When does the patent for Albumin expire?

Introduction to Albumin

Albumin is the most abundant protein in human plasma and serves critical biological functions. It is a globular protein responsible for maintaining colloid osmotic (oncotic) pressure in the blood, binding and transporting a wide range of endogenous and exogenous compounds (such as fatty acids, hormones, and drugs), and exhibiting important anti-inflammatory and antioxidant properties. Because albumin is naturally present in blood, its biochemical structure and many of its functions are well known and not subject to primary patent protection. However, inventions involving its preparation, modification, or therapeutic use have been the focus of extensive patenting activity.

Uses and Importance in Medicine 
Albumin plays a pivotal role in clinical medicine. It is used in volume resuscitation therapies, treatment of hypoalbuminemia, liver failure support, and as an adjunct in therapeutic drug delivery. Its multiple physiologic properties—ranging from oncotic regulation to antioxidant capacities—have led to its use in a variety of clinical settings, including stable fluid administration in critical care, management of ascites, and even the development of new medicinal formulations. In recent years, improvements and novel uses have spurred the application of albumin in drug formulations, diagnostics, and even in conjugated forms for the targeted treatment of diseases such as Alzheimer’s and diabetes.

Patent Information on Albumin

Overview of Albumin Patents 
Because albumin is ubiquitous in nature, the patents in this field do not cover the natural molecule itself but rather innovations associated with the preparation, formulation, and therapeutic use of albumin. Broadly speaking, there are several categories of albumin-related patents: 
- Pharmaceutical Compositions and Formulations: These patents relate to albumin-containing pharmaceutical compositions for treating conditions such as nephrosis or cognitive deficiency. 
- Use Patents: These cover the method of using albumin in new indications, such as diabetes, obesity, atherosclerosis, and neurodegenerative diseases. 
- Conjugate Patents: A number of patents have focused on albumin conjugated with peptides—for example, albumin–amyloid peptide conjugates aimed at addressing Alzheimer’s disease. 
- Improved Albumin Binders: A series of patents, such as those described under “Improved serum albumin binders”, have been filed to develop albumin binders that improve the pharmacokinetic properties or manufacturing robustness of albumin-based therapies. 

Each of these patent types will have its own filing date, claims, and consequently its individual expiration date.

Key Patents and Holders 
Several patents have been published on albumin-related innovations. For example: 
- The “Albumin-containing pharmaceutical composition and application thereof” patent details a formulation that includes an albumin solution for the treatment and prevention of nephrosis. 
- Patents on albumin–amyloid peptide conjugates focus on a conjugated product designed to mitigate the deposition of amyloid proteins, specifically directed toward the treatment of Alzheimer’s disease. 
- The “Use of human serum albumin in treatment of diseases” patent discusses a method for employing human serum albumin to treat various conditions, including diabetes, obesity, and Parkinson’s disease. 
- In addition, the “Improved serum albumin binders” patents (which represent internationally published PCT applications) have a defined filing date (17 January 2018) and address the design and use of binder molecules that attach to albumin to optimize properties such as half-life and drug delivery capacities.

Key patent holders are typically biopharmaceutical companies or research organizations that aim to protect technological advances related to albumin. For instance, some patents are assigned to well-established firms that focus on plasma-derived or recombinant albumin products, while others are held by companies innovating in targeted drug delivery and therapeutic conjugates.

Patent Expiration Details

Expiration Dates 
Because there is no singular “albumin patent,” the expiration date of a patent related to albumin depends strongly on its type, filing date, and legal provisions in the jurisdictions where protection is granted. Here are a few examples:

1. Improved Serum Albumin Binders: 
- The “Improved serum albumin binders” patents published under the Patent Cooperation Treaty (PCT) were filed on 17 January 2018. In most jurisdictions, a patent that is granted based on a filing date in 2018 has a maximum statutory term of 20 years from that filing date. This implies that if granted under standard conditions, these patents would expire around January 2038. 
- However, many countries provide mechanisms to extend patent terms—such as Patent Term Extensions (PTEs) in the United States or Supplementary Protection Certificates (SPCs) in Europe—to compensate for regulatory delays in obtaining marketing approvals. Therefore, these dates could be extended by up to five years in some cases, subject to local law and approval by regulatory agencies.

2. Use and Composition Patents Involving Albumin: 
- Patents such as the “Albumin-containing pharmaceutical composition” and “Use of human serum albumin in treatment of diseases” do not explicitly state in the provided reference content their filing dates or expiration dates. However, typically for such inventions, if they were filed many years ago, they may have already expired or be nearing their expiration. For instance, if a patent was filed in the 1990s (as is sometimes common for pharmaceutical compositions) then the expiration date would normally be 20 years from the filing date, barring any extensions or adjustments. Given that some albumin formulations have been used clinically for decades, many of the earlier formulations may have already expired, thereby opening the market for generic competition for those specific formulations. 
- On the other hand, patents protecting novel formulations or uses—especially those pertaining to new conjugates—may have been filed more recently and may still be under protection.

3. Albumin Conjugate Patents: 
- The patents for albumin–amyloid peptide conjugates likely have filing dates that determine their term. Without an exact filing date in the reference text, one can generally expect that if these patents were filed in the last decade, their statutory life would extend 20 years from that date. For example, if filed around 2010–2012, the expiration would be around 2030–2032, subject to any term adjustments.

Thus, the answer to “When does the patent for Albumin expire?” is not a single date. Rather, it reflects that different patent families addressing albumin and its applications have varying expiration dates. For improved binders filed on 17 January 2018, a typical expiration date will be around January 2038 (or later if a term extension is granted). Meanwhile, older patents covering albumin pharmaceutical compositions or usage may already have expired, whereas newer inventions may still be protected for many years into the future.

Factors Influencing Expiration 
Several factors influence the actual expiration date of a given albumin-related patent:

- Filing Date: 
The statutory 20-year term for patents is calculated from the filing date. Hence, more recently filed patents will have longer remaining protection periods. For example, the improved albumin binder patents filed in 2018 will expire 20 years from then (around 2038) unless an extension is granted.

- Patent Term Extensions and Adjustments: 
In many jurisdictions, especially for pharmaceutical inventions, regulatory delays (for example, the time taken to obtain FDA approval) can be compensated for through extensions such as Patent Term Extensions (PTEs) in the US or Supplementary Protection Certificates (SPCs) in Europe.

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