Posts Tagged: "drug pricing"

Three Letters Summarize the March-In/ Compulsory Licensing Debate

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.

Report Reveals Danger of Proposed Price Fixing to U.S. Biopharma Innovation

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.”

USPTO to Crack Down on ‘Incremental’ Patents in Response to Biden Executive Order’s Drug Pricing Mandate

The U.S. Patent and Trademark Office (USPTO) yesterday announced in a joint blog post with the Food and Drug Administration (FDA) that the Office plans 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 announcement came via a blog post jointly authored by USPTO Director Kathi Vidal and Food and Drug Administration (FDA) Commissioner Robert M. Califf. Biden’s Executive Order in part encouraged curbing some pharmaceutical companies’ practices, such as so-called pay-for-delay settlement agreements between brand pharmaceutical companies and generics manufacturers. The Order called for the USPTO and the FDA “to leverage [their] collective expertise in promoting innovation, competition, and the approval and regulation of safe and effective drugs to help provide relief to American families at the pharmacy.”

Tillis Blasts FDA for Refusing to Respond on Drug Patent Data Study

Senator Thom Tillis yesterday wrote to Food and Drug Administration (FDA) Commissioner Dr. Robert Califf, asking for a third time that the FDA conduct “an independent assessment and analysis of the sources and data that are being relied upon by those advocating for patent-based solutions to drug pricing.” Tillis expressed his frustration with the lack of response thus far, explaining that no formal reply has yet been received despite his first letter being sent in January 2022, and calling it “unacceptable” that the FDA apparently “refuses to reply to emails or to engage.”

Tillis Renews Request to FDA and USPTO for Independent Assessment of I-MAK Patent Data

On Friday, April 1, Senator Thom Tillis (R-NC) wrote to the Food and Drug Administration (FDA) and the U.S. Patent and Trademark Office (USPTO) to once again voice his concerns about several sources advancing data on the effects of pharmaceutical patents on drug pricing. Tillis is specifically troubled that the data seems to be based on opaque methodologies and to contain inaccurate or incomplete information that may mislead policymakers. In a previous letter to these organizations, he requested the agencies conduct an independent assessment of the accuracy and reliability of those sources. In the present letter, Tillis again highlights his concern about work from the Initiative for Medicines, Access & Knowledge (I-MAK). He had previously written to Tahir Amin, Co-Founder and Co-Executive Director of I-MAK, requesting that I-MAK provide a detailed explanation of its methods to allow others to check the accuracy of I-MAK’s patent data and to assess the credibility of its other assertions.

I-MAK Defends Integrity of Its Patent Data in Response to Tillis Letter

The Initiative for Medicines, Access & Knowledge (I-MAK) has responded to a letter it received from Senator Thom Tillis (R-NC) in January asking the organization to address claims that its data on the effects of pharmaceutical patents on drug pricing is faulty. In the letter, I-MAK defended its underlying patent data and, in reference to the question of why the data differs significantly from public sources like the Food and Drug Administration’s (FDA’s) Orange Book and court filings, explained that “relying on public sources and court filings is not an accurate methodology for identifying all patents on a drug.” I-MAK’s view is that the U.S. patent system creates patent monopolies that lead to the practice of “evergreening”, in which innovator pharmaceutical companies extend their rights beyond the original patent terms, preventing competition from generics, which in turn causes drug prices to remain high. As part of its mission, I-MAK has developed a database of patents covering key drugs. Its reports are often cited by academics, including in law journals, policymakers and in congressional hearings. As a result, I-MAK has become one of the most authoritative sources for information on patents in this space.

Tillis Wants More Info on I-MAK and Other Data Driving Anti-Patent Narratives Around Drug Pricing

Just over one week ago, Professor Adam Mossoff of the Antonin Scalia Law School at George Mason University published a Policy Memo with the Hudson Institute charging that some of the key data relied upon in the heated debate over the effects of pharmaceutical patents on drug pricing and access may be faulty. Now, Senator Thom Tillis (R-NC) has written letters to the key organization providing that data, the Initiative for Medicines, Access & Knowledge (I-MAK), as well as the Food and Drug Administration (FDA) and the U.S. Patent and Trademark Office (USPTO), expressing concern about the findings of Mossoff’s memo and requesting more information from I-MAK about its methodology.

Mossoff Policy Memo for Hudson Institute Calls for Transparency from I-MAK on Data Used in Drug Pricing Debate

A Policy Memo published by the Hudson Institute and authored by Professor Adam Mossoff of the Antonin Scalia Law School at George Mason University has charged that some of the key data relied upon in the heated debate over the effects of pharmaceutical patents on drug pricing and access may be faulty. The memo, titled “Unreliable Data Have Infected the Policy Debates Over Drug Patents,” specifically targets the Initiative for Medicines, Access & Knowledge (I-MAK), an advocacy organization that has become a “principal, go-to source” for data on the number of patents and patent applications covering pharmaceutical innovations.

Bankrupting Big Pharma Isn’t a Solution

Believe it or not, a recent op-ed in the Washington Post written by Robin Feldman took the position that pharmaceutical companies should charge prices for their drugs that would surely guarantee that they go bankrupt. An absurd position even for a law professor who is ideologically predisposed to an irrational hatred of patents, but precisely the position Feldman articulated. How someone as smart as a law professor does not understand basic business reality raises important questions about her intellectual honesty—or at the very least raises questions about whether she is truly an expert on this topic.

Senate Judiciary Committee Advances Legislation to Reduce Drug Prices, Rein in Pharma Industry Practices

Earlier today, the Senate Judiciary Committee held an Executive Business Meeting in which the Committee discussed and favorably reported four bills aimed at reducing prescription drug prices for consumers and curbing perceived abuses of the patent system by brand pharmaceutical companies. The bills would do so by increasing the Federal Trade Commission’s (FTC’s) authority to initiate enforcement actions against drug companies. Senator Dick Durbin (D-IL), Chair of the Senate Judiciary Committee, opened the meeting with an explanation of the need for the bills. He said that nearly 40% of U.S. patients struggle to pay for medication. The world’s best-selling drug, Humira, brought in $16 billion in sales in 2019 and Humira manufacturer, AbbVie, has obtained 130 patents on the drug, with 90% filed after Food and Drug Administration (FDA) approval.

House Committee Targets AbbVie Patent Practices, Urges FTC to Investigate

Yesterday, Representatives Carolyn Maloney (D-NY), Jerrold Nadler (D-NY) and David Cicilline (D-RI) asked Federal Trade Commission (FTC) Acting Chair Rebecca Kelly Slaughter to open a formal inquiry into pharmaceutical company AbbVie’s practices, which the representatives said have worked “to delay U.S. biosimilar entry for [AbbVie’s] blockbuster drug Humira.” The request was prompted by documents uncovered as part of an investigation being conducted by the House Committee on Oversight and Reform into the company. “Based on our review, these documents indicate that AbbVie delayed biosimilar competition for far longer than warranted by its own internal evaluations of the strength of its patent portfolio, which anticipated biosimilar entry no later than 2017,” said the letter.

Bills to Lower Prescription Drug Costs and Boost Biosimilars Sent to Biden’s Desk

The U.S. House of Representatives yesterday approved two bills meant to lower prescription drug prices and sent them on to President Joe Biden for approval. The Advancing Education on Biosimilars Act and the Ensuring Innovation Act were introduced by U.S. Senator Bill Cassidy, M.D. (R-LA) and broadly aim to improve the current market for cheaper generic drugs.

Industry Comments on Proposed Changes to Bayh-Dole Regulations Zero in on March-In Language

On January 12, the National Institute of Standards and Technology (NIST) published a request for comments on proposed changes to regulations that support the University and Small Business Patent Procedures Act of 1980, which is more commonly known as the Bayh-Dole Act. At the time, NIST explained that this important update to Bayh-Dole represents a key element of the Return on Investment Initiative, which seeks to maximize American innovation arising from the federal government’s more than $150 billion annual investment in research and development. Monday, April 5, was the deadline to submit comments to NIST on the proposed rule revisions. Below are a handful of excerpts to comments submitted, together with links to the full text of the comments.

No, You Can’t March in On Remdesivir

One thing you should never say in 2020 is: “Well, at least things can’t get any worse.” They can and often do. The latest exhibit—in the intellectual property space at least—is a letter to Health and Human Services (HHS) Secretary Azar, National Institutes of Health (NIH) Director Collins and Food and Drug Administration (FDA) Commissioner Hahn authored by California Attorney General Xavier Becerra and Louisiana Attorney General Jeff Landry. It’s also signed by 32 other state attorneys general, along with those representing the District of Columbia, Guam and American Samoa. They are demanding that the government use its authorities under the Bayh-Dole Act to march in against Gilead Sciences, the maker of the COVID-19-fighting drug remdesivir, so that it can be made more widely available at a lower cost.

Medical Innovation Depends on Bayh-Dole’s IP Protections

In this age of polarization, it’s almost impossible to imagine Congress enacting bipartisan legislation that would benefit businesses, higher education, and consumers alike. But that is exactly what happened 40 years ago, and it is worth remembering. As has been outlined elsewhere on IPWatchdog in 1980, Democrat Senator Bayh and Republican Senator Dole wrote a bill that seemed simple, but changed the face of American innovation. Prior to the Bayh-Dole law, anyone who accepted government funding of their research had to give any resulting patent rights to the government. Superficially, that sounded fair – if taxpayer money paid for research, the taxpayer should get the benefits. But the reality was that no one benefitted. Few companies had any interest in investing the substantial resources necessary to transform an early invention into a product when the underlying patents were held and controlled exclusively by the government. And those inventions that were developed simply sat on the shelf in government offices with no plans to bring them to market. Senators Bayh and Dole recognized this problem and their bill allowed research institutions to keep possession of the patent rights their research produced.