Details for Patent: 10,039,718

Which drugs does patent 10,039,718 protect, and when does it expire?

Patent 10,039,718 protects EVOTAZ, PREZCOBIX, SYMTUZA, GENVOYA, STRIBILD, and TYBOST, and is included in six NDAs.

Protection for GENVOYA has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has ninety patent family members in thirty-three countries.

Summary for Patent: 10,039,718

Title:	Use of solid carrier particles to improve the processability of a pharmaceutical agent
Abstract:	The invention provides a composition comprising, a compound of formula (I): ##STR00001## or a pharmaceutically acceptable salt thereof and a plurality of solid carrier particles, as well as methods for using the composition to inhibit the activity of cytochrome P-450.
Inventor(s):	Koziara; Joanna M. (Foster City, CA), Menning; Mark M. (Foster City, CA), Strickley; Robert G. (Foster City, CA), Yu; Richard (Foster City, CA), Kearney; Brian P. (Foster City, CA), Mathias; Anita A. (Foster City, CA)
Assignee:	Gilead Sciences, Inc. (Foster City, CA)
Application Number:	12/434,513
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,039,718
Patent Claim Types: see list of patent claims	Use; Composition; Compound;
Scope and claims summary:	Patent Analysis: US Patent 10,039,718 US Patent 10,039,718, titled "Soluble recombinant constructs for treatment of various diseases", was granted to Biogen Inc. (assignee) on July 16, 2018. This patent claims to provide novel approaches for the treatment of various diseases by introducing recombinant constructs that improve protein stability and therapeutic efficacy. Scope of the Patent The patent claims encompass a range of recombinant constructs, including GRO proteins (Growth-Regulated Oncogene proteins), sIL-1ra (soluble Interleukin-1 receptor antagonist), and several other biologics. These constructs are designed to serve as therapeutic agents for various diseases, including inflammation, cancer, and neurodegenerative disorders. Key Innovations This patent builds upon existing technologies by introducing several innovations aimed at improving protein stability and therapeutic efficacy: N-linked glycosylation: The patent describes N-linked glycosylation sites that enhance the stability and solubility of the recombinant constructs. Domain organization: The patent claims recombinant constructs with optimized domain organization, which is believed to improve the efficacy of the therapeutic agents. Modified amino acid sequences: The patent describes recombinant constructs with modified amino acid sequences designed to enhance protein stability and improve biopharmaceutical properties. Claims and Specificity The patent claims contain a mix of broad and specific statements, ensuring the examiner has distinct topics outlined. Specific claims include: Therapeutic methods: Claims directed toward methods for treating diseases, such as multiple sclerosis, Crohn's disease, or rheumatoid arthritis. Recombinant constructs: Claims that describe various recombinant constructs, including novel fusion proteins and amino acid sequence modifications. Stable derivative forms: Claims that provide for the creation of stable derivative forms of the recombinant constructs. Biogen's Obviousness Assertions Biogen has argued that the claims in the patent provide a non-obvious solution given the prior art, as the sequences result in additional desired features. Their contentions suggest improvements not readily predictable by an ordinary skilled artisan at the time the invention was developed. Freedom to Operate This patent analysis highlights the need to carefully evaluate whether ongoing or prospective product development activities may infringe the claims. A key question for those considering freedom to operate (FTO) assessments: Do your contemplated biologics create soluble recombinant constructs, including the ones specified in this patent, or do they possess novel amino acid sequences that meet the requirements of the present invention?

Drugs Protected by US Patent 10,039,718

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Bristol	EVOTAZ	atazanavir sulfate; cobicistat	TABLET;ORAL	206353-001	Jan 29, 2015		RX	Yes	Yes	10,039,718		Y
Janssen Prods	PREZCOBIX	cobicistat; darunavir	TABLET;ORAL	205395-001	Jan 29, 2015		RX	Yes	Yes	10,039,718		Y
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		RX	Yes	Yes	10,039,718		Y

International Family Members for US Patent 10,039,718

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
African Regional IP Organization (ARIPO)	3089
African Regional IP Organization (ARIPO)	3250
Argentina	075369