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Last Updated: December 22, 2024

Details for Patent: 10,266,822


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Which drugs does patent 10,266,822 protect, and when does it expire?

Patent 10,266,822 protects SPINRAZA and is included in one NDA.

Summary for Patent: 10,266,822
Title:Spinal muscular atrophy (SMA) treatment via targeting of SMN2 splice site inhibitory sequences
Abstract: The present invention is directed to methods and compositions capable of blocking the inhibitory effect of a newly-identified intronic inhibitory sequence element, named ISS-N1 (for "intronic splicing silencer"), located in the SMN2 gene. The compositions and methods of the instant invention include oligonucleotide reagents (e.g., oligoribonucleotides) that effectively target the SMN2 ISS-N1 site in the SMN2 pre-mRNA, thereby modulating the splicing of SMN2 pre-mRNA to include exon 7 in the processed transcript. The ISS-N1 blocking agents of the invention cause elevated expression of SMN protein, thus compensating for the loss of SMN protein expression commonly observed in subjects with spinal muscular atrophy (SMA).
Inventor(s): Singh; Ravindra N. (Shrewsbury, MA), Singh; Natalia N. (Shrewsbury, MA), Singh; Nirmal K. (Temple, TX), Androphy; Elliot J. (Natick, MA)
Assignee: UNIVERSITY OF MASSACHUSETTS (Boston, MA)
Application Number:15/269,259
Patent Claim Types:
see list of patent claims
 
Patent landscape, scope, and claims:

Understanding the Scope and Claims of a US Patent: A Detailed Analysis of United States Patent 10,266,822

Introduction

When navigating the complex world of patent law, understanding the scope and claims of a patent is crucial for inventors, patent holders, and legal professionals. This article will delve into the key aspects of patent claims, the importance of claim scope, and the broader patent landscape, using the example of United States Patent 10,266,822, though the specific details of this patent will not be directly available here.

The Importance of Claim Scope in US Patents

What is Claim Scope?

The claim scope in a patent defines the boundaries of what is protected by the patent. It is the heart of the patent application, as it specifies what the inventor considers to be the novel and non-obvious aspects of the invention[3].

Balancing Broad and Narrow Claims

A common misconception is that broader claims are always better. However, broader claims are more difficult to get granted and easier to invalidate. The ideal claim scope must be balanced between being broad enough to cover the invention's essence and narrow enough to avoid invalidation grounds such as the abstract idea exception or failure to meet the written description requirement[3].

Abstract Idea Exception

The abstract idea exception, as outlined in the Alice v. CLS Bank decision, is a critical consideration. Claims that are too broad and invoke generic processes or machinery without improving the relevant technology can be deemed unpatentable as abstract ideas. This highlights the need for claims to be specific and anchored to the embodiments disclosed in the specification[3].

Determining Inventorship

True and Only Inventors

US patent law mandates that only the true and only inventors be listed on the patent application. This involves a two-step process: conception of the idea and reduction of the idea to practice. Incorrect or incomplete identification of inventors can render a patent unenforceable[2].

Consequences of Incorrect Inventorship

The Court of Appeals for the Federal Circuit frequently addresses issues of proper inventorship, often reversing or vacating district court decisions. Ensuring accurate inventorship is vital for maintaining the enforceability of the patent[2].

Patent Prosecution Process

Filing a Patent Application

The process begins with filing a provisional patent application, which provides a temporary protection and allows for further development before filing a non-provisional application. The invention must be novel, non-obvious, enabled, and at risk of public disclosure or invention by others to be considered for patenting[5].

Examination and Rejection

During patent prosecution, the patent examiner reviews the application and may issue rejections if the claims are not patentable as submitted. Applicants can argue against these rejections or amend the claims to overcome the objections. If the examiner's final rejection is not overturned, the applicant may appeal to the Patent Trial and Appeal Board (PTAB) or the federal courts[5].

Obviousness-Type Double Patenting (ODP)

Definition and Impact

ODP prevents an inventor from securing a second, later-expiring patent for an invention covered by a patent that was filed at the same time but has a different patent term due to a grant of Patent Term Adjustment (PTA). This is particularly relevant in cases where multiple patents in a family have different expiration dates due to PTA grants[1].

Case Example: In re Cellect

In the case of In re Cellect, the Federal Circuit addressed ODP issues in a family of patents where some members received PTA, leading to different expiration dates. The court emphasized that ODP analysis must be performed to prevent later-expiring patents from covering the same invention[1].

International Patent Applications

Patent Cooperation Treaty (PCT)

For global protection, inventors can file a PCT application, which preserves the right to file patents in 153 countries within 30 months of the earliest priority date. This is particularly useful for inventions with high commercial value and near-term global licensing opportunities[5].

Costs and Commercial Considerations

Financial Implications

The cost of drafting and filing a non-provisional US patent application can range from $8,000 to $20,000, with international patents costing significantly more. These costs, along with the expenses incurred during patent prosecution, highlight the financial commitment required for patent protection[5].

Commercial Partnerships

Commercial partners often cover these costs, especially if they are identified early in the process. Even without a commercial partner, institutions like KUCTC may incur these costs if there is a reasonable likelihood of recovery from future commercial partnerships[5].

Key Takeaways

  • Claim Scope: The claim scope must be carefully balanced to ensure it is broad enough to protect the invention but narrow enough to avoid invalidation.
  • Inventorship: Accurate identification of the true and only inventors is crucial for maintaining the enforceability of the patent.
  • Patent Prosecution: The process involves filing provisional and non-provisional applications, addressing examiner rejections, and potentially appealing decisions.
  • ODP: Prevents securing later-expiring patents for the same invention, especially relevant in cases with different PTA grants.
  • International Protection: PCT applications provide a pathway for global patent protection.
  • Financial Considerations: Significant costs are associated with patent applications and prosecution, often covered by commercial partners.

FAQs

Q: What is the importance of claim scope in a US patent application?

A: The claim scope defines the boundaries of what is protected by the patent. It must be balanced to ensure it is broad enough to cover the invention but narrow enough to avoid invalidation grounds.

Q: How does the abstract idea exception impact patent claims?

A: The abstract idea exception, as outlined in Alice v. CLS Bank, makes claims that invoke generic processes or machinery without improving the relevant technology unpatentable. Claims must be specific and anchored to the embodiments disclosed in the specification.

Q: What are the consequences of incorrect inventorship in a patent application?

A: Incorrect or incomplete identification of inventors can render a patent unenforceable. Accurate inventorship is vital for maintaining the enforceability of the patent.

Q: What is the role of Patent Term Adjustment (PTA) in patent term?

A: PTA extends the term of a patent due to delays in the USPTO's processing time. However, it does not extend the term past the date of a terminal disclaimer, as seen in cases like In re Cellect[1].

Q: How does the Patent Cooperation Treaty (PCT) facilitate international patent protection?

A: The PCT allows applicants to file a single application that preserves the right to file patents in 153 countries within 30 months of the earliest priority date, providing a pathway for global patent protection[5].

Sources

  1. In re Cellect - United States Court of Appeals for the Federal Circuit[1]
  2. Determining Inventorship for US Patent Applications - Oregon State University[2]
  3. The Importance of Getting the Claim Scope Right in a US Patent Application - Rimon Law[3]
  4. Invention, Knowledge Transfer, and Innovation - National Science Foundation[4]
  5. Intellectual Property Protection - KU Office of Research[5]

More… ↓

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Drugs Protected by US Patent 10,266,822

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Biogen Idec SPINRAZA nusinersen sodium SOLUTION;INTRATHECAL 209531-001 Dec 23, 2016 RX Yes Yes ⤷  Subscribe ⤷  Subscribe TREATMENT OF SPINAL MUSCULAR ATROPHY BY INHIBITING AN SMN2 PRE-MRNA INTRONIC SPLICING SILENCER SITE ⤷  Subscribe
Biogen Idec SPINRAZA nusinersen sodium SOLUTION;INTRATHECAL 209531-001 Dec 23, 2016 RX Yes Yes ⤷  Subscribe ⤷  Subscribe TREATMENT OF SPINAL MUSCULAR ATROPHY BY INCREASING EXON-7 INCLUSION IN SMN2 MRNA ⤷  Subscribe
Biogen Idec SPINRAZA nusinersen sodium SOLUTION;INTRATHECAL 209531-001 Dec 23, 2016 RX Yes Yes ⤷  Subscribe ⤷  Subscribe TREATMENT OF SPINAL MUSCULAR ATROPHY ⤷  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

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