Details for Patent: 8,691,878

Summary for Patent: 8,691,878

Title:	Solid pharmaceutical dosage form
Abstract:	A solid pharmaceutical dosage form providing improved oral bioavailability is disclosed for inhibitors of HIV protease. In particular, the dosage form comprises a solid dispersion of at least one HIV protease inhibitor and at least one pharmaceutically acceptable water-soluble polymer and at least one pharmaceutically acceptable surfactant, said pharmaceutically acceptable water-soluble polymer having a Tg of at least about 50.degree. C. Preferably, the pharmaceutically acceptable surfactant has an HLB value of from about 4 to about 10.
Inventor(s):	Rosenberg; Jeorg (Ellerstadt, DE), Reinhold; Ulrich (Heidelberg, DE), Liepold; Bernd (Dossenheim, DE), Berndl; Gunther (Herxheim, DE), Breitenbach; Joerg (Mannheim, DE), Alani; Laman (Foster City, CA), Ghosh; Soumojeet (Lansdale, PA)
Assignee:	AbbVie Inc. (North Chicago, IL)
Application Number:	13/674,799
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,691,878
Patent Claim Types: see list of patent claims	Use; Dosage form; Formulation; Composition;

Here is a detailed analysis of the scope, claims, and patent landscape for United States Patent 8,691,878:

Overview of U.S. Patent 8,691,878

U.S. Patent 8,691,878, titled "Solid Pharmaceutical Dosage Form," was issued on April 8, 2014 to AbbVie Inc[1][9]. The patent relates to solid pharmaceutical dosage forms containing ritonavir, a protease inhibitor used in the treatment of HIV/AIDS.

Key Claims and Scope

The '878 patent contains 17 claims, with claims 1-8 and 13-17 being independent claims[1]. Some key aspects of the claims include:

Composition Claims

• Claim 1 covers a solid dispersion comprising ritonavir, a pharmaceutically acceptable water-soluble polymer, and a pharmaceutically acceptable surfactant[1].

• The water-soluble polymer is specified as polyvinylpyrrolidone or a copolymer thereof[1].

• The surfactant is specified as a polyoxyethylene-polyoxypropylene block copolymer or polyoxyethylene sorbitan fatty acid ester[1].

Dosage Form Claims

• Claims directed to tablets and capsules containing the solid dispersion[1].

• Claims specifying the ritonavir content (e.g. 50-800 mg per dosage unit)[1].

Method Claims

• Methods of treating HIV infection comprising administering the claimed solid dispersion formulations[1].

The broad scope of the independent claims covers a range of solid dispersion formulations containing ritonavir, rather than being limited to a specific composition. This provides wider patent protection for AbbVie's ritonavir products.

Patent Landscape and Related Patents

The '878 patent is part of a larger patent family protecting AbbVie's ritonavir formulations:

• Related patents include U.S. Patents 7,148,359, 7,364,752, 8,268,349, 8,399,015, and 8,470,347[1].

• These patents cover various aspects of ritonavir solid dispersions, including specific compositions, manufacturing methods, and dosage forms[1].

• The multiple related patents create a "patent thicket" providing layered protection for AbbVie's ritonavir products.

Patent Term and Expiration

• The '878 patent has a 20-year term from its earliest priority date[5].

• Based on the April 8, 2014 issue date, it is likely to expire in the early-mid 2030s, though the exact date would need to be confirmed.

• Patent term extensions may potentially extend protection further.

Litigation History

• AbbVie has asserted the '878 patent against generic manufacturers seeking to market generic ritonavir products[9].

• In 2014, AbbVie filed suit against Mylan Pharmaceuticals for infringement of the '878 patent following Mylan's Paragraph IV certification[10].

• The litigation history demonstrates AbbVie's active enforcement of this patent to protect its ritonavir franchise.

Impact on Generic Competition

• The broad claims and multiple related patents create significant barriers to generic entry.

• Generic manufacturers must navigate the patent thicket and potentially challenge or design around multiple patents to bring a generic ritonavir to market.

• This patent strategy has likely extended AbbVie's market exclusivity for ritonavir beyond the expiration of the original compound patent.

Prosecution History Insights

• The patent underwent significant prosecution, with multiple office actions and claim amendments[1].

• The final allowed claims are narrower than the originally filed claims, focusing on specific polymer and surfactant types[1].

• This prosecution history could impact claim interpretation in future litigation.

Key Takeaways

1. The '878 patent provides broad protection for solid dispersion formulations of ritonavir.

2. It is part of a larger patent family creating multiple layers of protection for AbbVie's ritonavir products.

3. The patent has been actively enforced by AbbVie against potential generic competitors.

4. The broad claims and related patents create significant barriers to generic entry in the ritonavir market.

5. The patent exemplifies the use of formulation patents to extend market exclusivity for pharmaceutical products beyond the original compound patent term.

In conclusion, U.S. Patent 8,691,878 represents a key component of AbbVie's intellectual property strategy for ritonavir, providing broad protection for solid dispersion formulations and creating obstacles for generic competition well beyond the expiration of the original compound patent.

"The '878 patent covers a solid dispersion comprising ritonavir, a pharmaceutically acceptable water-soluble polymer, and a pharmaceutically acceptable surfactant. This broad claim scope provides significant protection for AbbVie's ritonavir formulations." - From U.S. Patent 8,691,878[1]

Frequently Asked Questions

1. What is the main invention covered by U.S. Patent 8,691,878? The main invention is a solid dispersion formulation of ritonavir containing specific water-soluble polymers and surfactants.

2. How long will patent protection last for AbbVie's ritonavir products? Based on the '878 patent and related patents, protection likely extends into the early-mid 2030s, though exact expiration dates would need to be confirmed.

3. Can generic manufacturers easily bring ritonavir products to market? No, the multiple related patents create significant barriers to generic entry, requiring generic manufacturers to navigate a complex patent landscape.

4. Has AbbVie enforced the '878 patent against competitors? Yes, AbbVie has asserted the patent in litigation against generic manufacturers seeking to market generic ritonavir products.

5. How does this patent compare to the original ritonavir compound patent? This formulation patent provides additional protection beyond the original compound patent, extending AbbVie's market exclusivity for ritonavir products.

Drugs Protected by US Patent 8,691,878

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
No data available in table

International Family Members for US Patent 8,691,878

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	055734
Argentina	077411
Australia	2006216856
Brazil	122012031169
Brazil	PI0609173
Canada	2598827