“In our case at least, I-MAK seems to have reached an inflated figure by including 44 people. abandoned Patent applications that have never been issued as patents, and various patents that do not cover our drug. – Corey Salsberg, Novartis
In the days leading up to a recent full-day listening session on initiatives pursued by the United States Patent and Trademark Office (USPTO) and the United States Food and Drug Administration (FDA) to address pharmaceutical patent issues, 30 public comments were submitted. I was. A gazette published last November solicited input on how the agencies could foster both innovation and patient access to generic medicines. Some comments cited data pointing to the problem of artificially inflated market exclusivity for branded drugs, and at least one drug company famously accused it of inappropriately inflating its own patent data. I pointed out the data source. Proposals for cooperation within the agency included greater access to patent-pending drug dossier information, but it was decided that such increased involvement would be detrimental to all patent applicants. Concerns were also raised about the potential taxation of institutional resources.
Novartis: I-MAK used abandoned patents to inflate Gleevec market monopoly data
Novartis released a statement prepared by Corey Salsburg, the company’s vice president and global head of intellectual property affairs. Among them, drug developers use their own experience as part of the Initiative for Medicines, Access & Knowledge (I-MAK). In his I-MAK report, published in October 2017, Novartis’ cancer drug Gleevec has a patent term of 35 years for him, and generic competitors will not enter the U.S. market until 2029. claimed to be This leaves Gleevec with only 15 years of real life, excluding generic competition.
“The same report states that the actual number of US patents issued on Gleevec® is fivewith another 1-4 probably We will cover some of the ways to create it, but only if those methods were (optionally) used. At least in our case, the I-MAK seems to have reached an inflated number by including 44. abandoned Patent applications that have never been issued as patents, and various patents that do not cover our drug.
Misrepresentations about patents acquired by pharmaceutical R&D companies like Novartis have made it nearly impossible to understand the benefits to be gained from patent activity, which advocates of anti-drug patents often portray as frivolous. increase. With additional patent protection, Novartis is the same compound as Entrest in the treatment of heart failure, a combination drug utilizing previously approved compounds, and Piqray, Novartis’ breast cancer drug. Novartis believes that even when applying known pharmaceutical compounds, the increased cost of developing new uses will hinder the creation of these novel and successful treatments without the ability to patent post-launch inventions. He added that it would have interfered.
Pharmaceuticals: Belcher vs. Hospira Rarely exhibit systemic problems
In addition, comments submitted by the Research and Manufacturers of Pharmaceuticals in the United States (PhRMA) and authored by David Korn, PhRMA’s Vice President of IP and Legal, acknowledge the social benefits of post-approval innovation. The continuing practice, which has been targeted by anti-drug patent advocates for alleged creation of the so-called “patent thicket”, is to protect the rights of inventors to develop more patentable inventions while preserving the rights of inventors to develop more patentable inventions. The magazine says it will help achieve the system’s goals. PhRMA. PhRMA argues that restricting continuation practices will discourage innovators from filing patent applications if they fail to protect the full scope of their inventions.
Belcher Pharmaceuticals, LLC v. Hospira, Inc. (2021), a Federal Circuit decision cited by anti-drug patent advocates as emblematic of the need for greater cooperation between the USPTO and the FDA, “has little indication of a systemic problem.” said the PhRMA comment. Although the patent owner in this case failed to disclose material prior art to the USPTO and made inconsistent statements about the scope of the patent’s claims, the Federal Circuit found the patent unenforceable for unfair conduct. “In fact, there were 4,696 Hatch-Waxman lawsuits filed in U.S. District Court between 2008 and 2022, and there was no evidence of a widespread problem of conflicting statements to the FDA and USPTO. No,” said PhRMA.
PIRG: Tighter Patent Examination of Inventions for Marketed Drugs
The Public Interest Research Group (PIRG) argues that increased competition for generic drugs, which currently account for 20% of U.S. premium costs, could reduce prescription drug costs. Citing the House Oversight Committee’s December 2021 drug pricing report, PIRG identified that there are 600 patents covering 12 drugs, and the total exclusivity period for these patents is 300 years. The comment is that pharmaceutical companies are stifling competition and reducing corporate profits.
Among the PIRG’s recommendations for enhancing cooperation between the USPTO and the FDA are de-emphasizing expedited review of the 600,000 patent applications filed with the USPTO each year and providing high-quality review of pharmaceutical patent applications. It includes focusing on The PIRG further proposed that the USPTO create a system for flagging patent applications containing drug compounds currently listed in the Orange Book or Purple Book for stricter patent prosecution. Another initiative proposed by PIRG was the creation of a public database containing information on market-approved drugs and related patent activity from both the USPTO and FDA. This includes continuation applications and requests for continuation review.
Fresenius Kabi: Humira and Keytruda’s Gamesmanship Shows Need to Focus on High-Value Patents
Health care company Fresenius Kabi has submitted comments agreeing that pharmaceutical companies engage in tactics designed to artificially inflate the market exclusivity period of certain blockbuster drugs. Fresenius Kabi gives an example of “gamesmanship” in which a pharmaceutical company files an initial patent application disclosing the main “backbone” structure of a drug, followed by subsequent patent applications claiming other structural requirements of the same drug. I’ve listed a few. Examples of these included the inflammatory drug Humira, whose peptide sequence was disclosed in a 1996 patent application more than a decade before his patent application claiming protein levels in host cells. And the cancer drug Keytruda, which was first claimed in a 2008 patent application, 14 years before the 2002 patent application that claimed the drug’s oxidation levels.
Acknowledging that the USPTO already has a significant burden of prosecuting patent applications, Fresenius Kabi noted that FDA’s employees should seek specific material from drug regulatory documents relating to the structural and ancillary features of drugs. I proposed to provide it to the patent examiner. A patent examiner may also be provided with product development reports held within FDA’s drug dossiers, asking whether the ancillary features are clearer than the secondary considerations claimed. It helps you decide what to do. In addition, Fresenius Kabi recommends placing some of the liability on patent applicants by requiring them to stipulate in their patent applications that they have not made conflicting statements to the USPTO and FDA. .
AIPLA: Current Disclosure Rules Work, Information Sharing Becomes a Heavy Burden
In its comments, the American Intellectual Property Law Association (AIPLA) said the organization believed that the conflicting statements between the USPTO and the FDA were not a widespread issue that led to the granting of numerous patents that the USPTO should not have issued. showed. Enforcement of the obligation to disclose material patentability information already required by 37 CFR § 1.56 would prevent such disclosure during patent prosecution, including the risk that inconsistent statements could lead to an unenforceable grant of a patent. It already gives patent applicants strong incentives to make statements.
Initiatives to create an information sharing system between the USPTO and FDA would increase the burden not only on these agencies, but on all patent applicants, as limited agency resources would be diverted from general patent prosecution activities. increase. In addition, AIPLA notes that information shared between institutions may risk exposure of trade secrets, which may hinder future pharmaceutical innovation.
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