Unexpected results, not disclosed in the specification, of a compound may overcome a prima facie case of obviousness

Lee Wright | April 2, 2012

Genetics Institute, LLC v. Novartis Vaccines and Diagnostics, Inc.

August 23, 2011

Panel:  Lourie, Plager and Dyk.  Opinion by Lourie.  Concurrence-in-part and dissent-in part by Dyk.

Summary:

Today, we bring you the first in a series of three articles regarding an important case from last year.   This article discusses the following question:

Question:  Can evidence of unexpected results of a compound be used to overcome a prima facie case of obviousness, where the unexpected result is not disclosed in the specification as originally filed?

Answer: Yes.

Evidence of unexpected results to a property of a compound, where the unexpected result is not disclosed in the specification as originally filed, can be used to overcome a prima facie case of obviousness.

Details

At issue in this appeal are claims 1, 5, 9, and 10 of U.S. Patent 4,868,112 (the “’112 patent”).  These claim, respectively, a recombinant DNA whose expression results in a truncated Factor VIII protein; a host cell containing the recombinant DNA; method of producing the truncated Factor VIII protein by culturing the host cells; and a truncated human Factor VIII protein.

On May 16, 2008, Genetics sued Novartis in the United States District Court for the District of Delaware to determine priority of invention under 35 U.S.C. § 291.

The human Factor VIII protein is stabilized in the bloodstream by binding to von Willebrand factor (“vWF”), a large blood protein that prevents the degradation of Factor VIII.  If Factor VIII is not able to form a complex with vWF, the half-life of Factor VIII in plasma is reduced about five-fold.

The full-length Factor VIII protein consists of 2,332 amino acid residues—the chemical building blocks of proteins.  The protein contains several regions, or “domains,” each of which folds into a three-dimensional structure independent of the others.

Years after the Novartis application was filed, independent researchers discovered that the a3 region had the previously unforeseen benefit of being able to bind to von Willebrand Factor (“vWF”) and is therefore critical to Factor VIII’s performance.

In the District Court, one of the inventors testified that the Novartis patents “do[ ] not specifically tell you [the location of the vWF binding sites within the Factor VIII protein], [because] that was not the intention of the patent, to specify the binding to von Willebrand Factor.”

The claims of the Novartis patent retain proteins containing the a3 region.  The proteins of the ‘112 patent permit (but do not require) deletions in that region.  Novartis contends that the two-way test for determining whether an interference exists is not satisfied because the broader range of deletions permitted by the claims of the ’112 patent does not anticipate or render obvious the narrower range claimed in the Novartis patents.

Novartis asserts that only the claimed Novartis proteins retain the a3 region and possess the increased stability associated with vWF binding, and even if this increased stability was not known as of the priority dates of the Novartis patents, that property may nonetheless support the claimed proteins’ nonobviousness.

The district court credited the unexpected results of the claimed invention in a Novartis patent as part of its obviousness analysis.

On appeal, Genetics maintains that, because the importance of the a3 region to vWF binding was not known as of the filing date of the ’620 patent, the retention of the a3 region in the claimed proteins of the ’620 patent and their corresponding ability to bind vWF may not be relied upon to demonstrate the unexpected results of those proteins.

The Majority

The Court disagrees with Genetics:

Our case law is clear that the structure of a claimed compound and its properties are inseparable for purposes of § 103. Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075, 1086 (Fed. Cir. 2008) (“For chemical compounds, the structure of the compound and its properties are inseparable considerations in the obviousness determination.”); In re Papesch, 315 F.2d 381, 391 (CCPA 1963) (“From the standpoint of patent law, a compound and all of its properties are inseparable; they are one and the same thing.”).

Our law is equally clear that every property of a claimed compound need not be fully recognized as of the filing date of the patent application to be relevant to nonobviousness. Knoll Pharm. Co. v. Teva Pharms. USA, Inc., 367 F.3d 1381, 1385 (Fed. Cir. 2004) (“There is no requirement that an invention’s properties and advantages were fully known before the patent application was filed, or that the patent application contains all of the work done in studying the invention, in order for that work to be introduced into evidence in response to litigation attack.”).  For those reasons, we have held that evidence of unexpected results may be used to rebut a case of prima facie obviousness even if that evidence was obtained after the patent’s filing or issue date. Id. (“Evidence [of unexpected results] developed after the patent grant is not excluded from consideration, for understanding of the full range of an invention is not always achieved at the time of filing the patent application.”); In re Khelghatian, 364 F.2d 870, 876 (CCPA 1966) (holding the claimed invention nonobvious in view of post-filing evidence of an unexpected property not disclosed in the specification, while noting that the evidence “[wa]s directed to that which ‘would inherently flow’ from what was originally disclosed” (quoting In re Zenitz, 333 F.2d 924, 927 (CCPA 1964)); see also Eli Lilly & Co. v. Zenith Goldline Pharms., Inc., 471 F.3d 1369, 1378 (Fed. Cir. 2006) (“This court will not ignore a relevant property of a compound in the obviousness calculus.” (citing In re Lalu, 747 F.2d 703, 707 (Fed. Cir. 1984)).

The Dissent

Judge Dyk in the dissent argues that the unexpected properties must either be set forth in the specification or contemporaneously known to the inventors, rather than being discovered long after the fact.

The Judge Dyk criticizes the majority’s finding of nonobviousness as being based entirely on hindsight and happenstance, and not on what the inventors knew at the time the Novartis patents were filed, citing 35 U.S.C. § 103(a) “(stating that an invention cannot be patented if “the subject matter as a whole would have been obvious at the time the invention was made”) (emphasis added).”

Judge Dyk also notes the Supreme Court precedent on this issue:

The Supreme Court has never suggested that it is permissible to look beyond the inventor’s knowledge at the time of patent filing in determining unexpected results. To the contrary, the Supreme Court has characterized such after-acquired knowledge as an “afterthought,” Ball & Socket Fastener Co. v. Kraetzer, 150 U.S. 111, 117, 116–17 (1893), and has declined to give it weight in determining patent validity. For example, in Graham v. John Deere Co., 383 U.S. 1, 25 (1966), the Supreme Court rejected the patentee’s argument that his patented plow had the unexpected result of additional “flex” over the prior art, noting that “[n]o ‘flexing’ argument was raised in the Patent Office.” See also Lincoln Eng’g Co. v. Stewart-Warner Corp., 303 U.S. 545, 550 (1938) (“If this [new feature] were so vital an element . . . it is strange that all mention of it was omitted [in the specification].”).

Judge Dyk also argues that early cases from the Court of Customs and Patent Appeals (“CCPA”) “have gone so far as to hold that unexpected results must be described in the specification itself,” citing:

In re Herr, 304 F.2d 907, 909 (CCPA 1962) (“[If] an [unexpected advantage] is not disclosed in appellant’s application, he is not in a favorable position to urge it as a basis for the allowance of claims.”) (internal quotation marks omitted);

In re Crawford, 250 F.2d 370, 373 (CCPA 1957) (“[T]here is no disclosure in appellant’s application that the glass of which the casing is made has the property recited in [the claim] of ‘substantially complete disintegration at a vibration frequency corresponding to that of the shock wave generated by detonation of the explosive body’ and accordingly patentability cannot be predicated on that feature.”);

In re Stewart, 222 F.2d 747, 754 (CCPA 1955) (“[U]nexpected results sufficient to spell out patentability must be disclosed, not in briefs or affidavits filed in support of such patentability, but in-stead in the specification itself. In adjudging, in the first instance, a patent applicant’s right to a patent, we are guided in our determination by that which is taught in the application and not by some subsequent undisclosed discovery.”).

Judge Dyk concludes “[t]hus, the ability to bind to vWF was a wholly new and undisclosed function that did not “inherently flow from theindicated use” of the invention—the procoagulation of blood.  See Zenitz, 333 F.2d at 927. This later-discovered advantage should not have been allowed to defeat a finding of obviousness.”

Judge Dyk distinguishes SanofiKnoll, and Papesch cited by the majority as, “[i]n contrast to the present case, in each of these cases, it was shown that, as of the time of the invention, the inventor had contemplated that a particular claimed structure would confer a special and unanticipated advantage, even if the full scope of that advantage was unknown.”

Judge Dyk also argues that “[b]y ruling that a patentee can have a monopoly on the later-discovered properties of a structure merely by claiming the structure itself, the majority’s decision would discourage others from investing in future research into that very structure.”

Comments/Tips

While there have been other cases that have held that evidence and arguments directed to advantages not disclosed in the specification cannot be disregarded, I believe that this is the first case to directly involve evidence of unexpected results.

The majority opinion is based on the In re Papesch line of case law that, from the standpoint of patent law, a compound and all of its properties are inseparable; they are one and the same thing.  Therefore, it may be difficult to expand this decision past compounds or compositions of matter.

Full Opinion

Patent At Issue

More on this case coming soon!

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