The Federal Circuit’s decision in Vanda Pharm. Inc. v West-Ward Pharm. Intl. Ltd. (2016-2707, 2016-2708 April 13, 2018) provided some good news on the subject matter eligibility front for innovators and other stakeholders in the personalized medicine space, as discussed in a previous post. So there is some hope for getting issued claims that will withstand a validity challenge under the Mayo/Alice framework. But what about enforcement? How does one prove infringement of claims that require various discreet steps that can, and typically are, performed by separate actors?
The Federal Circuit provided a welcome boost for stakeholders in the field of personalized medicine with its recent decision in Vanda Pharm. Inc. v West-Ward Pharm. Intl. Ltd. (2016-2702, 2016-2708 April 13, 2018). Vanda Pharma’s asserted claims relate to a method of treating schizophrenia patients with iloperidone in which the dose is adjusted based upon the patient’s CYP2D6 genotype. The Federal Circuit agreed with the court below that these claims were both directed to patent eligible subject matter and infringed.
On September 21, 2017, the Comprehensive Economic and Trade Agreement (CETA) signed between the European Union (EU) and Canada provisionally entered into force in Canada. Among other things, this agreement seeks to harmonize laws relating to protection of intellectual property in the EU and Canada, thereby bringing about a number of changes in Canadian patent law, particularly with respect to laws relating to the issuance of patents covering pharmaceutical products. One of the biggest changes is the implementation of a Certificate of Supplementary Protection (CSP) Regime in Canada for pharmaceutical products that have been granted regulatory approval.
Yesterday, the U.S. Supreme Court heard oral argument in the much-anticipated Amgen v. Sandoz case, representing the first time the Court has had to grapple with the Biologics Price Competition and Innovation Act (“BPCIA”) since this key law went into effect in 2010. The BPCIA created a new, abbreviated pathway for highly similar biological products to enter the U.S. market by following in the footsteps of a reference biological product. The Court’s decision, which should issue in June, will be closely watched by participants in the pharmaceutical, biotech, and health care sectors.
To read our full alert on the oral argument, please click here.
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.
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.
Kyle Bass continues to make waves throughout the pharmaceutical industry. Since Bass founded Coalition for Affordable Drugs X LLC (“CFAD”) to challenge pharmaceutical patents, CFAD has filed over three dozen petitions as of this date with the Patent Trial and Appeal Board ( “PTAB”) of the U.S. Patent and Trademark Office ( “Office”) seeking to institute inter partes review (“IPR”) proceedings to invalidate a number of pharmaceutical patents.
On August 20, 2015, CFAD filed three separate petitions against Anacor Pharmaceuticals, Inc.’s Orange Book-listed U.S. Patent Nos. 7,582,621 (the “‘621 Patent”) and 7,767,657 (the “‘657 Patent”), — a continuation-in-part of the ‘621 Patent — covering Anacor’s first approved drug, KERYDIN® (tavaborole), an oxaborole antifungal topical solution approved by the U.S. Food and Drug Administration in July 2014 for the topical treatment of onychomycosis of the toenails. On February 23, 2016, the PTAB entered decisions to institute all three IPR proceedings, reaching the conclusions that there is a reasonable likelihood that CFAD would prevail in challenging pertinent claims as unpatentable.
We are excited to announce the arrival of Bill Kezer, PhD, the newest Member in our Intellectual Property Practice. Bill joins our team in San Francisco, where he deepens our bench in the
chemical and pharmaceutical spaces. He brings a unique perspective to client service, with experience as a research scientist and project leader at two major companies prior to law school, and then as in-house patent counsel before entering private practice.
Bill takes a business-based, product-driven approach to the strategic development of patent portfolios, due diligence reviews of targeted companies and technology, and comparative evaluations of competitive patented technologies. He also works with clients to procure global patent protection for pharmaceutical inventions, and focuses on product protection strategies involving formulations, drug delivery technologies, and dosing methods.
To read more about Bill’s arrival, please click here.
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.
In a confluence of IP and antitrust law, a three judge panel for the D.C. Circuit recently affirmed a lower court decision upholding the Federal Trade Commission’s (“FTC”) 2013 modification of regulations under the Hart Scott Rodino (“HSR”) Act to require reporting of even partial transfers of pharmaceutical patent rights as an “asset acquisition” if all commercially significant rights are transferred. Prior to the change, an acquisition of pharmaceutical patent rights was reportable only if all rights to “make, use and sell” the patented technology were transferred; that rule still applies to patent transfer practices in other industries. The FTC changed the rule with respect to pharmaceutical patents after observing that in recent years pharmaceutical companies had been transferring most of the essential (or “all commercially significant”) rights under an exclusive license, but were able to avoid reporting such transfers under the current approach of the HSR Act.
Pharmaceutical Research and Manufacturers of America (“PhRMA”), the pharmaceutical industry group challenging the FTC, argued that that the lower court decision should be overturned, as the agency does not have authority under the HSR Act to make industry-specific rules and that the FTC’s adoption of the rule was arbitrary and capricious. The panel disagreed, holding that Congress’s intent was not to restrict the agency’s authority under the Act to broad rules only. Further, they noted that PhRMA and other industry groups had significant opportunity to participate and comment during the rulemaking period.
Although this decision specifically targets pharmaceutical deals, other industry deals are not in the clear. The court and the FTC were unequivocal, stating that “if other industries adopted patent transfer practices of the sort found in the pharmaceutical industry, ‘such exclusive patent licenses remain potentially reportable.’” Thus, parties transferring patents in all industries should proceed with caution and consult counsel when structuring their deals.