The Filler Effect: One Line’s Monopoly on Pain Alleviation

Despite a lagged government at the beginning of the new year, IP related claims from a variety of all industries and places are already piling up.  Summarized by IPWatchDog’s “Other Barks & Bites” column, among the notable are China’s Beijing intellectual property courts that have created new formal requirements, the European Parliament members canceled meeting regarding copyright reforms, and the European Union recently revoking McDonald’s trademark registration for big mac. Back home in the States, Rihanna has filed a Trademark suit against her Father’s Entertainment company, Ed Sheeran has asked the Southern District of New York Judge to reconsider his copyright case for “Thinking out Loud,” and the Georgia GOP has sued over the use of Stacey Abrams Photo in the Governor’s campaign ad.

…it is likely that the court will permanently enjoin Prollenium within the United States…

Topping off the past week, I want to highlight “The Filler Effect.” In a petition filed by Allergan against a smaller Canadian rival, Prollenium Medical Technologies Inc., Allergen asserts that its competitor has infringed on two Juvéderm patents as part of Prollenium’s Revanesse Versa+ filler formulation. In the complaint under Docket No. 1:19-cv-00126 (D. Del. Jan 22, 2019), Allergan’s “Hyaluronic Acid-Based Gels Including Lidocaine” patent has helped alleviate the pain associated with the hyaluronic gel injections to the face. Lidocaine as a local anesthetic is thereby desirable for its pain reducing affect. The petition also alleges that although prior hyaluronic acid-based compositions have been attempted to include lidocaine during the manufacturing process, none were successful because they degraded at least in part upon injection. This patent represents the formulations for and methods of manufacturing, which Allergan made sure to emphasize.  They acknowledged a suit against them back in 2017, Teoxane S.A. v. Allergan, Docket No. IPR2017-01906 (P.T.A.B. Aug. 02, 2017). There, Teoxane alleged that an injectable soft tissue filler including lidocaine and hyaluronic acid would have been obvious to a person of the ordinary skill in the art. “HA-based soft tissue fillers were known and under rapid development since the FDA [U.S. Food and Drug Administration] approved the first HA-based soft tissue filler in December, 2003,” the petition states.  “In particular, crosslinked HA compositions/fillers had been used due to increased stability and durability.  . . . Lidocaine had been included in various dermal fillers to reduce pain upon injection, a major barrier to cosmetic treatments.” Other research tends to compliment these assertions being that many filler products contain lidocaine. However, the unique method and formula that Allergan asserts its patent over caused the P.T.A.B. to deny Teoxane’s petition. They ruled that Teoxane had not shown a reasonable likelihood of prevailing at trial with respect to any challenge of Allergan’s Juvéderm patent. Allergan is clearly a leader in the distribution of dermal filler. With one syringe of Juvéderm Voluma running between $700 to $1200 in major cities, and treatments varying from one to four syringes it’s no wonder that this line has topped $500 million of sales per year in the United States. Not to forget that Allegan has been effective in protecting its patent against market entrants. Therefore, it is likely that the court will permanently enjoin Prollenium within the United States from selling its Revanesse Versa+ filler formulation along with the damages Allergan seeks.

Katie Donald, 28 January 2019