On Mar. 22, 2024, Delaware district court rejected plaintiff’s infringement theory as speculative without evidence.

 

In the case of Galderma v. Lupin, Galderma holds patents for a doxycycline capsule called Oracea, used for inflammatory lesions of rosacea. Oracea’s patented formulation consists of an immediate-release portion containing about 30 mg of doxycycline and a delayed-release portion containing about 10 mg of doxycycline, coated to release at a higher pH level in the small intestine. Galderma alleged that Lupin infringed on its patents (US 7,749,532 & US 8,206,740) by submitting an Abbreviated New Drug Application for a similar doxycycline drug, claiming bioequivalence to Oracea. Lupin claimed that its drug would have a 22-mg immediate-release portion and an 18-mg delayed release portion.

 

During the trial, Galderma presented Dr. Edward Rudnic as its expert witness, who argued that Lupin’s drug design indicated an intent to infringe Galderma’s patents. He highlighted Lupin’s use of methylene chloride in coating, which is unusual due to its toxicity, and the low weight gain of the coating compared to industry norms. Dr. Rudnic claimed that these factors suggested Lupin’s deliberate design for the coating to be weak, causing the delayed-release portion to leak and release immediately.

 

However, Lupin contested Galderma’s claims, presenting evidence through its witnesses. Lupin’s executive vice president of research and development, refuted Dr. Rudnic’s claims about the manufacturing process and differences between large and small batches. Dissolution expert Vivian Gray criticized the reliability of the two-stage test used by Galderma, pointing out anomalies in the results and suggesting errors in the testing method. Lupin’s main expert, Dr. Graham Buckton, disputed Dr. Rudnic’s assertions about the coating and criticized the validity of drawing conclusions from the two-stage test.

 

In the ruling, the judge rejected Galderma’s infringement claim, citing lack of evidence to support their theory. Court said that Galderma must show that about 8 mg of Lupin’s 18-mg delayed-release portion releases immediately. That weak coat leaks, causing about 8 milligrams of doxycycline in the [delayed-release] portion … [to] immediately release. But Galderma did not show its work with proper evidence. The judge found Dr. Rudnic’s testimony unreliable, as it lacked solid evidence and was based on speculative assertions. Furthermore, the judge criticized Galderma’s reliance on the two-stage test, highlighting flaws in its methodology and inconsistencies in Galderma’s arguments based on the test results. Ultimately, the judge concluded that Galderma’s theory masquerades speculation as science. But it does not back up that theory with evidence.

Galderma failed to prove that Lupin’s drug infringed on its patents, and therefore, the patent infringement claim was rejected.

“District court opinion”