The Final Word: Who Weighed in After the Second Extension of USPTO’s Robust and Reliable Patents RFC

“The proposed initiatives will have, at best, zero measurable positive impact on the strength of U.S. patent rights.” – Comment of Stephen Susalka, AUTM

commentIn early March, the U.S. Patent and Trademark Office (USPTO) published the final batch of comments for its “Request for Comments on USPTO Initiatives to Ensure the Robustness and Reliability of Patent Rights.” In total, the USPTO received 227 comments, after extending the deadlines for submissions twice.

There were some concerns that the repeated extensions of the submission deadline created uncertainty. When IPWatchdog reached out to the USPTO, the organization had no official comment other than to note that a number of stakeholders had asked for more time to finalize and submit comments, and the Office wanted to hear from as many parties as possible.

Since IPWatchdog provided its last update on February 16, the USPTO has posted 96 comments. Here are a few of the most recent comments posted, perhaps most notably including the Department of Justice’s submission.

See reports on previous submissions here and here.

Department of Justice: Comment Posted Mar. 2 (Received Feb. 28)

The Antitrust Division of the Department of Justice (DOJ) generally supported the USPTO’s efforts in its comment. The Antitrust Division specifically mentioned its support of the USPTO revisiting patent prosecution procedures, including continuation practice and obviousness-type double patenting. The division clarified that it deferred to the USPTO on specific changes, but it repeated other commenters’ concerns about patent thickets, evergreening, and product hopping.

The Antitrust Division dedicated a significant portion of its comment to generic drugs. “Anticompetitive strategies that suppress or exclude competition from generic drugs deprive people of life-changing and even life-saving medicines,” wrote the division.

And while the Division acknowledged there are some legitimate reasons for continuation practice, it argued for reform in this area as well. “The strategic use of continuation applications can impede competition by expanding the scope of patent claims and capturing developments already in the marketplace; improvements to the practice could alleviate this concern,” commented the DOJ division.

The comment also cited Kaiser Permanente’s Feb.1 comment to the USPTO that discussed Humira’s evergreening strategy, which netted the pharmaceutical company $100 billion in additional sales while it kept generic competitors off the market. The Antitrust Division also mentioned product hopping, a practice where drug manufacturers submit an application to the FDA for a new product that is essentially the exact same as its original product.

Overall, the Antitrust Division made the case in its comment for the USPTO to continue working toward “alleviating unnecessary barriers” for generic entry and competition in the pharmaceutical and other industries. In addition, the DOJ division said that it supports the USPTO’s efforts to improve the examination process by providing additional resources and access to information.

The Pharmaceutical Research and Manufacturers of America (PhRMA): Comment Posted Mar. 2 (Received Feb. 28)

The Pharmaceutical Research and Manufacturers of America (PhRMA) followed up its comment in early February with supplemental comments responding to other submissions. PhRMA took issue with comments submitted by Professor Bernard Chao, Fresenius Kabi, and mAbxience.

According to PhRMA, the commentors “do not provide evidence for their assertions about costs to challenge” the “high number of reference product patents” that they say “correlates with delayed biosimilar launch.” Furthermore, PhRMA argued, “it is common and beneficial to invest in continuous improvements to a biopharmaceutical product, which provide significant benefits to patients those patents.

PhRMA also defended pharmaceutical companies from criticism brought by other submissions. The submission said that the three commentors mentioned “unduly focus on the number of patents in different jurisdictions and reach unsupported conclusions regarding how the number of patents relates to the timing of biosimilar entry.”

Additionally, PhRMA repeated its intent to contribute to a dialogue with the USPTO on how to bolster the robustness and reliability of patents.

Association of University Technology Managers (AUTM): Comment Posted Mar. 2 (Received Feb. 28)

The CEO of AUTM, Stephen J. Susalka, submitted a comment on behalf of his organization arguing that branded pharmaceutical products increase the number of generic products on offer. However, Susalka wrote, “the proposed initiatives will, on the whole, have the opposite effect,” and create a disincentive for the discovery and development of new branded drugs.

While AUTM agreed with several of the USPTO’s commitments, including increasing the robustness of patents and providing more examination time, the organization remained skeptical. “The proposed initiatives will have, at best, zero measurable positive impact on the strength of U.S. patent rights,” wrote Susalka.

Instead, AUTM advocated the removal or reform of the IPR procedure in order to improve the reliability and robustness of patents. Susalka also commented that uncertainty around subject matter eligibility harms universities and nonprofits.

International Federation of Intellectual Property Attorneys (FICPI): Comment Posted Mar. 2 (Received Feb. 28)

The International Federation of Intellectual Property Attorneys (FICPI) argued that some of the proposals would add cost to patent application prosecution. “However, some of the proposals appear to be proportionate and would help make patent prosecution in the US in line with practices in other IP Offices,” wrote FICPI.

FICPI responded directly to several of the questions proposed by the USPTO, including several aspects of question two about claim support and continuation practice. FICPI supported the a, c, and f portions of question two, but it had some reservations about other parts.

The group of IP attorneys took issue with part b which would “require applicants to explain or identify the corresponding support for each claim, or claim limitation, in the written description of every prior-filed application for which the benefit of an earlier filing date is sought.” According to FICPI, this would be “burdensome and generally unnecessary.”

FICPI also disagreed with part e, which would require “applicants to provide detailed analysis showing support for genus or Markush claims.” In the opinion of the attorney group, it would effectively discriminate against those seeking patents in the small molecule field, contrary to TRIPS.”

FICPI represents around 5,000 IP attorneys from 86 countries.

U.S. Department of Agriculture: Comment Posted Feb. 27 (Received Feb. 24)

The U.S. Department of Agriculture (USDA) provided a short comment outlining the agency’s continued collaboration with the USPTO to address competition issues and innovation in the U.S. agricultural industry.

The USDA mentioned its own request for public comments about its 25 multi-part questions that dealt with a wide range of issues including competition and intellectual property. The agency pointed the USPTO to the public comments for the notice for public comments on the “Competition and the Intellectual Property System: Seeds and Other Agricultural Inputs” which the agency said contained comments relevant to the USPTO’s request for comments.

The agency said it will release a report based on these public comments, and wrote, “we look forward to sharing this report and are eager to hear USPTO’s ideas for other opportunities for collaboration.”

The USPTO recently announced that it will be providing U.S. Food and Drug Administration or U.S. Department of Agriculture designated numbers for applicable patents listed on the public webpage that provides information on patent term extension applications.


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Join the Discussion

3 comments so far.

  • [Avatar for David Lewis]
    David Lewis
    March 23, 2023 01:07 pm

    It is funny how the anti-trust division of the DOJ makes comments in support of the efficient infringement policies of many of the behemoth-sized companies, that the antitrust laws, at least at the time of their inception, were likely designed to break up.

  • [Avatar for mike]
    March 23, 2023 01:06 am

    Fortunately the DOJ has only “one word” and not the final word. The comment from the DOJ Antitrust Division shows that they are way out of touch.

    1. The DOJ Antitrust Division forgot that patents for inventors and startups create the perfect anti-monopoly, and provide the very solution the Antitrust Division seeks. If the DOJ wants true competition, then inventors need to receive more patents, not less, and thus continuation applications are essential for inventors. Paul Morinville has written an excellent article regarding patents and their innate anti-monopoly characteristic, and the DOJ Antitrust Division would be fools not to abide by this.

    2. The Antitrust Division’s “notorious example” of Lemelson using continuation applications strategically is not even applicable anymore, as submarine patents are no longer possible. They only mention this to persuade the Office to take action that would benefit large companies and would ultimate would hurt inventors and startups.

    So with this, the DOJ’s entire comment is biased and flawed. My question is, who bought them this time? Given when they filed their comment, apparently this RFC wasn’t important to them until the deadline was extended … and probably after a phone call was made for them to get their comment in an effort to drown out the voice of inventors.

    Hopefully the Office will be wise and prioritize that it is the Inventors who the Constitution identifies in Art 1, Sec 8, Cl 8. I like what Jeff Hardin suggests in his comment. He reminds the Office that the voice of the Inventor is paramount and should be singled out as the signal from the noise:

    We encourage the Office to remember that the inventor is the source of innovation, and, for each comment received pursuant to this Request for Comments, to consider whether the comment is being provided by an inventor or is being provided by an entity preaching what amounts to Orwellian doublespeak. Respecting the voice of the inventor is paramount, as John M. Whealan, Intellectual Property Advisory Board Associate Dean for Intellectual Property Law Studies at George Washington Law School, reminds us of the unexpected consequences of the AIA: “A critical voice seems to have been missing from the discussion: that of patent owners—the innovators who invested thousands of dollars and months of effort in obtaining patents from the USPTO only to be later told by the same USPTO that their patents are worthless.” Whealan strongly recommended that the government consider the patentee’s perspective, emphasizing that “without the innovators, the inventors, and the patentees, none of us would be doing what we are today.” Thus, the voice of the inventor in this Request for Comments should be of utmost importance.

  • [Avatar for Pro Say]
    Pro Say
    March 22, 2023 08:45 pm

    DOI: Department of Injustice

    There. Fixed.

    Department leadership: How many of you, your employees, and members of yours and their families have been saved by patented — including with continuation patents — medicines over the past 25+ years?

    Same question for Patent Office leadership.

    Same question for each and every company and organization in support of any such changes.

    Same question for each and every politician in support of any such changes . . . and including for all your untold numbers of life-saved constituents.

    And to all of you: How many millions of Americans will die in the years to come because you supported / made changes to our already-crippled patent system?

    Their blood will be on your hands.

    Your hands.

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