This is case review discusses 1) standard of enablement and 2) standard for injunctions against future infringement.
Edwards Lifesciences (“Edwards”) sued defendants Corevalue for infringement of US patent No 5,411,552 (“’552 patent”). The 552 patent is directed towards a prosthetic device for a heart valve, where the valve is mounted on a stent and implanted in the heart via a catheter. A representative independent claim is reproduced below:
1. A valve prosthesis for implantation in a body channel, the valve prosthesis comprising a collapsible elastical valve which is mounted on an elastical stent, the elastical valve having a plurality of commissural points, wherein the stent comprises:
cylindrical support means which is radially collapsible for introduction within the body channel and which has a plurality of circumferentially-expandable sections such that the cylindrical support means is radially expandable for being secured within the body channel;and
a plurality of commissural supports projecting from one side of the cylindrical support means in a direction generally parallel to the longitudinal axis thereof for supporting the commissural points of the collapsible valve, at least one circumferentially-expandable section of the cylindrical support means lying between each of the commissural supports, such that the collapsible valve may be collapsed and expanded together with the cylindrical support means for implantation in the body channel by means of a technique of catheterization.
Initially, the district court held that Corevalue willfully infringed on Edwards ‘552 patent, and a jury awarded around 74 million in damages. Corevalue challenged the validity of the ‘552 patent on the grounds that the ‘552 patent lacked enablement because at the time of filing the ‘552 patent application the invention had only been implemented on pigs. Corevalue argued that in no event does testing in pigs enable the use in humans.
Citing MPEP section 2164.02, the appeals court stated that in the field of medicine it has long been recognized that experimentation on humans is inappropriate, and that in testing and development of drugs and medical devices that the enablement requirement may be met by animal tests or in vitro data. Further, the court stated that the standard for enablement under 35 USC 112 is summarized in In re Wands, 858 with the following factors:
(1) the quantity of experimentation necessary,
(2) the amount of direction or guidance presented,
(3) the presence or absence of working examples,
(4) the nature of the invention,
(5) the state of the prior art,
(6) the relative skill of those in the art,
(7) the predictability or unpredictability of the art, and
(8) the breadth of the claims.” Id. at 737.
In view of the above, the court of appeals held that there was substantial evidence supporting that Edwards had met the enablement requirements to obtain patent protection, even though the claims had not been tested on humans.
After determining that Corevalue had infringed claim 1 of the ‘552 patent the court of appeals discussed remedies for Edwards. Edwards requested an injunction against future infringement citing equitable concerns such as the importance of establishing customer relationships now that the product has been FDA approved, and that a large manufacturer such as Corevalue could overwhelm a smaller company such as Edwards.
The court of appeals stated when granting an injunction, a plurality of factors should be considered such as 1) public interest 2) granting licenses if the patentee would experience no competitive injury and 3) is infringer a direct market competitor for the patent subject matter. The court of appeals stated that because the circumstances of parties have not been fully explored on the record, the case is remanded to the district court for equitable consideration concerning an injunction.
AUSTIN PATENT ATTORNEY TAKE-A-WAYS:
1) A frequently asked question I receive from inventors is “Do I have to have a prototype for my invention or the coding for a mobile application.” In view of the above case and the factors in In re Wands it is clear that a functioning prototype or application does not have to be created to obtain patent protection. However, based on your patent application one skilled in the art would need to be enabled to be able to use/create your invention. As discussed in EDWARDS LIFESCIENCES v. COREVALVE, even though a working prototype for humans had not been created, because pig’s hearts resemble human hearts that prototypes for human hearts would be similar. It would be interesting to see if patents that are computer operating system/language dependent would be held invalid if they only include references to a single computing language.
2) Even if you are granted a monopoly on an invention via the patent process, courts will not automatically grant an injunction to stop others from making the products, but may instead for compensatory licenses for you invention.