An important precedential decision was decided recently on the issue of obviousness.  I have provided my summary of the case along with some take-home messages.

ALCON RESEARCH, LTD. (FORMERLY KNOWN AS ALCON MANUFACTURING, LTD.), ALCON LABORATORIES, INC., AND KYOWA HAKKO KIRIN CO. LTD., v. APOTEX INC. AND APOTEX CORP., Appeal No. 2011-1455 (Fed. Cir. August 8, 2012). Before Prost, Moore, and O’Malley. Appealed from S.D. of Indiana (Judge Young).

Background:

Alcon holds a patent which claimed methods for treating allergic eye diseases in humans by topically administering an olopatadine composition. olopatadine was known in the prior art as an effective antihistamine, and chemicals related to olopatadine were known to have mast cell stabilizing activity.  However, olopatadine was not known to stabilize mast cells.  Moreover, mast cells from different species, and even different tissue from the same species, can have different biological responses.  Therefore, even though the drug was already known in the art, Alcon’s scientists were the first to show that olopatadine could stabilize conjunctival mast cells in humans. The commercial embodiment of this patent was the anti-allergy eye drop Patanol.

Apotex submitted an Abbreviated New Drug Application (ANDA) to the Food and Drug Administration seeking approval to market a generic version of Patanol. Alcon sued Apotex for patent infringement. The district court held that the claims were not obvious over a Kamei reference, which disclosed an overlapping range of administration of olopatadine in guinea pigs. The claims required administering a therapeutically effective amount of the composition to stabilize the conjuctival mast cells. Dependent claims specified a range of amount that the olopatadine was administered. The district court primarily relied on Kamei’s disclosure that olopatadine was actually not a mast cell stabilizer in finding the claims non-obvious. Apotex appealed.

Issue/Holding:

Did the district court err in holding that the Kamei reference did not render obvious the claims of Alcon’s patent? Yes, reversed-in-part.

Discussion:

The Federal Circuit first reasoned that “a therapeutically effective amount” could not be a range less than 0.0001% w/v to 5% w/v, because a dependent claim cannot be broader than a claim from which it depends. Thus the claimed therapeutically effective amount had to include at least the dependent claim range or else the claim was inoperable. Furthermore, because the claims required that the mast cells be stabilized, because Alcon admitted that certain quantities within the dependent claimed range do not stabilize the mast cells, the district court improperly read out of the claims the limitation of its dosage amount. The dosage in the range that was thus not operable. When claiming a range, part of the range that is inoperative (i.e., not enabled), cannot be later disavowed. Instead, the entire claim is invalid. “Courts do not rewrite the claims to narrow them for the patentee to cover only the valid portion.”

The Federal Circuit reasoned that there was a motivation to apply Kamei to humans because the lower court found that animal models are predictive of antihistamic efficacy in humans. The “motivation to modify a prior art reference to arrive at the claimed invention need not be the same motivation that the patentee had.”

The Federal Circuit after balancing the objective considerations of outstanding commercial success of Patanol of achieving nearly 70% of the market share within two years of its launch, nearly $2billion in sales within 10 years and garnering wide-spread praise within the industry, that Apotex had established by clear and convincing evidence that claims 1-3 and 5-7 would have been obvious to one of ordinary skill in the art over Kamei.

The Federal Circuit further held that claims 4 and 8, which did not fall within the range recited by Kamei, were not rendered obvious over Kamei.

 

 

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