Home > Articles and Alerts > Medical Syringe Patent Limited in Scope
U.S. Patent for Medical Syringe Held
Partially Ineffective by Appellate Court
Although a patent applicant can never anticipate every possible way that every term in his/her application may be interpreted at a time when it really matters, such as in the court room, the applicant can and certainly should learn from the mistakes of others. In Retractable Technologies (RT) v. Becton, Dickinson & Co. (BD), Opinion 2010-1402, (Fed. Cir., July 8, 2011), BD’s patents were interpreted such that the claim term “syringe body” only applied to a one-piece body, and therefore BD could not succeed in its argument that one of RT’s competing medical device infringed its patents. Thus, RT is now free to compete in that respect without payment of damages or license royalties to BD.
A syringe having a retractable needle is certainly a desirable instrument for health care providers. Doctors and nurses using hypodermic syringes risk infection, perhaps mortally, if the needle of a syringe used on a patient punctures their skin. In response to the risks, some syringes have been designed to include extending shields to cover the needles, but the manual manipulation that some of them require can cause the operator's fingers to come close to the needle. Even for syringes having springs to automatically position the shields around the needle, they do not cover the needle’s tip, as do syringes having retracting needles. Thus, syringes having retractable needles definitely have a place in today’s market.
BD entered this market and obtained patents that ideally would have limited competition. The claims of the patents were lengthy, as is common in the mechanical arts, and one of the many elements recited in the claims was a “hollow syringe body.” Some claims specified that the syringe body was “one-piece,” which implies that the other claims should be broad enough to cover bodies that are either one-piece or multi-piece.
An implication like that of the previous paragraph is known in patent jargon as the doctrine of claim differentiation. I have no information regarding why the patent attorney prosecuting BD’s applications chose the claims he did, but perhaps he filed some claims explicitly reciting “one-piece” so that he could later argue that the other claims cover both one-piece and multi-piece syringe bodies.
If that were the patent attorney’s plan, he should have also known that the doctrine of claim differentiation is a relatively-weak doctrine that is often outweighed by opposing arguments. The patent attorney also should have seen that he was providing to the competition the arguments for outweighing a claim differentiation argument. I elaborate as follows:
The court cited multiple arguments against claim differentiation (see pages 15-17 of the slip opinion), but the most glaring argument in my opinion is based on the following text from the patent specifications:
Admittedly, the patents in this case were filed in the mid 90’s, and perhaps what is clear now was not as clear back then. In any case, we see that we need to constantly follow the case law to learn from the experiences of others.
Back to the present case: It is also unclear why, if the patent attorney chose to file claims explicitly reciting the one-piece structure, he did not include at least a short statement in the specification that syringes having multi-piece bodies were also within the scope of the invention. I am a firm believer in writing patent applications by writing the claims first (at least a rough draft of them) and then using those claims as a checklist for drafting the detailed description. If I saw on my “checklist” a narrow claim stating that the syringe body had a one-piece structure, I almost certainly would have written that multi-piece structures were also within the scope of the invention.
We can never predict with certainty how a court will hold, but I do believe the drafting practices discussed above would have helped the patent holder significantly.
An added point: The present case was an appeal from a trial court’s holding that the patent indeed covered both one-piece and multi-piece syringe bodies. The appellate court reversed this holding by a 2-1 panel decision. The dissent of Chief Judge Rader explained, quite cogently, why the court should have affirmed the trial court’s holding.
A three-judge appellate panel is chosen randomly. One wonders how likely a different panel would have instead affirmed the trial court’s holding given the quite reasonable basis to do so. Again, back to the drafting practices I discuss above. If the patent application were drafted accordingly, there would have been most likely no risk that Judge Rader would have taken the opposite position, but the chances would have increased that the two other judges on the panel would have ruled in favor of the patent holder. Thus, these drafting practices comport with both schools of thought.
A syringe having a retractable needle is certainly a desirable instrument for health care providers. Doctors and nurses using hypodermic syringes risk infection, perhaps mortally, if the needle of a syringe used on a patient punctures their skin. In response to the risks, some syringes have been designed to include extending shields to cover the needles, but the manual manipulation that some of them require can cause the operator's fingers to come close to the needle. Even for syringes having springs to automatically position the shields around the needle, they do not cover the needle’s tip, as do syringes having retracting needles. Thus, syringes having retractable needles definitely have a place in today’s market.
BD entered this market and obtained patents that ideally would have limited competition. The claims of the patents were lengthy, as is common in the mechanical arts, and one of the many elements recited in the claims was a “hollow syringe body.” Some claims specified that the syringe body was “one-piece,” which implies that the other claims should be broad enough to cover bodies that are either one-piece or multi-piece.
An implication like that of the previous paragraph is known in patent jargon as the doctrine of claim differentiation. I have no information regarding why the patent attorney prosecuting BD’s applications chose the claims he did, but perhaps he filed some claims explicitly reciting “one-piece” so that he could later argue that the other claims cover both one-piece and multi-piece syringe bodies.
If that were the patent attorney’s plan, he should have also known that the doctrine of claim differentiation is a relatively-weak doctrine that is often outweighed by opposing arguments. The patent attorney also should have seen that he was providing to the competition the arguments for outweighing a claim differentiation argument. I elaborate as follows:
The court cited multiple arguments against claim differentiation (see pages 15-17 of the slip opinion), but the most glaring argument in my opinion is based on the following text from the patent specifications:
- The invention is a reliable retractable tamperproof syringe …
- The syringe structure features a one piece hollow outer body …
Admittedly, the patents in this case were filed in the mid 90’s, and perhaps what is clear now was not as clear back then. In any case, we see that we need to constantly follow the case law to learn from the experiences of others.
Back to the present case: It is also unclear why, if the patent attorney chose to file claims explicitly reciting the one-piece structure, he did not include at least a short statement in the specification that syringes having multi-piece bodies were also within the scope of the invention. I am a firm believer in writing patent applications by writing the claims first (at least a rough draft of them) and then using those claims as a checklist for drafting the detailed description. If I saw on my “checklist” a narrow claim stating that the syringe body had a one-piece structure, I almost certainly would have written that multi-piece structures were also within the scope of the invention.
We can never predict with certainty how a court will hold, but I do believe the drafting practices discussed above would have helped the patent holder significantly.
An added point: The present case was an appeal from a trial court’s holding that the patent indeed covered both one-piece and multi-piece syringe bodies. The appellate court reversed this holding by a 2-1 panel decision. The dissent of Chief Judge Rader explained, quite cogently, why the court should have affirmed the trial court’s holding.
A three-judge appellate panel is chosen randomly. One wonders how likely a different panel would have instead affirmed the trial court’s holding given the quite reasonable basis to do so. Again, back to the drafting practices I discuss above. If the patent application were drafted accordingly, there would have been most likely no risk that Judge Rader would have taken the opposite position, but the chances would have increased that the two other judges on the panel would have ruled in favor of the patent holder. Thus, these drafting practices comport with both schools of thought.
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