Written by Gerald M. Murphy, Jr., Partner at Birch Stewart Kolasch & Birch, LLP
On December 1, in Teva Pharmaceutical Ind. Ltd. v. AstraZeneca Pharmaceuticals LP, the Federal Circuit explained when a secret invention can be considered “made” (or conceived and reduced to practice) so that it can be used as prior art against a patent. Briefly, the CAFC held that an invention can be considered “made” if the inventive entity “did not do so by accident and it knew what it had made.” It is not necessary for the prior inventor to “know everything about how or why its invention worked.”
Discussion
Teva obtained a patent for a “stabilized pharmaceutical composition for the treatment of dyslipidemia” comprising an active ingredient and a stabilizing effective amount of a particular amido- or amino-group containing polymeric compound, “wherein said stabilized pharmaceutical composition does not contain a stabilizing effective amount of another stabilizer or a combination of other stabilizers”.
In a motion for summary judgment, AstraZeneca argued that it had conceived and reduced to practice its drug prior to Teva’s first conception of the claimed subject matter. Although AstraZeneca presumably had non-infringement defenses, AstraZeneca conceded infringement for the limited purpose of its summary judgment motion of invalidity. More specifically, AstraZeneca argued that if the patent covered its accused product Crestor®, then it was the prior inventor of the claimed invention.
It was uncontested that prior to Teva’s invention date, AstraZeneca made a composition containing the claimed active ingredient and the amido- or amino-group containing polymeric compound. However, at the critical “prior invention date”, AstraZeneca did not appreciate that its amido-group containing polymeric compound had a stabilizing effect. Rather, AstraZeneca had included the amido-group containing polymer compound as a disintegrant.
The district court had to consider the following two legal principles (already developed to some extent in prior case law) and decide how to apply these principles to the case at hand.
(1) Under the “doctrine of inherency” (developed mostly in the context of prior art under 35 USC 102(b)), an invention that is made and placed into public use before the critical date can invalidate a later patent if it inherently possesses all of the claimed characteristics. The prior invention can invalidate the patent claim even if the prior inventor did not appreciate that the invention had the claimed characteristics.
(2) In a prior invention contest (where secret inventions can be considered prior art), a party trying to show that it is the prior inventor may need to show some level of appreciation of what he/she has made.
This case clarifies what a “prior inventor” needs to understand about how his/her invention works in order for the invention to be prior art under 35 USC 102(g)(2) against a subsequent inventor who has a patent. Relying on the precedent of the Dow, Mycogen Plant Sciences and Invitrogen cases, the CAFC held that “the party asserting [prior invention] must prove that it appreciated what it had made. The prior inventor does not need to know everything about how or why its invention worked.” Accordingly, the CAFC affirmed the district courts granting of the summary judgment of invalidity based on prior invention under 35 USC 102(g)(2).
Implications for the Future
Some might think that this case is not so important going forward because “secret prior art” under 35 USC 102(g) is being eliminated under the America Invents Act (AIA). However, many “old patents” (not subject to the new definition of prior art) will be litigated under the existing law.
The AIA has also created a type of “prior user rights” entitled: “Defenses to infringement based on earlier inventor” (see 35 USC 273). This “defense” to infringement requires a “commercial use”, which can be “an internal commercial use or an actual arm’s length sale or other arm’s length commercial transfer of a useful end result of such commercial use.” Under the AIA, completely internal (secret or non-public) non-commercial activities will not normally be considered “prior art” for purposes of defeating a patent. However, the point at which internal research or development work becomes “internal commercial use” is yet to be determined. It is possible that the Teva v. AstraZeneca case may be relevant to analyzing the ability of a company to obtain prior user rights under the AIA with respect to a prior “internal commercial use”.
Tags: AstraZeneca Pharmaceuticals, Birch Stewart Kolasch & Birch, CAFC, doctrine of inherency, Gerald M. Murphy, prior inventor, Teva Pharmaceutical, Teva Pharmaceutical Ind. Ltd. v. AstraZeneca Pharmaceuticals LP
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