Posts Tagged: "pharmaceuticals"

The U.S. Senate Committee on Health, Education Labor & Pensions held a hearing today on why the United States pays “by Far, the Highest Prices in the World for Prescription Drugs.” Patents came up throughout the hearing as one barrier to lowering prescription drug prices, while pharmaceutical industry representatives underscored the cost of bringing innovative and life-saving drugs to market and the superior access Americans have to such drugs compared with other countries.

Today, the U.S. Department of Health and Human Services (HHS) made its initial offers to pharmaceutical companies pursuant to the Biden Administration’s Inflation Reduction Act of 2022 (IRA), which allows the U.S. Government to “negotiate” Medicare drug prices under a set framework based upon the amount of time a drug has spent on the market. Opponents of the program, including the U.S. Chamber of Commerce, which is suing the government over the plan, argue it cannot be characterized as a voluntary negotiation since the affected companies would be subject to onerous excise taxes for refusing to participate and because it would have devastating consequences for patients if companies were to actually pull the affected drugs. The amounts of today’s initial offers were not revealed.

IPWatchdog’s Life Sciences Masters 2023 concluded today, following three days of panels that tackled some of the most pressing issues facing intellectual property professionals in the life sciences space. In the spotlight was the Biden Administration’s recent passage of the Inflation Reduction Act (IRA) and its potential impact on future drug development in the United States. Prescription drug pricing controls are one aspect of the IRA, a landmark piece of legislation passed by Congress last August that also directs funding to be spent on clean energy projects and increased tax enforcement. The IRA authorizes the Health and Human Services (HHS) Secretary to establish a Drug Price Negotiation Program, codified at 42 U.S.C. § 1320f, to establish maximum fair prices of certain drugs that become eligible for the program because they constitute a large portion of expenditures by Medicare Part B and Part D patients. Pharmaceutical companies who do not agree to the price set during negotiations with HHS will have to pay a new excise tax codified at 26 U.S.C. § 5000D calculated based on daily sales and starting at 65%.

On August 28, officials from the U.S. Chamber of Commerce held a video call to discuss the trade organization’s legal action against the U.S. Department of Health & Human Services (HHS), including a motion for preliminary injunction filed against the HHS last week in U.S. district court. The U.S. Chamber officials noted that the legal uncertainty looming over the HHS’ implementation of drug price control mechanisms under the Inflation Reduction Act (IRA) will cast a significant pall over the Biden Administration’s celebration of the program one year on.

A letter sent to the United Kingdom’s International Business and Trade Secretary today urged scrapping proposals that health groups say would undermine the generic medicines industry in India. The letter refers to a leaked document that indicates the UK will be asking India to agree to a number of patent provisions as the two countries negotiate a trade deal today.

On July 31, the National Institutes of Health (NIH) hosted a virtual workshop titled Transforming Discoveries into Products: Maximizing NIH’s Levers to Catalyze Technology Transfer. Public comments submitted to the NIH ahead of the event reflect current tensions between advocates supporting either private commercialization or government pricing control of federally-funded medical breakthroughs commercialized by private companies.

On June 9, the U.S. Chamber of Commerce and several affiliate organizations filed a lawsuit in the Southern District of Ohio raising a series of constitutional challenges to provisions of the Inflation Reduction Act (IRA). At issue in the lawsuit are several statutes granting the U.S. Department of Health & Human Services (HHS) the authority to set prices for Medicare drugs. The U.S. Chamber is challenging a lack of oversight for so-called “negotiation” procedures as well as an onerous excise tax on several grounds, including separation of powers and due process violations.

On Thursday, the Senate Judiciary Committee passed a number of bills targeting the pharmaceutical industry. The bills passed on a bipartisan basis and with minimal discussion, by a voice vote, though Senator Mike Lee (R-UT) reiterated concerns he has had since the bills’ introduction. Here is a recap of what the bills aim to do.

In the days leading up to the recent all-day listening session on initiatives pursued by the U.S. Patent and Trademark Office (USPTO) and the U.S. Food and Drug Administration (FDA) to address drug patent issues, 30 public comments were filed in response to the Federal Register notice issued last November seeking input on ways that both agencies could promote both innovation and patient access to generic pharmaceuticals. Some comments cited data pointing to supposed issues with artificially extended market exclusivity for branded drugs, while at least one pharmaceutical firm called out a well-known data source as improperly inflating that company’s patent data. Suggestions for intra-agency collaboration included more access to drug dossier information during patent prosecution, although concerns were also raised regarding the prospect that such increased engagement could tax agency resources to the detriment of all patent applicants.

The U.S. Patent and Trademark Office (USPTO) and the Food and Drug Administration (FDA) today jointly held an all-day listening session featuring speakers from patient advocacy and industry groups, academia, and brand and generic pharmaceutical companies who weighed in on the relationship between patents and affordable access to medicines. The session was announced via a Federal Register Notice and request for comments on the subject, published on November 7, 2022, stemming from a joint July 2022 announcement that the two agencies plan to execute a number of initiatives aimed at lowering drug prices, as directed in July 2021 by President Joe Biden’s “Executive Order on Promoting Competition in the American Economy.”

The process of bringing a new pharmaceutical drug to market is time-consuming and expensive. The process of naming the new drug, while not as scientifically complex, is often no less work. Drugs have several names, including their chemical (or scientific), generic (or non-proprietary) and brand (or proprietary) names. The chemical name specifies the molecular structure of the drug. The generic name specifies the underlying compound of the drug and includes a “stem” that informs health care professionals about how the drug will work in the body. In the United States, generic names must be approved by the United States Adopted Names (USAN) Council and the World Health Organization (WHO) INN Programme. While the chemical and generic names may be available for use by others in the industry, the brand name—under which the new drug is typically marketed—is unique and exclusive to the brand owner and is the focus of this article.

Health and Human Services (HHS) Secretary Xavier Becerra may consider himself a lucky man (which would probably sound ironic to him at the moment). He just received three letters which aptly summarize the fork in the road he faces in deciding which way to turn in a critical policy decision. On June 23, Senator Elizabeth Warren (D-MA) and Rep. Lloyd Doggett (D-TX), joined by 98 of their Democratic Congressional colleagues, sent him the latest in their series of letters urging him to use alleged existing authorities so that copycats can make expensive drugs to lower health care costs. That triggered an immediate rebuttal from six associations representing research universities and hospitals (including the Bayh-Dole Coalition, which I lead) and another from the Licensing Executives Society, USA & Canada, Inc. (LES), representing the licensing profession. It seems appropriate to let the letters speak for themselves, so let’s start with the Congressional letter, urging the Secretary to use tools they allege he already has to cut the Gordian Knot to lower drug costs.

Recently published research conducted by Vital Transformation shows legislative provisions similar to those found in the Inflation Reduction Act of 2022, which allows the U.S. Government to “negotiate” drug prices under a set framework based upon the amount of time a drug has spent on the market, would have significant, negative effects on patient access to new therapies because funding would be severely curtailed for research and development. According to Vital Transformation, the reduction of net earnings due to government price fixing would substantially reduce the amount of research and development of small biotech firms, which would negatively impact future drug discovery and development. The model used in the study estimates that with government price fixing “only 6 of 110 previously approved therapies would be considered ‘not at risk’ of being cancelled, or at very least divested.”

On July 11, Teva Pharmaceuticals USA filed a Petition for Writ of Certiorari to the U.S. Supreme Court asking it to review a decision of the U.S. Court of Appeals for the Federal Circuit (CAFC) in which the CAFC found that Teva could be held liable for inducement based on sections of a “skinny label” that provided information about unpatented uses. Teva claims that the decision by the CAFC would upend the legal rules governing the modern prescription-drug marketplace. The petition notes that the decision would wreak doctrinal havoc in two equally disturbing ways. First, the court’s decision eliminates the key element of inducement liability requiring plaintiffs to prove that a defendant took active steps to encourage the direct infringement. Secondly, it effectively nullifies a Congressional act that was enacted to bring low-cost generic drugs to market, which is precisely what Teva was doing.