Patent: 10,889,635

Summary for Patent: 10,889,635

Title:	Agents, uses and methods for the treatment of synucleinopathy
Abstract:	The invention relates to combinational treatment using a monoclonal anti-alpha-synuclein antibody and an additional medicament. The antibodies can be used for treating a synucleinopathy such as Parkinson's disease (including idiopathic and inherited forms of Parkinson's disease), Diffuse Lewy Body Disease (DLBD), Lewy body variant of Alzheimer's disease (LBV), Combined Alzheimer's and Parkinson disease, pure autonomic failure and multiple system atrophy together with another medicament of the invention.
Inventor(s):	Kallunki Pekka, Kristjansen Paul E. G.
Assignee:	H. Lundbeck A/S
Application Number:	US15812648
Patent Claims:	see list of patent claims

Comprehensive Analysis of United States Patent 10,889,635: Navigating the Complexities of Patent Law

Introduction

United States Patent 10,889,635, like any other patent, exists within a complex and evolving patent landscape. This analysis will delve into the key aspects of this patent, including its claims, the legal framework governing it, and the broader implications within the U.S. patent system.

Understanding the Patent Claims

Claim Construction

The claims of a patent are the heart of the invention, defining the scope of the patentee's rights. For U.S. Patent 10,889,635, each claim must be carefully constructed to meet the requirements of patentability, including novelty, nonobviousness, and utility[4].

Types of Claims

Patent claims can be independent or dependent. Independent claims stand alone and define the invention, while dependent claims refer back to and further limit an independent claim. The clarity and specificity of these claims are crucial for determining the patent's validity and enforceability.

Legal Framework: The America Invents Act (AIA)

Overview of the AIA

The Leahy-Smith America Invents Act (AIA) of 2011 significantly altered the U.S. patent landscape. It introduced new procedures for challenging patent validity, such as Inter Partes Review (IPR) and Post-Grant Review (PGR), which are adjudicated by the Patent Trial and Appeal Board (PTAB)[2].

PTAB and Its Role

The PTAB is a tribunal within the U.S. Patent and Trademark Office (USPTO) that hears challenges to the validity of patents. These challenges can be initiated by anyone, regardless of whether they are facing a lawsuit or the threat of one. This has led to concerns about the fairness and efficiency of the system, particularly for small businesses and independent innovators[3].

Obviousness-Type Double Patenting (ODP)

Definition and Implications

Obviousness-type double patenting (ODP) is a doctrine that prevents an inventor from securing a second, later-expiring patent for an invention that is not patentably distinct from an earlier patent. This is particularly relevant for patents that are part of the same family and claim priority from the same application, as seen in the case of In re Cellect LLC[1].

Case Law and Statutory Language

The Federal Circuit has clarified that ODP analysis must consider the date of expiration of a patent, including any Patent Term Adjustment (PTA) granted due to USPTO delays. This ensures that patents within the same family do not extend beyond the intended term, preventing undue extension of patent rights[1].

Patent Term Adjustments and Extensions

Patent Term Adjustment (PTA)

PTA is granted to compensate for delays during the prosecution of a patent application. However, as seen in In re Cellect LLC, PTA does not extend the term of a patent past the date of a terminal disclaimer. This distinction is crucial for maintaining the balance between rewarding inventors for delays and preventing the undue extension of patent terms[1].

Patent Term Extension (PTE)

Unlike PTA, a Patent Term Extension (PTE) under 35 U.S.C. § 156 can extend the term of a patent beyond the normal expiration date, typically due to regulatory delays. However, ODP does not invalidate a validly obtained PTE, as established in Novartis AG v. Ezra Ventures LLC[1].

Challenges and Litigation

Inter Partes Review (IPR) and Post-Grant Review (PGR)

IPR and PGR are administrative challenges that can be brought before the PTAB. These proceedings are generally faster and less expensive than federal court litigation and require a lower burden of proof to invalidate patents. This makes them attractive options for entities accused of patent infringement or those seeking to challenge patent validity[2].

Duplicative Challenges

The PREVAIL Act aims to address the issue of duplicative challenges by requiring a party to choose between making validity challenges before the PTAB or in another forum, such as federal court. This helps prevent inefficient and potentially inconsistent decisions between different tribunals[3].

Impact on Innovators and Small Businesses

Fairness and Efficiency

The current PTAB system has been criticized for its potential to unfairly burden small businesses and independent innovators. The PREVAIL Act proposes reforms to require standing for PTAB challengers and limit repeated petitions, aiming to promote fairness and efficiency in the patent system[3].

Resource Allocation

Small businesses often lack the resources to navigate the complex patent system. The PREVAIL Act includes provisions to support these entities by expanding access to patent-searching tools and requiring the Small Business Administration to examine the impact of patents and abusive demand letters on small businesses[3].

International and Economic Implications

Technological Leadership

Patented inventions are crucial for sustaining U.S. economic growth, protecting national security, and ensuring global technological leadership. The U.S. is in a competitive race with countries like China, and reforms to the patent system aim to ensure that the U.S. remains at the forefront of innovation[3].

Economic Growth

Patents incentivize investments in research and development (R&D) and enable the commercialization of emerging technologies. A robust and efficient patent system is essential for fostering innovation and economic growth[3].

Key Takeaways

• Patent Claims: The claims of a patent are critical and must meet the requirements of novelty, nonobviousness, and utility.
• AIA and PTAB: The America Invents Act introduced new challenges to patent validity, such as IPR and PGR, which are adjudicated by the PTAB.
• ODP: Obviousness-type double patenting prevents inventors from securing later-expiring patents for non-distinct inventions.
• PTA and PTE: Patent Term Adjustments and Extensions have different implications for patent term, with PTA not extending beyond the terminal disclaimer date.
• Challenges and Litigation: IPR and PGR provide faster and less expensive alternatives to federal court litigation but can be duplicative and inefficient.
• Impact on Innovators: Reforms like the PREVAIL Act aim to promote fairness and efficiency, particularly for small businesses and independent innovators.

FAQs

What is the role of the Patent Trial and Appeal Board (PTAB) in the U.S. patent system?

The PTAB is a tribunal within the USPTO that hears administrative challenges to the validity of patents, including Inter Partes Review (IPR) and Post-Grant Review (PGR).

How does Obviousness-Type Double Patenting (ODP) affect patent families?

ODP prevents an inventor from securing a second, later-expiring patent for an invention that is not patentably distinct from an earlier patent, ensuring that patents within the same family do not extend beyond the intended term.

What is the difference between Patent Term Adjustment (PTA) and Patent Term Extension (PTE)?

PTA compensates for delays during patent prosecution and does not extend the term beyond the terminal disclaimer date, while PTE can extend the term due to regulatory delays and is not invalidated by ODP.

How do IPR and PGR differ from federal court litigation?

IPR and PGR are faster, less expensive, and require a lower burden of proof to invalidate patents compared to federal court litigation.

What reforms does the PREVAIL Act propose for the PTAB system?

The PREVAIL Act proposes reforms to require standing for PTAB challengers, limit repeated petitions, end duplicative challenges, and ensure the USPTO has the necessary resources to administer the patent system efficiently.

Sources

1. In re Cellect, LLC, United States Court of Appeals for the Federal Circuit, August 28, 2023.
2. The Patent Trial and Appeal Board and Inter Partes Review, Congressional Research Service, June 29, 2023.
3. PREVAIL Act Fact Sheet, Senator Coons, [Date not specified].
4. Chisum on Patents, LexisNexis Store, [Date not specified].

Details for Patent 10,889,635

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Biogen Inc.	ADUHELM	aducanumab-avwa	Injection	761178	June 07, 2021	10,889,635	2037-11-14