On April 16, 2018 in a precedential opinion, the United States Court of Appeals for the Federal Circuit, Sumitomo Dainippon Pharma v. Emcure Pharms., Nos. 2017-1798, -1799, -1800, affirmed the United States District Court for the District of New Jersey by construing the claimed chemical structure diagram to encompass at least the specific enantiomer depicted, refusing to limit the claim to only cover a racemic mixture of the (+) and (–) enantiomers, absent clear indication that the depicted enantiomer should be excluded from the claim.
Adam Samansky is a Member based in the firm’s Boston office, where he focuses on intellectual property litigation and handles patent, trademark, and trade secret matters on behalf of innovators and investors. Adam’s core practice includes patent and trade secret litigation involving complex technologies in the pharmaceutical, medical, high-tech, and defense industries. He regularly conducts due diligence on blockbuster pharmaceutical assets, including reviewing and assessing litigation, regulatory, and competitive strategies.
An introduction to § 271
Section 271 of Title 35 of the United States Code is the statute that codifies unlawful acts of patent infringement. The most commonly asserted provisions are § 271(a) (direct infringement), § 271(b) (induced infringement), and § 271(c) (contributory infringement). However, other less frequently asserted provisions must also be considered when enforcing United States patents. For example, § 271(e) pertains to the infringement of patents on pharmaceuticals, specifically barring certain acts, while explicitly permitting others. Additionally, § 271(f) covers infringement by a party who supplies components of a patented invention to recipients outside of the United States with the knowledge the components will be combined “in a manner that would infringe the patent if such combination occurred within the United States.” And, finally, § 271(g) covers importation infringement, making liable a party that imports into the United States or offers to sell, sell or uses within the United States a product which is made by a patented process during the term of such a patent. While possibly the least often litigated, § 271(f) is now before the Supreme Court, in a case examining the applicability of foreign lost profits damages to § 271(f) infringement.
On Monday, November 27, 2017, the Supreme Court heard oral arguments in SAS Institute v. Matal.
Whether 35 U.S.C. § 318(a) requires that the Patent Trial and Appeal Board (PTAB or Board) issue a final written decision as to every claim challenged by a petitioner, or does it allow the Board to issue a final written decision with respect to the patentability of only some of the patent claims challenged by the petitioner.
On September 14, 2012, ComplementSoft sued SAS in the Northern District of Illinois for infringement of U.S. Patent No. 7,110,936. On March 29, 2013, SAS filed a petition with the PTAB for inter partes review (IPR) of the ‘936 Patent, challenging patentability of all 16 claims of that patent. The PTAB instituted IPR as to 9 claims (1 and 3-10) of the ‘936 patent and on August 6, 2014 issued a final written decision under 35 U.S.C. § 318(a), holding that claim 4 was not invalid over prior art, whereas claims 1-3 and 5-10 were unpatentable. SAS’ request for rehearing before the Board was denied. On June 10, 2016, the 2-1 divided Panel of the Federal Circuit Rejected SAS’s argument that the Board must address all claims challenged in an IPR petition in its final written decision, and affirmed the PTAB’s decision, except vacated with respect to claim 4. The Panel consisted of Judges Stoll, Chen, and Newman, with Judge Newman dissenting in part. As Judge Stoll stated, there is “no statutory requirement that the Board’s final decision address every claim raised in a petition for inter partes review. Section 318(a) only requires the Board to address claims as to which review was granted.” The Federal Circuit reasoned that 35 U.S.C. § 314 and 35 U.S.C. § 318(a) are different and that § 318(a) “does not foreclose the claim-by-claim approach the Board adopted [in Synopsys] and in this case.” In a dissenting opinion, Judge Newman stated that 35 U.S.C. § 314(a) required USPTO either refuse to institute IPR entirely, or to review all challenged claims when “there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.”
In a precedential opinion issued on October 11, 2017, the United States Court of Appeals for the Federal Circuit reversed the Patent Trial and Appeals Board’s (“PTAB”) finding of non-obviousness where the prior art taught away from some, but not all, of the embodiments covered by the challenged claims. In Owens Corning v. Fast Felt Corp., No. 2016-2613 (Fed. Cir. Oct. 11, 2017), the panel held that the PTAB had applied an unreasonably narrow construction to the exclusion of embodiments that were not taught away from by prior combinations disclosing all of the claim elements.
PTAB’s Improper Claim Construction
Fast Felt owns U.S. Patent No. 8,137,757 (“the ‘757 patent”), which it asserted against Owens Corning in the U.S. District Court for the Northern District of Ohio. In turn, Owens Corning petitioned for inter partes review of the claims of ‘757 patent, and the PTAB instituted trial. Owens Corning contended that the challenged claims were rendered obvious by prior art combinations disclosing all elements of the independent claims. However, in its final written decision, the Board determined that Owens Corning failed to provide a motivation to combine and upheld the patentability of the challenged claims. Owens Corning timely appealed.
On July 17, 2017, the United States Court of Appeals for the Federal Circuit reversed, in a precedential opinion in Millennium Pharmaceuticals, Inc. v. Sandoz, Inc., No. 2015-2066 (Fed. Cir. July 17, 2017), a district court ruling that claims of a patent directed to the Velcade® cancer treatment drug compound were invalid as obvious. The Court held that the District of Delaware clearly erred by finding U.S. Patent No. 6,713,446 (the ‘446 patent) prima facie obvious to one of skill in the art, and by misapplying the secondary indicia of unexpected success and long-unmet need.
On March 3, 2017, the United States Court of Appeals for the Federal Circuit reaffirmed, in a precedential opinion, that prosecution disclaimers may only limit the scope of a claim where the disclaimer is “both clear and unmistakable to one of ordinary skill in the art.” In Technology Properties Ltd. v. Huawei Technologies Co., Ltd., the Federal Circuit made clear that statements made during patent prosecution will not constitute a disclaimer of claim scope where the statements are “ambiguous or amenable to multiple reasonable interpretations,” but that a disclaimer based on unambiguous statements during prosecution may serve to surrender more claim scope than was necessary to overcome a rejection. Continue Reading Federal Circuit Reiterates That Patent Prosecution Disclaimers Must Be “Clear and Unmistakable”
On Monday, January 9, 2017, the U.S. Supreme Court denied, without comment, Mylan Pharmaceuticals’ petition for certiorari to reverse an opinion by the Court of Appeals for the Federal Circuit, which affirmed a broad scope of personal jurisdiction over generic ANDA filers in patent infringement suits under the Hatch-Waxman Act.
Plaintiffs bringing patent infringement complaints under the Iqbal/Twombly pleading standard should take notice. On September 30, 2016, a panel of the Federal Circuit affirmed a district court’s dismissal of a deficient complaint under Rule 12(b)(6). The panel agreed held that a complaint for joint infringement of a patent must show which alleged actor performed each of the required claim elements. The plaintiff’s amended complaint failed to plausibly allege that the defendants exercised the required “direction or control” such that the performance of every claim step could be attributable to them.
On Friday, March 18, the Court of Appeals for the Federal Circuit affirmed two District of Delaware rulings that non-resident defendant generic ANDA filer, Mylan, is subject to personal jurisdiction in two Hatch-Waxman suits filed in the state. (See Acorda Therapeutics Inc. v. Mylan Pharmaceuticals Inc., No. 14‐935‐LPS (D. Del. Jan. 14, 2015); AstraZeneca AB v. Mylan Pharmaceuticals Inc., No. 14‐696‐GMS (D. Del. Nov. 5, 2014). For coverage of the oral argument in these appeals, see our prior blog post.) The Federal Circuit found that specific personal jurisdiction exists over Mylan in Delaware because Mylan’s ANDA filings reliably indicate its intent to engage in actions that will harm plaintiffs’ patent rights in the jurisdiction. The court did not reach the issue on appeal of whether Mylan’s compliance with Delaware’s registration statute established consent to general personal jurisdiction in the state, an issue on which the lower court opinions split. However, Judge Kathleen M. O’Malley, concurring in the majority’s judgement, would also have found Mylan consented to general personal jurisdiction in light of Delaware’s interpretation of its registration statute.
Filing an ANDA Satisfies the Minimum Contacts Requirement of Specific Personal Jurisdiction
The court held that “the particular actions Mylan has already taken–its ANDA filings–for the purpose of engaging in that injury-causing and allegedly wrongful marketing conduct in Delaware” satisfy the minimum contacts with Delaware required to establish specific personal jurisdiction. The court began by observing that, if Mylan had already begun the generic drug marketing activities for which it seeks permission by filing an ANDA, “there is no doubt that it could be sued for infringement in Delaware,” and elsewhere that it seeks to market the generic ANDA products. Mylan’s ANDA filings, in turn, are “formal acts that reliably indicate plans to engage in” that same infringing activity. Thus, the ANDA filings, like the contemplated marketing acts they seek approval for, establish personal jurisdiction over Mylan in Delaware.
On Monday, January 4, the Court of Appeals for the Federal Circuit heard oral argument in two appeals that may determine what effect the Supreme Court’s Daimler AG v. Bauman decision will have on the exercise of personal jurisdiction over generic pharmaceutical manufacturers in Hatch-Waxman litigation.
Decisions Below Denying Motions to Dismiss for Lack of Personal Jurisdiction
Generic ANDA filer Mylan appealed from denial of its motion to dismiss in AstraZeneca AB v. Mylan Pharmaceuticals Inc., No. 14‐696‐GMS (D. Del. Nov. 5, 2014). Judge Gregory M. Sleet found specific personal jurisdiction over the foreign corporate defendant in Delaware based on Mylan’s sending a Paragraph IV notice letter to AstraZeneca in Delaware. Judge Sleet also found, citing the Supreme Court’s recent holding in Daimler AG v. Bauman, 134 S. Ct. 746 (U.S. 2014), that Mylan’s registration to do business in Delaware did not constitute consent to personal jurisdiction, and thus general personal jurisdiction, in Delaware.
On Monday Mylan also argued its appeal of the denial of a similar motion to dismiss in Acorda Therapeutics Inc. v. Mylan Pharmaceuticals Inc., No. 14‐935‐LPS (D. Del. Jan. 14, 2015). In that case, Chief Judge Leonard P. Stark found specific personal jurisdiction exists over Mylan in Delaware based on Mylan’s sending a Paragraph IV notice letter to the Delaware-incorporated Acorda, even though the notice letter was not mailed to Delaware. Judge Stark, unlike Judge Sleet, also found general personal jurisdiction over Mylan because Mylan consented to personal jurisdiction in the state by voluntarily registering to do business there.