Details for Patent: 8,148,374

Which drugs does patent 8,148,374 protect, and when does it expire?

Patent 8,148,374 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 two hundred and twelve patent family members in thirty-five countries.

Summary for Patent: 8,148,374

Title:	Modulators of pharmacokinetic properties of therapeutics
Abstract:	The present application provides for a compound of Formula IV, ##STR00001## or a pharmaceutically acceptable salt, solvate, and/or ester thereof, compositions containing such compounds, therapeutic methods that include the administration of such compounds, and therapeutic methods and include the administration of such compounds with at least one additional therapeutic agent.
Inventor(s):	Desai; Manoj C. (Pleasant Hill, CA), Liu; Hongtao (Cupertino, CA), Xu; Lianhong (Palo Alto, CA)
Assignee:	Gilead Sciences, Inc. (Foster City, CA)
Application Number:	12/036,124
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,148,374
Patent Claim Types: see list of patent claims	Compound; Composition; Use;

United States Patent 8,148,374: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 8,148,374, owned by Gilead Sciences, Inc., is a significant patent in the pharmaceutical industry, particularly in the field of HIV treatment. This patent covers the compound cobicistat, a crucial component in HIV therapy. Here, we delve into the scope, claims, and the broader patent landscape surrounding this patent.

Background and Patent Details

The patent in question, U.S. Patent No. 8,148,374, was filed by Gilead Sciences, Inc. on February 22, 2008, and issued on April 3, 2012. It pertains to the compound cobicistat, which is used as a pharmacokinetic enhancer in combination with other antiretroviral drugs for the treatment of HIV[4].

Scope of the Patent

The scope of the patent includes compounds, their stereoisomers, associated salts, and compositions, as well as methods for using these compounds in the treatment of HIV. Specifically, the patent claims cover cobicistat and its use in enhancing the pharmacokinetic properties of other antiretroviral agents[5].

Claims Analysis

The patent claims are critical in defining the scope of protection. Here, the claims are structured to encompass various aspects of cobicistat, including its chemical structure, pharmaceutical compositions, and methods of use.

• Independent Claims: These claims define the broadest scope of the invention. For U.S. Patent 8,148,374, the independent claims focus on the compound cobicistat itself and its pharmaceutical compositions.
• Dependent Claims: These claims narrow down the scope by adding specific limitations to the independent claims. They often include details about the methods of use, dosages, and specific combinations with other antiretroviral drugs[5].

Patent Examination Process

The examination process for this patent was marked by several key events that influenced its final scope and the calculation of Patent Term Adjustment (PTA).

• Restriction Requirement: On November 18, 2009, the USPTO issued a restriction requirement, which Gilead responded to on February 18, 2010. This is a common step in the patent examination process where the examiner requires the applicant to elect which claims to pursue[1][4].
• Supplemental Information Disclosure Statement (IDS): Gilead filed an IDS on April 16, 2010, which was 57 days after responding to the restriction requirement. This filing was a point of contention in the PTA calculation[1][4].

Patent Term Adjustment (PTA)

The PTA is a critical aspect of patent law that adjusts the term of a patent based on delays during the prosecution process. For U.S. Patent 8,148,374, the PTA calculation was complex and involved several categories of delays.

• Category A Delays: These delays are attributed to the USPTO and extend the patent term by one day for each day the USPTO fails to meet specified deadlines. Gilead was entitled to 245 days of Category A Delay[1].
• Category B Delays: These delays occur when the patent does not issue within three years of filing, extending the patent term by one day for each day exceeded, subject to certain exceptions. Gilead was entitled to 406 days of Category B Delay[1].
• Applicant-Induced Delays: The USPTO reduced the PTA by the period of time during which Gilead failed to engage in reasonable efforts to conclude prosecution. The filing of the IDS after the response to the restriction requirement was deemed an applicant-induced delay, reducing the overall PTA[1][4].

Legal Challenges and Interpretations

Gilead challenged the USPTO's interpretation and application of 35 U.S.C. § 154(b) regarding the reduction of PTA due to the IDS filing. The Federal Circuit upheld the USPTO's interpretation, stating that Congress intended to sanction not only applicant conduct that results in actual delay but also conduct that has the potential to result in delay, regardless of whether such delay actually occurred[1][4].

Impact on Patent Landscape

The decision in Gilead Sciences, Inc. v. Lee has significant implications for the patent landscape, particularly in how PTA is calculated and how applicant conduct is evaluated.

• Workload and Efficiency: The Federal Circuit's ruling emphasizes that applicant conduct, even if it does not cause actual delay, can increase the PTO's workload and make it difficult for the PTO to meet statutory time requirements[4].
• Strategic Considerations: Patent applicants must now be more cautious in their actions during the prosecution process, as potential delays can be sanctioned even if no actual delay occurs. This includes careful timing of IDS filings and responses to restriction requirements[1][4].

Patent Scope and Quality

The debate over patent scope and quality is ongoing, with some arguing that broader patents can diminish innovation incentives due to increased licensing and litigation costs. The examination process for U.S. Patent 8,148,374 illustrates how the scope of patent claims can be narrowed during examination, which can impact the patent's validity and enforceability[3].

Conclusion and Key Takeaways

• Scope and Claims: U.S. Patent 8,148,374 covers cobicistat, its stereoisomers, salts, compositions, and methods of use in HIV treatment.
• PTA Calculation: The patent term adjustment was reduced due to applicant-induced delays, highlighting the importance of timely and strategic actions during patent prosecution.
• Legal Interpretations: The Federal Circuit's decision in Gilead Sciences, Inc. v. Lee emphasizes that potential delays, not just actual delays, can be sanctioned.
• Impact on Patent Landscape: The ruling affects how applicants manage their patent prosecution and the PTO's workload and efficiency.

Key Takeaways

• Strategic Filing: Applicants should carefully plan their filings, including IDS submissions, to avoid potential delays.
• PTA Implications: Understanding the PTA rules and their implications is crucial for maximizing patent term.
• Scope and Quality: Narrower claims during examination can impact the patent's validity and enforceability.
• Legal Compliance: Complying with USPTO regulations and avoiding conduct that could potentially delay prosecution is essential.

Frequently Asked Questions (FAQs)

What is the main subject of U.S. Patent 8,148,374?

U.S. Patent 8,148,374 covers the compound cobicistat, its stereoisomers, associated salts, compositions, and methods for using these compounds in the treatment of HIV.

How was the Patent Term Adjustment (PTA) calculated for this patent?

The PTA was calculated based on Category A and Category B delays, with a reduction due to applicant-induced delays caused by the filing of a supplemental information disclosure statement (IDS).

What was the legal challenge in Gilead Sciences, Inc. v. Lee?

Gilead challenged the USPTO's interpretation of 35 U.S.C. § 154(b) regarding the reduction of PTA due to the IDS filing, arguing that only actual delays should be sanctioned.

What is the impact of the Federal Circuit's decision on patent applicants?

The decision emphasizes the need for careful planning and timely actions during patent prosecution to avoid potential delays and reductions in PTA.

How does the examination process affect the scope of patent claims?

The examination process can narrow the scope of patent claims, as seen in the case of U.S. Patent 8,148,374, where the claims were refined during the prosecution process.

Cited Sources:

1. Gibbons Law Alert: "Potential Delay Enough to Reduce PTA" - Gibbons Law Alert, March 9, 2015.
2. Supreme Court: "aids healthcare foundation, inc." - Supreme Court, August 7, 2018.
3. SSRN: "Patent Claims and Patent Scope" - SSRN, September 29, 2016.
4. Casetext: "Gilead Sciences, Inc. v. Lee" - Casetext, February 26, 2015.
5. RPX Insight: "in the united states district court for the district of delaware gilead" - RPX Insight, March 25, 2016.

Drugs Protected by US Patent 8,148,374

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			Y	Y		TREATMENT OF HIV INFECTION USING A COMPOSITION CONTAINING A PHARMACOKINETIC ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENASE
Janssen Prods	PREZCOBIX	cobicistat; darunavir	TABLET;ORAL	205395-001	Jan 29, 2015		RX	Yes	Yes			Y	Y		TREATMENT OF HIV INFECTION USING A COMPOSITION CONTAINING A PHARMACOKINETIC ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENASE
Janssen Prods	PREZCOBIX	cobicistat; darunavir	TABLET;ORAL	205395-001	Jan 29, 2015		RX	Yes	Yes			Y	Y		TREATMENT OF HIV INFECTION IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 40KG USING A COMPOSITION CONTAINING A PHARMACOKINETIC ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENASE
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		RX	Yes	Yes			Y	Y		TX OF HIV-1 INFECTION USING A COMPOSITION CONTAINING A PK ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENATES IN ADULTS WHO HAVE NO PRIOR ANTIRETROVIRAL TX HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		RX	Yes	Yes			Y	Y		TREATMENT OF HIV-1 INFECTION USING A COMPOSITION CONTAINING A PK ENHANCER THAT INHIBITS CY P450 MONOXYGENASE IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 40KG WHO HAVE NO PRIOR ARV TREATMENT HISTORY
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		RX	Yes	Yes			Y	Y		TREATMENT OF HIV-1 INFECTION USING A COMPOSITION CONTAINING A PK ENHANCER THAT INHIBITS CY P450 MONOXYGENASE IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 40KG WHO ARE VIROLOGICALLY SUPPRESSED ON A STABLE ARV REGIMEN FOR AT LEAST 6 MONTHS
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		RX	Yes	Yes			Y	Y		TX OF HIV1 INFECTION USING A COMPOSITION CONTAINING A PK ENHANCER THAT INHIBITS CY P450 MONOXYGENASE IN ADULTS & PEDIATRIC PATIENTS AT LEAST 40KG HAVING NO PRIOR ARV TX HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ARV REGIMEN FOR AT LEAST 6 MO

International Family Members for US Patent 8,148,374

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2049506		CA 2015 00060	Denmark
European Patent Office	2049506		PA2015040	Lithuania
European Patent Office	2049506		92864	Luxembourg
European Patent Office	2049506		15C0078	France
European Patent Office	2049506		300780	Netherlands
European Patent Office	2049506		61/2015	Austria
European Patent Office	2487162		PA2016040	Lithuania