Boston Scientific Corp. v. Johnson & Johnson, Cordis Corp. and Wyeth, Fed. Cir. June 7, 2011

Kumiko Ide and Ryan Chirnomas | June 15, 2011

Majority:  Moore, Bryson

概要

化学構造と機能性の相互関係についての記載がなく、化合物の大きな属を記載したクレームは、記載要件を満たしていないと見なされる。出願時、どの属に機能性があり、どの属に機能性がないかについての情報がなく、当該分野において不確実性が存在し、当業者がクレーム発明の範囲を理解することができないような場合は特にそのように見なされる。

出願手続きについてのアドバイス

–          特許請求の範囲は、広いものから狭いものまで含むことを推奨する。可能であれば、大きな属から特定の種のみならず、属と種の間の特定した化学構造を表す下位属も記載することを推奨する。

–          発明について何らかの不確実性が存在する場合、その不確実性について明細書に記載すべきでない。本件では、発明のある面について「現在調査進行中(under active investigation)」と示した特許権者のコメントは、化学構造と機能の相互関係について当該分野において公知であったという主張と矛盾していた。専門家証言も、同じ結果(当該分野において公知であった)になるかもしれないが、明細書にそれと矛盾する記載があった場合、裁判所が特許権者に有利な判決を下すことは難しくなる。

Summary

Claims which recite a very broad genus of compounds without providing some guidance as to a structural/functional correlation will be regarded as failing to comply with the written description requirement.  This is particularly true where there is uncertainty in the art at the time of filling such than one having ordinary skill in the art would be unable to visualize the scope of the claimed invention, since no guidance is available as to which members of the genus are functional or non-functional.

Prosecution Tips

-As always, we recommend a broad-to-narrow scope of claimed subject matter.  If possible, recite a large genus and a specific species, but also an intermediate sub-genus with some structural specifics.

-If there exists uncertainty in the art as to some aspect of the invention, do not comment on such uncertainty in the specification.  Here, the patentee’s comments about aspects of the invention being “under active investigation,” conflicted with the patentee’s arguments that the structural/functional correlation was known in the art.  Although expert testimony may result in the same conclusion, including such statements in the specification make it very difficult for the court to rule in the patentee’s favor. 

Case History:

Cordis is an assignee of three patents (USP 7,217,286; 7,223,286; 7,229,473) which claim priority to an April 1997 provisional application.  Cumulatively, these patents are referred to as “the 1997 patents.”  Cordis is also an assignee of USP 7,300,662 (“the ‘662 patent”) which has a 2001 priority date.   The District Court issued a summary judgment that claims of the 1997 patents are invalid for lack of written description and enablement, and that claims of the ‘662 patent are invalid for lack of written description.     

Technology:

The claims recite a stent which elutes a medicine for treatment of heart disease.  Specifically, the claims refer to rapamycin, a macrocyclic lactone analog of rapamycin, or a macrocyclic triene analog of rapamycin.  Rapamycin itself is illustrated below with relevant portions highlighted.  In claim construction, the District Court defined “macrocyclic lactone analog” and “macrocyclic triene analog” as any molecule with structural similarity to rapamycin. 

 

Prior to filing of this application, some rapamycin analogs were known, including everolimus, which is a rapamycin analog used in Boston Scientific’s products.  The language of “macrocyclic lactone analog” was first added to the claims in 2006 following a competitor’s use of a stent including everolimus. 

Specification

The specification of the 1997 patents identifies rapamycin as being important, but concedes that its mechanism is “still under investigation.”  The specification only makes a single reference to macrocyclic lactones, and does not include any actual or prophetic examples using anything other than rapamycin. 

The specification of the ‘662 patent defines rapamycin as “rapamycin, rapamycin analogs, derivates and congeners that bind FKB12 and possess the same pharmacologic properties as rapamycin,” but does not give any specific species of rapamycin analogs.  The specification also does not identify rapamycin triene analogs or give any examples thereof.  Again, the specification has no data relating to rapamycin analogs. 

Discussion

The District Court held that all of the claims in question failed to comply with the written description requirement.  The CAFC affirms. 

The patent owner argues that the structure, mechanism of action and biological activity of rapamycin and its analogs was known in the prior art, and thus, it is not necessary to disclose formulae, structures, etc of the analogs.  They argue that one having ordinary skill in the art was provided with a sufficient template to identify the analogs within the scope of the claims.  They also argue that the structural/functional relationship of rapamycin, its analogs and the desired function was known in the art.

Boston Scientific argues that the inventors were not in possession of the claimed invention in 1997.  They say that the claimed genus is very broad and does not meet the test from Eli Lilly:  “A written description of an invention involving a chemical genus, like a description of a chemical species, “requires a precise definition, such as by structure, formula, [or] chemical name,” of the claimed subject matter sufficient to distinguish it from other materials.” 

The majority agrees with Boston Scientific.  There was no virtually no guidance as to what is an analog that retains the intended function, and the claimed genus could include tens of thousands of potential analog compounds.  Although some analogs such as everolimus were known, the state of the art was too unpredictable at the time of filing for the limited disclosure to be considered sufficient for one having ordinary skill in the art to visualize the claimed embodiments.  Expert evidence showed that at the time of filing, there was little predictability.  Furthermore, the specification of the 1997 patents stated that the “precise mechanism of rapamycin is still under active investigation” and other similar statements.  As to the functional language in the claims, since a structural/functional correlation was not well known, this was insufficient to provide the necessary guidance to one having ordinary skill in the art.  The majority stated that since the claims are invalid due to failure to comply with the written description requirement, no comments about enablement are necessary.

With respect to the ‘662 patent, the majority reached a similar conclusion of invalidity due to the lack of actual or prophetic examples of analogs in the specification, statements in the specification that the molecular events involved are “still being elucidated,” and lack of a well known structural/functional correlation. 

Dissent

With respect to the 1997 patent, Judge Gajarsa indicates that he would invalidate the claims due to lack of compliance with the enablement requirement, not the written description requirement.  However, Judge Gajarsa does not state that the claims comply with the written description requirement. 

 

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