· ‘424 and ‘960 patents cover the OTC product and claim highly crystalline form of Omeprazole Magnesium( atleast 70%) and a unique water based process for making the same.
· If any party develops a product that does not reach 70% crystallinity then it would not infringe. DRL developed a different form, amorphous with less than 1% detectable crystallinity using a different manufacturing process that is alcohol based.
· Infringement requires proof that each and every element of the claim is present in the alleged infringing product. DRL contended that it did not meet atleast one limitation of the claim namely 70% crystallinity. Astrazeneca requested for samples from DRL and carried out its own testing. Astrazeneca further submitted to the court that the DRL capsules were tested and were not found to be infringing. However Astra contended that DRL might be using a crystalline material to make the amorphous product and might be adding water at some step.
· Instead of getting into a full fledged discovery the parties finished briefing this motion instead for a summary judgement. Astrazeneca was persisting on the argument that any batch of omeprazole salt containing water would somehow infringe the patent- even if additional quantities of water were not added deliberately to the salt during the manufacturing process but rather absorbed into the mixture by surrounding air. Astra hence essentially argues that “ by the addition of water” should be read as “ in the presence of water”( sufficient to facilitate crystallization). Any process that “adds water” relative to the amount of other solvents to facilitate crystallization will infringe the claims. DRL doesn’t agree, the plain meaning of “ adding water” means “ deliberately putting water”. Further during prosecution Astra amended all the claims to include “ by addition of water” limitation. A notice of allowance to Astra patents was finally issued because “ the process claims are patentable because of step of adding water to crystallize the claimed product”
· Give the above facts district court concluded that " under supreme court precedent Astrazeneca's amendment of the crystallization step to include " by the addition of water" after the repeated rejection of claims that did not have that limitation, absolutely prohibits it from obtaining a construction that cover what it gave up See Smith v Magic City Kennel Club Inc, 282. U.S 784, 790, 1931." Further the court stated that "the phrase " by the addition of water" as used thruout the '424 patent- in every claim in which it appears-means that a quantity of water that was not present during steps 1 and 2 of the 4 step process must be deliberatelty and affirmatively placed into the mixture during step 3 ( the crystallization step) which takes place following the separation of organic salts from the reaction mixture. I agree with defendents that there is no basis in the intrinsic evidence to suggest Astrazeneca's construction that the crystallization need only be " facilitated" by water that happened to be present , rather than being deliberatly put into the process"
· With respect to literal infringement of product claims , court ruled that DRL clearly does not infringe, but as DRL points out "a competitor wishing to introduce a lower cost competing product would be likely to design the product around the patent, even if the patented product is in some respects clinically superior. And since the principle and central claim of the patents in suit is highly crystalline omeprazole magnesium , the logical step for a competitor who wishes to use omeprazole in its antacid is to use a salt that is not highly crystalline ! Astrazeneca may well be right that Prilosec OTC is superior to DRL's, but the battle will be fought in the marketplace, it is for consumers to decide whether they can get sufficient relief - gastric and otherwise- using DRL's "inferior" but less expensive product"
· Under doctrine of equivalents court ruled that "Because Astrazeneca argued to the USPTO that its patented product could be distinguished from other products because it was more than 70% crystalline, it cannot now argue that a product less than 70% crystalline infringed and doctrine of equivalence. Springs Window fashion LP V. Novo Indus L.P 323 F.3d, 989, 995, ( Fed Cir 2003)
· With respect to process claims, Astra alleged that somewhere in the manufacturing step DRL might be making the patented crystalline product, and must do so by addition of water. Court found that DRL at no stage is using the claimed process and product. Further it is irrelevant whether DRL ‘s process at some stage uses the patented form as long as its absent in the final product( 271(g))
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