News & Analysis as of

Proposed Legislation Pharmaceutical Patents

Fish & Richardson

The PREVAIL Act Is Back. Will It Prevail This Time?

Fish & Richardson on

On May 1, 2025, Senators Chris Coons (D-DE), Thom Tillis (R-NC), Dick Durbin (D-IL), and Mazie Hirono (D-HI) reintroduced the Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. The...more

Morgan Lewis

Blockbuster Biologics Review | Issue 27

Morgan Lewis on

Welcome to the latest issue of Blockbuster Biologics Review, which covers the status and developments of post-grant challenges and patent litigations implicating blockbuster biologics and legislative proposals related to...more

Venable LLP

BiologicsHQ Monthly Injection - March 2025

Venable LLP on

On March 17, 2025, Senators Chuck Grassley (R-IA), John Cornyn (R-TX), Richard Blumenthal (D-CT), and Richard Durbin (D-IL) re-introduced the “Affordable Prescriptions for Patients Act” (“APPA”), which previously passed the...more

Latham & Watkins LLP

How Pharma Should Prep for the Six-bill Avalanche From Congress

Latham & Watkins LLP on

The bipartisan legislative push could create big hurdles for drug development, with concerns mounting over limited patent protections and increased litigation risks, hears Marisa Woutersen. The US pharmaceutical industry...more

McCarter & English, LLP

Senate Advances IP and Drug Pricing Legislation Amid Innovation Concerns

A Senate panel has advanced three sets of bipartisan bills purportedly aimed at reforming the intellectual property (IP) landscape and lowering the cost of prescription drugs. Together, these bills seek to address issues with...more

Venable LLP

Potential Impact of the Affordable Prescriptions for Patients Act Patent Limit on BPCIA Litigations

Venable LLP on

On March 17, 2025, Senators Chuck Grassley (R-IA), John Cornyn (R-TX), Richard Blumenthal (D-CT), and Richard Durbin (D-IL) re-introduced the “Affordable Prescriptions for Patients Act” (“APPA”), which previously passed the...more

Knobbe Martens

Renewed Efforts in Congress for Pharmaceutical Patent Reform

Knobbe Martens on

With the recent convocation of the 119th Congress, a change in administration, and resignation of USPTO Director Vidal, pharmaceutical patent reform is likely on the minds of many in Washington. Prior to this political...more

Knobbe Martens

Senate Seeks to Reduce Biosimilar Prices by “Pruning” “Patent Thickets”

Knobbe Martens on

On July 10, the Senate unanimously passed the Affordable Prescriptions for Patients Act of 2023 (S.150), which seeks to increase competition and lower drug prices by imposing limits on patent litigation related to biological...more

Jones Day

U.S. Senate Unanimously Passes Bill Limiting Number of Patents Asserted Against Biosimilar Applicants

Jones Day on

The Situation: Senate Bill 150 ("S.B. 150")—the Affordable Prescriptions for Patients Act of 2023—unanimously passed the Senate and would amend 35 U.S.C. § 272(e) to limit, under certain circumstances, the number of patents...more

A&O Shearman

Senate Bill Introduced to Examine Bayh-Dole Reporting Requirements

A&O Shearman on

On January 10, 2024, Senators Chris Coons and Thom Tillis introduced a bill titled Improving Efficiency to Increase Competition Act (“IEICA”). The IEICA would require that the Comptroller General provide a report to certain...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Legislative Efforts to Remove Impediments to Biosimilar Approvals and Marketing

Biosimilars are becoming increasingly important in healthcare as they offer a lower-cost alternative to biologic drugs, which can be expensive for patients, governments, and insurers. These biologic medicines, which are...more

Foley & Lardner LLP

Senate Judiciary Committee Pushes Pharma Patents and Pricing Bills Forward

Foley & Lardner LLP on

It is hard to predict whether a given bill will gain traction, but when the Senate Judiciary Committee reports out five bipartisan bills targeting pharmaceutical patents and pricing, it seems likely they are determined to get...more

Goodwin

The USPTO’s Increasing Focus on FDA Submissions and the Duty of Disclosure

Goodwin on

​​​​​​​The United States Patent and Trademark Office (USPTO) imposes a Duty of Disclosure, Candor and Good Faith (Duty of Disclosure) on all individuals associated with the filing and prosecution of a patent application...more

Jones Day

Vital Signs: Digital Health Law Update Winter 2022

Jones Day on

Note From the Editors With 2022 well underway, the rapid pace of statutory, regulatory, policy, and industry activities in digital health continues in force. We bring you Vital Signs, a curated, one-stop resource on the most...more

Goodwin

Year in Review: Top Legal Developments of 2021 Impacting Biosimilars

Goodwin on

As we close out another calendar year, we look back at the top legal developments of 2021 that could influence the market for biologics and biosimilars. There were many interesting decisions and other developments in district...more

Goodwin

Senate Judiciary Committee’s Antitrust Panel Discusses and Advances Proposed Generics and Biosimilars Bill

Goodwin on

On July 13, 2021, the Senate Judiciary Committee’s antitrust panel met to discuss biologic and biosimilar competition and its impact on drug prices. A group of senators, led by Senator Amy Klobuchar, are sponsors of a Senate...more

Zuckerman Spaeder LLP

Senate Tweaks Hatch-Waxman with Bill To Codify FDA’s “Active Moiety” Regulation

Zuckerman Spaeder LLP on

To clarify a long-running, hotly-litigated question regarding when a new drug qualifies for exclusive marketing rights intended to reward innovation, Congress has taken an important step toward amending the Federal Food,...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

MarkIt to Market® - March 2021

The March 2021 issue of Sterne Kessler's MarkIt to Market® newsletter discusses fair use cases for photographs and three recent developments in the cannabis space. We also highlight recent accolades earned by Sterne Kessler's...more

MoFo Life Sciences

Bill Proposes 10 Additional Years for COVID-19 Inventions

MoFo Life Sciences on

A proposed bill offers a potential boon to patent owners. If passed, the “Facilitating Innovation to Fight Coronavirus Act” will add ten years to the patent term of eligible inventions. However, the bill will temporarily...more

Knobbe Martens

“Term Act of 2019” Proposes Shifting Patent Challenge Burdens to Branded Companies

Knobbe Martens on

A new bill introduced in Congress last week may limit the ability of branded pharmaceutical companies to extend the period of exclusivity products beyond the term of a single patent. The bill, titled “Terminating the...more

Goodwin

The Biologic Patent Transparency Act: Proposed Revisions to Purple Book

Goodwin on

Earlier this month, a bipartisan group of six senators introduced the Biologic Patent Transparency Act (“BPTA”), which the senators say will “help increase patent transparency, promote biosimilar competition, bring needed...more

Polsinelli

Update on Pending Legislation: Three New Bills Have the Potential to Affect Generic Pharmaceutical Companies

Polsinelli on

In the first month of the 116th Congress, three bills have been introduced (or re-introduced) that have potential to impact generic pharmaceutical companies. ...more

Knobbe Martens

Proposed Legislation: The Hatch-Waxman Integrity Act

Knobbe Martens on

Senator Orrin Hatch (R-UT) recently introduced a bill titled the “Hatch-Waxman Integrity Act of 2018” (HWIA). Sen. Hatch suggests that the HWIA will (i) “restore the careful balance the Hatch-Waxman Act struck to incentivize...more

Fish & Richardson

Senator Hatch: Choose IPR or an Abbreviated Regulatory Pathway, But Not Both

Fish & Richardson on

Last week, Senator Orrin Hatch of Utah introduced the “Hatch-Waxman Integrity Act of 2018,” which seeks “to restore the careful balance the Hatch-Waxman Act struck to incentivize generic drug development.” ...more

Foley & Lardner LLP

Proposed Legislation Would Require Choice Between ANDA Litigation Or AIA Challenges

Foley & Lardner LLP on

On June 13, 2018, Sen. Hatch (R-Utah) introduced an amendment that would require generic ANDA filers to choose between litigating validity in Hatch-Waxman district court litigation or an AIA challenge (IPR or PGR), and on...more

30 Results
 / 
View per page
Page: of 2

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide