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Patent Term Extension and the Active Ingredient Problem


Patent Term Extension and the Active Ingredient Problem

Patent term extension (PTE) is a statutory mechanism to deal with this precise issue: it permits the inventor to recoup at least a portion of ...

Patent Term Extension and the Active Ingredient Problem

Patent term extension (PTE) is a statutorily-based mechanism to compensate inventors for patent term loss due to regulatory delay during the ...

Patent Term Extension Under 35 U.S.C. § 156 Covers an Active ...

In 2018, the alleged infringer submitted an application to market a generic version of its MMF pill, and the patentee instituted an infringement action. The ...

Understanding the Statute on Patent Term Extension

The Drug Price Competition and Patent Term Restoration Act of 1984, better known as the Hatch-Waxman Act, is responsible for allowing patent ...

Frequently Asked Questions on the Patent Term Restoration Program

A product is the active ingredients contained therein for patent term extension purposes. Active ingredient does not equal active moiety ( ...

Pharmaceutical Patent Term Extension: An Overview - Alacrita

Here, the primary issue is whether PTE is available for patents covering products that contain combinations of active ingredients, particularly where one or ...

Patent Term Extension Only Applies to Approved Product - IP UPDATE

In a case relating to a patented method for treating multiple sclerosis, the US Court of Appeals for the Federal Circuit found that patent ...

Patent Term Extensions and the Last Man Standing

The Hatch-Waxman Act allows drug companies to request a single extension to their patent, limited to a particular length. Nevertheless, drug companies continue ...

Patent Term Extension For Biologics | MoFo Life Sciences - JDSupra

After reviewing the PTE application, the USPTO issued a letter to Cabaret, stating that (a) the cells could not be the active ingredient because ...

2750-Patent Term Extension for Delays at other Agencies under 35 ...

The right to a patent term extension based upon premarket regulatory review is the result of the Drug Price Competition and Patent Term Restoration Act of 1984, ...

IP Alert: Calculating Patent Term Extension for FDA Delay

IP Alert: Calculating Patent Term Extension for FDA Delay: Original Patent or Reissue Patent Issue Date? ... active ingredient. Bridion® is used ...

Surely You Must be Kidding, PTO?!? “No, and Don't Call Me Shirley!”

The issue is whether 3 5 U.S.C. § 156 permits a patent owner who owns more than one patent to obtain more than one patent term extension for the ...

Patent term extension (PTE) under 35 USC 156 - AIPLA

ingredients, if any one active ingredient has not been previously approved, it can form the basis for extension, provided the patent claims that ingredient.

Strategic Considerations for Seeking Patent Term Extension (PTE ...

Strategic Considerations for Seeking Patent Term Extension (PTE) and its Scope for Drug Products · Same active ingredient – · Different salt – ...

Fixing PTE to Make Its 'Product' Fit for Biologics * - IPWatchdog.com

View Session Speakers · Patent Term Extension Under 35 USC 156 · Biogen v. Banner: Patent Term Extension Inquiry Centers on 'Active Ingredient', ...

Uncertainty In Patent Term Extension For Biologics | Fish

Congress intended that patent term extension not apply to minor structural variations of an approved active ingredient; thus, 35 U.S.C. § 156(f) ...

Federal Circuit Affirms Patent Term Extension Only Applies to FDA ...

On April 21, 2020, a Federal Circuit court affirmed a lower court decision holding that patent term extension protection applies only to ...

Federal Circuit Holds That Patent Term Extension Under The Hatch ...

In a recent decision, the issue before the Federal Circuit was the meaning of the term “product” in a patent term extension statute. Biogen Int'l GmbH v.

When a 20 year patent term just isn't enough: Patent term extensions

Patent term extension regimes have been implemented in a number of jurisdictions following recognition that the need to obtain regulatory ...

Patents and Exclusivity | FDA

Generally, the term of a new patent is 20 years from the date on which ... patents that claim the active ingredient(s);. • drug product patents ...