Unigen Agrees to Consolidate Three Pending Cases

Unigen Pharmaceuticals, maker of an herbal supplement Univestin (a blend of flavans from Acacia catechu and flavanoids from Chinese Skullcap (Scutellaria Baicalensis)) agreed Friday to consolidate three pending cases for infringement of US Patent No. 7,192,611. The claims of the '611 patent are directed to a method for treating osteoarthritis using what is known as a Free-B-Ring flavonoid, which includes baicalein. The three defendants are Walgreens, Target, and Perrigo Company of South Carolina Inc. The case against Perrigo was just recently filed late last month.

The Defendants have called the validity of the '611 patent into question in a motion for partial summary judgment of invalidity. The motion, pending before Judge Jones in the case against Defendant Walgreens (No. C07-0471 RAJ), argues that the claims of the '611 patent are invalid in view of US Patent No. 5,650,433 which discloses the use of Free-B-Ring flavanoids, including baicalein, to treat osteoarthritis. Because the '433 patent issued almost five years prior to Unigen's, Defendants argue that Unigen's '611 patent is invalid.

In a previous post, I commented on this case, and Judge Jones' request for an early claim construction "proffer" from Unigen, essentially asking for a good faith construction that would permit a jury to find both infringement and that the claims were not invalid. Unigen complied arguing essentially that the ’611 Patent claims a "method of alleviating those symptoms of osteoarthritis that result from cyclooxygenase enzyme (COX-2) mediated inflammation, while the ’433 Patent is directed towards a method of treating arthropathy generally by administering an agent that suppresses the destruction of articular cartilage.

The claim construction argument is as follows:

"In construing the claims of the ’611 Patent, a person of ordinary skill in the art would conclude that the preambles to Claims 1, 8 and 15—the three independent claims—constitute claim limitations and that those limitations mandate treating osteoarthritis by alleviating those symptoms of osteoarthritis that result from inflammation. In other words, the method of treating osteoarthritis in the ’611 Patent encompasses a reduction of inflammation within the joints themselves, rather than building a protective layer in the cartilage."

Given the above narrow construction of the claims and assuming for the sake of argument that a claim so construed would not be invalid over the '433 patent, this case will be one for inducement or contributory infringement, so Unigen must prove knowledge and intent that Defendants' herbal supplements are used in the above way. This will place defendants' advertising and labelling of the supplements into sharper focus than what one might expect in a garden variety patent case. I would expect to hear from some experts on product labelling and marketing. Perhaps some survey evidence. It will be very important to know what subjective understanding consumers have from reading the subject labelling. Presumably, careful labeling and marketing could be a complete defense in a case like this.