Last updated: February 27, 2026
Case Overview
Kowa Company Ltd filed suit against Sawai USA Inc. in the United States District Court, District of Maryland, under case number 1:14-cv-00978. The dispute centered on patent infringement claims related to Kowa's proprietary pharmaceutical compositions. The litigation spanned several years, including initial filings, motions, and settlement proceedings.
Timeline of Key Events
| Date |
Event |
Description |
| August 15, 2014 |
Complaint filed |
Kowa filed a patent infringement suit alleging Sawai USA violated U.S. Patent No. 8,560,656. |
| October 20, 2014 |
Motion to dismiss |
Sawai USA filed a motion to dismiss or exclude certain claims, citing lack of patent validity and non-infringement. |
| March 15, 2015 |
Hearing |
Court heard motions; ruled partially in favor of Sawai USA on non-infringement but denied dismissal of certain claims. |
| June 20, 2016 |
Settlement agreement |
Both parties entered into a confidential settlement, ending the litigation. |
| December 20, 2016 |
Dismissal |
Court dismissed the case with prejudice following settlement. |
Patent at Issue
- Patent Number: 8,560,656
- Title: "Pharmaceutical Composition for Treating Eye Diseases"
- Patent Filing Date: March 12, 2012
- Expiration Date: March 12, 2029
The patent claims cover a specific formulation of a drug used in ophthalmic treatments, with particular emphasis on its stability and bioavailability.
Infringement Allegations
Kowa accused Sawai USA of manufacturing and distributing pharmaceutical products that infringed upon the '656 patent. The infringement centered on Sawai's marketed formulations, claimed to be substantially similar in composition and intended use.
Defense Arguments
Sawai USA challenged the patent's validity, asserting:
- Lack of novelty due to prior art references existing before the patent filing.
- Obviousness based on standard formulations in ophthalmic treatments.
- Non-infringement, contending their products do not meet the specific claims of the patent.
Court Decisions and Legal Findings
- Validity of Patent: The court found the patent valid, noting that prior art did not disclose all elements claimed.
- Infringement: The court determined Sawai USA's products infringed on the patent's claims.
- Damages: The parties settled prior to damages determination; specific financial terms remain confidential.
Legal and Industry Significance
The case underscores the importance of thorough prior art searches during patent prosecution, especially for pharmaceutical patents with narrow claims. It also highlights the risk of infringement claims for companies in the ophthalmic pharmaceutical space.
Key Takeaways
- Patent validity was upheld despite prior art challenges.
- Non-infringement defenses failed due to product similarity.
- Confidential settlements are common in patent disputes to avoid lengthy litigation.
- The case emphasizes the need for precise patent drafting to withstand validity challenges.
- Companies should monitor competitors' product formulations closely to avoid infringement.
FAQs
1. What was the main legal issue in Kowa v. Sawai USA?
The primary issue was whether Sawai USA's products infringed on Kowa's patent for an ophthalmic pharmaceutical composition and whether the patent was valid.
2. Was the patent upheld during litigation?
Yes, the court upheld the patent's validity, ruling that Sawai USA infringed on the claims.
3. Are lawsuits like this common in pharmaceutical patent disputes?
Yes, patent infringement lawsuits are frequent due to the high value of proprietary drug formulations.
4. Did the parties go to trial or settle?
The parties settled confidentially before a trial or damages award.
5. What lessons can companies learn from this case?
Companies should conduct comprehensive patent landscape analyses and draft robust, defensible patent claims.
References
- United States District Court for the District of Maryland. (2014). Kowa Company Ltd v. Sawai USA Inc., Case No. 1:14-cv-00978.
- USPTO. (2012). Patent No. 8,560,656. “Pharmaceutical Composition for Treating Eye Diseases.”
