Washington-DC
Home / Policy & Advocacy

Executive Advocacy

AIPLA regularly provides comments to different agencies within the U.S. government, as well as to other domestic organizations, on matters impacting intellectual property laws and protection.

 

Internal Revenue Service
  • AIPLA Testimony on proposed revisions to 26 C.F.R. Parts 1 and 301, delivered February 21, 2008 before the Internal Revenue Service. (PDF)
  • AIPLA Response to the October 2007 rule proposed by the U.S. Internal Revenue Service (IRS) on “Patented Transactions,”submitted December 26, 2007 (3 pages - 37K* - Click PDF to view the Response; click HERE to view the IRS proposed rule (10/22/2007)
National Academy of Sciences
  • ​AIPLA Response to the National Research Council's Report on Reaping The Benefits of Genomic and Proteomic Research (31 pages –197K* Click HEREto view the Response; For information on the Report: Reaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation, and Public Health, please visit The National Academies Press by clicking HERE.)
  • AIPLA Response to the National Academies Report entitled "A Patent System for the 21st Century" (49 pages–243K* Click PDF to view the Response; Click PDF to view the Report.)
National Institutes of Health
  • Comments on Draft Report to the Secretary of Health and Human Services: "Public Consultation Draft Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests" 74(52) Federal Register 11730 (March 19, 2009) ( PDF)
National Institute of Standards and Technology
  • AIPLA Comments to NIST on March-In Rights Guidance, February 5, 2024 (PDF)
  • AIPLA Feedback to NIST Draft Green Paper on ROI Initiative February 8, 2019 (PDF)
  • AIPLA Response NIST Bayh-Dole Regulation, Dec 9, 2016 (PDF​)​
  • AIPLA Comments to the National Institute of Standards and Technology (National Science and Technology Council's Sub-Committee on Standards) on Standardization Feedback for Sub-Committee on Standards, February 18, 2011 (PDF)​
US Customs and Border Protection
  • AIPLA Comments to U.S. Customs and Border Protection on Customs 21st Century Framework, February 2, 2019 (PDF)​​
  • AIPLA Comments to U.S. Customs and Border Protection on Proposed Rulemaking, "Disclosure of Information for Certain Intellectual Property Rights Enforced at the Border," June 25, 2012 (PDF)​​
US International Trade Commission
  • AIPLA Comments on the International Trade Commission’s Investigation of Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), May 3, 2023 (PDF)
  • AIPLA Comments on Proposed Amendments to the Commission's Rules of General Application, Adjudication and Enforcement, November 23, 2015 (PDF)
  • AIPLA Comments on Commission FY2015 Budget and Space for Section 337 Investigations, May 19, 2014 (PDF)
  • AIPLA Comments to U.S. Intellectual Property Enforcement Coordinator in Response to Request for Public Comments:  "Interagency Review of Exclusion Order Enforcement Process," July 19, 2013 (PDF)
  • AIPLA Comments on "Notice of Proposed Rulemaking on Rules of General Application, Adjudication, and Enforcement,” December 4, 2012 (PDF)
  • AIPLA Comments on "Notice of Proposed Rulemaking on Rules of General Application, Adjudication, and Enforcement,” September 17, 2012 (PDF)
  • AIPLA Comments on Proposed Revisions to Rules of Practice and Procedure and Proposed Handbook on Filing Procedures, August 5, 2011 (PDF)
  • AIPLA Comments on proposed revisions to 19 C.F.R. Sections 201 and 210, filed March 19, 2008 at the US International Trade Commission (PDF)
US Securities and Exchange Commission
  • AIPLA Comments to Concept Release on Business and Financial Disclosure Required by Regulation S-K​, August 9, 2016 (PDF)​
US Trade Representative 
  • Letter Submitted to the Office of the US Trade Representative Supporting US Opposition to TRIPS Waiver Proposal, March 30, 2021 (PDF)
  • AIPLA Comments on the Draft Convention on the Recognition and Enforcement of Foreign Judgments Relating to Civil or Commercial Matters, March 19, 2018 (PDF)​
  • AIPLA and PhRMA Comments on Draft Convention on the Recognition and Enforcement of Foreign Judgments Relating to Civil or Commercial Matters​ Currently Being Negotiated at The Hague Conference on Private International Law​, July 19, 2017 (PDF)
  • AIPLA Comments on the proposed Anti-Counterfeiting Trade Agreement ("ACTA" or "Agreement") and the ongoing negotiations between the possible Member States, submitted September 27, 2010. (PDF)
  • AIPLA Comments on the Proposed Amendment and Correction of Trademark Registrations published in the Federal Register on December 18, 2003 (Comments submitted February 2, 2004) (PDF)
  • AIPLA Comments on the "Work Program set forth in the draft Ministerial Declaration submitted by the WTO General Council and WTO Director-General for consideration at the Fourth Session of the Ministerial Conference scheduled for Doha, Qatar next month" (October 11, 2001) (PDF​)
Other

AIPLA Files Comments to Health and Human Services (HHS) on the World Health Organization's (WHO) Proposed Pandemic Treaty

  • AIPLA Comments to HHS on WHO Pandemic Treaty, January 31, 2024 (PDF)

AIPLA Files Comments on Proposed Final Pretrial Conference Pilot and Order

  • AIPLA Files Comments on Proposed Final Pretrial Conference Pilot and Order, August 26, 2022 (PDF)

AIPLA Comments to ACUS on Patent Small Claims Court

  • AIPLA Comments on a Potential Small Claims Patent Court or Small Claims Patent Proceeding and its Impacts, July 5, 2022 (PDF)

Regarding the Position of the USPTO Director

  • AIPLA Comments to the Department of Commerce Regarding the Position of USPTO Director, June 28, 2017 (PDF​)
  • AIPLA White Paper Concerning the Recommended Qualifications for the Next Director and Deputy Director of the U.S. Patent and Trademark Office, November 2013 (PDF)​

​Office of the Presidential Transition

  • AIPLA Letter to Biden Administration, February 26, 2021 (PDF)
  • AIPLA Letter to President-Elect Donald Trump, January 4, 2017 (​​)​

U.S. Intellectual Property Enforcement Coordinator

  • AIPLA Comments to U.S. Intellectual Property Enforcement Coordinator on Development of the Joint Strategic Plan on Intellectual Property Enforcement, December 3, 2018 (PDF)
  • AIPLA Comments to U.S. Intellectual Property Enforcement Coordinator on Development of the Joint Strategic Plan on Intellectual Property Enforcement, October 30, 2015 (PDF)​
  • AIPLA Comments to U.S. Intellectual Property Enforcement Coordinator in Response to Request for Public Comments:  "Interagency Review of Exclusion Order Enforcement Process," July 19, 2013 (PDF)
  • AIPLA Comments to OMB Regarding Negative Impact of Sequestration on USPTO Funding and Operations, May 21, 2013 (PDF)
  • AIPLA Comments to U.S. Intellectual Property Enforcement Coordinator in Response to Request for Public Comments for "Trade Secret Theft Strategy Legislative Review," April 22, 2013 (PDF)
  • AIPLA Comments to U.S. Intellectual Property Enforcement Coordinator on Development of the Joint Strategic Plan on Intellectual Property Enforcement, August 10, 2012 (PDF)​

The Sedona Conference

  • AIPLA Comments on the Sedona Conference Report on the Markman Process, submitted February 2, 2007 (PDF)
  • AIPLA Comments on the Revised April 2005 Public Comment Draft" of The Sedona Guidelines: Best Practices Addressing Protective Orders, Confidentiality & Public Access in Civil Cases (the "Draft Guidelines"). Filed May 14, 2006. (PDF)
  • Letter expressing initial concerns of AIPLA on the Revised April 2005 Public Comment Draft" of The Sedona Guidelines: Best Practices Addressing Protective Orders, Confidentiality & Public Access in Civil Cases (the "Draft Guidelines"). Filed March 10, 2006. (PDF)

Miscellaneous

  • AIPLA Joint Comments to Mayor Eric Garcetti in Support of the Anti-Piracy Unit of the Los Angeles Police Department, March 9, 2018 (PDF)

In This Section

Recent Advocacy

Written June 4, 2026

On June 4, 2026, the Supreme Court issued a unanimous decision in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc.  While the Court reaffirmed existing law on pleading standards, it reversed the Federal Circuit’s decision that had focused on how relevant statements could be understood by medical providers as instructions to infringe. The amicus brief filed by AIPLA on March 27, 2026, advocated for affirmance and cautioned the Court not to change the patent infringement pleading standard or adopt any categorical exemption from inducement for a particular industry. To read the opinion of the Court, please click here.

 

BACKGROUND

Amarin markets icosapent ethyl under the brand name Vascepa®. The FDA approved Vascepa in 2012 for the treatment of severe hypertriglyceridemia (the SH indication) and later approved a second use in 2019 for reducing cardiovascular risk in certain patients with elevated triglyceride levels (the CV indication). Amarin listed patents covering the CV indication in the FDA's Orange Book.

Hikma sought approval to market a generic version of icosapent ethyl through an Abbreviated New Drug Application. After the FDA approved the CV indication, Hikma submitted a Section viii statement and omitted the patented CV use from its labeling, resulting in a so-called "skinny label" that sought approval only for the SH indication. The FDA approved Hikma's application in May 2020.

In November 2020, Amarin sued Hikma for induced infringement, alleging that Hikma's product labeling, press releases, and marketing materials encouraged use of the generic product for the patented CV indication. The district court dismissed the complaint, but the Federal Circuit reversed, holding that Amarin had plausibly alleged induced infringement. The Supreme Court granted certiorari to consider when a generic manufacturer that markets a skinny-label product may nevertheless be liable for induced infringement.


OPINION OF THE COURT

In a unanimous opinion authored by Justice Jackson, the Supreme Court reversed the Federal Circuit and held that Amarin failed to plausibly allege induced infringement under 35 U.S.C. § 271(b). The Court concluded that Hikma's skinny label, website statements, and press releases did not constitute the type of affirmative conduct required to show that a generic manufacturer of a skinny-label product actively encouraged infringement of a patented method of use.

The Court emphasized that the relevant inquiry is not whether physicians could potentially interpret a generic manufacturer's statements as encouraging an infringing use, but whether the manufacturer itself took affirmative steps to promote or encourage infringement. Applying the pleading standards of Twombly and Iqbal, the Court found that Hikma's statements were either required by law, consistent with standard industry practice to describe a generic drug as equivalent to an approved reference drug, or too vague and attenuated to plausibly constitute active steps to bring about infringement. The Court rejected the Federal Circuit's focus on how healthcare providers might understand Hikma's communications, explaining that inducement requires clear affirmative encouragement—whether express or implied—not mere speculation about how third parties might interpret otherwise lawful statements. As a result, the Court held that Amarin's complaint could not survive Hikma's motion to dismiss.