Posts Tagged: "evergreening"

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.

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.

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.

On the morning of Thursday, March 7, the House Ways & Means Committee’s Subcommittee on Health held a hearing titled Promoting Competition to Lower Medicare Drug Prices. The hearing focused a great deal on the effect of patents in the pharmaceutical industry as they relate to pricing. Although some of the Republican membership of the subcommittee pointed out issues with various proposals to limit patent protections for drugmakers, the panel acted largely as a firing squad for patents. In his closing statement, Rep. Doggett expressed his dissatisfaction with the tenor of the day’s debate. “I view it as encouraging that there is bipartisan recognition of the serious problems so many Americans are facing with, really, prescription price gouging,” he said. “The question is whether we’ll have any bipartisan agreement on doing anything about it.”

While the claims-in-suit had previously survived validity challenges in an inter partes review (IPR) proceeding at the Patent Trial and Appeal Board (PTAB) and in a District of Delaware case, Aly credited additional testimony and evidence in this case with leading Judge Pallmeyer towards finding that the claimed advance was inherent to the invention in the prior art. “In IPR, there’s a limited record so there’s not a lot of testing to examine, and two tests were submitted in the Delaware case,” Aly said. While that could have been enough, he noted that, in the Fresenius Kabi case, multiple companies had done more than 20 tests, all of which showed that the claimed advances were inherent to the stable product.

If a drug company plants a more than 100-patent thicket to protect market exclusivity, then it had better be able to justify why it should deserve the cumulative protection of patent term. Yes, the patent on the original formulation will fall into the public domain and may be capable of being made by generics long before the last of the patents expire, but often-times those follow on “innovations” are the kind of trivial advances that ordinarily shouldn’t support a fresh patent.

Michelle Lee talks about transparency, but the PTO is hiding behind redacted pages and claims of privilege to deny a legitimate FOIA request from Kyle Bass. “I don’t want to be embarrassed” is not a grounds for privilege and improperly asserting privilege is not being transparent… On page 407 there’s an email to Michelle Lee with briefing materials for the BIO meeting that were prepared by BIO. Not only are the many pages of the BIO briefing materials themselves redacted, but in the email the list of what’s included is redacted. We don’t even know what’s missing. How can materials prepared by BIO and shared with Ms. Lee be privileged?