United States Patent 8,557,993: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,557,993, hereafter referred to as the '993 patent, is a pivotal patent in the pharmaceutical industry, particularly in the context of cholesterol-lowering medications. This patent protects the polymorph of pitavastatin calcium, a key component of the drug Livalo®. Here, we delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background of the Patent
The '993 patent was granted to Kowa Company, Ltd., Kowa Pharmaceuticals America, Inc., and Nissan Chemical Corporation. It covers a specific polymorph of pitavastatin calcium, which is used in Livalo®, a statin medication designed to treat elevated cholesterol levels[2].
Scope of the Patent
The scope of the '993 patent is defined by its claims, which specify the particular polymorph of pitavastatin calcium and its use in pharmaceutical formulations. The patent's claims are crucial in determining what is protected and what would constitute infringement.
Claims Analysis
The '993 patent includes multiple claims that describe the polymorph, its preparation, and its use in treating hypercholesterolemia. These claims are detailed and specific, ensuring that the protection extends to the exact form of pitavastatin calcium used in Livalo®. For instance, the claims might include descriptions of the crystalline structure, methods of synthesis, and pharmaceutical compositions containing this polymorph[1].
Patent Validity and Infringement
The validity and infringement of the '993 patent have been extensively litigated. Here are some key points from these legal battles:
Anticipation and Obviousness
Defendants in the litigation, such as Amneal and Apotex, argued that the '993 patent was invalid due to anticipation or obviousness based on prior art. However, the court ruled that the patent was valid, finding that the defendants failed to provide clear and convincing evidence to overcome the presumption of patent validity[1].
Court Decisions
- District Court Decision: In April 2017, the U.S. District Court for the Southern District of New York upheld the validity of the '993 patent and found that Apotex's proposed ANDA product would infringe on it[2].
- Federal Circuit Appeal: The U.S. Court of Appeals for the Federal Circuit affirmed the District Court's decision, solidifying the patent's validity and infringement findings[2].
Patent Landscape
The '993 patent is part of a broader patent landscape that includes other patents related to Livalo® and its active ingredient.
Related Patents
Other patents, such as U.S. Patent No. 5,856,336, also cover aspects of Livalo®, including the pharmaceutical product and its use for treating elevated cholesterol. These patents collectively form a robust intellectual property portfolio that protects Livalo® from generic competition[2].
Generic Challenges
The '993 patent has faced challenges from generic drug manufacturers. Eight different generic manufacturers filed Abbreviated New Drug Applications (ANDAs) with the FDA, which led to extensive litigation. The successful defense of the '993 patent by Kowa and its partners has prevented these generics from entering the market until the patent's expiration[2].
Expiration and Pediatric Extension
The '993 patent is set to expire on February 2, 2024. However, it has benefited from a six-month pediatric extension, which is indicated by the *PED designation. This extension is granted for conducting pediatric studies, further extending the patent's protection period[5].
Impact on the Pharmaceutical Industry
The '993 patent has significant implications for the pharmaceutical industry, particularly in the area of cholesterol-lowering medications.
Innovation and Competition
The protection afforded by the '993 patent has allowed Kowa to maintain market exclusivity for Livalo®, which can impact innovation and competition. While it ensures that Kowa can recoup its investment in research and development, it also delays the entry of generic alternatives, which can increase drug costs for consumers[3].
Litigation and Licensing
The extensive litigation surrounding the '993 patent highlights the complexities and costs associated with patent disputes in the pharmaceutical sector. It also underscores the importance of robust patent portfolios and effective legal strategies in protecting intellectual property[2].
Key Takeaways
- Patent Validity: The '993 patent has been upheld as valid against challenges of anticipation and obviousness.
- Infringement: The patent's infringement has been established against generic manufacturers, preventing them from marketing their versions of Livalo®.
- Patent Landscape: The '993 patent is part of a broader intellectual property portfolio protecting Livalo®.
- Expiration: The patent is set to expire on February 2, 2024, with a six-month pediatric extension.
- Industry Impact: The patent affects innovation, competition, and drug pricing in the cholesterol-lowering medication market.
FAQs
What is the '993 patent, and what does it protect?
The '993 patent protects the polymorph of pitavastatin calcium, a key component of the cholesterol-lowering drug Livalo®.
Who are the holders of the '993 patent?
The patent is held by Kowa Company, Ltd., Kowa Pharmaceuticals America, Inc., and Nissan Chemical Corporation.
What were the outcomes of the litigation involving the '993 patent?
The District Court and the Federal Circuit upheld the validity of the '993 patent and found that generic manufacturers' proposed products would infringe on it.
When is the '993 patent set to expire?
The patent is set to expire on February 2, 2024, with a six-month pediatric extension.
How does the '993 patent impact the pharmaceutical industry?
It maintains market exclusivity for Livalo®, affects innovation and competition, and influences drug pricing by delaying the entry of generic alternatives.
Sources
- Case 1:14-cv-02758-PAC Document 168 Filed 09/19/17 Page 1 of 98
- Victory on Appeal After Lengthy Litigation Over Cholesterol Inhibitor
- Patent Claims and Patent Scope - Hoover Institution
- 208379Orig1s000 - accessdata.fda.gov
- Details for Patent: 8557993 - DrugPatentWatch
