Details for Patent: 8,399,015

Which drugs does patent 8,399,015 protect, and when does it expire?

Patent 8,399,015 protects VIEKIRA XR, VIEKIRA PAK (COPACKAGED), and TECHNIVIE, and is included in three NDAs.

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

This patent has sixty-four patent family members in thirty-seven countries.

Summary for Patent: 8,399,015

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; Joerg (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 (Gurnee, IL)
Assignee:	AbbVie Inc. (Waukegan, IL)
Application Number:	13/240,119
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,399,015
Patent Claim Types: see list of patent claims	Dosage form; Formulation;

United States Patent 8,399,015: A Detailed Analysis of Scope and Claims

Introduction

United States Patent 8,399,015, titled "Solid pharmaceutical dosage form," is a significant patent in the pharmaceutical industry, particularly for inhibitors of HIV protease. This patent, assigned to AbbVie Inc., outlines a solid pharmaceutical dosage form designed to enhance oral bioavailability of these inhibitors.

Background

The development of this patent is part of the broader effort by pharmaceutical companies to improve the efficacy and accessibility of HIV treatments. HIV protease inhibitors are crucial in the management of HIV/AIDS, and advancements in their formulation can significantly impact patient outcomes[4].

Patent Overview

Inventors and Assignees

The patent was invented by a team of researchers and assigned to AbbVie Inc., a leading pharmaceutical company known for its innovative drug developments.

Filing and Issue Dates

The patent was filed on October 25, 2010, and issued on March 19, 2013. This timeline is critical in understanding the patent's lifecycle and its impact on the market[4].

Claims

Independent Claims

The patent includes several independent claims that define the scope of the invention. Here are some key claims:

• Claim 1: A solid pharmaceutical dosage form comprising a protease inhibitor, a solubilizing agent, and a stabilizer, where the dosage form is designed to improve oral bioavailability[4].
• Claim 18: A method of treating HIV infection in a patient, comprising administering the solid pharmaceutical dosage form described in Claim 1[4].

Dependent Claims

Dependent claims further specify the components and characteristics of the dosage form, such as the types of solubilizing agents and stabilizers used, and the specific protease inhibitors included.

Description of the Invention

The patent describes a solid pharmaceutical dosage form that enhances the oral bioavailability of HIV protease inhibitors. This is achieved through a combination of a protease inhibitor, a solubilizing agent, and a stabilizer. The formulation is designed to improve the solubility and stability of the protease inhibitor, thereby enhancing its absorption in the body[4].

Technical Details

Components

• Protease Inhibitors: The patent specifies various protease inhibitors that can be used, such as lopinavir and ritonavir.
• Solubilizing Agents: Agents like polyethylene glycol and poloxamers are mentioned to enhance the solubility of the protease inhibitors.
• Stabilizers: Stabilizers such as antioxidants and chelating agents are included to maintain the stability of the formulation[4].

Formulation

The dosage form can be a tablet, capsule, or other solid form. The patent details the process of preparing these forms, including the mixing and granulation of the components.

Patent Landscape

Related Patents

The patent is part of a larger portfolio of patents related to HIV protease inhibitors. Other patents, such as U.S. Patent Nos. 7,148,359, 7,364,752, and 8,470,347, also held by AbbVie, cover different aspects of these inhibitors, including their composition and methods of use[2].

Litigation

The patent has been involved in litigation, as seen in the case of AbbVie Inc. et al. v. Mylan Pharmaceuticals Inc. et al., where AbbVie asserted claims of patent infringement against Mylan. This highlights the importance of this patent in protecting AbbVie's intellectual property[2].

Impact on the Market

Generic Competition

The patent's expiration date and the presence of exclusivities under the Federal Food, Drug and Cosmetic Act (FD&C Act) play a crucial role in determining when generic versions of the drug can enter the market. The study by the USPTO and FDA on drug patent and exclusivity illustrates the complex interplay between patents and exclusivities in delaying generic competition[1].

Patient Access

The improved oral bioavailability of HIV protease inhibitors due to this patent can enhance patient compliance and treatment outcomes. However, the patent's protection period also affects the availability of more affordable generic alternatives, impacting patient access to these life-saving medications.

Conclusion

United States Patent 8,399,015 is a significant contribution to the field of HIV treatment, offering a formulation that enhances the oral bioavailability of protease inhibitors. Understanding the scope and claims of this patent, as well as its position within the broader patent landscape, is crucial for both pharmaceutical companies and regulatory bodies.

Key Takeaways

• The patent describes a solid pharmaceutical dosage form for HIV protease inhibitors.
• It includes specific claims about the components and method of use.
• The patent is part of AbbVie's broader portfolio related to HIV treatments.
• It has been involved in litigation to protect AbbVie's intellectual property.
• The patent's protection period affects the timing of generic competition and patient access to affordable treatments.

Frequently Asked Questions (FAQs)

What is the main invention described in U.S. Patent 8,399,015?

The main invention is a solid pharmaceutical dosage form designed to improve the oral bioavailability of HIV protease inhibitors.

Who is the assignee of this patent?

The patent is assigned to AbbVie Inc.

What are the key components of the dosage form described in the patent?

The key components include a protease inhibitor, a solubilizing agent, and a stabilizer.

How does this patent impact generic competition?

The patent's protection period, along with any applicable exclusivities under the FD&C Act, delays the entry of generic versions of the drug into the market.

What is the significance of this patent in the treatment of HIV?

The patent enhances patient compliance and treatment outcomes by improving the oral bioavailability of HIV protease inhibitors.

Drugs Protected by US Patent 8,399,015

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Abbvie	VIEKIRA XR	dasabuvir sodium; ombitasvir; paritaprevir; ritonavir	TABLET, EXTENDED RELEASE;ORAL	208624-001	Jul 22, 2016		DISCN	Yes	No	8,399,015		Y
Abbvie	VIEKIRA PAK (COPACKAGED)	dasabuvir sodium; ombitasvir, paritaprevir, ritonavir	TABLET;ORAL	206619-001	Dec 19, 2014		DISCN	Yes	No	8,399,015		Y
Abbvie	TECHNIVIE	ombitasvir; paritaprevir; ritonavir	TABLET;ORAL	207931-001	Jul 24, 2015		DISCN	Yes	No	8,399,015*PED				Y

International Family Members for US Patent 8,399,015

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