Tenofovir alafenamide – USA

Tenofovir alafenamide – USA

Plaintiff: Gilead Sciences, Inc.

Defendants: Apotex / Lupin / Laurus Labs / Shilpa Medicare / Sunshine Lake / Natco / Cipla / Macleods / Hetero

Case No.: No. 20-189

Judge: Maryellen Noreika

Date: 05/26/2021

Patents at issue: US 7,390,791, US 7,803,788, US 8,754,065 & US 9,296,769

Court: District of Delaware – MEMORANDUM ORDER – Claim construction

 

A) Agreed-upon construction: (US’791 & US’788)

1.Diastereomerically enriched” means “enriched relative to all other diastereomers” (’791 Patent – Claims 1, 4, 7, & 8; ’788 Patent – Claims 1–7).

 

B) Disputed claim terms construction: (US’065 & US’769)

1.tenofovir alafenamide hemifumarate” means “a hemifumarate form of tenofovir alafenamide” (’065 Patent – Claims 1, 4, 6, 27, & 30; ’769 Patent – Claim 1).

Court analysis – Plaintiff proposes the construction, “a hemifumarate form of tenofovir alafenamide.” Defendants propose, “a hemifumarate salt of tenofovir alafenamide.” The crux of the dispute is whether the term is limited to salts, or whether other forms, such as co-crystals, are encompassed. Court agreed with Plaintiff because it found support in the specifications of the ’065 and ’769 patents, which repeatedly refer to a hemifumarate form of tenofovir alafenamide or “TAF.” Defendants argued that a person of ordinary skill would recognize that the terms “hemifumarate” and “monofumarate” identify specific salts of TAF. Court said that Correspondence with the FDA as well as articles submitted in connection with the briefing, however, use the term hemifumarate to include things other than salts, such as co-crystals. Thus, the word “hemifumarate” does not necessarily imply a salt as a matter of nomenclature. Court also did not find Defendants arguments convincing with respect to intrinsic evidence and prosecution history support.

 

2.tenofovir alafenamide monofumarate” means “a monofumarate form of tenofovir alafenamide” (’769 Patent – Claims 1–3).

Court analysis – Plaintiff proposes the construction, “a monofumarate form of tenofovir alafenamide.” Defendants propose, “a monofumarate salt of tenofovir alafenamide.” Again, the crux of the dispute is whether the term is limited to salts, and again, Court adopt Plaintiff’s construction. Court said that although the patents do not expressly define “tenofovir alafenamide monofumarate” as they do “tenofovir alafenamide hemifumarate,” the patents use the two terms consistently, contrasting the “monofumarate form” from the “hemifumarate form of tenofovir alafenamide. Finding no reason to treat the two terms differently, Court adopted the construction, “monofumarate form of tenofovir alafenamide.

 

3.fumaric acid” means

 

 

 

and includes ionized and/or associated forms of fumaric acid (’065 Patent – Claims 6–9, 27, & 30; ’769 Patent – Claims 4–5).

Court analysis – Plaintiff proposes that the term corresponds to a particular chemical structure, “including its ionized and/or associated forms.” Defendants propose the construction, “the compound having the chemical name trans-1,2-ethylenedicarboxylic acid” and having the same chemical structure. The crux of the parties’ dispute is whether “fumaric acid” includes its ionized and/or associated forms. Court agreed with Plaintiff. Court said that the asserted patents do not offer a definition of “fumaric acid.” The claims recite “fumaric acid” as a starting material for preparing TAF. When used as a starting material, fumaric acid is non-ionized and unassociated. When appearing as a component of TAF Hemi, fumaric acid is ionized or otherwise associated with the tenofovir alafenamide component. Therefore, a POSA would understand that “fumaric acid” in the patents describes both non-ionized/unassociated fumaric acid and ionized/associated fumaric acid.

 

4. “tenofovir alafenamide” means

 

 

 

 

 

and includes ionized and/or associated forms of tenofovir alafenamide (’065 Patent – Claims 6–9, 27, & 30; ’769 Patent – Claims 4–5).

Court analysis – As with “fumaric acid,” Plaintiff proposes that the term “tenofovir alafenamide” corresponds to a certain chemical structure, “including its ionized and associated forms.” Defendants propose the construction, “the compound having the chemical name 9-[(R)-2-[[(S)-[[(S)-1-(isopropoxycarbonyl)ethyl] amino] phenoxyphosphinyl] methoxy]propyl]adenine” and having the same chemical structure. Court said that because the parties agree on the chemical structure and principally argue what forms are encompassed, it will not adopt a chemical name into the construction of “tenofovir alafenamide.” The crux of the parties’ dispute is whether “tenofovir alafenamide” includes its ionized and/or associated forms. As with “fumaric acid,” the patents recite “tenofovir alafenamide” as a starting material for preparing TAF Hemi. The claims also recite “tenofovir alafenamide” as a component of a composition comprising TAF Hemi. The written description also discloses “tenofovir alafenamide” as a component of TAF Hemi. Thus, as with “fumaric acid,” these disclosures suggest that “tenofovir alafenamide” includes both non-ionized/unassociated and ionized/associated forms.

 

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