Details for Patent: 7,579,473

Which drugs does patent 7,579,473 protect, and when does it expire?

Patent 7,579,473 protects COMETRIQ and CABOMETYX and is included in two NDAs.

This patent has seventy-four patent family members in seventeen countries.

Summary for Patent: 7,579,473

Title:	c-Met modulators and methods of use
Abstract:	The present invention provides compounds for modulating protein kinase enzymatic activity for modulating cellular activities such as proliferation, differentiation, programmed cell death, migration and chemoinvasion. More specifically, the invention provides quinazolines and quinolines which inhibit, regulate, and/or modulate kinase receptor, particularly c-Met, KDF, c-Kit, flt-3 and flt-4, signal transduction pathways related to the changes in cellular activities as mentioned above, compositions which contain these compounds, and methods of using them to treat kinase-dependent diseases and conditions. The present invention also provides methods for making compounds as mentioned above, and compositions which contain these compounds.
Inventor(s):	Bannen; Lynne Canne (Pacifica, CA), Chan; Diva Sze-Ming (San Francisco, CA), Forsyth; Timothy Patrick (Hayward, CA), Khoury; Richard George (Redwood City, CA), Leahy; James William (San Leandro, CA), Mac; Morrisson B. (San Francisco, CA), Mann; Larry W. (Richland, MI), Nuss; John M. (Danville, CA), Parks; Jason Jevious (Sacramento, CA), Wang; Yong (Foster City, CA), Xu; Wie (Danville, CA)
Assignee:	Exelixis, Inc. (South San Francisco, CA)
Application Number:	12/393,806
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,579,473
Patent Claim Types: see list of patent claims	Compound; Composition;

Understanding the Scope and Claims of United States Patent 7,579,473

Introduction

The United States Patent 7,579,473, hereafter referred to as the '473 patent, is a significant patent in the pharmaceutical industry, particularly related to the drug cabozantinib. This patent has been at the center of several legal disputes, notably involving Exelixis, Inc. and MSN Laboratories Private Limited. Here, we will delve into the details of the patent's scope, claims, and the surrounding patent landscape.

Background of the '473 Patent

The '473 patent, titled "Pyridine derivatives and methods of use," was granted to Exelixis, Inc. and has a priority date of September 26, 2003[2][4].

Claims of the '473 Patent

The '473 patent includes several claims, but the focus has often been on specific claims that have been disputed in litigation.

Claim 5

Claim 5 of the '473 patent is particularly noteworthy as it specifies "A compound of the formula: [ \text{cabozantinib or a pharmaceutically acceptable salt thereof.} ] This claim is crucial because it defines the chemical structure of cabozantinib, a tyrosine kinase inhibitor used in the treatment of various cancers[1].

Infringement Disputes

MSN Laboratories Private Limited has been involved in several disputes with Exelixis, Inc. regarding the infringement of the '473 patent.

Submission of ANDA

MSN submitted an Abbreviated New Drug Application (ANDA) to the FDA, seeking approval to manufacture, use, offer for sale, sell, and/or import a generic version of cabozantinib before the expiration of the '473 patent. This submission was considered an act of infringement under 35 U.S.C. § 271(e)(2)(A)[2].

Commercial Activities

MSN's commercial activities, including the manufacture, use, offer for sale, sale, and/or importation of the generic product, were alleged to infringe claims 1-7 of the '473 patent. Exelixis argued that these activities would infringe the claims either literally or under the doctrine of equivalents[2].

Validity of the '473 Patent

The validity of the '473 patent, particularly Claim 5, has been a subject of contention.

Obviousness

MSN argued that Claim 5 of the '473 patent is invalid as obvious under 35 U.S.C. § 103. The legal standard for obviousness requires that the differences between the claimed invention and the prior art must be such that the claimed invention as a whole would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention[1][4].

Prior Art and Ordinary Skill

The court considered the scope and content of the prior art, the differences between the prior art and the claims, and the level of ordinary skill in the pertinent art. Experts testified about the synthesis and analysis of complex organic compounds, preparation of pharmaceutical formulations, and treatment of cancer patients, which are relevant to determining the obviousness of the claimed invention[1].

Patent Scope and Quality

The scope and quality of patent claims are critical in patent litigation and innovation.

Metrics for Patent Scope

Research has suggested using metrics such as independent claim length and independent claim count to measure patent scope. Narrower claims at publication are associated with a higher probability of grant and a shorter examination process compared to broader claims[3][5].

Examination Process

The examination process tends to narrow the scope of patent claims in terms of both claim length and claim count. This narrowing is more significant when the duration of examination is longer, indicating that the patent office is more thorough in evaluating patents that really matter[3][5].

Litigation and Legal Precedents

The '473 patent has been involved in several legal cases, providing insights into patent litigation and the interpretation of patent claims.

Exelixis, Inc. v. MSN Labs

In this case, Exelixis, Inc. brought an action against MSN Laboratories Private Limited for infringement of the '473 patent. The trial involved disputes over the validity of Claim 5 and the infringement of other claims. MSN filed Paragraph IV certifications, asserting the invalidity of the claims, which led to the lawsuit[1].

Induced Infringement

The concept of induced infringement is relevant, where a party can be liable for inducing others to infringe a patent. This requires showing direct infringement and specific intent to encourage another's infringement[4].

Key Takeaways

• Claim Specificity: Claim 5 of the '473 patent specifically defines the chemical structure of cabozantinib or its pharmaceutically acceptable salts.
• Infringement Disputes: MSN's ANDA submission and commercial activities were alleged to infringe the '473 patent claims.
• Validity Challenges: The patent's validity has been challenged on grounds of obviousness, with the court considering prior art and ordinary skill in the pertinent art.
• Patent Scope Metrics: Narrower claims are associated with a higher probability of grant and shorter examination processes.
• Litigation Insights: The case highlights the importance of claim construction, obviousness determinations, and induced infringement in patent litigation.

FAQs

1. What is the main subject of the '473 patent? The '473 patent primarily deals with pyridine derivatives, specifically cabozantinib, a tyrosine kinase inhibitor used in cancer treatment.

2. Why is Claim 5 of the '473 patent significant? Claim 5 is significant because it specifies the chemical structure of cabozantinib or its pharmaceutically acceptable salts, which is crucial for defining the scope of the patent.

3. What was the basis of MSN's challenge to the '473 patent? MSN challenged the '473 patent on the basis of invalidity, specifically arguing that Claim 5 is obvious under 35 U.S.C. § 103.

4. How does the examination process affect patent claims? The examination process tends to narrow the scope of patent claims, with narrower claims at publication associated with a higher probability of grant and a shorter examination process.

5. What is the relevance of induced infringement in this context? Induced infringement is relevant as it holds a party liable for knowingly inducing others to infringe a patent, requiring proof of direct infringement and specific intent to encourage another's infringement.

Sources

1. Exelixis, Inc. v. MSN Labs Private - Casetext
2. IN THE UNITED STATES DISTRICT COURT FOR THE ... - RPX Insight
3. Patent Claims and Patent Scope - Hoover Institution
4. 22-228.pdf - U.S. District Court for the District of Delaware
5. Patent Claims and Patent Scope - SSRN

Drugs Protected by US Patent 7,579,473

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Exelixis	COMETRIQ	cabozantinib s-malate	CAPSULE;ORAL	203756-001	Nov 29, 2012		RX	Yes	No	7,579,473		Y	Y
Exelixis	COMETRIQ	cabozantinib s-malate	CAPSULE;ORAL	203756-002	Nov 29, 2012		RX	Yes	Yes	7,579,473		Y	Y
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-001	Apr 25, 2016		RX	Yes	No	7,579,473		Y	Y
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-002	Apr 25, 2016		RX	Yes	No	7,579,473		Y	Y
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-003	Apr 25, 2016		RX	Yes	Yes	7,579,473		Y	Y

International Family Members for US Patent 7,579,473

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2213661		C300678	Netherlands
European Patent Office	2213661		CA 2014 00039	Denmark
European Patent Office	2213661		PA2014033	Lithuania
European Patent Office	2213661		C20140029 00117	Estonia
European Patent Office	2213661		1490053-4	Sweden
European Patent Office	2213661		14C0067	France