Biogen loses to Mylan in request for rehearing over issues in patent for multiple sclerosis [MS] drug related to fumarates
Biogen International BmbH and Biogen MA, Inc. filed
a combined petition for panel rehearing and rehearing en
banc.
IT IS ORDERED THAT:
The petition for panel rehearing is denied.
The petition for rehearing en banc is denied.
Note XTian's comment at PatentlyO, about "proving a negative":
MPEP 2121 Prior art is presumed enabling. “When the reference relied on expressly anticipates or makes obvious all of the elements of the claimed invention, the reference is presumed to be operable.” Not just what is claimed, but whatever is written into the specification. It is per se enabled. It is up to the applicant to show the prior art is non-enabling, i.e., to prove a negative. Moreover, “proof of efficacy is not required for a prior art reference to be enabling for purposes of anticipation.” Impax Labs. Inc. v. Aventis Pharm . Inc., 468 F.3d 1366, 1383, 81 USPQ2d 1001, 1013 (Fed. Cir. 2006). See also MPEP § 2122. In this instance, Biogen’s patent with support in the specification claiming the specific dose of DMF to treat MS is enabled for prior art purposes, but not sufficiently enabled to be claimed. This case also raises further questions: Why wasn’t post filing data allowed to rebut the rejection? See Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313 (Fed. Cir. 2003). Finally, how does this decision affect prophetic examples? The litigators should just thank the Fed Cir. for their part in ensuring their job security.
Dissent in the Mylan case (by Lourie, joined by Newman and Moore):
Appeal from the United States District Court for the Northern District of West Virginia in No. 1:17-cv-00116- IMK-JPM, Judge Irene M. Keeley. ______________________ LOURIE, Circuit Judge, with whom MOORE, Chief Judge, and NEWMAN, Circuit Judge, join, dissenting from the denial of the petition for rehearing en banc. On March 2, 2010, this court sitting en banc in Ariad Pharms., Inc. v. Eli Lilly & Co., reaffirmed the proposition that “written description” is a requirement that exists in the patent statute separate and apart from any other requirements for patentability. 598 F.3d 1336, 1351 (Fed. Cir. 2010). We stated very clearly that “the hallmark of written description is disclosure.” Id. The test for written description “requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.” Id. “Based on that inquiry”— and not based on other considerations—“the specification must describe an invention understandable to that skilled artisan and show that the inventor actually invented the invention claimed.” Id.
We have found lack of written description in a variety of contexts and circumstances. For example, we found a lack of written description when a patent specification described only rat insulin-encoding cDNA but the claimed microorganism encompassed human insulin-encoding CDNA. See Regents of Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997). We found a lack of written description when a patent specification identified only one possible location for controls on a reclining sofa but the claim recited the controls in a different location. See Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473, 1479–80 (Fed. Cir. 1998). In another case, we found a lack of written description when claims were directed to a method comprising administering a compound to achieve a particular result but the specification failed to disclose any compounds that could be used in the claimed method. See Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927 (Fed. Cir. 2004). We also found a lack of written description when a specification disclosed small numbers of species of antibodies that did not reasonably represent the breadth of antibodies encompassed by the claimed genus. See Abbvie Deutschland GmbH & Co. v. Janssen Biotech, Inc., 759 F.3d 1285, 1300–01 (Fed. Cir. 2014). These decisions, and many more like them, are supported by case law dating back to before this court existed. See, e.g., In re Ruschig, 379 F.2d 990, 995 (C.C.P.A. 1967) (finding that the claimed compound was not described in the specification). Indeed, these decisions are supported by Supreme Court precedent dating back almost two centuries when the Court found that Samuel Morse’s eighth patent claim was invalid because “he claims an exclusive right to use a manner and process which he has not described and indeed had not invented, and therefore could not describe But in all that history, this case, in which every claim limitation is expressly described in the disclosure of the patent specification, is at the farthest end of the spectrum of cases where written description has not been found. It is an outlier. Today, by denying rehearing en banc, the judges of this court have let a panel majority opinion stand that imports extraneous considerations into the written description analysis and blurs the boundaries between the written description requirement and the other statutory requirements for patentability. In doing so, the court has contributed to the muddying of the written description requirement. Accordingly, I respectfully dissent from that denial. I Biogen International GmbH (“Biogen”) owns U.S. Patent 8,399,514 (“the ’514 patent”). Mylan Pharmaceuticals Inc. (“Mylan”) contended that the claims of the ’514 patent are invalid for lack of written description support in the specification. In asserting that challenge, Mylan bore the burden of proving by clear and convincing evidence that the disclosure of the ’514 patent specification failed to demonstrate to a person of ordinary skill in the art that the inventors invented what is claimed. The district court found that Mylan met its burden. Biogen Int’l GmbH v. Mylan Pharms. Inc., No. 1:17-cv-116, 2020 WL 3317105 (N.D. W. Va. June 18, 2020) (“District Court Decision”). The panel majority affirmed. See Biogen Int’l GMBH v. Mylan Pharms. Inc., 18 F.4th 1333 (Fed. Cir. 2021) (“Panel Maj. Op.”). I begin by explaining why it should have reversed and why this court should have granted the petition for rehearing en banc.
Claim 1:
A method of treating a subject in need of treatment for multiple sclerosis comprising orally administering to the subject in need thereof a pharmaceutical composition consisting essentially of (a) a therapeutically effective amount of dimethyl fumarate, monomethyl fumarate,1 or a combination thereof, and (b) one or more pharmaceutically acceptable excipients, wherein the therapeutically effective amount of dimethyl fumarate, monomethyl fumarate, or a combination thereof is about 480 mg per day.
In evaluating whether the written description requirement has been met with respect to claim 1, we must look to what is disclosed in the patent specification. See, e.g., D Three Enters., LLC v. SunModo Corp., 890 F.3d 1042, 1052 (Fed. Cir. 2018) (“[A]dequate written description . . . asks what is disclosed.”); Ariad, 598 F.3d at 1351 (“[T]he hallmark of written description is disclosure.”). The ’514 patent sets forth a number of embodiments, including five methods. Most relevant here, “method 4” includes “methods of treating a neurological disease.” ’514 patent at col. 8 ll. 35–36. And, pointedly, the title of the patent is “Treatment for Multiple Sclerosis.”
Whatever shortcomings exist in this unfocused patent specification, failure of written description with respect to claim 1 is not one of them.
The issues for the dissent:
As a general matter, the panel majority and the district court erred by analyzing factual and legal considerations that are not properly contained within the written description analysis.
More specifically, I identify four individual points of error that the en banc court should have corrected. First, the panel majority and the district court overly emphasized unclaimed disclosures in the specification. Second, they erroneously imposed a heightened burden on the patentee to show that the specification proves efficacy. Third, they imported legal factors from other patentability requirements. And fourth, they were influenced by irrelevant extrinsic evidence. I will address each of these points of error in turn.
MPEP 2121 Prior art is presumed enabling. “When the reference relied on expressly anticipates or makes obvious all of the elements of the claimed invention, the reference is presumed to be operable.” Not just what is claimed, but whatever is written into the specification. It is per se enabled. It is up to the applicant to show the prior art is non-enabling, i.e., to prove a negative. Moreover, “proof of efficacy is not required for a prior art reference to be enabling for purposes of anticipation.” Impax Labs. Inc. v. Aventis Pharm . Inc., 468 F.3d 1366, 1383, 81 USPQ2d 1001, 1013 (Fed. Cir. 2006). See also MPEP § 2122. In this instance, Biogen’s patent with support in the specification claiming the specific dose of DMF to treat MS is enabled for prior art purposes, but not sufficiently enabled to be claimed. This case also raises further questions: Why wasn’t post filing data allowed to rebut the rejection? See Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313 (Fed. Cir. 2003). Finally, how does this decision affect prophetic examples? The litigators should just thank the Fed Cir. for their part in ensuring their job security.
Dissent in the Mylan case (by Lourie, joined by Newman and Moore):
Appeal from the United States District Court for the Northern District of West Virginia in No. 1:17-cv-00116- IMK-JPM, Judge Irene M. Keeley. ______________________ LOURIE, Circuit Judge, with whom MOORE, Chief Judge, and NEWMAN, Circuit Judge, join, dissenting from the denial of the petition for rehearing en banc. On March 2, 2010, this court sitting en banc in Ariad Pharms., Inc. v. Eli Lilly & Co., reaffirmed the proposition that “written description” is a requirement that exists in the patent statute separate and apart from any other requirements for patentability. 598 F.3d 1336, 1351 (Fed. Cir. 2010). We stated very clearly that “the hallmark of written description is disclosure.” Id. The test for written description “requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.” Id. “Based on that inquiry”— and not based on other considerations—“the specification must describe an invention understandable to that skilled artisan and show that the inventor actually invented the invention claimed.” Id.
We have found lack of written description in a variety of contexts and circumstances. For example, we found a lack of written description when a patent specification described only rat insulin-encoding cDNA but the claimed microorganism encompassed human insulin-encoding CDNA. See Regents of Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997). We found a lack of written description when a patent specification identified only one possible location for controls on a reclining sofa but the claim recited the controls in a different location. See Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473, 1479–80 (Fed. Cir. 1998). In another case, we found a lack of written description when claims were directed to a method comprising administering a compound to achieve a particular result but the specification failed to disclose any compounds that could be used in the claimed method. See Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927 (Fed. Cir. 2004). We also found a lack of written description when a specification disclosed small numbers of species of antibodies that did not reasonably represent the breadth of antibodies encompassed by the claimed genus. See Abbvie Deutschland GmbH & Co. v. Janssen Biotech, Inc., 759 F.3d 1285, 1300–01 (Fed. Cir. 2014). These decisions, and many more like them, are supported by case law dating back to before this court existed. See, e.g., In re Ruschig, 379 F.2d 990, 995 (C.C.P.A. 1967) (finding that the claimed compound was not described in the specification). Indeed, these decisions are supported by Supreme Court precedent dating back almost two centuries when the Court found that Samuel Morse’s eighth patent claim was invalid because “he claims an exclusive right to use a manner and process which he has not described and indeed had not invented, and therefore could not describe But in all that history, this case, in which every claim limitation is expressly described in the disclosure of the patent specification, is at the farthest end of the spectrum of cases where written description has not been found. It is an outlier. Today, by denying rehearing en banc, the judges of this court have let a panel majority opinion stand that imports extraneous considerations into the written description analysis and blurs the boundaries between the written description requirement and the other statutory requirements for patentability. In doing so, the court has contributed to the muddying of the written description requirement. Accordingly, I respectfully dissent from that denial. I Biogen International GmbH (“Biogen”) owns U.S. Patent 8,399,514 (“the ’514 patent”). Mylan Pharmaceuticals Inc. (“Mylan”) contended that the claims of the ’514 patent are invalid for lack of written description support in the specification. In asserting that challenge, Mylan bore the burden of proving by clear and convincing evidence that the disclosure of the ’514 patent specification failed to demonstrate to a person of ordinary skill in the art that the inventors invented what is claimed. The district court found that Mylan met its burden. Biogen Int’l GmbH v. Mylan Pharms. Inc., No. 1:17-cv-116, 2020 WL 3317105 (N.D. W. Va. June 18, 2020) (“District Court Decision”). The panel majority affirmed. See Biogen Int’l GMBH v. Mylan Pharms. Inc., 18 F.4th 1333 (Fed. Cir. 2021) (“Panel Maj. Op.”). I begin by explaining why it should have reversed and why this court should have granted the petition for rehearing en banc.
Claim 1:
A method of treating a subject in need of treatment for multiple sclerosis comprising orally administering to the subject in need thereof a pharmaceutical composition consisting essentially of (a) a therapeutically effective amount of dimethyl fumarate, monomethyl fumarate,1 or a combination thereof, and (b) one or more pharmaceutically acceptable excipients, wherein the therapeutically effective amount of dimethyl fumarate, monomethyl fumarate, or a combination thereof is about 480 mg per day.
In evaluating whether the written description requirement has been met with respect to claim 1, we must look to what is disclosed in the patent specification. See, e.g., D Three Enters., LLC v. SunModo Corp., 890 F.3d 1042, 1052 (Fed. Cir. 2018) (“[A]dequate written description . . . asks what is disclosed.”); Ariad, 598 F.3d at 1351 (“[T]he hallmark of written description is disclosure.”). The ’514 patent sets forth a number of embodiments, including five methods. Most relevant here, “method 4” includes “methods of treating a neurological disease.” ’514 patent at col. 8 ll. 35–36. And, pointedly, the title of the patent is “Treatment for Multiple Sclerosis.”
Whatever shortcomings exist in this unfocused patent specification, failure of written description with respect to claim 1 is not one of them.
The issues for the dissent:
As a general matter, the panel majority and the district court erred by analyzing factual and legal considerations that are not properly contained within the written description analysis.
More specifically, I identify four individual points of error that the en banc court should have corrected. First, the panel majority and the district court overly emphasized unclaimed disclosures in the specification. Second, they erroneously imposed a heightened burden on the patentee to show that the specification proves efficacy. Third, they imported legal factors from other patentability requirements. And fourth, they were influenced by irrelevant extrinsic evidence. I will address each of these points of error in turn.
posted by Lawrence B. Ebert at 2:32 PM
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