## Facts

- BlephEx owned U.S. Patent No. 10,449,087, directed to an instrument for removing debris from an eye during treatment of ocular disorders such as blepharitis.
- The asserted claim (claim 16) covered an electromechanical handpiece with a rotating shaft and an attached swab for treating ocular disorders.
- Myco marketed the “AB Max,” a device for treating blepharitis, beginning in February 2019.
- BlephEx filed the patent application in March 2019; the patent issued October 22, 2019.
- On the issuance date, BlephEx sued Myco and Myco’s chairman in the Eastern District of Michigan for infringement and sought a preliminary injunction to stop sales and distribution of AB Max during the case.
- Myco argued claim 16 was invalid as anticipated or obvious over a prior published application (“Nichamin”), which disclosed (i) a wand using an abrasive swab on the eyelid and (ii) an electromechanical device used to remove debris, but did not expressly describe attaching a swab to an electromechanical device.
- The district court granted a preliminary injunction and later denied reconsideration.

## Issues

1. Whether the district court erred in concluding BlephEx was likely to succeed on the merits by rejecting Myco’s anticipation and obviousness challenges to claim 16.
2. Whether the district court clearly erred in finding irreparable harm and in weighing the balance of hardships and public interest.
3. Whether the district court abused its discretion in defining the scope of the preliminary injunction.

## Decision

- The Federal Circuit affirmed the preliminary injunction.
- On anticipation, the court agreed Nichamin did not disclose every claim 16 limitation arranged as required, particularly the attachment of a swab to an electromechanical device for ocular treatment.
- On obviousness, the court held Myco failed to make a strong showing that a skilled artisan would have been motivated to combine Nichamin’s separate embodiments in the claimed manner on the preliminary record; conclusory “common sense” assertions were insufficient.
- The court upheld the district court’s findings of irreparable harm based on loss of market share, price erosion, harm to customer relationships, and loss of exclusivity from direct competition.
- The court agreed the balance of hardships favored BlephEx because Myco’s hardship stemmed from being restrained from selling an accused product.
- The court agreed the public interest favored enforcement of patent rights, and Myco did not show patients would lose access to necessary treatment.
- The court held the injunction’s scope was appropriately focused on the accused product and related infringing conduct, and did not improperly reach unrelated activities.

## Legal Principles

- A preliminary injunction in a patent case is reviewed for abuse of discretion; underlying factual findings are reviewed for clear error and legal conclusions de novo.
- Anticipation requires a single prior art reference to disclose all claim limitations arranged as in the claim; separate embodiments do not anticipate absent disclosure of the specific claimed combination.
- At the preliminary-injunction stage, a challenger must make a strong showing of invalidity to defeat likelihood of success; unsupported assertions that a combination would be routine or “common sense” generally do not suffice without evidentiary support.
- Irreparable harm may be shown by evidence of direct competition causing loss of market share, price erosion, damaged relationships, and impairment of patent exclusivity.
- The hardship to an accused infringer from being enjoined from infringing typically carries limited weight compared to a patentee’s harm from continued alleged infringement.
- Injunctive relief should be tailored to the accused product and the proscribed infringing acts.

## Conclusion

The Federal Circuit affirmed a preliminary injunction barring sales and distribution of Myco’s accused device, holding that Myco had not shown a strong likelihood that the asserted patent claim was anticipated or obvious on the preliminary record and that the district court’s findings on irreparable harm, equitable factors, and injunction scope were not erroneous.


BlephEx, LLC v. Myco Indus., Inc., 24 F.4th 1391 (Fed. Cir. 2022)