United States Patent 7,767,429: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 7,767,429, issued to Halozyme Therapeutics, Inc., is a pivotal patent in the field of biotechnology, particularly focusing on the recombinant human hyaluronidase enzyme platform (rHuPH20). This patent is crucial for understanding the innovative advancements and the protective scope it offers in the pharmaceutical industry.
Background and Inventors
The patent was filed by Halozyme Therapeutics, Inc., with inventors including Louis H. Bookbinder, Anirban Kundu, Gregory I. Frost, Michael F. Haller, Gilbert A. Keller, and Tyler M. Dylan, although Haller, Keller, and Dylan were later removed as inventors during the prosecution of the application[1][4].
Patent Scope and Claims
Claims Overview
The patent claims cover a broad range of innovations related to the rHuPH20 enzyme platform. Key claims include:
- The human PH20 glycoprotein and its PEGylated variants.
- The glycoprotein produced by recombinant methods.
- Pharmaceutical compositions that include rHuPH20 combined with other therapeutic agents such as antibodies, insulins, cytokines, and anti-infectives[4][5].
Compositions of Matter
The patent protects compositions of matter involving the rHuPH20 enzyme, including its soluble forms and pharmaceutical compositions. These compositions are designed to enhance the delivery and efficacy of various therapeutic agents by breaking down hyaluronic acid, a key component of the extracellular matrix[5].
Pharmaceutical Compositions
The claims extend to pharmaceutical compositions that incorporate rHuPH20 with other drugs, facilitating improved drug delivery and absorption. This includes combinations with antibodies, insulins, cytokines, and other therapeutic classes, which are significant for treating a variety of diseases[4].
Patent Landscape
Global Protection
The patent provides extensive global protection, with similar claims granted in several countries including India, Japan, Eurasia, Hong Kong, Mexico, New Zealand, Singapore, and South Africa. A broad European counterpart, EP1603541, also offers protection until March 5, 2024[4].
Patent Term and Adjustments
In the United States, the patent was set to expire on March 5, 2024, but it has been extended until September 23, 2027, due to patent term adjustments totaling 1,297 days[4].
Significance and Impact
Innovation Recognition
The issuance of this patent is a significant recognition of Halozyme's biotechnology innovations. According to Gregory Frost, Ph.D., Halozyme’s chief scientific officer, these patents are of substantial value to Halozyme and its development partners, covering major pharmaceutical markets worldwide[4].
Market and Development Implications
The protection offered by this patent is crucial for Halozyme's development and commercialization strategies. It ensures that the company can leverage its proprietary technology without immediate competition, thereby enhancing its market position and potential for innovation[4].
Challenges and Litigation
Obviousness-Type Double Patenting (ODP) Rejections
During the prosecution of the patent application, Halozyme faced several rejections based on obviousness-type double patenting over other patents, including U.S. Patent No. 7,846,431 and U.S. Patent No. 7,829,081. Halozyme chose not to file terminal disclaimers to overcome these rejections, leading to further litigation[1].
Litigation with USPTO
Halozyme filed a complaint against the USPTO, challenging the Patent Trial and Appeal Board's decision to affirm the rejections. The case involved a bench trial and multiple amendments to the complaint, highlighting the complexities and challenges in patent litigation[1].
Metrics for Patent Scope
Independent Claim Length and Count
Research on patent scope suggests that metrics such as independent claim length and count can be used to measure the breadth of a patent. Narrower claims, as seen in the examination process of this patent, are often associated with a higher probability of grant and a shorter examination process[3].
Forward Citations and Patent Maintenance
The patent's impact can also be gauged by its forward citations and patent maintenance payments. Patents with narrower claims at publication tend to have more forward citations and require fewer maintenance payments, indicating their significance and validity[3].
Conclusion and Key Takeaways
- Broad Coverage: The patent covers a wide range of compositions and pharmaceutical compositions involving the rHuPH20 enzyme.
- Global Protection: Extensive global protection in major pharmaceutical markets.
- Significant Value: Recognized as valuable for Halozyme and its development partners.
- Litigation Challenges: Faced rejections and litigation related to obviousness-type double patenting.
- Metrics for Scope: Narrower claims associated with higher grant probability and shorter examination process.
FAQs
Q: What is the main subject of United States Patent 7,767,429?
A: The main subject is the recombinant human hyaluronidase enzyme platform (rHuPH20) and its various applications.
Q: Who are the inventors listed on the patent?
A: The inventors include Louis H. Bookbinder, Anirban Kundu, Gregory I. Frost, Michael F. Haller, Gilbert A. Keller, and Tyler M. Dylan, although Haller, Keller, and Dylan were later removed.
Q: What are the key claims protected by the patent?
A: The patent protects claims related to the human PH20 glycoprotein, its PEGylated variants, and pharmaceutical compositions combining rHuPH20 with other therapeutic agents.
Q: How long is the patent term for U.S. Patent 7,767,429?
A: The patent term has been extended until September 23, 2027, due to patent term adjustments.
Q: What are some of the countries where similar claims have been granted?
A: Similar claims have been granted in India, Japan, Eurasia, Hong Kong, Mexico, New Zealand, Singapore, and South Africa.
Cited Sources
- Halozyme, Inc. v. Iancu, 320 F. Supp. 3d 788 - Casetext.
- United States Patent - googleapis.com, U.S. Pat. No. 7,767,429.
- Patent Claims and Patent Scope, SSRN.
- Halozyme Therapeutics, Inc. Announces Issuance of U.S. Patent for rHuPH20 Enzyme Platform, Biospace.
- Soluble hyaluronidase glycoprotein (sHASEGP), Google Patents.
