Mintz Levin’s Biosimilar webinar series continued this month with Linda Bentley and Joanne Hawana’s Biosimilars FDA/Regulatory Overview presentation on the Biologics Price Competition and Innovation Act (“BPCIA”) and its implementation. Some of the key takeaways include:
- overviews of FDA guidance on demonstrating biologic product biosimilarity and “interchangeability” (the latter of which means that the biosimilar may be substituted for the FDA-approved reference product without intervention by the prescribing health care provider);
- FDA’s “stepwise” approach to determining biosimilarity, under which more robust initial comparative evidence may reduce FDA clinical study requirements later on;
- current state of FDA draft product labeling guidance that would require, for example, reference products and biosimilars to share a common core name with unique suffixes; and
- exclusivity periods for original reference and biosimilar products.
For a more detailed write-up of the presentation, see our post on Mintz Levin’s Health Law & Policy Matters blog, here.
Tom Wintner, a member in Mintz Levin’s Intellectual Property group, will present the next webinar in the Biosimilar series – BPCIA Patent Litigation – on Thursday, February 25, 2016. This session will offer practical advice regarding litigating patents under the BPCIA and provide an update on current litigation under the law.
Sign up here to attend Tom’s litigation webinar or the other Biosimilar webinars coming up in March and April.
The University of Massachusetts’ Medical Device Development Center (M2D2) has launched the 5th Annual M2D2 $100K Challenge, an opportunity designed to showcase the innovative ideas and entrepreneurial spirit of seed and early-stage biotech and medical technology companies. Apply now!
The M2D2 $100K Challenge Program is sponsored in partnership with Mintz Levin, BD, Boston Scientific, MPR Product Development, Omni Components and R&Q (Regulatory & Quality Solutions). The M2D2 $100K Challenge will award up to $100,000 in service or grant awards provided by the program sponsors. Applicants from across the nation and beyond are invited to participate and past years have included entrepreneurs from Europe, Israel and throughout the eastern seaboard of the US. Continue Reading
In Pfizer v. Lee (No. 2015-1265, January 22, 2016), the Federal Circuit upheld the U.S. Patent and Trademark Office’s (USPTO) determination that the toll period for A-type patent term adjustment (PTA) delay stops upon the mailing of a deficient USPTO paper. Conversely, by statute, an applicant’s submission of a deficient paper to the USPTO does not stop the toll period for applicant delay that is subtracted from PTA accrued due to USPTO delay. Before further considering the Pfizer decision and its contrast with applicant delay, let’s start with a reminder of PTA rules.
35 U.S.C. § 154 provides for three types of USPTO delay in prosecution that entitle a patent to an extension of term beyond the standard term of the patent:
- A-Delay: accrued when the USPTO does not mail a response to the applicant within time periods provided in 35 U.S.C. 154(b)(1)(A).
- B-Delay: accrued, per 35 U.S.C. § 154(b)(1)(B), when a patent does not issue within three years of the filing date, subject to reductions upon certain occurrences including the filing of a Request for Continued Examination (RCE), appeal, and applicant-requested delay.
- C-Delay: derivation proceedings, secrecy orders, and appeals trigger PTA, per 35 U.S.C. § 154(b)(1)(C).
It can be tricky to evaluate written description support under 35 U.S.C. § 112 for negative claim limitations since the support may amount to the absence of a feature from an invention that is described positively with respect to what it includes, as opposed to what it does not. The Court of Appeals of the Federal Circuit provided some clarity on this issue in Inphi Corp. v. Netlist, Inc., which is discussed below along with some practice tips in view of the decision.
The Federal Circuit held in Inphi Corp. v. Netlist, Inc. that describing alternative features, without identifying the comparative advantages or disadvantages of each feature, could constitute a “reason to exclude” to satisfy the written description requirement under 35 U.S.C. § 112 for a negative claim limitation under the Santarus standard, which states that “[n]egative claim limitations are adequately supported when the specification describes a reason to exclude the relevant limitation.”
On January 27, 2016, the International Trade Commission (ITC) formally requested a rehearing en banc of a November 10, 2015, Federal Circuit panel decision in ClearCorrect Operating, LLC v. ITC. The Federal Circuit’s panel opinion struck a blow to both the ITC and the entertainment and software industries by overturning the ITC’s opinion and finding that the ITC’s jurisdiction was limited to “material things” and did not include the ability to bar digital imports. No. 2014-1527, Slip Op. at 3 (Fed. Cir. Nov. 10, 2015).
In an ITC investigation instituted in April 2012, Align Technology claimed that Respondents ClearCorrect Pakistan and ClearCorrect Operating LLC infringed claims of seven patents relating to a system and methods for repositioning teeth. ClearCorrect made models of the U.S. patients’ teeth which were then scanned and converted into digital data sets, which were then transmitted to Pakistan. In Pakistan the data sets were manipulated, and the adjusted data sets were sent back to ClearCorrect in the United States, where they were used to create the aligners used by the patents via 3D printing. Thus, no physical articles were imported – the only item imported was a digital data set. In April 2014, the ITC found that ClearCorrect infringed the patents, and issued exclusion and cease and desist orders barring ClearCorrect from importing the data sets.
The Patent Trial and Appeal Board recently designated as precedential its decision in Westlake Services, LLC v. Credit Acceptance Corp., CBM2014-00176, Paper 28 (PTAB May 14, 2015) addressing the scope of estoppel under 35 U.S.C. § 325(e). As a result, the Westlake holding that § 325(e) estoppel does not apply to patent claims that were not the subject of a final written decision on patentability under 35 U.S.C. § 328(a) is now binding on the PTAB in other post-grant proceedings.
In Westlake, the Petitioner initially petitioned for Covered Business Method (“CBM”) review of claims 1-42 of U.S. Patent No. 6,950,807. Westlake Services, LLC v. Credit Acceptance Corp., CBM2014-00008, Paper 1 (PTAB Oct. 11, 2013). The PTAB instituted CBM trial as to claims 1-9, 13, and 34-42, but denied the petition as to claims 10-12 and 14-33.
As 2016 begins and IP strategies are being developed for the new year, it is a good time to reflect on what IP issues were prominent in 2015. According to the many readers of Global IP Matters, hot topics included navigating the waters of U.S. patent prosecution, analyzing Federal Circuit appeals from the International Trade Commission, and handling Japanese patent oppositions.
Here are 2015’s top 5 most popular blog posts at Global IP Matters:
- RCEs and the New USPTO Patent Term Adjustment Rules – This post discusses U.S. Patent and Trademark Office (USPTO) rules for Patent Term Adjustment for patents where a request for continued examination (RCE) was filed during prosecution. In general, the first new rule, effective January 9, 2015, provides that applicants are entitled to B-Delay between allowance and issuance, and the second new rule, effective March 10, 2015, creates a new type of applicant delay when an RCE is filed after allowance.
- Suprema v. ITC: En Banc Federal Circuit Overturns Panel Decision, Finds ITC Has Jurisdiction Over Induced Infringement of Method Claims – This decision is particularly important for cases involving the software and high tech industries, which often rely heavily on induced infringement allegations. This blog post provides a detailed breakdown of the Federal Circuit’s opinion.
- Prepare for the Japanese Patent Opposition System Coming Soon – In advance of Japanese Patent Act revisions effective May 14, 2015, this post provided an overview of the changes and indicated how parties may wish to begin preparing and considering being more aggressive in monitoring competitors’ Japanese patent applications and allocating resources to file oppositions in Japan.
- Understanding Post-AIA Power of Attorney Procedures – Although the America Invents Act (AIA) implemented changes affecting Powers of Attorney in U.S. patent applications on September 16, 2012, pre-AIA Powers of Attorney are still relevant for many pending applications filed before that date. This post discusses in simple terms how Power of Attorney can be properly established before the USPTO in pre-AIA and post-AIA cases.
- ClearCorrect v. ITC: Federal Circuit Hears Argument in Case Which Will Decide Whether ITC Has Jurisdiction Over Digital Imports – ClearCorrect v. International Trade Commission decided whether the ITC has power to exclude intangible items imported digitally rather than physically. This post summarizes the case’s intense oral arguments. (Global IP Matters later covered the case’s decision that overturned the ITC’s opinion.)
Last week, the PTAB designated two recent post-grant proceeding decisions as “precedential,” marking only the second and third time it has designated one of its opinions as binding on all PTAB judges. One of those decisions—the Decision Denying Institution of Inter Partes Review in LG Electronics, Inc. v. Mondis Technology Ltd., IPR2015-00937—addresses the scope of the one-year statutory bar on IPR petitions and will likely guide how the PTAB applies that bar for the foreseeable future.
Under the one-year statutory bar set forth in 35 U.S.C. § 315(b), a petitioner must file a petition for inter partes review of a patent within one year of being served with a complaint for infringement of that patent:
An inter partes review may not be instituted if the petition requesting the proceeding is filed more than 1 year after the date on which the petitioner, real party in interest, or privy of the petitioner is served with a complaint alleging infringement of the patent.
In Ethicon Endo-Surgery, Inc. v. Covidien LP, a 2-1 panel split of the Federal Circuit held that neither the American Invents Act (“AIA”) nor the Constitution precludes the same panel of the Patent Trial & Appeal Board (“PTAB” or “Board”) from both deciding whether to institute an inter partes review (“IPR”) of a challenged U.S. Patent and making the final patentability determination in that IPR.
Under the AIA, an IPR validity challenge can hinge on two major determinations: whether to institute a requested IPR trial, and, if the IPR is instituted, whether the challenged claims were proven unpatentable during that IPR trial. Under the United States Patent and Trademark Office’s (“PTO”) current implementation of the AIA, both of these determinations are typically made by the same Board panel of three Administrative Law Judges.
Consistent with that implementation, when Covidien petitioned the PTO for inter partes review of Ethicon patent claims, the same Board panel decided to institute the IPR and then issued a final written decision finding the challenged Ethicon patent claims unpatentable.
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.