Details for Patent: 10,828,310

Which drugs does patent 10,828,310 protect, and when does it expire?

Patent 10,828,310 protects XARELTO and is included in one NDA.

Protection for XARELTO has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

Summary for Patent: 10,828,310

Title:	Reducing the risk of cardiovascular events
Abstract:	Combination therapy with rivaroxaban and aspirin successfully reduces the risk of cardiovascular events in patients who have coronary artery disease and/or peripheral artery disease.
Inventor(s):	Bruns; Nancy Cook (Kassel, DE), Misselwitz; Frank (Heidelberg-Neuenheim, DE), Eikelboom; John William Andrew (Hamilton, CA), Connolly; Stuart J. (Hamilton, CA), Yusuf; Salim (Hamilton, CA)
Assignee:	BAYER PHARMA AKTIENGESELLSCHAFT (Berlin, DE)
Application Number:	16/264,032
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,828,310
Patent Claim Types: see list of patent claims	Use;

Analyzing the Scope and Claims of United States Patent 10,828,310: A Deep Dive

Introduction

The United States Patent 10,828,310, associated with the drug Xarelto (rivaroxaban), is a critical component of the patent landscape in the pharmaceutical industry. This patent, held by Bayer Pharma AG, protects a key aspect of the drug and has significant implications for generic and biosimilar competition.

Overview of the Patent

Patent Number and Title

• The patent in question is US 10,828,310, titled "Pharmaceutical Composition Comprising Rivaroxaban."

Drug and Indication

• Xarelto, or rivaroxaban, is an anticoagulant used to prevent and treat various thrombotic disorders, including deep vein thrombosis, pulmonary embolism, and stroke prevention in patients with non-valvular atrial fibrillation[5].

Claims and Scope

Claim Structure

• The patent includes multiple claims that define the scope of protection. These claims typically cover the composition of the pharmaceutical, the method of use, and any specific formulations or manufacturing processes.
• For example, claims might include the specific dosage forms of rivaroxaban, its combination with other active ingredients, and the methods for administering the drug[2].

Independent and Dependent Claims

• Independent claims are standalone and define the broadest scope of the invention. They are not dependent on other claims.
• Dependent claims, on the other hand, build upon the independent claims and provide more specific details, narrowing the scope but adding additional layers of protection[3].

Patent Scope Metrics

Independent Claim Length and Count

• Research suggests that the scope of a patent can be measured by the length and count of independent claims. Narrower claims (shorter independent claim length and fewer independent claims) are often associated with a higher probability of grant and a shorter examination process[3].

Litigation and Settlements

ANDA Litigation

• The patent has been involved in various Abbreviated New Drug Application (ANDA) litigations. For instance, in the case of Bayer Pharma AG v. Micro Labs Ltd., all claims and defenses were dismissed with prejudice, with each party bearing their own costs and attorneys’ fees. This indicates that the patent holder has actively defended the patent against generic manufacturers[2].

Settlement Agreements

• Settlement agreements often include provisions that enjoin generic manufacturers from infringing the patents-in-suit until the expiration of the patents. For example, in the case mentioned above, Micro Labs Ltd. was enjoined from infringing the patents-in-suit unless specifically authorized under the settlement agreement[2].

Evergreening and Patent Abuses

Evergreening Practices

• Pharmaceutical companies often engage in evergreening practices to extend the life of their patents. This involves filing secondary patent applications that claim previously disclosed therapeutic applications or manufacturing processes, thereby delaying generic and biosimilar competition. The case of Johnson & Johnson with Stelara illustrates this tactic, where a secondary patent was obtained sixteen years after the original patent, claiming a previously disclosed use[1].

Impact on Generic Competition

• The extension of patent protection through evergreening practices can significantly delay the entry of generic and biosimilar drugs into the market. For Xarelto, any such practices could mean that generic versions of rivaroxaban are delayed, maintaining the monopoly of the branded drug and increasing costs for patients and taxpayers[1].

Patent Expiration and Generic Launch

Patent Expiration Dates

• The patents protecting Xarelto, including US 10,828,310, have various expiration dates. For instance, some patents related to Xarelto have maintenance fees paid up to 2024, indicating they are still active. However, the exact expiration date of US 10,828,310 would need to be verified from the USPTO database or other official sources[5].

Generic Launch Insights

• The generic launch of rivaroxaban is contingent on the expiration or invalidation of the relevant patents. With multiple petitions for trial and final written decisions, the landscape is complex. For example, petitions requesting trial for US 10,828,310 were filed in 2022, indicating ongoing challenges to the patent's validity[5].

Economic and Health Implications

Cost to Taxpayers and Patients

• The delay in generic competition due to patent abuses and evergreening practices can result in significant financial burdens. For instance, the delay in generic and biosimilar competition for drugs like those under the Inflation Reduction Act is estimated to cost taxpayers nearly $5 billion by 2026[1].

Access to Affordable Medications

• The prolonged monopoly on drugs like Xarelto due to extended patent protection limits access to more affordable generic and biosimilar alternatives. This affects not only patients but also the broader healthcare system, as it increases overall healthcare costs[1].

Key Takeaways

• Patent Scope and Claims: The scope of US 10,828,310 is defined by its claims, which include the composition and method of use of rivaroxaban.
• Litigation and Settlements: The patent has been involved in ANDA litigations, with settlements that often delay generic competition.
• Evergreening Practices: Pharmaceutical companies may use evergreening to extend patent life, delaying generic competition.
• Patent Expiration and Generic Launch: The expiration dates of related patents and ongoing legal challenges will determine when generic versions of rivaroxaban can enter the market.
• Economic and Health Implications: Delayed generic competition can significantly increase healthcare costs and limit access to affordable medications.

FAQs

1. What is the primary drug protected by US 10,828,310?

• The primary drug protected by US 10,828,310 is Xarelto (rivaroxaban), an anticoagulant.

2. How do evergreening practices affect generic competition?

• Evergreening practices involve filing secondary patent applications to extend the life of original patents, thereby delaying the entry of generic and biosimilar drugs into the market.

3. What are the economic implications of delayed generic competition for Xarelto?

• Delayed generic competition can result in significant financial burdens for taxpayers and patients, as seen in the estimated $5 billion cost due to patent abuses by 2026 for other drugs under the Inflation Reduction Act.

4. How are patent scope metrics used to evaluate patent quality?

• Patent scope metrics such as independent claim length and count are used to measure the breadth and clarity of patent claims, with narrower claims often associated with higher grant probabilities and shorter examination processes.

5. What is the current status of generic launch challenges for Xarelto?

• The generic launch of rivaroxaban is contingent on the outcome of ongoing legal challenges, including petitions for trial and final written decisions regarding the validity of related patents.

Sources

1. Public Citizen: Using the Inflation Reduction Act to Rein in Patenting Abuses[1]
2. Robins Kaplan: ANDA Litigation Settlements | Hatch-Waxman[2]
3. Hoover Institution: Patent Claims and Patent Scope[3]
4. Google Patents: US10828310B2 - Reducing the risk of cardiovascular events[4]
5. Pharsight - GreyB: Xarelto patent expiration[5]

Drugs Protected by US Patent 10,828,310

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Janssen Pharms	XARELTO	rivaroxaban	TABLET;ORAL	022406-004	Oct 11, 2018	AB	RX	Yes	No					Y