Case #1: Prometheus Laboratories, Inc. v. Roxane Laboratories, I

In this case, Prometheus Laboratories, Inc. v. Roxane Laboratories, courts decided that Prometheus' patent claim was invalid.

Background:

Prometheus’ Lotronex is a pharmaceutical product to treat Irritable Bowl Syndrome in women (Year 2000, then later relaunched in 2002)

Roxane Laboratories wants to make generic version of this drug (2009 FDA filing).

Patent- (Source: PharmaPatents)

The ’770 patent is directed to “[m]edicaments for the treatment of non-constipated female irritable bowel syndrome,” and includes claims that correspond to the approved use of Lotronex®. The patent issued in 2001, and Prometheus sought reexamination of the patent in 2009. A reexamination certificate issued on October 19, 2010, with the following claims amended or added during reexamination:

5. A method for treating a diarrhea-predominant female IBS patient, while excluding those with predominant constipation, said method comprising: assessing whether said diarrhea-predominant female IBS patient has experienced symptoms for least six months; and administering an effective amount of alosetron or a pharmaceutically acceptable derivative thereof to said patient who has experienced symptoms for at least six months, wherein said effective amount is dependent on the condition of the patient and is at the discretion of the attendant physician.

10. The method for treating according to claim 5, further comprising assessing whether said female IBS patient has experienced at least moderate pain prior to administration of alosetron.

13. A method for treating a diarrhea-predominant female IBS patient, while excluding those with predominant constipation, said method comprising:
assessing whether said diarrhea-predominant female IBS patient has experienced symptoms for at least six months; assessing whether said nonconstipated female IBS patient experiences at least moderate baseline pain from IBS; and administering an effective amount of alosetron or a pharmaceutically acceptable derivative thereof to said patient who has experienced symptoms for at least six months and who experiences at least moderate baseline pain from IBS, wherein said effective amount is dependent on the condition of the patient and is at the discretion of the attendant physician.

Case Results (Source: PharmaPatents)

Roxane challenged the validity of the claims as obvious or invalid for obviousness-type double patenting (OTDP) over a now-expired Prometheus patent—U.S. Patent No. 5,360,800. The ’800 patent included claims directed to treating IBS generally, the claims were directed to a genus of the claims in the ’770 patent. 

Federal Circuit agreed that Prometheus had not meet its burden of producing sufficient evidence to show a nexus between the claimed methods and commercial success. 

“We affirm the district court’s holding that the challenged claims of the ’770 patent would have been obvious over the ’800 patent and other prior art.”

Analysis:

Essentially, because the company claimed many things in the '800 patent, the information and claims within the '770 were deemed prior art and constituted obviousness. While many of scientific and medical claims are not obvious for laypeople, the '770 patent claims were deemed obvious for normal people after  reading the '800 patent. Thus, it is a bit of crafty perspective on Roxane Laboratories part to convince the courts. 

Source:

https://www.pharmapatentsblog.com/2015/11/24/obviousness-versus-obviousness-type-double-patenting/