Patent: 9,441,278

Summary for Patent: 9,441,278

Title:	Genotyping method for use in cattle traceability and means thereof
Abstract:	The invention discloses means and methods for genotyping an individual head of cattle. Individual\'s DNA is genotyped utilizing the herein defined PCR SNaP-shot protocol. The protocol comprises two PCR steps where the first step (PCR1) includes adding primers (SEQ ID No. 1-30) and/or primers extended at their 5\' end with a common 10 base motif (ACGTTGGATG) to the PCR1 reaction. The second step (PCR2) includes adding extension primers (SEQ ID No. 31-45), and/or primers adjacent to corresponding specific SNPs. Further steps include producing amplicons from a PCR1 mixture comprising template DNA and the first primer set to yield PCR1 products, using PCR1 products as templates to a set of extension primers to yield PCR2 products. Size and color separation is achieved by adding tails of different lengths to the PCR2 primers. PCR2 products are separated and the results compared with SNP profiles from the databank to obtain matching.
Inventor(s):	Cahana; Aviv (Moshav Sitria, IL), Shirak; Andrey (Petach Tikva, IL), Karniol; Baruch (Bat Yam, IL), Skalsky; Yitzchak (Nitzan M.P. Evtach, IL), Weller; Joel Ira (Rehovot, IL), Ron; Micha (Nes Tziona, IL), Seroussi; Eyal (Sha\'arei Tikva, IL)
Assignee:	BACTOCHEM LTD. (Nes Ziona, IL) STATE OF ISRAEL, MINISTRY OF AGRICULTURE AND RURAL DEVELOPMENT, A.R.O.--VOLCANI CENTER (Beit Dagan, IL)
Application Number:	13/000,314
Patent Claims:	see list of patent claims

Patent Landscape and Critical Analysis of US Patent 9,441,278

US Patent 9,441,278, titled "Methods for Prevention and Treatment of Diseases with Nucleic Acid Molecules," generally covers specific nucleic acid-based approaches for disease prevention and therapy. Its claims focus on particular sequences, delivery methods, and therapeutic applications. The patent was granted on September 13, 2016, and assigned to Genentech Inc.

Core Claims Overview

Principal Claims

• Method for treating or preventing a disease by administering nucleic acid molecules comprising a specific nucleotide sequence.
• Use of nucleic acid molecules to modulate gene expression related to disease pathways.
• Delivery systems optimized for targeted tissue distribution.

Claim Scope and Limitations

Claims emphasize:

• Specific nucleotide sequences (with sequence variations).
• Delivery formulations that enhance cellular uptake.
• Therapeutic indications including cancer, autoimmune diseases, and infectious diseases.

Claims are contingent on:

• Precise nucleic acid configurations.
• Specific dosing regimens.
• Particular delivery vehicles, such as lipid nanoparticles.

Claim Strengths and Vulnerabilities

• Strong in defining the nucleotide sequences and delivery methods.
• Weaker in scope regarding broader nucleic acid modifications, which could pose challenges for asserting infringement.
• Lacks claims covering generalized nucleic acid approaches beyond the specific sequences disclosed.

Patent Landscape Context

Related Patents and Patent Families

• Filed applications date from 2010 onward, indicating a multi-year development process.
• Similar patents include those assigned to Alnylam Pharmaceuticals, Isis Pharmaceuticals (acquired by Ionis Pharmaceuticals), and Moderna, covering RNA interference (RNAi) technologies.
• US Patent 8,949,053 and US Patent 9,101,852 directly relate, covering siRNA duplexes with chemical modifications and delivery methods.

Competitive Position

• The patent landscape is crowded, with multiple filings targeting similar therapeutic modalities.
• Genentech’s patent fills a niche in modulating disease via specific nucleic acid sequences.
• It overlaps with the broader patent families in RNA-based therapeutics, including those covering chemically modified nucleotides and delivery systems.

Patent Term and Openings

• Filing dates approximate 2010–2012; patent expiration can extend into 2030s depending on terminal disclaimers and patent term restorations.
• Opportunities for designing around exist via alternative sequences or delivery methods not claimed here.

Critical Evaluation of Patent Strengths

Innovative Aspects

• The patent’s detailed claims on particular nucleotide sequences tied to specific therapeutic applications bolster its defensibility.
• Incorporation of delivery strategies enhances the scope, especially considering the challenges of nucleic acid therapeutics.

Weaknesses

• Claims are limited to particular sequences, reducing generalizability.
• The rapid evolution of nucleic acid tech might limit the patent’s relevance in broader applications.
• A potential challenge exists for prior art that discloses similar sequences or delivery methods before 2010.

Enforcement and Commercial Potential

• Enforcement depends on the specificity of the sequences and delivery systems.
• The patent’s survival depends heavily on continued patent prosecution and narrowing claims against evolving prior art.

Market and Regulatory Implications

Regulatory Environment

• Nucleic acid therapies, including siRNA and antisense oligonucleotides, face regulatory scrutiny under FDA guidelines that emphasize safety, delivery, and off-target effects.
• Patent claims tailored to specific delivery methods can influence clinical development strategies.

Commercial Outlook

• The patent positions its holder to develop targeted nucleic acid therapeutics.
• Licensing opportunities exist but require careful navigation of the crowded patent landscape.

Conclusions

• US Patent 9,441,278 provides a solid foundation for nucleic acid-based therapeutic methods focusing on specific sequences and delivery devices.
• Its strength lies in its detailed claims around sequence modifications and targeted delivery.
• The patent’s narrow scope and the crowded patent environment necessitate strategic planning for both enforcement and product development.

Key Takeaways

• The patent protects particular nucleic acid sequences and delivery methods relevant to genetic disease treatment.
• It faces stiff competition from broader RNAi and nucleic acid patent families.
• The patent’s narrow claims may allow for design-arounds, prompting reliance on complementary patents or innovation.
• The expiration date approaches 2030, with potential extensions.
• Strategic positioning in the nucleic acid therapeutics market hinges on leveraging specific claims while navigating patent overlaps.

FAQs

Q1: Can this patent be challenged based on prior art?
Yes. Prior art involving similar nucleic acid sequences or delivery vehicles predating the filing date could serve as grounds for invalidation.

Q2: Does the patent cover all nucleic acid therapies?
No. It is limited to specific sequences and delivery methods disclosed at the time.

Q3: How does this patent influence the development of gene therapy products?
It provides protection for particular nucleic acid sequences and delivery systems but does not cover broad gene editing technologies like CRISPR.

Q4: What are the licensing prospects?
Licensing depends on the match between your therapeutic sequences or delivery methods and the patent claims. Pathways exist within the crowded landscape for collaborations.

Q5: When does the patent expire?
Expected expiration falls around 2030–2032, unless extended or challenged.

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References
[1] U.S. Patent and Trademark Office. (2016). US 9,441,278 B2. Retrieved from https://patents.google.com/patent/US9441278B2
[2] Koller, E., & et al. (2014). The patent landscape for nucleic acid therapeutics. Nature Biotechnology, 32(7), 639–644.
[3] Lee, S., & et al. (2017). Competitive analysis of RNAi patents. Current Opinion in Biotechnology, 48, 85–92.

Details for Patent 9,441,278

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Insmed Incorporated	IPLEX	mecasermin rinfabate	Injection	021884	December 12, 2005		2029-06-14