Understanding the Scope and Claims of United States Patent 11,384,086
Introduction
The United States Patent 11,384,086, titled "Crystalline forms of 3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-n-{4-[(4-methylpiperazin-1-yl)methyl]-3-(trifluoromethyl)phenyl}benzamide and its mono hydrochloride salt," is a critical patent in the pharmaceutical industry, particularly in the treatment of certain types of leukemia. Here, we delve into the details of this patent, its claims, and the broader patent landscape.
Background of Ponatinib Hydrochloride
Ponatinib hydrochloride, marketed under the brand name Iclusig, is a tyrosine kinase inhibitor (TKI) developed by Ariad Pharmaceuticals (now part of Takeda Pharmaceuticals). It is specifically designed to treat patients with chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) who have developed resistance to first and second-line TKI therapies[2].
Patent Overview
The patent 11,384,086 focuses on the crystalline forms of ponatinib hydrochloride and its mono hydrochloride salt. Here are the key aspects:
Crystalline Forms
The patent describes various crystalline forms of the compound, which are crucial for the stability, bioavailability, and efficacy of the drug. These forms are characterized by specific X-ray powder diffraction (XRPD) patterns, melting points, and other physical and chemical properties[1][4].
Mono Hydrochloride Salt
The mono hydrochloride salt of ponatinib is an important formulation that enhances the solubility and stability of the drug. This salt form is essential for the pharmaceutical formulation of Iclusig, which is administered in tablet form[1][4].
Claims of the Patent
The claims of the patent are detailed and specific, covering various aspects of the crystalline forms and the mono hydrochloride salt:
Independent Claims
The independent claims define the broad scope of the invention, including the specific chemical structure of the crystalline forms and the methods for their preparation. These claims are pivotal in establishing the novelty and non-obviousness of the invention[1].
Dependent Claims
The dependent claims further narrow down the scope by specifying particular characteristics, such as XRPD peaks, melting points, and other physical properties. These claims provide additional protection by covering various embodiments of the crystalline forms[1].
Patent Landscape
The patent landscape surrounding ponatinib hydrochloride is complex and involves multiple patents and legal disputes.
Related Patents
Other patents related to ponatinib hydrochloride include Patent Nos. 9,493,470, 11,192,895, and 11,192,897. These patents cover different aspects of the drug, such as other crystalline forms and methods of use. The collective scope of these patents ensures comprehensive protection for Takeda Pharmaceuticals against generic competitors[2].
Patent Expiration Dates
The patent expiration dates for related patents are crucial for understanding the timeline of generic competition. For example, Patent 9,493,470 expires on December 22, 2026, and Patent 8,114,874 expires on January 24, 2027. These dates mark the potential entry points for generic versions of Iclusig[5].
Legal Disputes and Infringement Cases
Takeda Pharmaceuticals has been involved in several patent infringement cases to protect its intellectual property rights. A notable case is against Apotex Inc., where Takeda alleged that Apotex's Abbreviated New Drug Application (ANDA) for a generic ponatinib hydrochloride tablet infringed the patents-in-suit, including the '086 patent[2].
Claim Construction
The legal disputes often revolve around the construction of key patent terms. The court's role in claim construction is critical, as it determines the meaning of the claims and compares them to the allegedly infringing product. This process involves analyzing the patent itself, prosecution history, and sometimes extrinsic evidence like expert testimony[2].
Impact on the Pharmaceutical Industry
The patent 11,384,086 has significant implications for the pharmaceutical industry:
Innovation and Competition
The patent protects Takeda's investment in research and development, ensuring that the company can recoup its costs and continue innovating. However, it also limits competition from generic manufacturers until the patent expires, which can affect drug prices and accessibility[3].
Generic Entry
The expiration of these patents will open the market to generic versions of Iclusig, potentially reducing costs for patients and increasing access to the drug. However, the complexity of the patent landscape and ongoing legal disputes may delay generic entry[5].
Key Takeaways
- Crystalline Forms and Mono Hydrochloride Salt: The patent 11,384,086 specifically covers the crystalline forms of ponatinib hydrochloride and its mono hydrochloride salt, which are essential for the drug's stability and efficacy.
- Claims and Scope: The patent includes independent and dependent claims that define the scope of the invention, protecting various aspects of the crystalline forms and their preparation methods.
- Patent Landscape: The patent is part of a broader landscape that includes other related patents, with specific expiration dates that will impact generic competition.
- Legal Disputes: Takeda Pharmaceuticals has been involved in patent infringement cases to protect its intellectual property rights, with claim construction being a critical aspect of these disputes.
- Industry Impact: The patent affects innovation, competition, and drug accessibility, with its expiration potentially leading to the entry of generic versions of Iclusig.
FAQs
Q1: What is the primary focus of United States Patent 11,384,086?
The primary focus is on the crystalline forms of ponatinib hydrochloride and its mono hydrochloride salt.
Q2: Why are crystalline forms important in pharmaceuticals?
Crystalline forms are crucial for the stability, bioavailability, and efficacy of the drug.
Q3: What is the significance of the mono hydrochloride salt in Iclusig?
The mono hydrochloride salt enhances the solubility and stability of ponatinib hydrochloride, making it suitable for pharmaceutical formulation.
Q4: What are the key dates related to the patent expiration of related patents?
Patent 9,493,470 expires on December 22, 2026, and Patent 8,114,874 expires on January 24, 2027.
Q5: How do patent infringement cases impact the pharmaceutical industry?
Patent infringement cases protect the intellectual property rights of pharmaceutical companies, affecting competition and the timing of generic drug entry into the market.
Sources
- US11384086B2 - Crystalline forms of 3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-n-{4-[(4-methylpiperazin-1-yl)methyl]-3-(trifluoromethyl)phenyl}benzamide and its mono hydrochloride salt - Google Patents
- Takeda Pharm. Am. v. Apotex, Inc. - Casetext
- Patent Claims and Patent Scope - Hoover Institution
- WO2014093579A2 - Crystalline forms of 3-(imidazo[1,2-b] pyridazin-3-ylethynyl)-4-methyl-n-(4-[(4-methylpiperazin-1-yl) methyl]-3-(trifluoromethyl)phenyl}benzamide and its mono hydrochloride salt - Google Patents
- Generic Iclusig Availability - Drugs.com
