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Understanding the Claims and Patent Landscape of US Patent 10,336,983

Introduction

US Patent 10,336,983, titled "Method for increasing the specific production rate of eukaryotic cells," is a significant patent in the field of biotechnology. To analyze this patent comprehensively, we need to delve into its claims, the broader patent landscape, and the legal and procedural aspects surrounding it.

The Patent Claims

Overview of the Invention

The patent describes a method for increasing the specific production rate of eukaryotic cells, particularly those producing or expressing polypeptides. The invention involves the use of meta-tyrosine to enhance cellular productivity[4].

Types of Claims

The claims in this patent can be categorized into several types, including:

Process (or method) claims: These claims define the steps involved in the method for increasing the specific production rate of eukaryotic cells.
Product claims: While not the primary focus, these could include claims related to the cells or polypeptides produced using the method.
Composition claims: These might involve the specific composition of the medium or solution used in the process.

Claim Structure and Clarity

Effective patent claims must be clear, concise, and well-defined to avoid ambiguity and ensure enforceability. The WIPO Patent Drafting Manual emphasizes the importance of clarity, word choice, and consistency in claim drafting. Claims should define terms clearly, distinguish elements, and avoid relative terms and inconsistencies[3].

Broad and Narrow Claims

The patent likely includes a mix of broad and narrow claims. Broad claims aim to capture the essence of the invention, while narrow claims provide specific details to protect against infringement. The balance between broad and narrow claims is crucial for maximizing patent protection while avoiding invalidation due to prior art or lack of novelty[3].

Patentability Requirements

Novelty

For a patent to be granted, the claimed invention must be novel, meaning it must not have been previously disclosed in the prior art. The USPTO cannot issue a patent if the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date[2].

Nonobviousness

The invention must also be nonobvious, meaning it must involve an inventive step beyond what would be obvious to a person of ordinary skill in the relevant field. This requirement ensures that the patent protects genuine innovations rather than trivial improvements[2].

Industrial Applicability

The invention must be industrially applicable, or useful, to be patentable. This means the invention must have a practical application and be capable of being made or used in some form of industry[3].

The Patent Landscape

Patent Allowance Rates

Understanding the patent landscape involves analyzing the probability of receiving a patent. The USPTO's allowance rates vary based on several factors, including the technology field and the type of applicant. For instance, the family allowance rate, which includes the outcomes of continuation applications, provides a more comprehensive view of the patent examination process[1].

Continuation Procedures

The patent landscape is also influenced by continuation procedures, such as Requests for Continued Examination (RCEs) and continuation-in-part (CIP) applications. These procedures allow applicants to refine their applications and introduce new subject matter, complicating the calculation of allowance rates but providing additional opportunities for patent protection[1].

Inter Partes Review (IPR) and Patent Trial and Appeal Board (PTAB)

The Leahy-Smith America Invents Act (AIA) introduced significant changes to U.S. patent law, including the creation of the PTAB and IPR procedures. These mechanisms allow for faster and more cost-effective challenges to patent validity compared to federal court litigation. This can impact the enforceability and validity of patents like US 10,336,983, especially if they are challenged by competitors or accused infringers[2].

Drafting and Prosecution

Patent Application Preparation

The preparation of a patent application involves several key steps, including drafting claims, descriptions, drawings, and an abstract. The WIPO Patent Drafting Manual provides detailed guidance on these aspects, emphasizing the importance of clarity and consistency in the application[3].

Responding to Office Actions

During the prosecution phase, applicants must respond to office actions from the USPTO. This involves addressing examiner objections, amending claims, and ensuring that the application meets all legal requirements. Effective communication and strategic amendments are crucial for overcoming rejections and securing patent protection[3].

Critical Analysis

Market Value and Innovation

While the number of patents filed can indicate a country's or company's innovative activity, not all patents have equal market value. Only a fraction of patents, such as US 10,336,983, may represent significant innovations with market potential. This highlights the need to critically evaluate patent data to understand true innovativeness[5].

Competitive Landscape

In the biotechnology sector, patents like US 10,336,983 can be critical for competitive advantage. Companies must carefully manage their patent portfolios to protect their inventions and prevent infringement. The use of continuation procedures and defensive strategies can be essential in maintaining a strong patent position[1].

Key Takeaways

Clear and Well-Defined Claims: Effective patent claims must be clear, concise, and well-defined to ensure enforceability.
Patentability Requirements: The invention must meet novelty, nonobviousness, and industrial applicability requirements to be patentable.
Continuation Procedures: Continuation procedures can significantly impact the patent examination process and the overall patent landscape.
IPR and PTAB: The PTAB and IPR procedures can affect the validity and enforceability of patents, making them important considerations in patent strategy.
Market Value: Not all patents have equal market value, and critical evaluation of patent data is necessary to understand true innovativeness.

FAQs

Q: What is the main invention described in US Patent 10,336,983?

A: The main invention is a method for increasing the specific production rate of eukaryotic cells using meta-tyrosine.

Q: What are the key requirements for a patent to be granted in the United States?

A: The invention must be novel, nonobvious, and industrially applicable.

Q: How do continuation procedures affect the patent examination process?

A: Continuation procedures allow applicants to refine their applications and introduce new subject matter, complicating the calculation of allowance rates but providing additional opportunities for patent protection.

Q: What is the role of the Patent Trial and Appeal Board (PTAB) in patent law?

A: The PTAB hears administrative challenges to the validity of patents, providing a faster and more cost-effective alternative to federal court litigation.

Q: Why is it important to critically evaluate patent data?

A: Not all patents have equal market value, and critical evaluation helps to understand true innovativeness and the competitive landscape.

Sources

Carley, M., & Hegde, D. (n.d.). What Is the Probability of Receiving a US Patent?. Retrieved from https://yjolt.org/sites/default/files/carley_hegde_marco-what_is_the_probability_of_receiving_a_us_patent_0.pdf
Congressional Research Service. (2024). The Patent Trial and Appeal Board and Inter Partes Review. Retrieved from https://crsreports.congress.gov/product/pdf/R/R48016
WIPO. (n.d.). WIPO Patent Drafting Manual: Second Edition. Retrieved from https://www.wipo.int/edocs/pubdocs/en/wipo-pub-867-23-en-wipo-patent-drafting-manual.pdf
Google Patents. (n.d.). Method for increasing the specific production rate of eukaryotic cells. Retrieved from https://patents.google.com/patent/US10336983B2/en
Center for Strategic and International Studies. (2022). What Can Patent Data Reveal about U.S.-China Technology Competition?. Retrieved from https://www.csis.org/analysis/what-can-patent-data-reveal-about-us-china-technology-competition

Title:	Method for increasing the specific production rate of eukaryotic cells
Abstract:	The current invention reports the use of meta-tyrosine for increasing the specific productivity of a eukaryotic cell that produces/expresses a polypeptide. In the current method it is not necessary to perform a temperature-, osmolality- or pH shift or to add drugs like valproic acid or sodium butyrate to modulate the specific productivity of the cultivated cells. The method does not affect cell viability or product titer.
Inventor(s):	Popp Oliver
Assignee:	Hoffmann-La Roche Inc.
Application Number:	US15428279
Patent Claims:	see list of patent claims
Patent landscape, scope, and claims summary:	Understanding the Claims and Patent Landscape of US Patent 10,336,983 Introduction US Patent 10,336,983, titled "Method for increasing the specific production rate of eukaryotic cells," is a significant patent in the field of biotechnology. To analyze this patent comprehensively, we need to delve into its claims, the broader patent landscape, and the legal and procedural aspects surrounding it. The Patent Claims Overview of the Invention The patent describes a method for increasing the specific production rate of eukaryotic cells, particularly those producing or expressing polypeptides. The invention involves the use of meta-tyrosine to enhance cellular productivity[4]. Types of Claims The claims in this patent can be categorized into several types, including: Process (or method) claims: These claims define the steps involved in the method for increasing the specific production rate of eukaryotic cells. Product claims: While not the primary focus, these could include claims related to the cells or polypeptides produced using the method. Composition claims: These might involve the specific composition of the medium or solution used in the process. Claim Structure and Clarity Effective patent claims must be clear, concise, and well-defined to avoid ambiguity and ensure enforceability. The WIPO Patent Drafting Manual emphasizes the importance of clarity, word choice, and consistency in claim drafting. Claims should define terms clearly, distinguish elements, and avoid relative terms and inconsistencies[3]. Broad and Narrow Claims The patent likely includes a mix of broad and narrow claims. Broad claims aim to capture the essence of the invention, while narrow claims provide specific details to protect against infringement. The balance between broad and narrow claims is crucial for maximizing patent protection while avoiding invalidation due to prior art or lack of novelty[3]. Patentability Requirements Novelty For a patent to be granted, the claimed invention must be novel, meaning it must not have been previously disclosed in the prior art. The USPTO cannot issue a patent if the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date[2]. Nonobviousness The invention must also be nonobvious, meaning it must involve an inventive step beyond what would be obvious to a person of ordinary skill in the relevant field. This requirement ensures that the patent protects genuine innovations rather than trivial improvements[2]. Industrial Applicability The invention must be industrially applicable, or useful, to be patentable. This means the invention must have a practical application and be capable of being made or used in some form of industry[3]. The Patent Landscape Patent Allowance Rates Understanding the patent landscape involves analyzing the probability of receiving a patent. The USPTO's allowance rates vary based on several factors, including the technology field and the type of applicant. For instance, the family allowance rate, which includes the outcomes of continuation applications, provides a more comprehensive view of the patent examination process[1]. Continuation Procedures The patent landscape is also influenced by continuation procedures, such as Requests for Continued Examination (RCEs) and continuation-in-part (CIP) applications. These procedures allow applicants to refine their applications and introduce new subject matter, complicating the calculation of allowance rates but providing additional opportunities for patent protection[1]. Inter Partes Review (IPR) and Patent Trial and Appeal Board (PTAB) The Leahy-Smith America Invents Act (AIA) introduced significant changes to U.S. patent law, including the creation of the PTAB and IPR procedures. These mechanisms allow for faster and more cost-effective challenges to patent validity compared to federal court litigation. This can impact the enforceability and validity of patents like US 10,336,983, especially if they are challenged by competitors or accused infringers[2]. Drafting and Prosecution Patent Application Preparation The preparation of a patent application involves several key steps, including drafting claims, descriptions, drawings, and an abstract. The WIPO Patent Drafting Manual provides detailed guidance on these aspects, emphasizing the importance of clarity and consistency in the application[3]. Responding to Office Actions During the prosecution phase, applicants must respond to office actions from the USPTO. This involves addressing examiner objections, amending claims, and ensuring that the application meets all legal requirements. Effective communication and strategic amendments are crucial for overcoming rejections and securing patent protection[3]. Critical Analysis Market Value and Innovation While the number of patents filed can indicate a country's or company's innovative activity, not all patents have equal market value. Only a fraction of patents, such as US 10,336,983, may represent significant innovations with market potential. This highlights the need to critically evaluate patent data to understand true innovativeness[5]. Competitive Landscape In the biotechnology sector, patents like US 10,336,983 can be critical for competitive advantage. Companies must carefully manage their patent portfolios to protect their inventions and prevent infringement. The use of continuation procedures and defensive strategies can be essential in maintaining a strong patent position[1]. Key Takeaways Clear and Well-Defined Claims: Effective patent claims must be clear, concise, and well-defined to ensure enforceability. Patentability Requirements: The invention must meet novelty, nonobviousness, and industrial applicability requirements to be patentable. Continuation Procedures: Continuation procedures can significantly impact the patent examination process and the overall patent landscape. IPR and PTAB: The PTAB and IPR procedures can affect the validity and enforceability of patents, making them important considerations in patent strategy. Market Value: Not all patents have equal market value, and critical evaluation of patent data is necessary to understand true innovativeness. FAQs Q: What is the main invention described in US Patent 10,336,983? A: The main invention is a method for increasing the specific production rate of eukaryotic cells using meta-tyrosine. Q: What are the key requirements for a patent to be granted in the United States? A: The invention must be novel, nonobvious, and industrially applicable. Q: How do continuation procedures affect the patent examination process? A: Continuation procedures allow applicants to refine their applications and introduce new subject matter, complicating the calculation of allowance rates but providing additional opportunities for patent protection. Q: What is the role of the Patent Trial and Appeal Board (PTAB) in patent law? A: The PTAB hears administrative challenges to the validity of patents, providing a faster and more cost-effective alternative to federal court litigation. Q: Why is it important to critically evaluate patent data? A: Not all patents have equal market value, and critical evaluation helps to understand true innovativeness and the competitive landscape. Sources Carley, M., & Hegde, D. (n.d.). What Is the Probability of Receiving a US Patent?. Retrieved from https://yjolt.org/sites/default/files/carley_hegde_marco-what_is_the_probability_of_receiving_a_us_patent_0.pdf Congressional Research Service. (2024). The Patent Trial and Appeal Board and Inter Partes Review. Retrieved from https://crsreports.congress.gov/product/pdf/R/R48016 WIPO. (n.d.). WIPO Patent Drafting Manual: Second Edition. Retrieved from https://www.wipo.int/edocs/pubdocs/en/wipo-pub-867-23-en-wipo-patent-drafting-manual.pdf Google Patents. (n.d.). Method for increasing the specific production rate of eukaryotic cells. Retrieved from https://patents.google.com/patent/US10336983B2/en Center for Strategic and International Studies. (2022). What Can Patent Data Reveal about U.S.-China Technology Competition?. Retrieved from https://www.csis.org/analysis/what-can-patent-data-reveal-about-us-china-technology-competition More… ↓ ⤷ Try for Free

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate

Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085	February 26, 2004	10,336,983	2037-02-09
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

Patent: 10,336,983

Summary for Patent: 10,336,983