“At best, the proposed initiative will not have a measurable positive impact on the strength of US patent rights.” – Stephen Susalka, AUTM comments
In early March, the United States Patent and Trademark Office (USPTO) published the final batch of comments for its Request for Comments on the USPTO’s Initiative to Ensure the Robustness and Reliability of Patent Rights. The USPTO received a total of 227 comments after he extended the filing deadline twice.
There was also concern that the multiple extensions of submission deadlines created uncertainty. When IPWatchdog reached out to his USPTO, the organization had no official comment other than noting that many stakeholders requested more time to submit their comments en masse. And the office wanted to hear from as many parties as possible.
Since IPWatchdog provided its last update on February 16th, the USPTO has posted 96 comments. Here are some of the most recent comments posted. Perhaps most notable is the Justice Department filing.
Reports on previous posts can be found here and here.
Department of Justice: Comment posted March 2 (received February 28)
The Department of Justice’s (DOJ) Antitrust Division generally supported the USPTO’s efforts in its comments. The Antitrust Division specifically stated its support for the USPTO to reconsider the patent prosecution process. The division clarified that he would refer certain changes to the USPTO, but echoed other commenters’ concerns about patent thickets, evergreening, and product hopping.
The Antitrust Division devoted a significant portion of its comments to generic drugs. “Anti-competitive strategies that stifle or eliminate competition from generic drugs change people’s lives and deprive them of even life-saving medicines,” the department wrote.
And while the department acknowledged that there are several good reasons for continued practice, it also advocated reform in this area. “By acquiring developments already on the market, we may stifle competition. Improving practices may alleviate this concern,” the DOJ division said.
The comment also cites Kaiser Permanente’s February 1 comment to the USPTO, which discussed Humira’s evergreen strategy, which could generate an additional $100 billion in additional sales for the pharmaceutical company. We were able to achieve this and keep generic competitors out of the market. The Antitrust Office also referred to product hopping, the practice of drug manufacturers submitting applications to the FDA for new products that are essentially identical to the original product.
Overall, the Antitrust Office argued in its comments that the USPTO continue to work toward “relieving unnecessary barriers” to generic market entry and competition in generic drugs and other industries. Additionally, the DOJ division said it supports his USPTO efforts to improve the examination process by providing access to additional resources and information.
The Pharmaceutical Research and Manufacturers of America (PhRMA): Comment posted March 2 (received February 28)
The U.S. Research and Manufacturers of Pharmaceuticals (PhRMA) added comments in early February and added additional comments in response to other submissions. PhRMA disputed comments submitted by Prof. Bernard Chao, Fresenius Kabi, and mAbxience.
According to PhRMA, commentators “correlate with delays in launching biosimilars” to “the evidence for their claims regarding the cost of challenging the high number of patents on the reference products” they say. does not provide Additionally, PhRMA claims that:
PhRMA also defended the pharmaceutical company against criticism by other submissions. The submission was “overly focused on the number of patents in different jurisdictions, with unsupported conclusions about how the number of patents relates to the timing of biosimilar entry,” three commenters noted. has reached,” he said.
In addition, PhRMA reiterated its intention to contribute to the USPTO’s dialogue on how to strengthen the robustness and credibility of patents.
Association of University Technology Managers (AUTM): Comment posted March 2nd (Received February 28th)
AUTM CEO Stephen J. Susalka submitted comments on behalf of his organization, arguing that branded medicines would increase the number of generic medicines offered. But Susalka writes that “the proposed initiative as a whole has the opposite effect” and discourages the discovery and development of new branded drugs.
Although the AUTM agreed with some of the USPTO’s commitments, such as improving patent robustness and extending prosecution times, the organization remained skeptical. “At best, the proposed initiative would have no measurable positive impact on the strength of US patent rights,” he wrote Susalka.
Instead, AUTM advocated elimination or reform of IPR procedures to improve patent credibility and robustness. Susalka also commented that uncertainty about subject eligibility hurts universities and nonprofits.
International Federation of Intellectual Property Attorneys (FICPI): Comments posted 2 March (received 28 February)
The International Federation of Intellectual Property Lawyers (FICPI) argued that some of the proposals add to the cost of examining patent applications. “However, some of the proposals appear to be balanced and will help bring U.S. patent filings in line with the practices of other IP offices,” FICPI wrote. .
FICPI responded directly to some questions posed by the USPTO. This includes some aspects of Question 2 regarding claims support and continuation practices. FICPI upheld parts a, c, and f of Question 2, but made some reservations about the other parts.
A group of intellectual property attorneys objected to part b. This part b “requires applicant to explain or identify the corresponding support for each claim or claim limitation, and in the written description of all previously filed applications, early It is something that gives you the benefit of the filing date of the sought.” According to FICPI, this is “burdensome and generally unnecessary.”
FICPI also disagreed with Part e, which “requires applicants to submit detailed analyzes to support the genus or Markush claims.” In the opinion of the legal group, contrary to TRIPS, it would effectively discriminate against those seeking patents in the small molecule field. ”
FICPI represents approximately 5,000 IP attorneys in 86 countries.
USDA: Comment posted Feb. 27 (received Feb. 24)
The United States Department of Agriculture (USDA) provided a brief commentary outlining the agency’s ongoing collaboration with the USPTO to address competition issues and innovation in the U.S. agricultural industry.
The USDA noted its own request for public comment on 25 multi-part questions covering a wide range of issues, including competition and intellectual property. The agency has submitted public comments to the USPTO on its notice of public comment on “Competition and the Intellectual Property System: Seeds and Other Agricultural Inputs,” which it said contained comments related to the USPTO’s request for comment. bottom.
The agency said it would release a report based on these public comments, writing, “We look forward to sharing this report and would like to hear the USPTO’s ideas regarding other collaboration opportunities.” .
The USPTO recently announced that it will provide US Food and Drug Administration or USDA designation numbers for applicable patents on its public web pages that provide information on patent term extension applications.
