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Last Updated: March 14, 2025

Patent: 10,220,072


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Summary for Patent: 10,220,072
Title:Mesalamine for the treatment of cancer
Abstract: Methods of treating renal cancer, including renal cell carcinoma, using mesalamine are disclosed herein. Mesalamine can be administered as a monotherapy or as part of a comprehensive treatment program, which can also include administration with other anti-cancer drugs, surgical treatments or exposure to ionizing radiation.
Inventor(s): Malhotra; Geena (Mumbai, IN), Joshi; Kalpana (Maharashtra, IN), Ghosalkar; Jeevan (Thane, IN)
Assignee: Cipla Limited (Mumbai, IN)
Application Number:15/833,430
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Analyzing the Claims and Patent Landscape of United States Patent 10,220,072

Introduction

When analyzing the claims and patent landscape of a specific patent, such as United States Patent 10,220,072, it is crucial to consider several key aspects, including the patent's claims, the legal framework governing patentability, and recent developments in patent law and practice.

Understanding the Patent Claims

To begin, it is essential to carefully review the claims of the patent in question. The claims define the scope of the invention and are critical in determining the patent's validity and enforceability. Here are some key points to consider:

Claim Construction

Claim construction involves interpreting the meaning of the terms used in the patent claims. This process is vital for understanding what the patent covers and what it does not. Courts and the USPTO use various tools, such as the patent specification, prosecution history, and extrinsic evidence, to construe claim terms[3].

Claim Types

Patents can have different types of claims, including independent and dependent claims. Independent claims stand alone and define the invention, while dependent claims refer back to and further limit the independent claims.

Patentability Requirements

For a patent to be valid, it must meet the requirements of patentability under U.S. law, which includes novelty, nonobviousness, and subject matter eligibility.

Novelty

The invention must be new and not anticipated by prior art. This is governed by 35 U.S.C. § 102, which outlines what constitutes prior art and when an invention is considered novel[2].

Nonobviousness

The invention must be nonobvious, meaning it must not be an obvious variation of existing technology. This is evaluated under 35 U.S.C. § 103, which requires that the invention as a whole would not have been obvious to a person of ordinary skill in the relevant art at the time of the invention[3].

Obviousness-Type Double Patenting (ODP)

ODP is a doctrine that prevents an inventor from securing a second, later-expiring patent for an invention that is obvious in light of an earlier patent. This is particularly relevant when dealing with patent families and terminal disclaimers. For example, in the case of In re Cellect, the court emphasized that ODP analysis must consider the adjusted expiration date of the patent after any patent term adjustment (PTA)[1].

Prior Art Considerations

Prior art is crucial in determining both novelty and nonobviousness. Under Pre-AIA § 102(e), international applications must explicitly designate the U.S. and be published in English to be considered as prior art. This was highlighted in the case of Regents of the Univ. of Minnesota v. AT&T Mobility LLC, where a PCT application that did not designate the U.S. was not considered prior art[2].

Objective Evidence of Nonobviousness

In addition to the statutory requirements, objective evidence of nonobviousness, such as commercial success, long-felt but unsolved needs, and skepticism of experts, can be critical in supporting the patentability of an invention. This evidence must be tied to the unique characteristics of the claimed invention to establish a nexus[3].

Lead Compound Analysis in Chemical Patents

For chemical patents, the Lead Compound Analysis (LCA) framework is often used to assess obviousness. This framework requires that the prior art compound to be modified exhibits beneficial properties that distinguish it from other compounds in the art. Recent PTAB decisions have shown a shift away from strict adherence to LCA, potentially impacting the landscape for chemical compound patents[5].

Patent Term Adjustments and Terminal Disclaimers

Patent term adjustments (PTA) and terminal disclaimers can significantly impact the patent's term. PTA extends the patent term to compensate for delays in the patent prosecution process, while terminal disclaimers are used to overcome ODP rejections. However, as seen in In re Cellect, a grant of PTA does not extend the term of a patent past the date of a terminal disclaimer[1].

Litigation and Enforcement

The enforceability of a patent is also a critical aspect of its landscape. Patents that are more clearly defined and have a strong foundation in terms of novelty and nonobviousness are more likely to withstand litigation challenges.

Recent Court Decisions

Recent court decisions can provide valuable insights into how patents are being interpreted and enforced. For example, the decision in Regents of the Univ. of Minnesota v. AT&T Mobility LLC highlights the importance of explicit designation of the U.S. in PCT applications for prior art purposes[2].

Industry Impact and Public Perception

The strength and validity of a patent can also impact public perception and industry confidence. Patents that survive challenges and are upheld in court can reinforce the public's faith in the patent system, as seen with the near-universal survival of compound claims under the LCA framework until recent PTAB decisions cast doubt on this trend[5].

Key Takeaways

  • Claim Construction: Accurate interpretation of claim terms is crucial for understanding the scope of the patent.
  • Patentability Requirements: The invention must meet novelty, nonobviousness, and subject matter eligibility criteria.
  • ODP and Terminal Disclaimers: These can significantly impact the patent term and must be considered in patent strategy.
  • Prior Art: Explicit designation of the U.S. in PCT applications is necessary for prior art consideration under Pre-AIA § 102(e).
  • Objective Evidence: Tying evidence of nonobviousness to the unique characteristics of the claimed invention is essential.
  • Litigation and Enforcement: Clear and strong patents are more likely to withstand litigation challenges.

FAQs

What is the significance of ODP in patent law?

ODP prevents an inventor from securing a second, later-expiring patent for an invention that is obvious in light of an earlier patent, ensuring that the patent term is not extended unnecessarily.

How does the Lead Compound Analysis impact chemical patents?

The LCA framework requires that the prior art compound to be modified exhibits beneficial properties, raising the standard for showing obviousness in chemical arts and benefiting patent owners by making it harder to challenge compound patents.

Why is explicit designation of the U.S. in PCT applications important?

Explicit designation of the U.S. in PCT applications is necessary for the application to be considered as prior art under Pre-AIA § 102(e), as highlighted in Regents of the Univ. of Minnesota v. AT&T Mobility LLC[2].

What role does objective evidence play in nonobviousness determinations?

Objective evidence, such as commercial success and industry skepticism, must be tied to the unique characteristics of the claimed invention to establish a nexus and support the nonobviousness of the invention[3].

How do patent term adjustments and terminal disclaimers affect the patent term?

PTA extends the patent term to compensate for prosecution delays, but a grant of PTA does not extend the term past the date of a terminal disclaimer, which is used to overcome ODP rejections[1].

Sources

  1. In re Cellect, United States Court of Appeals for the Federal Circuit, 2023.
  2. Regents of the Univ. of Minnesota v. AT&T Mobility LLC, U.S. District Court for the District of Minnesota, 2024.
  3. Manual of Patent Examining Procedure, USPTO, 2023.
  4. Teva Pharms. Int’l GmbH v. Sandoz, Inc., Federal Circuit, 2020.
  5. Is the Tide Turning on Chemical Patent Challenges at the PTAB?, Sterne, Kessler, Goldstein & Fox P.L.L.C., 2022.

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Details for Patent 10,220,072

ApplicantTradenameBiologic IngredientDosage FormBLAApproval DatePatent No.Expiredate
Genentech, Inc. RITUXAN rituximab Injection 103705 November 26, 1997 10,220,072 2036-06-30
Genentech, Inc. HERCEPTIN trastuzumab For Injection 103792 September 25, 1998 10,220,072 2036-06-30
Genentech, Inc. HERCEPTIN trastuzumab For Injection 103792 February 10, 2017 10,220,072 2036-06-30
Genzyme Corporation CAMPATH alemtuzumab Injection 103948 May 07, 2001 10,220,072 2036-06-30
Genzyme Corporation LEMTRADA alemtuzumab Injection 103948 November 14, 2014 10,220,072 2036-06-30
Genzyme Corporation CAMPATH alemtuzumab Injection 103948 October 12, 2004 10,220,072 2036-06-30
Eli Lilly And Company ERBITUX cetuximab Injection 125084 February 12, 2004 10,220,072 2036-06-30
>Applicant>Tradename>Biologic Ingredient>Dosage Form>BLA>Approval Date>Patent No.>Expiredate
Showing 1 to 7 of 7 entries

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