-Orange Book-listed patent directed to treating a disease or condition.

Innovator (or “reference”) biologic drug makers and small-molecule drug makers face differing legal obligations with respect to public patent disclosures. Under the Hatch-Waxman Act, reference small-molecule drug makers are required to provide to the U.S. Food and Drug Administration (FDA) a list of the patents covering the active ingredients, compositions, formulations, and methods of treatment for their approved reference drug products, which the FDA in turn is required to publish in its “Orange Book.”  21 U.S.C. § 355(b)(1), (c)(2). The publication of such patents in the FDA Orange Book thus gives all generic drug applicants advance notice of the patents to be asserted by a reference drug maker in future Hatch-Waxman litigation.

Late Monday evening, Congress passed a massive omnibus budget bill to avert a federal government shutdown and provide critical COVID-19 relief.  But that is not all – much to the surprise of the intellectual property world, the last-minute bill included several pieces of legislation, previously thought to be sidetracked in light of the current lame duck administration, that will alter the landscape of trademark, copyright and patent law as we know it. The changes include a Trademark Modernization Act that restores the rebuttable presumption of irreparable harm when a Lanham Act violation has been proven, allowing brand owners to more easily obtain injunctions, and the creation of a copyright small claims tribunal within the Copyright Office.

On June 1, the Food and Drug Administration (FDA) published a notice in the Federal Register announcing that the agency was establishing a public docket for the receipt of public comments regarding the types of patent information published in the FDA’s Orange Book, a collection of FDA-approved drugs and their therapeutic equivalents designed to improve competition from generic drugmakers. While the request for comments only seeks early input on the subject, public responses could influence regulatory action that later changes the types of patents that a branded pharmaceutical manufacturer must disclose to inform generic drugmakers of their infringement liability risk.

In July 2012, the U.S. Food and Drug Administration (FDA) first approved Truvada, an acquired immunodeficiency syndrome (AIDS) treatment manufactured by Gilead Sciences as a daily pre-exposure prophylactic (PrEP) treatment to reduce the risk of contracting human immunodeficiency virus (HIV) in sexually active individuals. Recently, this HIV PrEP treatment and its patent have been thrust into the spotlight thanks to a commercial for Truvada that Gilead ran during the January 27 broadcast of Rent: Live on the Fox television network. While many were encouraged by the fact that a national TV network was raising awareness about PrEP treatment, the commercial sparked a return to a debate over the high price of Truvada. As of June 2018, news reports indicated that once-daily Truvada treatment cost about $1,500 per month, or around $18,000 per year. Although the cost of Truvada is often covered by health insurance, the treatment hasn’t been adopted as widely as was expected when the drug was approved. Between January 2012 and March 2014, a review of half of U.S. pharmacies by Gilead showed that only 3,253 had begun a PrEP regimen during that time, far less than the estimated 500,000 people who would make good candidates for Truvada. That number has expanded rapidly to 77,120 U.S. PrEP users in 2016 and an estimated 136,000 users by the end of 2017’s first quarter, but that’s still far short of the estimated 1.2 million American adults at high risk of HIV infection who could benefit from PrEP. “Based on feedback from partners and our work in the field, we believe that one of the greatest barriers to Truvada for PrEP access today is limited awareness of Truvada for PrEP’s role in HIV prevention,” Gilead told IPWatchdog. “Data from our patient support programs do not suggest that cost is a primary obstacle to treatment. The majority of people receiving Truvada for PrEP today who utilize our co-pay coupons pay less than $5 per bottle.”

While part one of this two-part series on intellectual property (IP) due diligence focused on a life science company’s own IP portfolio, part two will address a company’s understanding of how it fits into the market by considering its freedom to operate, as well as its competitors’, and the interplay of patent and regulatory exclusivity as it relates to the company’s product. Patent and regulatory exclusivity—two areas that can provide the most value and protection to a life science product—are very interrelated. Simply identifying when a key patent naturally expires is not sufficient, because regulatory exclusivity could possibly extend the company’s ability to keep competitors off the market or allow competitors to speed up entry in certain situations.

Since its inception, the Patent Trial and Appeal Board (PTAB) has been a frequent venue for patent challenges in the pharmaceutical and biotechnology industries. By the end of the U.S. Patent and Trademark Office’s (USPTO’s) 2018 fiscal year, patents in those fields were targeted in nearly 10% of all petitions for inter partes review (IPR), totaling approximately 900 individual petitions. Of these 900 petitions, roughly 5% challenged patents listed in the FDA’s Orange Book for approved drug products. The remaining petitions challenged biologic drugs (1.3%) and other biologic-, biotechnology-, or pharmaceutical-related patents (3.5%). Many of these petitions have ultimately resulted in the cancellation of all challenged claims, including those of a significant number of Orange Book patents. Based on the PTAB’s initial high rate of claim cancellation in pharma and other areas, critics of the PTAB were quick to deem it a patent “death squad.” Does the PTAB still deserve the “death squad” label when it comes to Orange Book patents? In this article, we examine the rates of challenge, institution, and final written decision outcomes for patents listed in the Orange Book, from the PTAB’s inception through the end of its 2018 fiscal year.

Out of the 230 Orange Book patents challenged in IPR proceedings, 90.4% (208) of these patents were also challenged in Hatch-Waxman litigation perhaps due to the lucrative 180-day exclusivity incentive available to the first generic manufacturer to file a paragraph IV challenge when the Orange Book drug patent is successfully invalidated in a subsequent district court proceeding. Therefore, the IPR process has provided generic manufacturers a dual track option for challenging Orange Book patents by initiating Hatch-Waxman litigation and also pursuing IPRs. Overall, because the rate of settlement in IPRs is much lower than in Hatch-Waxman litigation, both generic manufacturers and patent owners obtain more favorable final decisions in IPRs as compared to their Hatch-Waxman litigation outcomes.

While the changes to the Trial Practice Guide begin to move the rules in the right direction, more is needed before post-grant proceedings will be accepted as neutral to all parties.  The PTAB should endeavor to adopt the time-honored burdens, presumptions and procedures used in the district courts for trying patent cases whenever reasonably possible.  Petitioners should be required to prove that the art upon which they rely is not cumulative to that previously before the USPTO, a patent owner’s Preliminary Response presenting evidence raising genuine issues of material fact should be treated as it would be if presented in opposition to a summary judgment motion brought in the courts, and the presiding panel should determine witness credibility by hearing testimony and cross examination live.

The Federal Circuit’s decision in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals, No. 2016-2707, addresses the complicated topic of patent eligibility in the pharmaceutical space. Much of the decision compares Vanda’s claims to those found ineligible for patent protection in the U.S. Supreme Court’s decision in Mayo Collaborative Services v. Prometheus Laboratories, 132 S. Ct. 1289 (2012). While the ultimate patentability conclusions are opposite, the claims in Vanda and Mayo are very similar, highlighting the thin—and often unpredictable—line that divides eligible and ineligible subject matter. Generic drug manufacturers must account for this unpredictability in gauging their litigation risks.

In 2017, U.S. district courts saw a total of 417 patent infringement suits related to ANDA filings made by drugmakers with the U.S. Food and Drug Administration (FDA) seeking to bring generic versions of brand-name pharmaceuticals to the U.S. market. This total number of ANDA cases was below recent highs set in 2014 (437 cases) and 2015 (475 cases) but it was also a significant increase over the 324 ANDA cases filed in 2016. Going back to 2009, 2017 saw the third-highest number of ANDA cases in a single year. The fact that ANDA litigation is rising is pretty consistent with the number of ANDA applications being received by the FDA. In 2017, the FDA approved a record number of ANDAs with 763 such approvals that year; the agency attributed this uptick to an increased number of agency hires.

AbbVie’s maneuver worked like clockwork to induce regulatory gridlock, which prevented generic competition and kept the company’s profits high at public expense, for years. Fortunately, the FTC would have none of it. The agency filed suit against AbbVie in the Eastern District of Pennsylvania in 2014, accusing the company of illegal monopolization under the antitrust laws. The gravamen of the FTC’s complaint was that AbbVie wrongfully filed objectively-baseless sham litigations, to block generic competition.

On Thursday, October 12th, a pair of letters addressed to the bipartisan leadership of the Senate Judiciary Committee were delivered in an attempt to inform Senators on that committee of various issues in play regarding the recent patent deal between multinational pharmaceutical firm Allergan and the sovereign St. Regis Mohawk Tribe. The two groups sending the letters represent stakeholders in the U.S. patent system coming from very different backgrounds who realize that there are fundamental flaws in the system created by inter partes review (IPR) proceedings which are carried out at the Patent Trial and Appeal Board (PTAB).