Patent: 10,028,955

Summary for Patent: 10,028,955

Title:	FGFR inhibitor for use in the treatment of hypophosphatemic disorders
Abstract:	The present invention relates generally to 3-(2,6-Dichloro-3,5-dimethoxy-phenyl)-1-{6-[4-(4-ethyl-piperazin-1-yl)-ph- enylamino]-pyrimid-4-yl}-1-methyl-urea or a pharmaceutically acceptable salt or solvate thereof or a pharmaceutical composition comprising 3-(2,6-Dichloro-3,5-dimethoxy-phenyl)-1-{6-[4-(4-ethyl-piperazin-1-yl)-ph- enylamino]-pyrimid-4-yl}-1-methyl-urea or a pharmaceutically acceptable salt or solvate thereof for use in the treatment of X-linked hypophosphatemic rickets (XLH), autosomal dominant hypophosphatemic rickets (ADHR), autosomal recessive hypophosphatemic rickets (ARHR), tumor-induced osteomalacia, post-renal transplant hypophosphatemia, epidermal nevus syndrome, osteoglophonic dysplasia or McCune-Albright syndrome.
Inventor(s):	Kneissel; Michaela (Basel, CH), Guagnano; Vito (Basel, CH), Graus Porta; Diana (Basel, CH), Wohrle; Simon (Vienna, AT)
Assignee:	Novartis AG (Basel, CH)
Application Number:	15/272,633
Patent Claims:	see list of patent claims

Analyzing the Claims and Patent Landscape of United States Patent 10,028,955

Introduction

Understanding the intricacies of a patent, particularly one like United States Patent 10,028,955, involves a deep dive into its claims, the patent landscape, and the legal and procedural context in which it exists. This analysis will cover the key aspects of the patent, including its claims, the novelty and nonobviousness requirements, the role of the Patent Trial and Appeal Board (PTAB), and the impact of recent legal and procedural changes.

Patent Claims and Their Significance

Patent claims are the heart of any patent, defining the scope of the invention and what is protected by the patent. For a patent like 10,028,955, the claims must meet the novelty and nonobviousness requirements as outlined by U.S. patent law[2].

Novelty Requirement

The claimed invention must be novel, meaning it must not have been patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. This ensures that the inventor has added something new to the existing body of knowledge[2].

Nonobviousness Requirement

Even if a claimed invention is novel, it must also be nonobvious. This means that the invention must not be obvious to a person having ordinary skill in the relevant field at the time of the invention. The nonobviousness requirement is a critical hurdle that ensures only truly innovative inventions are patented[2].

The Role of the Patent Trial and Appeal Board (PTAB)

The PTAB, established by the Leahy-Smith America Invents Act (AIA) in 2011, plays a crucial role in challenging the validity of patents. PTAB procedures, such as Inter Partes Review (IPR) and Post-Grant Review (PGR), provide a more efficient and cost-effective way to adjudicate patent validity issues compared to federal court litigation[2].

IPR and PGR Procedures

IPR and PGR allow anyone to challenge patents before the USPTO, and if successful, can result in the cancellation of patent claims that PTAB concludes should not have issued. These procedures are particularly advantageous for accused patent infringers due to their faster and less expensive nature, as well as the lower burden of proof required to invalidate patents[2].

Obviousness-Type Double Patenting (ODP)

ODP is a doctrine that 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 factors like Patent Term Adjustment (PTA). This doctrine is crucial in ensuring that patents do not extend beyond their intended term and that inventors do not exploit the patent system by securing multiple patents for essentially the same invention[1].

Impact of Patent Term Adjustment (PTA)

PTA can extend the term of a patent due to delays in the patent prosecution process. However, the ODP analysis must consider the adjusted expiration date of the patent, including any PTA. This ensures that the patent term is not extended beyond what is intended by the statute, preventing abuse of the system[1].

Advanced Patent Searching Techniques

When analyzing a patent like 10,028,955, advanced patent searching techniques are essential. These techniques involve leveraging tools and strategies to identify variations in claims across related patents within a patent family. Claims may be amended or narrowed during the prosecution process, and understanding these changes is critical for comprehensive patent insights[3].

Director Review and Its Implications

Recent changes in Director Review processes at the USPTO can impact the validity and enforcement of patents. Director Review allows for an independent review of PTAB decisions, which can lead to rehearing or remand for further proceedings. This process ensures that decisions are thoroughly scrutinized, adding another layer of oversight to the patent system[4].

Patent Assertion Entities (PAEs)

PAEs, often referred to as "patent trolls," can significantly impact the patent landscape. These entities acquire and assert patents, often without manufacturing or selling the patented products. The FTC has identified two main business models for PAEs: Portfolio PAEs and Litigation PAEs. Understanding the behavior and strategies of these entities is crucial for navigating the patent landscape effectively[5].

Critical Analysis of the Patent Landscape

Legal and Procedural Context

The legal and procedural context in which a patent exists is dynamic. Recent changes, such as those introduced by the AIA and subsequent court decisions, have reshaped how patents are challenged and validated. For example, the two-step test for patentable subject matter, known as the Alice test, has significantly impacted what types of inventions are considered patentable[2].

Industry Impact

The patent landscape is also influenced by industry practices and technological advancements. For instance, the dominance of Information and Communication Technology (ICT) patents, particularly software-related patents, has been a significant trend. PAEs often focus on acquiring and asserting these types of patents, which can have broad implications across various industries[5].

Key Takeaways

• Patent Claims: The claims of a patent define its scope and must meet novelty and nonobviousness requirements.
• PTAB Procedures: IPR and PGR provide efficient means to challenge patent validity.
• ODP and PTA: ODP prevents extending patent terms through multiple patents, and PTA adjustments must be considered in ODP analyses.
• Advanced Searching: Comprehensive searches require understanding claim variations and prosecution histories.
• Director Review: Ensures thorough scrutiny of PTAB decisions.
• PAEs: Impact the patent landscape through their assertion and litigation strategies.

FAQs

Q1: What is the significance of the novelty requirement in patent law? The novelty requirement ensures that the claimed invention is new and not previously disclosed, adding to the total stock of knowledge.

Q2: How does the PTAB differ from federal court litigation in challenging patents? PTAB procedures are generally faster, cheaper, and require a lower burden of proof compared to federal court litigation.

Q3: What is Obviousness-Type Double Patenting (ODP), and why is it important? ODP prevents inventors from securing multiple patents for essentially the same invention, ensuring that patents do not extend beyond their intended term.

Q4: How do Patent Assertion Entities (PAEs) impact the patent landscape? PAEs acquire and assert patents, often without manufacturing or selling the patented products, and can significantly influence patent litigation and licensing practices.

Q5: What is the role of Director Review in the USPTO? Director Review provides an independent review of PTAB decisions, ensuring thorough scrutiny and potentially leading to rehearing or remand for further proceedings.

Sources

1. In re Cellect - 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, Updated May 28, 2024.
3. Advanced patent searching techniques - CAS.org, July 24, 2023.
4. 2023 Changes in Director Review - Sterne Kessler, February 8, 2024.
5. Patent Assertion Entity Activity: An FTC Study - Federal Trade Commission.

Details for Patent 10,028,955

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Takeda Pharmaceuticals U.s.a., Inc.	NATPARA	parathyroid hormone	For Injection	125511	January 23, 2015		2032-03-30