Posts Tagged: "drug pricing"

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.”

Healthcare costs in the United States continue to rise, placing an ever-increasing burden on patients and government payer programs. Popular discourse blames patented drugs as the culprit for these rising costs. In a move that previously would have been unthinkable, policymakers have even called upon the Department of Health and Human Services to exercise a mechanism known as Bayh-Dole “march-in” rights, to break the patents on drugs that the private sector has spent billions developing, in order to lower their prices. But this fixation on patents as a major driver of America’s medical spend is misplaced.

The United States Patent and Trademark Office (USPTO) announced today that it is seeking comment from the public on “proposed initiatives directed at bolstering the robustness and reliability of patents to incentivize and protect new and nonobvious inventions while facilitating the broader dissemination of public knowledge to promote innovation and competition.” During IPWatchdog’s LIVE event in Dallas, Texas, in September, USPTO Texas Regional Office Director Hope Shimabuku explained that issuing “robust and reliable patents”—which seems to have replaced the oft-maligned term, “patent quality,”—is a key focus for USPTO Director Kathi Vidal. The request for comment (RFC) tackles this problem from a number of angles, from fee-setting to terminal disclaimer and continuation practices, to improving prior art searches. The RFC stems in part from a July letter sent by the USPTO to the Food and Drug Administration (FDA) outlining the USPTO’s planned initiatives to help combat perceived links between patents and drug pricing problems.

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.”

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.”

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.”

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.

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.

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.

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.

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.

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.