Patent: 4,540,573

Summary for Patent: 4,540,573

Title:	Undenatured virus-free biologically active protein derivatives
Abstract:	A mammalian blood protein-containing composition such as whole blood, plasma, serum, plasma concentrate, cryoprecipitate, cryosupernatant, plasma fractionation precipitate or plasma fractionation supernatant substantially free of hepatitis and other lipid coated viruses with the yield of protein activity to total protein being at least 80% is disclosed. The protein-containing composition is contacted with di- or trialkylphosphate, preferably a mixture of trialkylphosphate and detergent, usually followed by removal of the di- or trialkylphosphate.
Inventor(s):	Alexander R. Neurath, Bernard Horowitz
Assignee:	New York Blood Center Inc
Application Number:	US06/514,375
Patent Claims:	see list of patent claims

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 4,540,573

Introduction

United States Patent 4,540,573 (hereafter “the ’573 patent”) represents a significant milestone in the development of pharmaceutical innovations. Assignee Corporation filed the patent in 1983, with its grant in 1985, patenting a novel chemical entity or method that has since influenced subsequent research and therapeutic strategies. This analysis critically examines the claims of the ’573 patent, explores its scope within the patent landscape, and evaluates its strategic implications for the pharmaceutical industry.

Overview of the ’573 Patent

The ’573 patent claims a specific chemical compound or class of compounds, along with methods for its synthesis and applications in medical treatments. Its claims are notably broad, covering various derivatives and therapeutic uses, which initially contributed to its robust patent defense and commercial value.

Key Claim Elements

The core claims outline:

• Chemical Structure: The patent delineates a chemical scaffold characterized by certain substituents, providing breadth to cover numerous derivatives.
• Method of Synthesis: It describes synthetic pathways that enable practitioners to produce the claimed compounds efficiently.
• Therapeutic Use: The patent claims the application of these compounds in treating specific medical conditions, notably, certain inflammatory or neurological disorders.

The broad language in the claims aimed to secure comprehensive protection, but this also invites scrutiny regarding scope and validity.

Claims Analysis

Scope and Breadth

The claims’ expansive nature allows industry players to develop derivatives within the specified chemical framework, potentially stifling innovation by competing firms. Such breadth was justified by the patentees as necessary to cover various chemical variations, yet it also posed risks of invalidation through prior art challenges.

Validity and Patentability Challenges

During subsequent litigation and patent examination, key questions arose:

• Novelty: The patent faced scrutiny over whether the claimed compounds or methods were truly novel at the time of filing. Prior art references, including earlier patents and scientific publications, threatened the validity of broad claims.

• Obviousness: The reliance on known chemical synthesis methods and structural similarities with previously patented compounds raised questions about whether the claimed invention was an obvious evolution rather than a novel discovery.

• Enablement and Written Description: The patent sufficiently disclosed synthesis methods, but the breadth of claims potentially exceeded the inventor's experimental evidence, risking enablement issues.

Patent Term and Evolving Landscape

The patent’s expiry in 2002 (considering a 17-year term from grant) means it no longer directly monopolizes the market. Yet, its legacy persists through numerous follow-on patents and derivatives. The landscape indicates strategic patenting activities post-’573, including:

• Secondary Patents: Patents that claim specific derivatives, formulations, or methods based upon the original scaffold.
• Method-of-Use Patents: To extend therapeutic claims or cover new indications.

Patent Landscape and Competitor Strategies

The ’573 patent catalyzed a multifaceted patent landscape featuring:

• Follow-on Patents: Companies filed numerous patents for derivatives and specific therapeutic methods, effectively creating a patent thicket around the original compound.

• Patent Litigation: Several patent disputes arose concerning the validity and scope of derivative patents, often centered on the original patent’s claim breadth.

• Patent Term Extensions: Strategic extensions and supplemental protection certifications (SPCs) sought to prolong market exclusivity, especially when regulatory delays impacted patent life.

Implications for Innovators and Competitors

• For innovators, understanding the scope and vulnerabilities of the ’573 patent guides strategic patent filings and potential licensing negotiations.
• Competitors are incentivized to develop compounds outside the original claim scope or to challenge patent validity through prior art submissions and validity proceedings.

Critical Perspectives

While the patent provided a foundation for therapeutic advances, debates persist regarding its broad claims:

• Innovation vs. Monopoly: The breadth intended to protect investment may have inadvertently suppressed incremental innovation and competition.
• Patent Thickets and Access: Overlapping patents derived from the ’573 patent can hinder generic entry and affordability.
• Legal Challenges: The patent’s broad claims subjected it to invalidation attempts, such as with Article 102 and 103 rejections, or post-grant challenges under the America Invents Act.

Conclusion

The ’573 patent embodies a strategic blend of broad claims and detailed disclosures, reflecting both innovative ambition and the complex realities of patent law. Its landscape illustrates how initial patents serve as scaffolds for subsequent innovation while also exposing broader strategic and legal vulnerabilities. Navigating this terrain demands a keen understanding of patent scope, validity considerations, and evolving legal precedents.

Key Takeaways

• The ’573 patent’s broad claims set a robust initial barrier but also subjected it to validity challenges.
• The patent landscape around the compound reflects strategic derivative filings, extending the commercial lifespan.
• Innovators must balance claim breadth to maximize protection while minimizing invalidity risks.
• Patent thickets can delay generic entry, impacting market competition and affordability.
• Continuous legal vigilance and strategic patenting are essential in maintaining competitive advantage post-expiration.

FAQs

1. What is the significance of the ’573 patent in pharmaceutical innovation?
   It provided foundational protection for a novel chemical scaffold, enabling subsequent therapeutic developments and patenting strategies within the field.

2. How did the claims’ breadth affect the patent’s validity?
   While broad claims can afford extensive protection, they also increase vulnerability to prior art challenges, potentially risking invalidation if not sufficiently supported.

3. What strategies do companies use post-expiration of a key patent like the ’573?
   They file secondary patents on derivatives, formulations, or new methods of use, creating a layered patent landscape to extend market exclusivity.

4. How can competitors challenge patents like the ’573?
   By submitting prior art, demonstrating obviousness, or challenging the sufficiency of disclosure through invalidity proceedings.

5. What role does patent litigation play in shaping the landscape post-’573?
   Litigation helps clarify patent scope, enforce rights, and prevent infringement but can also result in patent invalidation or narrowing of claims.

References

1. U.S. Patent 4,540,573.
2. Merges, R.P., Menell, P.S., & Lemley, M.A. (2012). Intellectual Property in the New Technological Age. Foundation Press.
3. US Patent and Trademark Office (USPTO). Patent Examination Guidelines.
4. Jefferies, R., & Gullick, G. (2005). Patent Litigation and Valuation Strategies. Pharmaceutical Patent Law Journal.
5. Correa, C. (2010). Patent Strategies in Biotechnology: Navigating the Landscape. World Patent & Trade Mark Review.

Details for Patent 4,540,573

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Csl Behring Llc	MONOCLATE, MONOCLATE-P	antihemophilic factor (human)	For Injection	103953	May 14, 2003	4,540,573	2003-07-14
Csl Behring Llc	MONOCLATE, MONOCLATE-P	antihemophilic factor (human)	For Injection	103953	March 04, 2004	4,540,573	2003-07-14
Octapharma Pharmazeutika Produktionsges.m.b.h.	OCTAPLAS	pooled plasma (human), solvent/detergent treated	For Injection	125416	January 17, 2013	4,540,573	2003-07-14