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Last Updated: March 17, 2025

Details for Patent: 8,246,989


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Which drugs does patent 8,246,989 protect, and when does it expire?

Patent 8,246,989 protects ATELVIA and is included in one NDA.

This patent has eighty-four patent family members in thirty-three countries.

Summary for Patent: 8,246,989
Title:Dosage forms of bisphosphonates
Abstract: Oral dosage forms of a bisphosphonate comprised of a safe and effective amount of a pharmaceutical composition comprising a bisphosphonate, a chelating agent, and, means for effecting delayed release of the bisphosphonate and the chelating agent in the lower gastrointestinal tract provide delivery of the pharmaceutical composition to the lower gastrointestinal tract of the mammal subject and pharmaceutically effective absorption of the bisphosphonate with or without food or beverages. The present invention substantially alleviates the interaction between bisphosphonates and food or beverages, which interaction results in the bisphosphonate active ingredient not being available for absorption. The resulting oral dosage form may thus be taken with or without food. Further, the present invention effects delivery of the bisphosphonate and the chelating agent to the lower GI tract, substantially alleviating the upper GI irritation associated with bisphosphonate therapies. These benefits simplify previously complex treatment regimens and can lead to increased patient compliance with bisphosphonate therapies.
Inventor(s): Dansereau; Richard John (Cincinnati, OH), Burgio, Jr.; David Ernest (Liberty Township, OH)
Assignee: Warner Chilcott Company, LLC (Fajardo, PR)
Application Number:12/637,100
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,246,989
Patent Claim Types:
see list of patent claims
Compound; Dosage form; Formulation;
Patent landscape, scope, and claims:

United States Patent 8,246,989: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 8,246,989, hereafter referred to as the '989 patent, is a significant patent that has been involved in several legal and technical discussions, particularly in the context of pharmaceuticals. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.

Background of the Patent

The '989 patent is one of several patents owned by Warner Chilcott Company, LLC, and is related to pharmaceutical formulations. The patent was part of a legal dispute involving Warner Chilcott and Teva Pharmaceuticals USA, Inc., which highlighted the importance of patent claims and their construction in legal proceedings[5].

Patent Claims and Construction

Claim Language and Scope

The claims of the '989 patent are crucial in defining the scope of the invention. Patent claims must be clear, distinct, and particularly point out the subject matter of the invention. The language of the claims is interpreted by the court through the lens of a person skilled in the art as of the effective date of the patent. This interpretation includes considering the claims, the written description, and the prosecution history of the patent[2].

Intrinsic and Extrinsic Evidence

When construing patent claims, courts primarily consult intrinsic evidence, which includes the claims themselves, the written description, and the prosecution history. Extrinsic evidence, such as expert testimony, is used more cautiously and has limited scope. The court's analysis must begin with the language of the claims, ensuring that the terms are understood in the context of the entire patent specification[2].

Claim Terms and Definitions

Claim terms are given their plain and ordinary meaning to a person of ordinary skill in the art unless the patentee provides a specific definition in the specification. If a definition is provided, it controls the interpretation of the claim term. This ensures consistency and clarity in the scope of the patent[2].

Patentability Requirements

For a patent like the '989 patent to be granted, it must meet several patentability requirements:

Utility

The invention must be operable and provide some tangible benefit to satisfy the utility requirement[1].

Novelty

The invention must not be fully anticipated by prior patents, publications, or other state of the art knowledge, known as the "prior art"[1].

Nonobviousness

The invention must not have been readily within the ordinary skills of a competent artisan at the time it was made. This ensures that the invention is innovative and not simply an obvious extension of existing knowledge[1].

Legal Disputes and Infringement

The '989 patent was involved in a significant legal dispute between Warner Chilcott and Teva Pharmaceuticals. The case centered on whether Teva's filing of an Abbreviated New Drug Application (ANDA) constituted an act of statutory infringement under 35 U.S.C. § 271(e)(2)(A). The court ultimately ruled on the validity of specific claims of the '459 and '460 patents, which are related to the '989 patent, finding some claims invalid due to obviousness[5].

Patent Scope and Quality

The scope of a patent, including the '989 patent, is a critical aspect of patent quality debates. Metrics such as independent claim length and independent claim count can be used to measure patent scope. Narrower claims are often associated with a higher probability of grant and a shorter examination process, indicating better patent quality[3].

Examination Process and Allowance Rates

The examination process for patents like the '989 patent involves several stages, including initial examination, potential continuations, and divisional applications. The allowance rates for patents can vary, with factors such as the origin of the application, the entity size of the applicant, and the technology field influencing the outcome. For instance, the family allowance rate, which includes the outcomes of continuation applications, provides a comprehensive view of the patent's journey through the USPTO[4].

Impact on Innovation and Licensing

The breadth and clarity of patent claims, such as those in the '989 patent, can significantly impact innovation and licensing costs. Overly broad or unclear patents can lead to increased litigation and licensing costs, potentially diminishing incentives for innovation. Conversely, well-defined and narrow claims can facilitate clearer boundaries and reduce legal disputes[3].

Key Takeaways

  • Claim Construction: The interpretation of patent claims is crucial and involves intrinsic and extrinsic evidence.
  • Patentability Requirements: Patents must meet utility, novelty, and nonobviousness requirements.
  • Legal Disputes: The '989 patent was involved in significant legal disputes regarding infringement and validity.
  • Patent Scope: Metrics like independent claim length and count can measure patent scope and quality.
  • Examination Process: The examination process involves multiple stages, and allowance rates vary based on several factors.

FAQs

What are the key requirements for a patent to be granted in the United States?

A patent must be useful, novel, and nonobvious, and it must claim patentable subject matter[1].

How are patent claims constructed and interpreted?

Patent claims are interpreted by courts using intrinsic evidence (claims, written description, prosecution history) and extrinsic evidence (expert testimony) with a focus on the language of the claims and the context of the entire patent specification[2].

What is the significance of the '989 patent in legal disputes?

The '989 patent was part of a legal dispute involving Warner Chilcott and Teva Pharmaceuticals, focusing on statutory infringement and the validity of specific claims[5].

How does the scope of a patent affect innovation?

The scope of a patent, measured by metrics like independent claim length and count, can impact innovation by influencing licensing and litigation costs. Narrower, clearer claims generally facilitate innovation by reducing legal disputes[3].

What are the different types of allowance rates in the patent examination process?

Allowance rates include the first-action allowance rate, progenitor allowance rate, and family allowance rate, each capturing different aspects of the examination process and continuation procedures[4].

Sources

  1. Congressional Research Service. Patents and Innovation Policy, August 2022.
  2. United States District Court for the District of New Jersey. NOT FOR PUBLICATION, January 2014.
  3. SSRN. Patent Claims and Patent Scope, September 2016.
  4. Yale Journal of Law and Technology. What Is the Probability of Receiving a US Patent?, 2015.
  5. United States District Court for the District of New Jersey. CLOSED UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY, March 2015.

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Drugs Protected by US Patent 8,246,989

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Patented / Exclusive UseSubmissiondate
Apil ATELVIA risedronate sodium TABLET, DELAYED RELEASE;ORAL 022560-001 Oct 8, 2010 AB RX Yes Yes 8,246,989 ⤷  Try for Free Y ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Patented / Exclusive Use>Submissiondate
Showing 1 to 1 of 1 entries

International Family Members for US Patent 8,246,989

CountryPatent NumberEstimated ExpirationSupplementary Protection CertificateSPC CountrySPC Expiration
Argentina 049022 ⤷  Try for Free
Argentina 098686 ⤷  Try for Free
Australia 2005247299 ⤷  Try for Free
Austria E475412 ⤷  Try for Free
>Country>Patent Number>Estimated Expiration>Supplementary Protection Certificate>SPC Country>SPC Expiration
Showing 1 to 4 of 4 entries

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