- The Patent Court Further Broadens the Definition of "New Chemical ...🔍
- Determination of Regulatory Review Period for Purposes of Patent ...🔍
- Patent Term Extension🔍
- Distorted Drug Patents🔍
- Patent and Marketing Exclusivities 101 for Drug Developers🔍
- 24|1936 Document🔍
- Patent Law and Its Application to the Pharmaceutical Industry🔍
- Patent|Term Extension and the Pharmaceutical Industry 🔍
Patent Term Extension and the Active Ingredient Problem
The Patent Court Further Broadens the Definition of "New Chemical ...
... patent term extension (PTE) of a patent covering the PEGylated drug. ... The drug Avonex® comprising the active ingredient "interferon beta-1α" had ...
Determination of Regulatory Review Period for Purposes of Patent ...
FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), ...
Patent Term Extension - Orange Book Blog
The patentee relied on earlier decisions that had held that ODP challenges to patents with patent-term extensions (“PTE”)—additional patent term ...
later-filed patent will generally issue later, so less of the clinical period ... patent term extension on their key active ingredient patent, ...
Patent and Marketing Exclusivities 101 for Drug Developers - PMC
... ingredient, and typically only one patent may be extended per new active ingredient. ... 2018. 41a. Clark L., Beadle D. Patent term extensions: Issues ...
In other words, a patent for one active ingredient can claim a product with multiple active ingredients. ... patent term extension (“PTE”) statute ...
Patent Law and Its Application to the Pharmaceutical Industry
agent must file an application with the USPTO requesting term ... At issue is whether or not the patent term extension provisions and market exclusivity.
Patent-Term Extension and the Pharmaceutical Industry (August 1981)
ess is essential for an understanding of the issues surrounding patent-term extension. ... combinations of active ingredients, or new uses for existing drugs. Of ...
*API: Active Pharmaceutical Ingredient. ** FDF: Finished Dosage Form ... • The multiple substance problem: MSD v Sandoz [2022] FCAFC 40 March 22.
The Case Of The Missing Device Patents, Or - Fordham Law
By way of contrast, for drug innovators the critical lifecycle moment is no earlier than expiration of the active ingredient patent, which ...
A Cheat Sheet to Navigate the Complex Maze of Exclusivities in the ...
other market or patent exclusivities covering drugs from the applicant containing the same active ingredient. ... Section 2750: “Patent Term Extension for Delays ...
A More Detailed Overview of China's Patent Term Extension (PTE ...
If the Patent Office thinks that a patent is not eligible for PTE, it will issue a notice and the patentee will have a chance to response. After ...
Patent term extension in China - FICPI
According to the Amended Patent Law, PTE allows extension of the 20-year term of a patent related to a new pharmaceutical product approved for ...
Patent term extensions in Australia and beyond: Part 3
Even if a patent covered the same active ingredient but for a different therapeutic use, this would also not be eligible for a patent term ...
Australian Patent Term Extensions - Pharmaceutical Substance ...
The issue in these cases was whether the products as disclosed and claimed in the patents in question were “pharmaceutical substances” within the meaning of ...
Patent Term Extensions for Pharmaceutical Patents in Singapore
Patent term extensions are granted to patents where the subject of the patent includes “any substance which is an active ingredient of any pharmaceutical ...
Surely You Must be Kidding, PTO?!? “No, and Don't Call Me Shirley!”
... Patent Term Extension (“PTE”) decisions under 35 U.S.C. § 156, as ... patent that claims the product despite revocation of the active ingredient.
The Use of Ultra Long Patent Terms to Incentivize the Development ...
Even if a bacteria is immune to a novel antibiotic, this does not mean a patent term extension has proven useless. That novel antibiotic may ...
Erika Lietzan 49 SETON HALL LAW REVIEW (forthcoming 2018)
... active ingredient patent. The final ... 195 Alfred Engelberg, Patent Term Extension: An Overreaching Solution to a Nonexistent Problem,.
New Ruling on Scope of Protection of Extended Patent Rights in ...
As to the first issue, previously, when the pharmaceutical of a later disposition has the same “active ingredient” and “efficacy/effect” as an earlier ...