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PTO Asks Whether Legislative Action for Experimental Use Exception Is Warranted

The US Patent & Trademark Office (PTO) issued a request for comments concerning the public’s views on the common law experimental use exception and whether Congress should enact a statutory experimental use exception. 89 Fed. Reg. 53963 (June 28, 2024).

The experimental use defense for alleged patent infringement has been part of US jurisprudence for more than 200 years. The current state of experimental use exception jurisprudence in the United States is set forth in Madey v. Duke University, 307 F.3d 1351 (Fed. Cir. 2002). In that case, the Federal Circuit proffered a “very narrow and strictly limited experimental use defense” prohibiting an alleged infringer from invoking such a defense for “use that is in any way commercial in nature” or “any conduct that is in keeping with the alleged infringer’s legitimate business, regardless of commercial implications.”

The Madey decision has been met with a mix of opinions, some arguing that the Federal Circuit’s construction encourages innovation and others arguing that it impedes innovation. Limited exemptions have been carved out in the US. For example, 35 U.S.C. § 271(e)(1) established a safe harbor (the Bolar exemption) allowing for the experimental use of a patented invention by parties to collect regulatory approval data for medical devices or drugs. The Plant Variety Protection Act also provides for exemptions allowing the use of protected plant varieties for research and breeding of new varieties.

While many European and Asian nations have statutory experimental use exceptions in place, legislative efforts for codifying a statutory experimental use exception in the US have thus far failed. With the intent to promote fair competition and innovation, the PTO seeks to revisit this issue by collecting the public’s views on the impact of the experimental use exception in all technology areas. Of particular interest, the PTO seeks comments on one or more topics, including:

  • How current US experimental use exception jurisprudence impacts investment and/or research and development in any field of technology.
  • Whether certain technologies are negatively affected by the current experimental use exception jurisprudence.
  • The impact that a statutory experimental use exception would have on the innovation and commercialization of new technologies with respect to research and development, ability to obtain funding, investment strategy, licensing of patents and patent applications, product development, sales (including downstream and upstream sales), competition, and patent enforcement and litigation.
  • The impact of current experimental use exception jurisprudence on decisions made with respect to filing, purchasing, licensing, selling or maintaining patent applications and patents in the US.
  • Reasons for adopting a statutory experimental use exception or maintaining the status quo.
  • How a statutory experimental use exception should be defined to ensure that patent rights are preserved.
  • Recommendations for enhancing and facilitating experimental research on patent inventions in the US.

When responding to the questions, commenters are further asked to identify whether they represent, for example:

  • An inventor, patent owner or investor.
  • A licensee or user of patented technology.
  • An entity representing inventors or patent owners (g., law firms).
  • A recipient of [...]

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International Trade Commission Seeks Feedback on Proposed Updates to Practice and Procedure

The US International Trade Commission issued a Federal Register notice of proposed rulemaking related to 19 C.F.R. Parts 201, 205, 207 and 210, which govern the Commission’s Rules of Practice and Procedure. The Commission seeks feedback by May 20, 2024. Proposed Rules, 89 Fed. Reg. 61, 22012-39 (Mar. 28, 2024).

The notice specifies that the “amendments are necessary to make certain technical corrections, to clarify certain provisions, to harmonize different parts of the Commission’s rules, and to address concerns that have arisen in Commission practice.” The proposed amendments are intended to “facilitate compliance with the Commission’s Rules and improve the administration of agency proceedings.”

Proposed global updates to the rules include the replacement of gender-specific language with gender-neutral terminology. The Commission’s proposals also include permanent adoption of the rules related to filing electronic (in lieu of paper) copies of documents, which were put in place as a temporary measure during the COVID-19 pandemic.

In addition to the global measures, the Commission proposes specific changes to the procedures associated with commencement of investigations and the discovery process during an investigation. With respect to commencement of investigations, the Commission proposes the following changes:

  • Amending 210.8(c) to allow members of the public, interested government agencies or proposed respondents to file comments that address not only the public interest but also other issues in response to a complaint filed with the Commission
  • Amending 210.12(a)(8)(i) to require alleging specific facts that show the existence of each element of the cause of action underlying complaints based on an unfair act or method of competition under § 337(a)(1)(A)
  • Adding a new mechanism to 210.14(g) that allows the Chief Administrative Llaw Judge to consolidate investigations that are before different administrative law judges

The notice also proposes updates to the discovery process that are largely designed to conform the Commission’s rules to those found in the Federal Rules of Civil Procedure. Such changes include:

  • Aligning the scope of discovery found in 210.27 with that of Fed. R. Civ. Pro. 26. In particular, the proposed changes include deleting the reference to information that “appears reasonably calculated to lead to the discovery of admissible evidence” and inserting language emphasizing that discovery must be proportional to the needs of the investigation.
  • Updating 210.28, which governs the procedures and limits associated with depositions. Proposed updates include adding language that clarifies that third-party depositions count toward a party group’s overall deposition limit, changing the number of depositions a complainant may take from five fact depositions per respondent to 20 total fact depositions, and limiting deposition time to one day of seven hours per witness (which may be altered upon agreement of the parties or order of the presiding administrative law judge).
  • Adding a clarification to 210.30, which governs the production of documents, to conform with Fed. R. Civ. Pro. 34 by requiring that if a party is withholding documents based on an objection, it must affirmatively state that it is doing so.
  • Codifying 210.32 to provide that the administrative law judge, [...]

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Copyright Office Seeks Comments on Artificial Intelligence

The US Copyright Office (CO) issued a notice, seeking comments on copyright law and policy issues raised by artificial intelligence (AI) systems. Artificial Intelligence and Copyright, 88 Fed. Reg. 59942 (Aug. 30, 2023).

The purpose of the notice is to collect factual information and views relevant to the copyright law and policy issues raised by recent advances in generative AI. The CO intends to use this information to advise Congress by providing analyses on the current state of the law, identifying unresolved issues and evaluating potential areas for congressional action. The CO will also use this information to inform its regulatory work and to offer resources to the public, courts and other government entities considering these issues. The questions presented in the notice are grouped into the following categories:

  • General high-level questions
  • AI training, including questions of transparency and accountability
  • Generative AI outputs, including questions of copyrightability, infringement and labeling or identification of such outputs
  • Other issues related to copyrights.

The specific questions can be found in the notice. Given the importance of using shared language when discussing AI, a glossary of terms is also provided, on which commentators can provide feedback. The CO indicated that it does not expect every party choosing to respond to the notice to address every question raised. Instead, the questions are designed to gather views from a broad range of stakeholders.

Written comments are due no later than 11:59 pm (EDT) on October 18, 2023. Written reply comments are due no later than 11:59 pm (EST) on November 15, 2023.




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PTO Seeks Comments on Strategies to Address Counterfeiting and Piracy

On May 25, 2023, the US Patent & Trademark Office (PTO) requested comments on strategies to address counterfeiting and piracy. The PTO requested information on current anti-counterfeiting and anti-piracy strategies that have proven effective, as well as ideas for future strategies.

The PTO requested comments on the 14 points listed below. Respondents may address any, all or none of these points. The PTO will receive any input relevant to future strategies in the fight to prevent counterfeited and pirated goods from entering the stream of commerce and reaching the hands of consumers.

1. Current anti-counterfeiting and anti-piracy strategies, and any trends in how often such practices guide plans for addressing these issues in the future.

2. The types of harms observed from sales of counterfeited and pirated goods.

3. How to educate consumers about the harms and dangers that may result from the use and sale of counterfeited or pirated products.

4. Current anti-counterfeiting and anti-piracy strategies that have proven successful, and those that have not. Information relating to targets of anti-counterfeiting and anti-piracy efforts, such as ecommerce platforms, physical markets and social media.

5. Anticipated challenges in the fight to prevent counterfeited and pirated goods from entering the stream of commerce and reaching the hands of consumers, and how to address those challenges.

6. Observed patterns and trends in counterfeiting and piracy during the COVID-19 pandemic. An indication of whether the commenter anticipates that such patterns and trends will continue post-pandemic.

7. Patterns and trends observed in counterfeiting and piracy due to shifts in the economy. An indication of whether the commenter anticipates that such patterns and trends will continue and if so, an explanation regarding the expected impact on current and future strategic plans to combat counterfeiting and piracy.

8. The commenter’s thoughts on whether any strategic plans to combat counterfeiting and piracy might include collaboration with private or public parties. If a strategic plan is not collaborative, why not? If collaborative, a discussion of the anti-counterfeiting and anti-piracy strategies employed in the collaboration.

9. New collaborative efforts contemplated to combat counterfeiting and piracy and factors that will affect implementation decisions. Discussion of how future collaborations might be composed.

10. Effective technologies to prevent counterfeited and pirated goods from entering the stream of commerce and reaching the hands of consumers, such as counterfeit product identification devices or advanced algorithms to secure supply chains and provide the identity of counterfeit goods online. A discussion of how anticipated strategies will improve an overall anti-counterfeiting and anti-piracy strategy.

11. How online enforcement activities intersect with trademark and copyright laws or procedures. Do online enforcement strategies include employing existing trademark laws to combat online counterfeiting? Do online enforcement strategies use existing copyright laws to combat online piracy? If so, describe these activities and suggestions for maximizing these practices.

12. Description of any fraudulent documentation or materials observed in the furtherance of online counterfeiting and piracy activity. For example, comment on whether, after reporting an infringement to a platform, a counter-notification was attached [...]

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PTO to Host Listening Session on Role of AI in Innovation

As previously reported, the US Patent & Trademark Office (PTO) published a Request for Comments Regarding Artificial Intelligence and Inventorship, seeking input from stakeholders on inventorship issues that may arise as artificial intelligence (AI) and emerging technologies play a greater role in the innovation process. In the wake of the request, the PTO published a Notice announcing that it is hosting a listening session to address the “current state of AI technologies and inventorship issues,” including whether AI should qualify as an inventor and whether the PTO should expand its current guidance.

The listening session will be held at the PTO’s headquarters in Alexandria, Virginia, on April 25, 2023, from 10:30 am to 2:45 pm EDT. Anyone seeking to speak at the listening session must register by 5:00 pm EDT on April 20, 2023. Anyone seeking to attend, either virtually or in person, but not speak at the event must register by April 24, 2023.

Registration information is available here.




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PTO Seeks Comments on Role of Artificial Intelligence in Inventorship

The US Patent & Trademark Office (PTO) published a Request for Comments Regarding Artificial Intelligence and Inventorship seeking input from stakeholders on inventorship issues that may arise as artificial intelligence (AI) and emerging technologies play a greater role in the innovation process. The deadline to submit comments is May 15, 2023.

As background, the PTO held its inaugural AI and Emerging Technologies Partnership meeting, during which panelists discussed AI’s increasing role in innovation, in June 2022. Although there appeared to be consensus that AI cannot “conceive” of inventions, some panelists contended that AI is merely a tool like any other tool used in the inventive process, while others pointed to situations in which AI systems can output patentable inventions or contribute at the level of a joint inventor. While the PTO has been exploring the contours of inventorship law with respect to AI-generated inventions, in August 2022, the US Court of Appeals for the Federal Circuit issued its decision in Thaler v. Vidal, finding that inventorship is limited to natural persons. The Court explained, however, that it was not confronted with “the question of whether inventions made by human beings with the assistance of AI are eligible for patent protection.”

Recognizing the uncertainty surrounding the role of AI inventorship in the wake of the Thaler decision, the PTO seeks public comment on several questions, including the following:

1. How is AI, including machine learning, currently being used in the invention creation process?

2. How does the use of an AI system in the invention creation process differ from the use of other technical tools?

3. If an AI system contributes to an invention at the same level as a human who would be considered a joint inventor, is the invention patentable under current patent laws?

4. Do inventions in which an AI system contributed at the same level as a joint inventor raise any significant ownership issues?

5. Is there a need for the PTO to expand its current guidance on inventorship to address situations in which AI significantly contributes to an invention? How should the significance of a contribution be assessed?

6. Should the PTO require applicants to provide an explanation of contributions AI systems made to inventions claimed in patent applications? If so, how should that be implemented, and what level of contributions should be disclosed? Should contributions to inventions made by AI systems be treated differently from contributions made by other (e., non-AI) computer systems?

7. What additional steps, if any, should the PTO take to further incentivize AI-enabled innovation (e.g., innovation in which machine learning or other computational techniques play a significant role in the invention creation process)?

8. What statutory changes, if any, should be considered as to US inventorship law, and what consequences do you foresee for those statutory changes?




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Calling All US IP Owners: Submit Your Comments on IP-Lax States

The Office of the US Trade Representative (USTR) seeks public commentary regarding countries that deny adequate and effective protection of intellectual property rights, or deny fair and equitable market access to US persons that rely on intellectual property protections. Comments are due by January 30, 2023.

Each year the USTR requests that intellectual property owners, stakeholders and other interested parties submit commentary regarding countries that weaken protections and benefits associated with intellectual property ownership and registration in the United States. The USTR interprets the feedback and compiles an annual report.

The USTR’s authority for such action arises out of Sections 301-305 of the Trade Act (19 U.S.C. §§ 2411-2415). These “Special 301 Provisions” require the USTR to determine which, if any, of the countries submitted by commenters should be identified as Priority Foreign Countries. In furtherance of this goal, the USTR maintains a Priority Watch List and a Watch List. The Special 301 listings and actions announced in the annual report are the result of intensive deliberations among all relevant agencies within the US government, which in turn are informed by extensive consultations with participating stakeholders, foreign governments, the US Congress and other interested parties.

The 2022 report identified a wide range of concerns, including the following:

  • Challenges with border and criminal enforcement against counterfeits, including in the online environment
  • High levels of online and broadcast piracy, including through illicit streaming devices
  • Inadequacies in trade secret protection and enforcement in China, Russia and other countries
  • Troubling “indigenous innovation” and forced technology transfer policies that may unfairly disadvantage US right holders in markets abroad
  • Other ongoing, systemic issues regarding intellectual property protection and enforcement, as well as market access, with many trading partners around the world.

The 2022 report listed the following countries on the Priority Watch List: Argentina, Chile, China, India, Indonesia, Russia and Venezuela. The report listed the following countries on the Watch List: Algeria, Barbados, Bolivia, Brazil, Canada, Colombia, Dominican Republic, Ecuador, Egypt, Guatemala, Mexico, Pakistan, Paraguay, Peru, Thailand, Trinidad and Tobago, Turkey, Turkmenistan, Uzbekistan and Vietnam.

The USTR is soliciting comments for this year’s report via the online Federal eRulemaking Portal in lieu of an in-person hearing.  Commenters are encouraged to include detailed information, including the following:

  • Specific references to laws, regulations and policy statements, including innovation policies; executive, presidential or other orders; and administrative, court or other determinations that should factor into the review
  • Particular regions, provinces, states or other subdivisions of a country in which an act, policy or practice is believed to warrant special attention
  • Data, loss estimates and other information regarding the economic impact on the United States, US industry and US workforce caused by the denial of adequate and effective intellectual property protection.

Commentators should act now, as the window to submit public commentary ends on January 30, 2023. Keep an eye out for the 2023 report, which is scheduled for release on or around April 18, 2023.




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PTO Extends Deadline for Comments on Initiatives to Ensure Patent Robustness, Reliability

On November 3, 2022, the US Patent & Trademark Office (PTO) announced that it is extending the deadline for public input on its proposed initiatives aimed at ensuring the robustness and reliability of patent rights from January 3, 2023, to February 1, 2023.

For further details about the extension of the deadline, check out the notice here.




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PTO Requests Comments on Initiatives to Expand Board Opportunities, Registration to Practice Criteria

In a pair of notices, the US Patent & Trademark Office (PTO) announced on October 18, 2022, that it is seeking public input on proposed initiatives directed at expanding opportunities to appear before the Patent Trial & Appeal Board, (Board) and expanding admission criteria for registration to practice in patent cases before the PTO. PTO Director Kathi Vidal explained that “[t]hese proposals are part of our broader initiatives to improve quality and participation.”

Regarding the expansion of opportunities to appear before the Board, the PTO requested comments on the following six questions:

  1. Are there any changes to Board rules or procedures that the PTO or the Board should make to increase opportunities to appear and/or serve as counsel and/or the lead counsel in America Invents Act (AIA) proceedings?
    1. If “yes” to question 1 as to the lead counsel, should the rules require that a non-registered practitioner have prior experience in AIA proceedings and/or have completed training before being designated as the lead counsel? What level of experience and/or type of training should be required?
  2. Should any rule or procedure revised by the PTO that permits a non-registered practitioner to be designated as the lead counsel in an AIA proceeding also require that any such non-registered practitioner be accompanied by a registered practitioner as backup counsel? If not, are there any circumstances or events that might occur during an AIA proceeding (g., the contemplated or actual filing of a motion to amend) that might warrant requiring a registered practitioner to then appear as backup counsel?
  3. Would a rule requiring that the lead counsel or backup counsel in an AIA proceeding be a registered practitioner have a significant impact on the cost of such a proceeding? If so, what would the impact be and would the impact be justified?
  4. Should any of the changes discussed above, if adopted, be implemented as a pilot program?
  5. Are there additional training and/or development programs the PTO should offer to increase opportunities for less experienced practitioners to appear as counsel and/or serve as the lead counsel in AIA proceedings?
  6. Are there any changes to the Legal Experience and Advancement Program (LEAP) that the PTO should make to increase opportunities to appear and/or serve as the lead counsel in AIA proceedings?

Regarding expanding the admission requirements to practice in patent matters before the PTO, comments on the following five topics were requested:

  1. The General Requirements Bulletin (GRB) lists three categories of scientific and technical qualifications typically used for eligibility for admission to the registration examination: (1) Category A, for specified bachelor’s, master’s and PhD degrees; (2) Category B, for other bachelor’s, master’s and PhD degrees with technical and scientific training; and (3) Category C, for individuals who rely on practical engineering or scientific experience and have passed the Fundamentals of Engineering test. The PTO is seeking comments as to acceptable degrees and whether it should add Category B degrees on a predetermined timeframe (g., every three years).
  2. Should the PTO accept [...]

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PTO Requests Comments on Initiatives to Ensure Patent Robustness, Reliability

The US Patent & Trademark Office (PTO) is seeking public input and guidance on proposed initiatives directed at bolstering the robustness and reliability of patents. The request for comments was spurred in part by US President Joe Biden’s July 9, 2021, executive order on Promoting Competition in the American Economy, and a June 8, 2022, letter from Senators Leahy, Blumenthal, Klobuchar, Cornyn, Collins and Braun raising concerns about patent thickets.

The PTO identified four broad topics and initiatives that it is considering:

  • Prior Art Searching
  • Support for Patent Claims
  • Request for Continued Examination (RCE) Practice
  • Restriction, Divisional, Rejoinder and Non-Statutory Double Patenting Practice.

The PTO seeks comments on 11 main questions and several sub-questions. The first five questions are directed to the PTO initiatives while questions six through 11 address concerns raised by the senators.

PTO Initiatives

  1. How should the PTO facilitate an applicant’s submission of prior art that is not accessible in the Patents End-to-End Search system (e.g., “on sale” or prior public use)?
  1. How, if at all, should the PTO change claim support requirements and/or continuation practice?
  1. How, if at all, should the PTO change RCE practice?
  1. How, if at all, should the PTO limit or change restriction, divisional, rejoinder and/or non-statutory double patenting practice?
  1. Provide any other input on any of the proposals listed under the PTO initiatives.

Senator Inquiries

  1. How would eliminating terminal disclaimers, thus prohibiting patents that are obvious variants of one another, affect patent prosecution strategies and overall patent quality?
  1. Should patents that are tied together by a terminal disclaimer because of an obviousness-type double patenting rejection stand or fall together if their validity is subsequently challenged?
  1. Should the PTO require a second look by a team of patent quality specialists before issuing a continuation patent on a first office action?
  1. Should there be heightened examination requirements for continuation patents?
  1. Should the PTO implement a rule change that requires any continuation application to be filed within a set timeframe of the ultimate parent application?
  1. If filing fees were increased to cover the actual cost of obtaining a patent, would this increase patent quality? And if the fees for continuation applications were increased, would applicants be less likely to file continuations for obvious variants?

Among the proposals under consideration are whether to require applicants to identify corresponding support in the original disclosure for each claim in a continuation application, whether applications should be reassigned to a different examiner after a set number of RCEs are filed, whether the PTO should adopt the unity of invention standard, and whether divisionals should be filed within a set time period.

Click here for further details on the PTO initiatives.

Comments must be received by January 3, 2023, to ensure consideration.




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