United States Patent 7,015,315: A Comprehensive Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 7,015,315, issued to Isis Pharmaceuticals (now Ionis Pharmaceuticals), is a significant patent in the field of antisense drug technology. This patent covers a range of innovations related to antisense oligonucleotides, particularly those with modified sugars, known as "chimeric" oligonucleotides or "gapmers."
Background on Antisense Technology
Antisense oligonucleotides are short, synthetic strands of nucleotides designed to bind to specific messenger RNA (mRNA) sequences. This binding can prevent the translation of the mRNA into a protein, making antisense technology a powerful tool for treating genetic diseases.
Scope of the Patent
The patent 7,015,315 broadly covers oligonucleotides with increased nuclease resistance and improved binding affinity, achieved through specific chemical modifications. Here are the key aspects of its scope:
Chemical Modifications
The patent includes claims for oligonucleotides modified with substituent groups, such as 2'-methoxyethoxy (2'-MOE) nucleosides, which enhance the stability and efficacy of the antisense drugs[1][4].
Gapped Oligonucleotides
The term "gapped oligonucleotides" or "gapmers" refers to oligonucleotides with a central region of deoxyribonucleotides flanked by regions of modified ribonucleotides. This design improves the nuclease resistance and binding affinity of the oligonucleotides[4].
Second-Generation Chemistry
The patent specifically covers Isis' proprietary second-generation chemistry, including generation 2.2 chemistry, which represents a significant advancement in antisense drug design. This chemistry involves specific sugar modifications that enhance the therapeutic properties of the oligonucleotides[1].
Claims of the Patent
The claims of the patent are detailed and extensive, covering various aspects of the oligonucleotides and their applications:
Independent Claims
The patent includes multiple independent claims that define the scope of the invention. These claims specify the structure of the oligonucleotides, including the types of nucleotide units, the regions of modification, and the overall composition of the gapped oligonucleotides[4].
Dependent Claims
Dependent claims further elaborate on the independent claims, providing additional details on the chemical modifications, the length of the oligonucleotides, and the specific applications of these compounds.
Patent Landscape
The issuance of this patent significantly extends Isis' control over antisense drug chemistry and design, adding to their substantial patent estate.
Extensive Patent Portfolio
Isis Pharmaceuticals holds approximately 1,500 issued patents worldwide, covering most oligonucleotide chemistries, designs of antisense drugs, mechanisms of action, specific drugs and gene targets, and manufacturing and analytical methods[1][2].
Commercial Implications
The patent protection provided by 7,015,315 is crucial for Isis' commercial strategy. It extends the patent life of their second-generation antisense drugs, creating valuable commercial opportunities. At the time of the patent's issuance, Isis and its partners had 12 second-generation antisense drugs in clinical development covered by this patent[1].
Impact on Innovation and Licensing
The extensive patent portfolio, including 7,015,315, not only protects Isis' innovations but also forms the basis for lucrative licensing and partnering arrangements. For example, the strategic alliance between Regulus (a joint venture between Isis and Alnylam) and GSK could provide up to nearly $600 million, highlighting the financial significance of these patents[2].
Metrics for Measuring Patent Scope
The scope of a patent like 7,015,315 can be measured using metrics such as independent claim length and independent claim count. These metrics have been shown to have explanatory power for correlates of patent scope, including patent maintenance payments, forward citations, and the breadth of patent classes[3].
Examples and Applications
Mipomersen
One notable example of a drug covered by this patent is mipomersen, an antisense drug developed by Isis and its partner Genzyme. Mipomersen was in Phase 3 studies at the time of the patent's issuance and was intended for the treatment of hypercholesterolemia[2].
AIR645
Another example is AIR645, an antisense drug licensed to Altair for treating respiratory conditions. This drug also benefits from the patent protection provided by 7,015,315[2].
Conclusion and Key Takeaways
- Broad Coverage: The patent 7,015,315 covers a wide range of antisense oligonucleotides with modified sugars, including chimeric oligonucleotides and gapmers.
- Second-Generation Chemistry: It specifically protects Isis' proprietary second-generation chemistry, extending the patent life of these drugs.
- Commercial Significance: The patent is crucial for Isis' commercial strategy, enabling lucrative licensing and partnering arrangements.
- Innovation Protection: The extensive patent portfolio, including this patent, protects Isis' innovations and forms a strong foundation for their business.
- Metrics for Scope: The scope of the patent can be measured using metrics like independent claim length and count, which have significant implications for patent quality and innovation.
FAQs
What is the main focus of United States Patent 7,015,315?
The main focus of this patent is on antisense oligonucleotides with modified sugars, particularly chimeric oligonucleotides or gapmers, which enhance the stability and efficacy of antisense drugs.
How does this patent extend Isis' control over antisense drug chemistry?
This patent extends Isis' control by providing additional patent protection for their second-generation antisense drugs, significantly prolonging the period of protection until March 2023.
What are some examples of drugs covered by this patent?
Examples include mipomersen for treating hypercholesterolemia and AIR645 for treating respiratory conditions.
How does the patent portfolio of Isis Pharmaceuticals impact their business?
Isis' extensive patent portfolio protects their innovations, forms the basis for lucrative licensing and partnering arrangements, and is crucial for their commercial strategy.
What metrics can be used to measure the scope of a patent like 7,015,315?
Metrics such as independent claim length and independent claim count can be used to measure the scope of a patent, providing insights into its breadth and impact.
Sources:
- Isis Pharmaceuticals Receives Another Important Antisense Patent - PR Newswire.
- United States Securities and Exchange Commission - Ionis Pharmaceuticals.
- Patent Claims and Patent Scope - SSRN.
- US7015315B1 - Gapped oligonucleotides - Google Patents.
- Drugs covered by patent 7,015,315 - Drug Patent Watch.
