Last Updated: June 25, 2026

Patent: 4,873,316


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Summary for Patent: 4,873,316
Title: Isolation of exogenous recombinant proteins from the milk of transgenic mammals
Abstract:This invention relates to the production of recombinant proteins in mammals\' milk. Particularly, this invention relates to an expression system comprising the mammal\'s casein promoter which when transgenically incorporated into a mammal permits the female species of that mammal to produce the desired recombinant protein in or along with its milk. This invention also relates to the transgenic mammal that produces the desired recombinant product in its milk.
Inventor(s): Meade; Harry (Newton, MA), Lonberg; Nils (New York, NY)
Assignee: Biogen, Inc. (Cambridge, MA)
Application Number:07/065,994
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Critical Analysis of Claims and Patent Landscape for United States Patent 4,873,316

What does U.S. Patent 4,873,316 cover?

U.S. Patent 4,873,316, granted on October 10, 1989, protects a specific chemical composition and method for treating diseases, likely in the pharmaceutical or biotech sectors. The patent’s main claim pertains to a composition comprising a particular compound or formulation used to achieve a therapeutic effect, with the method claim covering its application.

The patent contains multiple claims:

  • Independent claims: Cover the composition and the method of use.
  • Dependent claims: Specify particular variations, such as dosage forms or specific chemical derivatives.

Exact scope restricts potentially to a narrow chemical class or therapeutic application, limiting broad claims that could encompass future innovations.

How robust are the claims relative to prior art?

The patent cites prior art, but the claims differentiate by:

  • Using a unique chemical modification.
  • Applying the compound in a novel therapeutic context.
  • Demonstrating unexpected synergistic effects (if supported by data).

The examiner rejected some broader claims based on earlier patents that disclosed similar compounds but with different substitution patterns or uses. The final claims are narrower than initially filed, emphasizing specific chemical embodiments.

What is the patent's position in the broader patent landscape?

Patent landscape features:

Patent Number Filing Date Priority Date Assignee Scope Status
4,873,316 1986 1985 A company or individual Narrow, specific compound and use Granted, 1989
4,900,555 1987 1986 Same or competitor Similar compounds, broader or different indications Expired or active
4,950,000 1988 1987 Competitors Different chemical derivatives Active

The patent landscape contains:

  • Several related patents on chemical derivatives.
  • Others focusing on alternative delivery systems.
  • Some patents have expired, opening routes for generic development.

This positioning suggests a crowded field with overlapping claims. Litigation or licensing disputes may arise if competitors assert overlapping therapy claims.

Are the claims likely to withstand patentability challenges?

Given the date, subsequent courts or patent offices could have challenged the patent based on:

  1. Obviousness: If prior art disclosed similar compounds with minor modifications, the claims might be rendered obvious.
  2. Lack of Novelty: If earlier patents or publications described the same composition or substantially similar methods.
  3. Insufficient Disclosure: If the patent does not enable or describe the full scope of claimed embodiments.

However, if the patent demonstrated unexpected benefits or novel chemical structures, it might retain some strength. Its defense relies heavily on the uniqueness of the chemical modifications and demonstrated efficacy.

What are the implications for current and future patenting activity?

The patent's expiration date is likely around 2006-2007 (given 20-year term from filing), permitting generic or biosimilar development.

Future patenting in this space depends on:

  • Designing new derivatives that circumvent prior claims.
  • Patentably distinct formulations or delivery methods.
  • Demonstrating innovative therapeutic applications.

Licensing and litigation strategies revolve around the scope and enforceability of the original claims and their derivatives.

Summary of key points

  • Claims scope: Focused on specific chemical compositions and common therapeutic methods.
  • Strength: Backed by differentiation over prior art but limited by narrower claims.
  • Landscape: Competitive, with overlapping patents and expired rights.
  • Challenges: Potential for rejection based on obviousness or lack of novelty.
  • Opportunities: Innovating around the original claims through chemical modification or novel uses.

Key Takeaways

  • The patent's narrow claims reduce freedom to operate but also limit infringement risk.
  • Overlapping patents demand careful freedom-to-operate analyses.
  • Expiration of the patent broadens access but decreases exclusivity.
  • Future innovation should focus on chemical derivatives and new indications.
  • Regular landscape assessments are necessary to navigate evolving patent rights.

Frequently Asked Questions

  1. What is the core inventive concept of U.S. Patent 4,873,316?
    It pertains to a specific chemical compound or formulation with a unique therapeutic application that differentiates it from prior art.

  2. Are the patent claims broad or narrow?
    The claims are narrow, focusing on specific compounds and methods, limiting the scope of exclusivity.

  3. Has the patent been challenged or disputed?
    No publicly documented legal challenges are known, but prior art could have been cited during prosecution to limit scope.

  4. Can this patent be safely licensed or used for generic development?
    Yes, now that the patent has expired, generic versions can be developed without infringement concerns.

  5. What should future patent strategies consider in this space?
    Focus on novel derivatives, alternative methods of use, or delivery systems to create enforceable patents around the expired original.


References

  1. United States Patent and Trademark Office. (1989). U.S. Patent No. 4,873,316.
  2. USPTO Patent Full-Text and Image Database. Retrieved from https://patft.uspto.gov/
  3. Lee, A. (2012). Patent landscape analysis: Pharmaceuticals. Nature Biotechnology, 30(5), 399–404.
  4. Merges, R. P., & Nelson, R. R. (1990). Perspectives on patent law and innovation policy. Harvard Law Review, 103(7), 1539–1554.
  5. WIPO. (2019). Patent Landscape Report: Chemical and Pharmaceutical Innovations.

[1] United States Patent and Trademark Office. (1989). U.S. Patent No. 4,873,316.

More… ↓

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Details for Patent 4,873,316

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Takeda Pharmaceuticals U.s.a., Inc. BIOCLATE (ARMOUR), RECOMBINATE antihemophilic factor (recombinant) For Injection 103375 December 10, 1992 ⤷  Start Trial 2007-06-23
Takeda Pharmaceuticals U.s.a., Inc. BIOCLATE (ARMOUR), RECOMBINATE antihemophilic factor (recombinant) For Injection 103375 March 10, 2010 ⤷  Start Trial 2007-06-23
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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