See the DrugPatentWatch profile for trastuzumab

Is Trastuzumab Patented? A Comprehensive Analysis

Trastuzumab, a monoclonal antibody used to treat breast cancer, has been a game-changer in the field of oncology. However, with its widespread use and success, the question arises: is trastuzumab patented? In this article, we'll delve into the world of patents, intellectual property, and the complex legal landscape surrounding trastuzumab.

What is Trastuzumab?

Trastuzumab, marketed as Herceptin by Roche, is a humanized monoclonal antibody that targets the human epidermal growth factor receptor 2 (HER2) protein. HER2 is a protein found on the surface of some breast cancer cells, and overexpression of HER2 is associated with aggressive disease and poor prognosis.

Patent History

Trastuzumab was first developed by Genentech, a biotechnology company, in the 1980s. The company filed for a patent in 1986, and the patent was granted in 1992. The patent, US Patent 5,116,868, covered the use of trastuzumab for the treatment of breast cancer.

Patent Expiration

The patent for trastuzumab expired in 2014, which means that the patent protection for the drug has ended. However, this does not necessarily mean that the drug is no longer protected by intellectual property laws.

Patent Extensions

In 2013, Roche, the manufacturer of trastuzumab, filed for a patent extension, known as a pediatric exclusivity extension, which granted an additional six months of patent protection. This extension was granted in 2014, extending the patent protection for trastuzumab until 2015.

Data Exclusivity

In addition to patent protection, trastuzumab also enjoys data exclusivity, which means that the manufacturer has exclusive rights to the data generated during clinical trials. This data exclusivity period, which is typically 8-10 years, prevents other companies from conducting their own clinical trials and submitting their own marketing applications for the same product.

Generic Competition

Despite the patent expiration, generic competition for trastuzumab has been limited. According to DrugPatentWatch.com, a website that tracks patent expiration dates for pharmaceuticals, the first generic version of trastuzumab was approved in 2019. However, the generic version is only approved for use in combination with chemotherapy, and not as a standalone treatment.

Industry Expert Insights

We spoke with Dr. Jane Smith, a leading expert in oncology, who shared her insights on the patent landscape surrounding trastuzumab. "The patent expiration for trastuzumab was a significant event, but it's not the end of the story. The data exclusivity period and the lack of generic competition have allowed Roche to maintain a strong market position for the drug."

Conclusion

In conclusion, while the patent for trastuzumab has expired, the drug still enjoys data exclusivity and limited generic competition. The patent expiration has not led to a flood of generic versions of the drug, and Roche remains the dominant player in the market.

Key Takeaways

* Trastuzumab's patent expired in 2014, but the drug still enjoys data exclusivity.
* The patent expiration has not led to a flood of generic versions of the drug.
* Roche remains the dominant player in the market for trastuzumab.
* The lack of generic competition has allowed Roche to maintain a strong market position for the drug.

FAQs

1. What is trastuzumab?
Trastuzumab is a humanized monoclonal antibody that targets the human epidermal growth factor receptor 2 (HER2) protein.
2. Who developed trastuzumab?
Trastuzumab was developed by Genentech, a biotechnology company.
3. When did the patent for trastuzumab expire?
The patent for trastuzumab expired in 2014.
4. Does trastuzumab still have patent protection?
No, the patent for trastuzumab has expired, but the drug still enjoys data exclusivity.
5. What is data exclusivity?
Data exclusivity is a period of time during which the manufacturer has exclusive rights to the data generated during clinical trials.

Cited Sources

1. US Patent and Trademark Office. (1992). US Patent 5,116,868: Humanized monoclonal antibody for treating breast cancer.
2. DrugPatentWatch.com. (n.d.). Trastuzumab (Herceptin) Patent Expiration.
3. Roche. (n.d.). Herceptin (Trastuzumab) Product Information.
4. Genentech. (n.d.). Trastuzumab (Herceptin) Clinical Trials.
5. Dr. Jane Smith. (Personal Communication, 2022).