Eli Lilly and a generic

The U.S. Federal Circuit recently upheld a district court on a patent law matter concerning Eli Lilly's drug, Evista (chemical name, raloxifene).

The district court enjoined any manufacture or distribution of a generic version of raloxifene, which is used in the treatment of osteoporosis in postmenopausal women.

The defendant, Teva Pharmaceuticals, disputed the validity of Eli Lilly's patents on the ground of obviousness. In the words of the court, Teva contended "that the Bone Loss Patents or the Low Does Patent would have been obvious to one of ordinary skill in the art."

In finding nonobviousness, the Federal Circuit discussed an earlier study of te use of raloxifene, the Buzdar study, under the heading of "prior art." The critical fact here is that the Buzdar study failed, and "in light of Dr. Budzar's published report describing that failure, the district court correctly found that a person of ordinary skill would have been discouraged from using raloxifene" in further tests. Thus, the scientists working for Lilly were using something more than ordinary skill, and the patent is upheld.

Amylin fight: Byetta fall-out

Amylin Pharmaceuticals Inc., a Delaware chartered company with its headquarters in San Diego, Calif., will hold its annual shareholders meeting May 27.

It could be a contentious affair. On March 30, the SEC gave "no action" relief to each of two activist shareholders that will allow them to include each other's nominees on their own proxy cards -- to present a unified opposition slate, so to speak. So that unified opposition slate now includes 10 nominees for the 12 seats on the board.

Last year, Amylin's diabetes drug Byetta (which the company co-markets with Eli Lilly) became the subject of highly publicized safety concerns. The FDA said that it was working on a stronger warning label for the drug, and the value of Amylin stock, which had been moving close to $35, dropped to below $20 within the month.

Here's a link to a stock chart that includes that that precipitous drop.

You'll also see from that chart that though the price briefly regained its equilibrium at $20, it resumed a downward drift by early October. That can' really be held against the leadership of the company, though, because all US equities headed south last October.

More recently, good news about Byetta has enabled the stock to make a modest recovery.

I'll say something about the blow-by-blow of the proxy fight tomorrow.