enablement : CAFC Alert

When is Evidence of Written Description Too Late?

Scott Daniels | October 24, 2017

Amgen v. Sanofi

October 5, 2017

Before Prost, Taranto and Hughes. Opinion by Judge Prost.

Procedural History:

The two patents-in-suit disclose and claim a set of antibodies.  The following claim is representative:

An isolated monoclonal antibody,

 wherein, when bound to PCSK9, the monoclonal antibody binds to at least one of the following residues: S153, I154, P155, R194, D238, A239, I369, S372, D374, C375, T377, C378, F379, V380, or S381 of SEQ ID NO:3, and

 wherein the monoclonal antibody blocks binding of PCSK9 to LDL[-]R.

The technical background of the invention involves statins that are administered to patients to reduce high levels of LDL-C in the blood.  When these statins do not work, doctors sometimes administer PCSF9 inhibitor as well – PCSK9 being a naturally occurring protein that binds to and destroys liver cell LDL-receptors that take LDL-C from the blood.

The claim recites a genus of antibodies that bind to PCSK9 at the recited residue sites, thereby preventing PCSK9 from interfering with LDL-C removal from the blood.

The specification, common to both patents, discloses “85 antibodies that blocked interaction between the PCSK9 . . . and the LDLR [at] greater than 90%,”  It also discloses the three-dimensional structures, obtained via x-ray crystallography, of two antibodies known to bind to residues recited in the claims—21B12 (Repatha) and 31H4.

Appellant/Defendant Sanofi markets an antibody named Praluent® alirocumab.  Appellee/Patentee sued Sanofi for patent infringement.  Sanofi replied, inter alia, that the claims did not comply with the written description and enablement requirements.

In a jury trial, the judge excluded from the evidentiary record all post-priority-date information that Sanofi proffered to show that the written description and enablement requirements were not met.  Specifically, Sanofi’s proffered evidence that included its own later-developed Praluent product that was developed after the priority date of Amgen’s patents.

Ultimately, the jury issued a verdict that the patents were valid and infringed.

The CAFC reversed the trial judge’s exclusionary ruling and vacated the jury’s verdict.  It first set forth the legal background, specifically, that a patentee must convey in its disclosure that it “had possession of the claimed subject matter as of the filing date” and that to provide this “precise definition” for a claim to a genus, a patentee must disclose “a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” (Emphasis added).

Here, Sanofi’s evidence regarding Praluent was relevant to the material issue of whether the two patents disclosed a representative number of species within the claimed genus.  The CAFC therefore held that the trial judge erred in excluding Sanofi’s evidence and ordered a new trial on written description.  It also ordered a new trial on enablement for the same reasons.

The CAFC summarized the legal basis for its holding: evidence that explains the state of the art after the priority date is not relevant to written description. On the other hand, where a patent claims a genus, it must disclose “a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Accordingly, evidence showing that a claimed genus does not disclose a representative number of species may include evidence of species that fall within the claimed genus but are not disclosed by the patent, and evidence of such species is likely to postdate the priority date.

Take Away

The lesson is that the purpose for which post-priority date evidence is proffered determines whether it is admissible.

Full Opinion

 

Nothing Lost but Nothing Gained: Generic Producer Evades Infringement but Fails to Invalidate Patent under §112.

Adele Critchley | April 3, 2014

Alcon Research Ltd., v. Barr Laboratories, Inc.

March 18, 2014.

Before Newman, Lourie and Bryson. Opinion by Lourie.

Summary:

The CAFC reversed the District Court’s judgment that Alcon’s patents lacked enabling disclosure and sufficient written description as Barr had failed to demonstrate that some experimentation was required, let alone undue experimentation.  Barr’s allegations that the claims were “too broad,” the specification was “too limited,” and the art was “too unpredictable,” was not sufficient without evidence to support that undue experimentation was required in order to practice the patented method.

The CAFC, however, affirmed the District Court’s judgment of non-infringement since Alcon had failed to prove that the polyethoxylated castor oil (“PECO)” in Barr’s product was present in a “chemically-stabilizing amount.”

The CAFC denied Barr’s judgment as a matter of law (“JMOL”) and Rule 59(e) (alter or amend a judgment) motions on non-infringement for the two patents that were omitted from the pretrial order and not litigated.


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Improper NDA Defeats Trade Secrets and Overly Broad Patent Claims are Invalid

Tang O. Tang | July 29, 2013

Convolve v. Compaq Computer

July 1, 2013

Panel:  Rader, Dyk and O’Malley.  Opinion by O’Malley

Summary

Convolve, Inc. (“Convolve”) and Massachusetts Institute of Technology (“MIT”) appeal the decision of the U.S. District Court for the Southern District of New York (“District Court”) granting summary judgment in favor of Compaq Computer Corp. (“Compaq”), Seagate Technology LLC. and Seagate Technology, Inc. (“Seagate”).

Convolve and MIT sued Compaq and Seagate in July 2000 for breach of contract; misappropriation of trade secrets listed in Amended Trade Secret Identification (ATSI); direct patent infringement; and inducement of patent infringement along with other complaints such as fraud; violation of California Business and Professions Code §17200 (“CA Unfair Competition”), etc.

In May 2006, the District Court disposed of all other charges from the suit except the breach of contract, misappropriation of trade secrets and patent infringement charges. The District Court later granted summary judgment in favor of Compaq and Seagate and dismissed the remaining charges. With regard to the trade secret charges, the District Court found that:

(1)    some of Convolve’s trade secrets (ATSI 1B, 2A, 2C, 2E, and 3B-D) were covered under a Non-Disclosure Agreement (NDA), which Convolve failed to properly preserve according to the NDA procedures;

(2)    some of Convolve’s trade secrets (ATSI 2A, 6B, and 7A) were public known or common knowledge in the industry, which were not entitled to protection;

(3)    some of Convolve’s trade secrets were never used by the defendants (ATSI 2F and 7E); and

(4)    because New York law does not extend trade secret protection to marketing concepts, some of the trade secrets alleged by Convolve are not recognized by the District Court.

With regard to the patent infringement charges, the District Court found that:

(1)   out of the four models of products alleged by Convolve as infringing Patent’473, none read on the claims of the patent;

(2)   Patent’635 was found invalid for being non-enabling based on the inventor’s testimony; and

(3)   since no direct infringement was found, the claim for inducement of patent infringement must fail.

Taking all inference in favor of Convolve, the CAFC affirmed all counts of summary judgment with regard to the trade secret allegations, as well as the invalidity of Patent’635, but reversed the non-infringement decision about Patent’473.

 

Convolve (原告)与Compaq, Seagate(康柏电脑和希捷数码,被告)就原告开发的一些硬盘技术进行技术合作谈判,双方就谈判涉及内容签订了保密协议。但原告在向被告透露相关技术时没有严格按保密协定约定的程序处理涉密内容。后来改谈判未能达成一致,原告诉被告在谈判涉及的保密内容上侵犯商业机密及在另一些技术问题上专利侵权。一审结果,联邦区域法院裁定原告败诉。

上述法院均认定,尽管侵犯商业机密属于一个侵权法的范畴,然而在已签订合同中原被告双方均已同意以合同条款规定商业机密的范畴,故侵权法默认的商业机密标准不适用。因原告在履行保密协议过程中未遵循商定的处理程序,原告在此案中已丧失对该商业机密的索赔权。

另外, 关于专利侵权案,原告的专利在当年提出申请时对该发明的描述超过了发明人的当时可以实施实际该发明的范畴,故该专利被认定未能适当描述其实施方法因而无效。上述法院部分维持一审法院的判决。


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CAFC clarifies the presumption that prior art is enabled after In re Antor Media Corp (Fed. Cir. 2012)

Michael Caridi | April 10, 2013

In re Steve Morsa

April 5, 2013

Panel:  Rader, Lourie and O’Malley.  Opinion by O’Malley.

Summary

The Board of Patent Appeals and Interferences (“Board”) had affirmed an Examiner’s finding that a short press release, relied on for an anticipation rejection, was enabling.  In making its decision, the Board had held that arguments alone by the applicant were insufficient to rebut the presumption that a reference was enabling.  The CAFC found that the Board and the examiner had failed to engage in a proper enablement analysis of the reference and vacated the anticipation finding.


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Like prior art patents, potentially anticipatory non-patent printed publications are presumed to be enabling

Cindy Chen | October 5, 2012

In re Antor Media Corporation

July 27, 2012

Panel: Rader, Lourie and Bryson. Opinion by Lourie.

Summary

Antor Media Corp. appeals from the decision of the Board of Patent Appeals and Interferences rejecting on reexamination the claims of its patent as anticipated and obvious over four prior art references.  The prior art references include three printed publications and one U.S. patent.  The Board found that two of the printed publications anticipated the claims in Antor’s patent. Here, Antor argues that since the printed publications are not enabling, they could not have anticipated the claims. Antor further argues that unlike prior art patents, prior art printed publications are not presumptively enabling.  The principal issue on appeal is therefore whether the presumption that prior art patents are enabling can be logically extended to printed publications. The Federal Circuit answers that it can, holding that a prior art printed publication cited by an examiner is presumptively enabling barring any showing to the contrary by a patent applicant or patentee.


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Can an open-ended claim range be enabled?

Bill Schertler | August 22, 2012

Magsil Corp. and MIT v. Hitachi Global

August 14, 2012

Panel:  Rader, O’Malley, Reyna.  Opinion by Rader.

Summary

The U.S. District Court for the District of Delaware granted summary judgment finding claims 1-5, 23, 26 and 28 of appellants’ U.S. Patent No. 5,629,922 (the ‘922 patent) invalid as a matter of law for lack of enablement and therefore non-infringed.  At issue was whether the specification enabled the broad scope of the claimed “open-ended” range of values having a lower threshold, but no upper limit, defined by “a change in the resistance by at least 10% at room temperature”.

Magsil appealed the district court’s decision.  On appeal, the CAFC affirmed the district court’s finding that claims 1-5, 23, 26 and 28 of the ‘922 patent are invalid for lack of enablement.


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Presumption of validity attaches to all issued patents, even incorrectly issued patents

Andrew Melick | July 5, 2012

Sciele Pharma Inc. v. Lupin Ltd.

July 2, 2012

Panel: Lourie, Prost, Moore.  Opinion by Moore

Summary

Shionogi (new name for Sciele Pharma) obtained US Patent No. 6,866,866 (“the ‘866 patent”) which included broader claims that were intended to be cancelled in favor of narrower claims in response to a rejection.  Shionogi brought suit against Lupin for infringement of the ‘866 patent including claims that were to be cancelled.  Lupin began selling the alleged infringing product and Shionogi moved for a preliminary injunction.  The District Court granted Shionogi’s request for preliminary injunction and Lupin appealed.  On appeal, the CAFC stated that even though the ‘866 patent issued with the incorrect claims, the ‘866 patent nonetheless had a presumption of validity and that the clear and convincing evidentiary standard applied for invalidating the patent.  The CAFC also stated that there is not a heightened standard just because references were considered by the PTO.  With the proper clear and convincing evidentiary standard applied to the ‘866 patent, the CAFC stated that Lupin has raised a substantial question of invalidity, and thus, the preliminary injunction is vacated.


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