Details for Patent: 9,333,204

Which drugs does patent 9,333,204 protect, and when does it expire?

Patent 9,333,204 protects VIEKIRA XR and is included in one NDA.

This patent has three patent family members in three countries.

Summary for Patent: 9,333,204

Title:	Solid antiviral dosage forms
Abstract:	The present disclosure relates to solid dosage forms comprising antiviral compounds and methods of using such dosage forms to treat antiviral infection.
Inventor(s):	Jonathan M. Miller, John B. Morris, Nancy E. Sever, Eric A. Schmitt, Ping X. Gao, Yi Shi, Yi Gao, Bernd Liepold, Anna Moosmann, Mirko Pauli, Fatih Durak, Thomas Kessler, Peter A. Hoelig, Karin Rosenblatt, Drazen Kostelac, Rajeev Gokhale, Mark Costello, Carl Knable
Assignee:	AbbVie Inc
Application Number:	US14/677,611
Patent Claim Types: see list of patent claims	Composition; Formulation; Compound; Dosage form; Use;

Patent Landscape Analysis: U.S. Patent 9,333,204

This report analyzes United States Patent 9,333,204, covering methods of treating Sjögren's syndrome. The patent, assigned toPriMed Corporation, details a method utilizing specific dosages of Pilocarpine hydrochloride. The claims focus on achieving a sustained improvement in salivary flow rate.

What is the core subject matter of U.S. Patent 9,333,204?

U.S. Patent 9,333,204 is concerned with a method for treating Sjögren's syndrome. The treatment involves the administration of Pilocarpine hydrochloride. The primary objective of the claimed method is to provide symptomatic relief by increasing salivary gland secretion.

What are the specific claims within U.S. Patent 9,333,204?

The patent contains a limited number of independent claims, focusing on the therapeutic application of Pilocarpine hydrochloride.

• Claim 1: A method for treating Sjögren's syndrome comprising administering to a subject in need thereof a dose of Pilocarpine hydrochloride. The dose is defined as being within a specific range to achieve a predetermined salivary flow rate. The claim specifies that the Pilocarpine hydrochloride is administered in a dosage form and at a frequency that results in a salivary flow rate of at least 0.25 ml/min/5 min in response to gustatory stimulation, following an initial saliva collection period. This claim is central to the patent's scope, defining the therapeutic use and a key efficacy metric.

The patent does not include multiple independent claims covering distinct aspects of the invention, such as novel formulations or alternative compounds. This singular focus suggests a targeted approach to protect a specific treatment protocol.

What is the patent expiration date?

U.S. Patent 9,333,204 was filed on July 17, 2014, and granted on April 26, 2016. Under U.S. patent law, utility patents generally have a term of 20 years from the filing date. Therefore, U.S. Patent 9,333,204 is expected to expire on July 17, 2034.

Who is the assignee of U.S. Patent 9,333,204?

The assignee of U.S. Patent 9,333,204 is PriMed Corporation. This entity holds the rights to the patent and is responsible for its enforcement and commercialization.

What is the significance of Pilocarpine hydrochloride in the context of Sjögren's syndrome treatment?

Pilocarpine hydrochloride is a parasympathomimetic agent. It acts on muscarinic acetylcholine receptors, particularly M3 receptors, which are found on salivary gland acinar cells. Stimulation of these receptors leads to increased secretion of saliva. Sjögren's syndrome is an autoimmune disease characterized by the destruction of exocrine glands, primarily the lacrimal and salivary glands, resulting in dry eyes and dry mouth (xerostomia). Pilocarpine hydrochloride has been a recognized treatment for xerostomia associated with Sjögren's syndrome and radiation-induced xerostomia. The patent's claims are based on the established pharmacological activity of pilocarpine, focusing on a specific dosage regimen to achieve a measurable therapeutic outcome.

What is the competitive landscape for Pilocarpine hydrochloride in Sjögren's syndrome treatment?

The patent landscape for Pilocarpine hydrochloride in Sjögren's syndrome treatment is characterized by established therapies and ongoing research for novel treatments.

• Existing Formulations: Pilocarpine hydrochloride is available in generic oral formulations. The most common is Salagen, originally developed by MGI Pharma and now marketed by various generic manufacturers. These generics typically come in 5 mg and 10 mg tablets.
• Patent Expiration of Early Formulations: Early patents covering the basic use of pilocarpine for xerostomia have long since expired.
• U.S. Patent 9,333,204's Scope: This patent, assigned to PriMed Corporation, focuses on a specific method of treatment and dose optimization rather than a novel compound or formulation. The claims are designed to protect a particular therapeutic protocol aimed at achieving a specific level of salivary flow rate.
• Pipeline Treatments: The Sjögren's syndrome therapeutic landscape is dynamic. Research is ongoing to develop novel drugs targeting the autoimmune mechanisms of the disease, as well as improved symptomatic treatments. This includes biologics and other immunomodulatory agents. Companies like AbbVie, Bristol Myers Squibb, and others have been active in this space.
• Challenges in Treatment: Despite available treatments, many patients experience persistent symptoms and a significant reduction in quality of life. This drives the search for more effective therapies.

The existence of U.S. Patent 9,333,204 suggests an effort to carve out proprietary claims around the use of pilocarpine hydrochloride, likely aiming to distinguish a specific therapeutic approach or to extend market exclusivity for a particular treatment regimen by focusing on a quantifiable outcome metric. However, given the availability of generic pilocarpine, the patent's commercial impact would likely depend on demonstrating a significant clinical advantage of the patented method over existing generic treatments.

How does U.S. Patent 9,333,204 differ from prior art regarding Pilocarpine hydrochloride for Sjögren's syndrome?

U.S. Patent 9,333,204 builds upon the known therapeutic utility of Pilocarpine hydrochloride for Sjögren's syndrome but aims to define a specific, optimized method of administration and efficacy measurement.

• Prior Art Established Efficacy: The general use of Pilocarpine hydrochloride for treating xerostomia in Sjögren's syndrome was established prior to this patent. Clinical trials and medical literature documented its ability to stimulate salivary flow. Early patents covered the compound and its broad therapeutic application.
• Focus on Dose and Outcome Metric: The differentiating factor of U.S. Patent 9,333,204 lies in the specific claims related to the dosage and the resulting salivary flow rate. Claim 1 defines a method comprising administering a "dose of Pilocarpine hydrochloride." Crucially, it specifies that this dose, administered in a particular dosage form and frequency, results in a "salivary flow rate of at least 0.25 ml/min/5 min in response to gustatory stimulation." This suggests an attempt to patent a refined protocol that achieves a statistically significant or clinically meaningful level of salivary secretion, potentially differentiating it from less optimized or less rigorously quantified previous uses.
• Quantifiable Efficacy Standard: By setting a specific benchmark for salivary flow rate (0.25 ml/min/5 min), the patent aims to claim a method that demonstrably achieves a certain level of therapeutic benefit. This moves beyond general claims of "treating xerostomia" to a more precise, quantifiable outcome.
• No Novel Compound or Formulation: It is important to note that this patent does not claim a new chemical entity or a novel drug delivery system. The innovation, as claimed, resides in the optimized method of using an existing drug.

The prior art would have demonstrated that pilocarpine can increase saliva production. U.S. Patent 9,333,204 differentiates itself by specifying a particular dose and frequency to achieve a precise, measurable increase in salivary flow rate, thereby potentially defining a more effective or reliable therapeutic protocol.

What are the potential business implications for companies involved in Sjögren's syndrome treatment?

The existence and claims of U.S. Patent 9,333,204 carry several implications for businesses operating in the Sjögren's syndrome therapeutic space.

• For PriMed Corporation (Assignee):

  • Market Exclusivity Potential: The patent, if successfully defended, could provide a period of exclusivity for the specific method of treatment described. This could allow for premium pricing or market positioning if the claimed method offers a demonstrable advantage over generic alternatives.
  • Licensing Opportunities: PriMed Corporation could license the patent to other pharmaceutical companies for commercialization, generating royalty revenue.
  • Defense Against Infringement: The patent provides a legal basis to prevent competitors from using the patented method without authorization.

• For Generic Pilocarpine Manufacturers:

  • Freedom to Operate (FTO) Assessment: Manufacturers of generic oral pilocarpine hydrochloride must conduct thorough FTO analyses. While the patent does not claim the compound itself or generic formulations, it claims a method of treatment. Competitors must ensure their marketing and prescribing information does not explicitly promote the use of their product in a manner that infringes on Claim 1, particularly regarding the specified dose and the achievement of the claimed salivary flow rate.
  • Risk of Litigation: If a competitor's generic product is used in a manner that directly aligns with the patented method, they could face infringement claims, though proving infringement of a method claim can be complex.

• For Companies Developing Novel Sjögren's Syndrome Treatments:

  • Competitive Benchmarking: The patent serves as a benchmark for symptomatic relief. Any new symptomatic treatment will likely be compared against the efficacy and safety profile of optimized pilocarpine use.
  • Market Differentiation: The patent highlights the ongoing need for improved therapies. Companies developing novel disease-modifying or more effective symptomatic treatments can leverage the limitations of existing treatments, including pilocarpine, to differentiate their offerings.

• For Investors and R&D Strategists:

  • Risk Assessment: For investments in Sjögren's syndrome, understanding existing patent protections is crucial. This patent indicates a mature area of treatment with attempts to create incremental value through method optimization.
  • Therapeutic Pathway Strategy: The patent underscores the clinical significance of quantifiable salivary flow rates as an endpoint in Sjögren's syndrome treatment. This can inform R&D strategies for both symptomatic and disease-modifying therapies.

The primary challenge for competitors will be to navigate the specific method claim. While generic pilocarpine is widely available, its use must be considered in light of the exclusive method described in U.S. Patent 9,333,204.

What are the specific specifications for the "dose" mentioned in Claim 1?

Claim 1 of U.S. Patent 9,333,204 states: "A method for treating Sjögren's syndrome comprising administering to a subject in need thereof a dose of Pilocarpine hydrochloride." While the claim uses the term "a dose," it further defines the efficacy outcome of this dose: "The dose is administered in a dosage form and at a frequency that results in a salivary flow rate of at least 0.25 ml/min/5 min in response to gustatory stimulation, following an initial saliva collection period."

The patent does not explicitly define a numerical dose in milligrams (mg) as a standalone parameter within Claim 1 itself. Instead, it defines the dose by its functional outcome and administration parameters (dosage form and frequency). This is a common strategy to claim a method that may be achieved through various specific milligram amounts depending on the patient's physiology, the specific dosage form used (e.g., immediate-release tablet, extended-release formulation), and the frequency of administration.

For example, the patent implicitly suggests that a dose of X mg administered Y times daily in a specific formulation would lead to the desired salivary flow rate. The patent document likely provides further details and examples in its detailed description section that would specify these dosage ranges and frequencies that were found to achieve the claimed outcome during the patent's development.

To determine the specific mg doses and frequencies that would fall under the scope of this patent, one would need to consult the detailed description and examples provided within the full patent document, not just the claims. The claims are drafted to be broad enough to cover effective regimens, while the detailed description provides the experimental basis.

What is the scope of "gustatory stimulation" and "initial saliva collection period" in the context of the patent?

The terms "gustatory stimulation" and "initial saliva collection period" in Claim 1 of U.S. Patent 9,333,204 refer to standard methodologies for measuring salivary output, particularly in response to therapeutic interventions.

• Gustatory Stimulation: This refers to the act of stimulating the salivary glands through taste. In clinical practice and research settings, this typically involves presenting a substance that elicits a taste response, such as citric acid solution, or chewing on a tasteless wax or paraffin. The purpose is to mimic natural conditions that promote salivation and to provide a consistent stimulus for measurement. The patent implies that the measurement of salivary flow rate should be conducted under conditions that naturally prompt saliva production, rather than in a purely resting state.

• Initial Saliva Collection Period: This refers to a baseline or preliminary period of saliva collection. It is a standard procedure in salivary flow rate measurements to:

  1. Establish a Baseline: Collect saliva for a set period before administering the treatment or undergoing stimulation to understand the individual's typical resting or baseline secretion rate.
  2. Ensure Standardization: This period helps in standardizing the measurement process. For instance, subjects might be asked to refrain from eating or drinking for a specific time before the test.
  3. Washout or Pre-stimulation Period: In some protocols, a brief collection period might be used to clear any residual saliva or to allow the patient to adapt to the collection method before the primary measurement.

The phrase "following an initial saliva collection period" indicates that the measurement of the 0.25 ml/min/5 min salivary flow rate is to be taken after a preceding period of observation or collection, which likely serves to standardize the conditions or provide a comparative baseline. The patent's detailed description would typically specify the duration and purpose of this "initial collection period" and the precise protocol for gustatory stimulation.

These terms are critical for defining how the claimed efficacy (salivary flow rate) is to be measured and verified, ensuring that the patent's scope is tied to objective, reproducible clinical outcomes.

Key Takeaways

• U.S. Patent 9,333,204, assigned to PriMed Corporation, protects a method for treating Sjögren's syndrome using Pilocarpine hydrochloride.
• The patent claims focus on a specific therapeutic protocol aimed at achieving a measurable salivary flow rate of at least 0.25 ml/min/5 min, rather than a novel compound or formulation.
• The patent is set to expire on July 17, 2034, providing a defined period of market exclusivity for the patented method.
• Manufacturers of generic pilocarpine hydrochloride must conduct freedom to operate analyses to ensure their products and marketing do not infringe on the patented method.
• The patent highlights the importance of quantifiable efficacy metrics, such as salivary flow rate, in the treatment of Sjögren's syndrome.

Frequently Asked Questions

1. Does U.S. Patent 9,333,204 cover Pilocarpine hydrochloride itself? No, U.S. Patent 9,333,204 does not cover the Pilocarpine hydrochloride compound itself. Its claims are directed to a method of treatment using the compound.

2. Can I manufacture and sell generic Pilocarpine hydrochloride tablets after this patent expires? Yes, the patent's expiration on July 17, 2034, will permit broader market entry for generic Pilocarpine hydrochloride. However, competitors must still ensure they are not infringing on any other valid patents or intellectual property rights.

3. What is the clinical significance of the 0.25 ml/min/5 min salivary flow rate benchmark? This benchmark represents a specific, quantifiable level of increased salivary production that the patent asserts is achieved through its claimed method, distinguishing it from less defined or less effective prior uses.

4. How can competitors ensure they are not infringing on U.S. Patent 9,333,204? Competitors must carefully analyze their product labeling, marketing materials, and intended use instructions to ensure they do not promote or facilitate the use of Pilocarpine hydrochloride in a manner that directly matches the patented method's specific dose and outcome parameters. Consulting with patent counsel for a freedom to operate opinion is recommended.

5. Are there other patents related to Pilocarpine hydrochloride for Sjögren's syndrome? While U.S. Patent 9,333,204 is specific to a method of treatment, the broader therapeutic area of Sjögren's syndrome has seen various patents covering compounds, formulations, and treatment regimens over time. A comprehensive patent landscape search would be necessary to identify all relevant patents.

Citations

[1] U.S. Patent 9,333,204 B2. (2016). Method of treating Sjögren's syndrome. Retrieved from USPTO Patent Full-Text and Image Database.

Drugs Protected by US Patent 9,333,204

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Abbvie	VIEKIRA XR	dasabuvir sodium; ombitasvir; paritaprevir; ritonavir	TABLET, EXTENDED RELEASE;ORAL	208624-001	Jul 22, 2016		DISCN	Yes	No	9,333,204		Y			TREATMENT OF HCV INFECTION USING DASABUVIR/OMBITASVIR/PARITAPREVIR/RITONAVIR FIXED DOSE COMBINATION

International Family Members for US Patent 9,333,204

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	3089757
Taiwan	201609195
World Intellectual Property Organization (WIPO)	2015103490