You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

Details for Patent: 8,222,222


✉ Email this page to a colleague

« Back to Dashboard


Which drugs does patent 8,222,222 protect, and when does it expire?

Patent 8,222,222 protects LEQVIO and is included in one NDA.

This patent has forty-two patent family members in fourteen countries.

Summary for Patent: 8,222,222
Title:Compositions and methods for inhibiting expression of the PCSK9 gene
Abstract: The invention relates to a double-stranded ribonucleic acid (dsRNA) for inhibiting the expression of the PCSK9 gene (PCSK9 gene), comprising an antisense strand having a nucleotide sequence which is less that 30 nucleotides in length, generally 19-25 nucleotides in length, and which is substantially complementary to at least a part of the PCSK9 gene. The invention also relates to a pharmaceutical composition comprising the dsRNA together with a pharmaceutically acceptable carrier; methods for treating diseases caused by PCSK9 gene expression and the expression of the PCSK9 gene using the pharmaceutical composition; and methods for inhibiting expression of a PCSK9 gene in a cell.
Inventor(s): Tan; Pamela (Kulmbach, DE), Bramlage; Birgit (Kulmbach, DE), Frank-Kamenetsky; Maria (Brookline, MA), Fitzgerald; Kevin (Brookline, MA), Akinc; Akin (Needham, MA), Kotelianski; Victor E. (Boston, MA)
Assignee: Alnylam Pharmaceuticals, Inc. (Cambridge, MA)
Application Number:12/554,231
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Understanding the Scope and Claims of U.S. Patents: A Detailed Analysis

Introduction

When navigating the complex landscape of U.S. patents, it is crucial to understand the scope and claims that define the intellectual property rights of an inventor. This article will delve into the key aspects of patent law, using the context of significant court cases and statutory requirements to illustrate the principles.

Patent-Eligible Subject Matter

Under U.S. patent law, an inventor can patent "any new and useful process, machine, manufacture, or composition of matter" as outlined in Section 101 of the Patent Act[2][3].

Statutory Subject Matter

The Supreme Court has emphasized that Congress intended for Section 101 to be broadly inclusive, covering "anything under the sun that is made by man"[1][2]. However, there are exceptions to this broad scope, including laws of nature, natural phenomena, and abstract ideas.

The State Street Bank Case: A Landmark Decision

The case of State Street Bank & Trust v. Signature Financial Group, Inc. is pivotal in understanding what constitutes patentable subject matter. Here, the Federal Circuit ruled that software programs that transform data are patentable, as they fall within the category of "machine" or "process"[1].

Claims and Subject Matter

In this case, the patented invention involved a system for managing financial services configurations, which was deemed a "machine" under Section 101. The court emphasized that the claims must be directed to one of the four enumerated categories of patentable subject matter: process, machine, manufacture, or composition of matter[1].

Types of Patent Claims

Patent claims can be categorized into various types, each serving a specific purpose.

Independent and Dependent Claims

Independent claims stand alone and define the invention, while dependent claims refer back to and further limit an independent claim[5].

Means-Plus-Function Claims

These claims describe a function and the means for achieving that function. They are interpreted to include the equivalents of the structures disclosed in the written description of the patent[1].

Beauregard Claims

These claims are directed to a computer-readable medium containing program instructions. However, after the Alice Corp. v. CLS Bank International decision, the patent eligibility of such claims has become uncertain, as merely recasting a method claim in Beauregard format does not improve its patent eligibility[5].

The Importance of Claim Scope

The scope of patent claims is critical in defining the boundaries of the patent owner’s rights.

Broad vs. Narrow Claims

Broad claims can provide more meaningful patent protection but risk being invalidated if they are not commensurate with the disclosure in the patent application. Narrow claims, on the other hand, can be easily designed around by competitors[3].

Enablement Requirement

The written description and enablement requirements under 35 U.S.C. § 112 ensure that the patent specification is detailed enough for a person skilled in the art to make and use the invention. This is particularly challenging for genus claims, where the scope must be balanced to avoid undue experimentation or insufficient disclosure[3].

Patent Assignment and Market Dynamics

Patent assignments and transactions play a significant role in the redistribution and value of intellectual property.

The USPTO Patent Assignment Dataset

This dataset provides detailed information on patent assignments and transactions, including the identities of parties, transaction dates, and the nature of conveyance. It helps in understanding market dynamics and the rate of technological change[4].

Judicial Exceptions to Patentable Subject Matter

Despite the broad language of Section 101, the courts have established exceptions to what can be patented.

Mathematical Algorithm Exception

This exception excludes pure mathematical algorithms from being patented, as they are considered abstract ideas[1].

Business Method Exception

Historically, business methods were also considered non-patentable, but this exception has been somewhat eroded by cases like State Street Bank, which allowed for the patenting of certain business methods that transform data[1].

The Impact of Recent Jurisprudence

Recent court decisions have significantly impacted the patent landscape, particularly in the pharmaceutical and biotechnology industries.

Alice Corp. v. CLS Bank International

This Supreme Court decision clarified that abstract ideas, even when implemented on a computer, are not patentable. This has led to increased scrutiny of software and business method patents[5].

Genus Claims in Pharmaceutical and Biotechnology

The Federal Circuit's current stance on genus claims has made it challenging for innovators in these industries to obtain valuable patent protection. The rigid enablement requirements and written description standards have created a dilemma where claims are either too broad or too narrow, each with its own set of problems[3].

Key Takeaways

  • Patent-Eligible Subject Matter: Patents can be obtained for new and useful processes, machines, manufactures, or compositions of matter, but not for laws of nature, natural phenomena, or abstract ideas.
  • Claim Scope: The breadth of patent claims is crucial and must be balanced to ensure meaningful protection without violating statutory requirements.
  • Judicial Exceptions: Mathematical algorithms and business methods, under certain conditions, are not patentable.
  • Market Dynamics: Patent assignments and transactions are vital in understanding the redistribution and value of intellectual property.
  • Recent Jurisprudence: Decisions like Alice Corp. v. CLS Bank International and the Federal Circuit's stance on genus claims have significantly impacted the patent landscape.

FAQs

What types of inventions are not patentable under U.S. law?

Inventions that are laws of nature, natural phenomena, or abstract ideas are not patentable under U.S. law[2][3].

How do means-plus-function claims work in patent law?

Means-plus-function claims describe a function and the means for achieving that function, and they are interpreted to include the equivalents of the structures disclosed in the written description of the patent[1].

What is the significance of the State Street Bank case in patent law?

The State Street Bank case established that software programs that transform data are patentable subject matter under Section 101 of the Patent Act[1].

How do recent court decisions impact the patentability of software and business methods?

Recent decisions, such as Alice Corp. v. CLS Bank International, have made it more challenging to patent software and business methods by excluding abstract ideas, even when implemented on a computer[5].

What are the challenges faced by innovators in the pharmaceutical and biotechnology industries regarding genus claims?

Innovators in these industries face challenges due to the rigid enablement requirements and written description standards, which make it difficult to claim the full scope of their inventions without violating statutory requirements[3].

Sources

  1. State Street Bank & Trust v. Signature Financial Group, Inc. - BitLaw
  2. Patent-Eligible Subject Matter - Constitution Annotated
  3. Eviscerating Patent Scope - DigitalCommons@NYLS
  4. The USPTO Patent Assignment Dataset - USPTO
  5. List of patent claim types - Wikipedia

More… ↓

⤷  Subscribe


Drugs Protected by US Patent 8,222,222

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Novartis LEQVIO inclisiran sodium SOLUTION;SUBCUTANEOUS 214012-001 Dec 22, 2021 RX Yes Yes 8,222,222 ⤷  Subscribe AS AN ADJUNCT TO DIET AND STATIN THERAPY FOR THE TREATMENT OF ADULTS WITH PRIMARY HYPERLIPIDEMIA, INCLUDING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH), BY INHIBITING EXPRESSION OF THE PCSK9 GENE ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.