Coming Down the Pipeline: Patent Cases to Watch in 2017

The Supreme Court returns from recess on February 17, and alongside the likely confirmation of Neil Gorsuch to the bench, a plethora of IP cases are on their agenda.

Let’s take a look at some of the cases that SCOTUS  will hear in the spring that may have significant impact on biotech IP:

The Supreme Court granted certiorari last month to hear arguments for dual petitions involving the Federal Circuit’s 2015 interpretation of the Biologics Price Competition and Innovation Act (BPCIA).

The Federal Circuit had previously ruled in a split panel decision (1) that the disclosures set forth in subsection (l)(2)(A) of the BPCIA are not mandatory and that the statute allows a biosimilar applicant to choose between either disclosing its subsection (k) application and manufacturing information, or not disclosing such information and instead facing an immediate infringement action from the reference product sponsor and (2) that a notice of commercial marketing pursuant to subsection (l)(9)(A) of the BPCIA can be given only after FDA approval of the biosimilar product.

The briefing schedule has been set and can be found on SCOTUS Blog.

The Supreme Court granted certiorari to decide: “Whether 28 U.S.C. § 1400(b) is the sole and exclusive provision governing venue in patent infringement actions and is not to be supplemented by 28 U.S.C. § 1391(c).”

28 U.S.C. § 1400(b) states that “any civil action for patent infringement may be brought in the judicial district where the defendant resides, or where the defendant has committed acts of infringement and has a regular and established place of business.”

28 U.S.C. § 1391(c) states that “For all venue purposes—

  1. A natural person, including an alien lawfully admitted for permanent residence in the United States, shall be deemed to reside in the judicial district in which that person is domiciled;
  2. An entity with the capacity to sue and be sued in its common name under applicable law, whether or not incorporated, shall be deemed to reside, if a defendant, in any judicial district in which such defendant is subject to the court’s personal jurisdiction with respect to the civil action in question and, if a plaintiff, only in the judicial district in which it maintains its principal place of business; and
  3. A defendant not resident in the United States may be sued in any judicial district, and the joinder of such a defendant shall be disregarded in determining where the action may be brought with respect to other defendants.

The Supreme Court’s decision may limit the districts in which patentees can bring infringement lawsuits and return to a narrower venue rule as outlined in 28 U.S.C. § 1400(b).

Oral arguments are set for March 27, 2017.

This case involves the scope of patent exhaustion.

The first question before the Supreme Court is whether a “conditional sale” that transfers title to a patented item, but also restricts the article’s use or resale post-sale, avoids the patent exhaustion doctrine.  The second question is whether a sale of a patented article (i) occurring outside the United States but (ii) with the U.S. patentee’s authorization exhausts the U.S. patent rights in that article.

“The Federal Circuit ruled en banc that the sale of a product abroad by a U.S. patent holder (or others) does not exhaust the patent owner’s U.S. patent rights, such as the right to exclude sale or importation of that product within the United States.  The Federal Circuit also ruled that, when a U.S. patent holder sells a product with expressed restrictions on resale or reuse of that product, the patent exhaustion doctrine does not preclude the patent owner from exercising its rights to exclude resale or reuse of that product.”

Oral arguments are set for March 21, 2017.

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IP Sessions at BIO 2016–Come Join us in San Francisco!

That’s right, we’re back at it again! This year’s BIO International Convention will host several innovative educational sessions on the state of intellectual property in the biotech sector.   BIO‘s top-notch education program covers the biotechnology and pharma industry’s most relevant and timely topics in intellectual property.  In each session, top thought leaders will offer insights on issues essential to the industry and provide a wealth of information of strategic relevance to the IP biotech sector. 

Well, what are you waiting for? Check out our IP sessions below, and don’t forget to register!

Rise of the Biosimilars: Recent Developments and Strategies for Innovators and Biosimilar Applicants for Resolving Patent Disputes Under the BPCIA

1:00 PM–2:00 PM Jun 7, 2016

The Biologics Price Competition and Innovation Act (BPCIA) defines a process for resolving patent disputes before the launch of a biosimilar product. Although the purpose is similar to the process under the Hatch-Waxman Act, the process is substantially different and biosimilar applicants have pursued varied approaches to date. The session will explore recent legal developments in the field of biosimilars, including the patent dance and litigation under the BPCIA. Additionally, the panel, comprised of IP experts, will discuss strategies for both innovators and biosimilar applicants.

Room West 3008

Will the PTAB be a Road Block for Biotech? Lessons Learned from the First Three Years of Inter-Partes Review and Future Prospects

2:15 PM–3:15 PM Jun 7, 2016

Inter-partes review proceedings before the Patent Trial and Appeal Board (PTAB) have transformed patent practice and unsettled expectations for patent holders while empowering patent challengers. In the first three years of this practice, the Board has invalidated patent claims and entire patents with such frequency that some see the proceedings as a road block for patents. Most of the affected patents have been outside the biotech and pharma area but recently patents on these technologies have also been subject to IPR with greater frequency. As the PTAB has developed procedures for instituting and holding IPR proceedings there has developed a belief that some of those practices be modified, including the standard used for claim construction and the ability of a patent holder to amend claims during proceedings. This panel will explore these issues and proposals for change in the context of using IPRs as an adjunct to biosimilars litigation under the Biologics Price Competition and Innovation Act.

Room West 3008

Piecing Together the Hatch-Waxman, BPCIA and PTAB Puzzle: Revealing the Big Picture in Patent Challenges Brought in Multiple Fora

3:30 PM–4:30 PM Jun 7, 2016

In the United States, drug and biologic drug patents are subject to special rules and standards when litigated in court. The same patents can also be challenged in new administrative proceedings in the US Patent and Trademark Office, under different rules and standards, giving rise to perplexing questions and unexpected developments. In 2015, by all accounts, there was a sizeable increase in the number of inter parties review (IPRs) filed at the Patent Trial and Appeal Board (PTAB) which challenged pharmaceutical and biotechnology patents. Some sources show that the majority of all IPRs in the biomedical space are now being brought by generic drug companies. The approach to IPRs seem to stem from filings by generic drug companies to interfere with the market prospects of other generic companies, filings resulting in parallel proceedings with litigation under the Hatch-Waxman Act, and filings in anticipation of the BPCIA “patent dance.” Designed for corporate decision makers and practicing IP professionals, this panel will address the interplay between these two systems – the Hatch-Waxman Act and BPCIA patent litigation pathways – and the inter parties review proceedings at the Patent Trial and Appeal Board.

Room West 3008

US Patents and Global Business: Clear Borders or Blurred Lines?

10:45 AM–11:45 AM Jun 8, 2016

Biotechnology companies are operating in a global environment at every turn with strategic supply-chain decisions, complex licensing agreements and regional pricing decisions. At the same time, the extraterritorial effect of US patent rights is in flux with decisions including Suprema v. ITC, Lexmark v. Impression Products and Promega v. Life Technologies. This session will flag some of the hot topics involving the extraterritorial reach of US patents including patent infringement and inducement under sections 102(f) and 102(g), the jurisdictional scope of the International Trade Commission, international patent exhaustion and the implications of off-shore activity in patent damages. The panel will address hypothetical scenarios to delineate best practices for IP counsel and business decision-makers, including supply chain managers, to manage patent rights and patent risks in this evolving landscape.

Room West 3008

Successful Pharmaceutical Branding: Key Insights from the Business, Legal and Creative Perspectives

1:00 PM–2:00 PM Jun 8, 2016

Pharmaceutical brands can rise to be among the most valuable brands in the world, often symbolizing enormous goodwill and customer loyalty. A brand may therefore be a valuable company asset driving increased profitability and mitigating competitive erosion of marketshare, even from generic competition. Creating these brands is challenging due to the need to meet the requirements of both the trademark (U.S. Patent & Trademark Office) and drug regulatory (Food & Drug Administration) regimes. This panel will provide a broad overview of the role brands play in the increasingly competitive pharmaceutical marketplace, review the pharmaceutical branding process from creative naming inception to approval and registration with the FDA and U.S. trademark office and offer insights on issues which arise post introduction into the marketplace. Panelists, including representatives from premier pharmaceutical companies, a branding agency and a law firm, will provide diverse perspectives and considerations on the issues arising in the business, creative and legal contexts.

Room West 3008

Protecting Biomedical Innovation in a Shifting Patent-Eligibility Landscape

2:15 PM–3:15 PM Jun 8, 2016

Patenting in the biotechnology space has been beset by a new uncertainty in recent years. Irrespective of other requirements for patenting such as whether an invention is new, not obvious over existing technology or sufficiently described, the requirement of patent eligibility excludes from patent protection inventions whose subject matter is deemed directed to judicially created subject matter exceptions: abstract ideas, laws of nature and natural phenomena. The patent eligibility doctrine is not new, but courts and the USPTO have followed the US Supreme Court’s recent lead in invoking it to deny patent protection, particularly in the biomedical and biotechnological fields, even for admittedly “breakthrough” inventions. The panel, with representatives from the judiciary, USPTO and industry, will discuss how stakeholders can maneuver the still-changing landscape in this challenging area and where it may be heading moving forward.

Room West 3008

No Patent, No Cure

3:30 PM–4:30 PM Jun 8, 2016

The EU has specific legislation on the legal protection of biotechnological inventions (IP) known as Directive 98/44/EC (July 6, 1998).Different stakeholders have argued of a review of this legislation in order to reduce or modify the scope of IP in the field of biotechnology and more recently the discussion has been raised at the level of European Councils of Ministers. On the other side of the Atlantic, the 2013 Supreme Court “gene patenting” case and the USPTO Interim guidance on patent subject matter have led to increased uncertainty for biotech companies in the area of IP. Against this backdrop, the aim of this session is to understand the effects that such changes or proposed changes could and do have on the business model of biotech companies on both sides of the Atlantic, and help companies successfully navigate these uncertain waters.

Room West 3008

Intellectual Property Track Reception

4:30 PM–5:30 PM Jun 8, 2016

Room West Third Floor Lobby Intellectual Property Reception

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