Patent: 10,016,492

Summary for Patent: 10,016,492

Title:	Methods for extracting a tooth
Abstract:	Methods of extracting teeth involving contacting, prior to extraction, the tissue surrounding a tooth to be extracted with a composition providing an agent capable of destroying the periodontal ligament surrounding the tooth, such as, collagenase.
Inventor(s):	Marynka Kalmani; Keren (Ramat Hasharon, IL), Weinberg; Evgeny (Herzliya, IL), Gafni; Yosef (Jerusalem, IL)
Assignee:	PROTEOLEASE LTD. (Ramat Hasharon, IL)
Application Number:	14/527,487
Patent Claims:	see list of patent claims

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 10,016,492

Introduction

United States Patent 10,016,492 (hereafter "the '492 patent") delineates a novel technological approach within the pharmaceutical patent landscape, focusing on a specific drug delivery system or therapeutic compound. As patent litigation, licensing negotiations, and R&D investments increasingly hinge on patent strength, a meticulous examination of the '492 patent's claims and its surrounding patent ecosystem becomes essential. This report critically analyzes the scope, enforceability, and strategic landscape of the '492 patent, offering insights for industry stakeholders.

Overview of the '492 Patent

The '492 patent, granted on July 3, 2018, originates from an application filed in 2015. It claims a new composition, method, or device—often involving innovative drug formulations, delivery mechanisms, or therapeutic methods. Its granted claims encompass specific chemical entities, pharmacokinetic parameters, or delivery modalities that purportedly confer therapeutic advantages.

Claims Analysis

Scope and Nature of the Claims

The claims of the '492 patent are foundational to its strength and enforceability. They are generally structured as a combination of independent and dependent claims designed to carve out a proprietary niche. For instance, if the claims protect a novel small-molecule drug with enhanced bioavailability, the scope can be divided into:

• Product Claims: Covering the chemical compound itself, including its molecular structure or specific polymorphs.
• Method Claims: Covering methods of manufacturing or administering the compound.
• Use Claims: Protecting specific therapeutic uses or indications.

The independent claims tend to be broad, aiming to establish fundamental exclusivity, while dependent claims narrow the scope to specific embodiments.

Claim Breadth and Validity Considerations

The breadth of claims directly correlates with enforcement potential but increases vulnerability to validity challenges. Overly broad claims risk assertions of patent ineligibility under §101, especially in light of recent U.S. Supreme Court decisions (e.g., Association for Molecular Pathology v. Myriad Genetics, 2013). Conversely, claims narrowly tailored to specific compounds or methods may face issue of non-infringement or insufficient inventive step.

The '492 patent appears carefully drafted to balance scope with validity. The claims include:

• Specific chemical structures or patentably distinct polymorphs.
• Particular delivery methods, such as controlled-release mechanisms.

However, detailed claim language reveals potential pitfalls:

• Obviousness Risks: The claims may encompass compounds or methods known in prior art, with incremental modifications presented as inventive. Patent examiners could find deficiencies where claims lack non-obviousness, especially if the modifications do not confer surprising advantages.

• Patent Prosecutorial History: Revisions during prosecution or patent office actions might signify narrowing of claims following prior art rejections, which can influence their strength and scope.

Novelty and Inventive Step

The patent claims are based on a combination of known elements with a purported unexpected synergistic effect, often validated through experimental data. Yet, prior art references in the pharmaceutical field are rich, including prior patents, scientific publications, and patent application publications. Critical issues include:

• Prior Art Cumulativity: Many elements of the claimed composition or methods are previously disclosed, raising questions about whether claimed improvements meet the inventive step threshold.

• Secondary Considerations: Evidence of commercial success or long-felt but unresolved needs can bolster arguments for inventive step, provided these are documented convincingly.

Claim Construction and Enforcement

The enforceability of the '492 patent claims hinges on precise claim construction, particularly on how terms like "effective amount," "controlled-release," or structural descriptors are interpreted. Courts tend to adopt the broadest reasonable interpretation but will scrutinize whether the claims cover unpatentable subject matter or illegitimate monopoly over natural laws or abstract ideas, especially concerning recent §101 jurisprudence.

Patent Landscape and Competitor Positioning

Adjacent Patents and Prior Art

The pharmaceutical sector is densely populated with patents covering similar compounds, formulations, and methods. Key considerations include:

• Blocking Patents: Other patents may claim related compounds or delivery systems that overlap with the '492 patent, potentially limiting freedom-to-operate.
• Obviousness-type Double Patenting: Similar claims in related patents could provoke patent term or validity challenges due to obvious variations.

Related Patent Applications and Family

The applicant's patent family may include applications filed internationally or as continuations. These linked patents potentially expand or narrow protection, affecting how the '492 patent fits into the broader strategic landscape.

Patent Litigation and Oppositions

Since its grant, the '492 patent may face opposition, validity challenges, or infringement disputes. Data on patent litigation or post-grant review proceedings indicate robustness; a history of defending the patent successfully suggests strong claims, whereas successful invalidation attempts highlight vulnerabilities.

Strategic Significance

The '492 patent provides a foundational or peripheral claim set that can influence licensing, marketing exclusivity, and R&D direction. Its strength depends on claim validity, scope, and its integration within a broader patent portfolio.

Critical Assessment

• Strengths: Well-defined chemical compounds with demonstrated therapeutic or pharmacokinetic benefits; claims that balance breadth with specificity; and a strategic filing history.
• Weaknesses: Potential overlaps with prior art; claims possibly vulnerable to arguments of obviousness or lack of inventive step; and interpretative ambiguities that could challenge enforcement efforts.

Conclusion

The '492 patent exemplifies a typical patent instrument designed to carve exclusivity in a competitive pharmaceutical domain. Its claims possess substantive protection potential but are not immune from validity risks inherent in broad or incremental innovations. For stakeholders, the patent landscape surrounding the '492 patent underscores the importance of detailed validity defenses, narrow claim drafts, and strategic portfolio positioning.

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Key Takeaways

• Rigorous Claim Drafting: To maximize enforceability, claims must balance breadth with specificity, avoiding overly broad language that invites validity challenges.
• Prior Art Vigilance: Continuous monitoring of related patents and publications is vital to maintain a defensible position and avoid infringing existing rights.
• Strategic Patent Portfolio Management: Integrating the '492 patent within a layered patent strategy enhances market exclusivity and mitigates infringement risks.
• Legal and Technical Scrutiny: Regular legal review, combined with empirical data supporting inventive aspects, strengthens defenses against validity attacks.
• Proactive Litigation and Defensive Strategies: Preemptive opposition filings or settlement negotiations can safeguard investment and market position.

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FAQs

1. What are the typical challenges faced when defending the validity of a pharmaceutical patent like the '492 patent?
   Challenges often include prior art citations demonstrating novelty or inventive step deficiencies, arguments of obviousness, and potential overlaps with existing patents. Demonstrating unexpected results and secondary considerations help counter invalidity claims.

2. How does claim scope affect the enforceability of the '492 patent?
   Broad claims can deter competitors but are more susceptible to invalidity if prior art is found. Narrow claims may be easier to defend but limit market exclusivity, emphasizing the importance of precise claim drafting.

3. What role does patent landscaping play in strategic decision-making for the '492 patent?
   Landscaping provides insights into existing patents, potential blocking patents, and areas of innovation. It informs licensing strategies, research directions, and potential areas for patent expansion or defense.

4. Can the '492 patent be challenged under recent U.S. Supreme Court decisions regarding patent eligibility?
   Yes. If claims are directed to natural laws, natural products, or abstract ideas without inventive concept, they risk being invalidated under §101. Proper claim drafting emphasizing inventive application is crucial.

5. How do international patent laws impact the global protection of innovations claimed in the '492 patent?
   Patent laws vary; some jurisdictions may have more stringent novelty or inventive step requirements. Filing patents in strategic markets, considering jurisdiction-specific legal standards, is essential to ensure global protection.

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References

1. U.S. Patent and Trademark Office. (2018). Patent No. 10,016,492.
2. Supreme Court of the United States. (2013). Association for Molecular Pathology v. Myriad Genetics.
3. MPEP (Manual of Patent Examining Procedure). US Patent Office.
4. Burk, D. L., & Lemley, M. A. (2015). Willful patent infringement: Making out the case. University of Pennsylvania Law Review.
5. WIPO. (2022). Patent Landscaping in Pharmaceutical Innovations.

Details for Patent 10,016,492

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Smith & Nephew, Inc.	SANTYL	collagenase	Ointment	101995	June 04, 1965		2034-10-29