Posts Tagged: "pharmaceutical patents"

A terrible idea – wayward and ill-conceived, criticized by all economic, political and geopolitical fronts – has come to fruition. The World Trade Organization’s (WTO) TRIPs waiver on patents related to COVID-19 vaccines will disincentivize the entire industry from investing in vaccine production. To understand what happens next, let’s understand history first.

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.”

As Knowledge Ecology International and its allies await the decision of the National Institutes of Health (NIH) on their latest attempt to misuse the Bayh-Dole Act for the government to set prices on any product based on a federally funded invention, they’re growing more uneasy. And that’s understandable. If you’d bet the house on an ivory tower theory that’s been summarily rejected for the past 18 years every time it’s been trotted out, you’d be uneasy too. They know that if the Biden Administration rejects the pending petition to march in on the prostate cancer drug Xtandi because of its cost, this leaky vessel can’t be credibly refloated again.

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 debate around whether patents are unnecessarily propping up drug prices has been simmering for years. A recent policy memo from the Hudson Institute has thoughtfully raised concerns about the data underlying this debate, and the memo made its way up to the U.S. Senate Judiciary Subcommittee on Intellectual Property. While the memo may have successfully poked holes in some of the data, it draws questionable conclusions regarding what those holes might mean. Unpacking this debate is therefore necessary to guide the correct policy on the intersection of patents and drug prices.

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.

A key issue of discussion with respect to the Brazilian patent system has to do with patents granted by the Brazilian Patent and Trademark Office (BPTO) under the following sole paragraph of Article 40 of the Brazilian IP Law: “Article 40 – The term of a patent for an invention shall be 20 (twenty) years and for a utility model 15 (fifteen) years as from the filing date. Sole Paragraph – The term shall not be less than 10 (ten) years for inventions and 7 (seven) years for utility models, as from the date of grant, except where INPI is prevented from carrying out the substantive examination of the application due to pending litigation or for reasons beyond its control.” This provision guarantees that patentees enjoy a 20-year term from filing and is particularly relevant due to the considerable examination backlog at the BPTO.

The Brazilian Patent and Trademark Office (BPTO) presently offers more than 15 programs to speed up examination of patent applications. The prioritization of certain patent applications by means of Patent Prosecution Highway (PPH) programs and other fast-track options has been very effective in reducing pendency. Brazil’s backlog has already been reduced by around 40% and the BPTO estimates an additional 40% reduction by August 2021.

Section 156 of the Hatch-Waxman Act provides for restoring some of a patent’s term consumed during clinical testing and Food and Drug Administration (FDA) review of a New Drug Application (NDA) for a product covered by the patent. The extension afforded under Section 156 is of great importance to a drug manufacturer given that development of a new drug from discovery through FDA approval often takes a decade or more (10-15 years), leading to the loss of a significant portion of the term of a patent covering the drug. The dispute in Biogen International Gmbh v. Banner Life Sciences LLC, No. 2020-1373 (Fed. Cir. April 21, 2020) (Biogen v. Banner) centers around the very meaning of the term “product” as used in Section 156.

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 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.

On Thursday, May 9, the Affordable Prescriptions for Patients (APP) Act was introduced into the U.S. Senate by Senators John Cornyn (R-TX) and Richard Blumenthal (D-CT). If passed by Congress and signed into law, the bill would modify the Federal Trade Commission (FTC) Act to give the FTC additional antitrust authority to challenge the anticompetitive nature of certain actions by pharmaceutical patent owners in the service of providing more consumer access to generic and biosimilar drugs.