In a few short days, the United States will mark the eight-year anniversary of the Biologics Price Competition and Innovation Act (“BPCIA”). Signed into law on March 23, 2010, the BPCIA creates a regulatory pathway for the approval of biosimilar drugs in the United States and a mechanism, albeit voluntary, for resolving patent right disputes relating to the innovator biologic products.  Continue Reading “Rigged” Pricing, Contracting and Rebate “Schemes,” and Drug Pricing “Shell Games:” FDA Commissioner Scott Gottlieb Lets Loose on the U.S. Biosimilar Market While Offering Peek at New Policies

The Hatch-Waxman Act was enacted in 1984 to address two main congressional goals: (1) to encourage innovation in pharmaceutical research and development; and (2) to help generic drugs reach the market more quickly. Through amendments to both the patent and the food and drug laws, the Act established several practices intended to provide brand-name firms with incentives to innovate while facilitating the marketing of generic pharmaceuticals. Whether or not it was envisioned at the time, the use of generic drugs in the US has seen a tremendous increase since the enactment of the Act. From about 13% (of all prescriptions) in 1984, use of generic drugs grew to 50% by the late 1990s and currently constitute well over 80% of all prescriptions in the US.

Among other things, the Act included elaborate provisions governing the mechanisms through which a potential generic manufacturer may obtain marketing approval for a drug that has been patented by another party. It also put in place an expedited approval processes for generic drugs. In doing so, the Act launched a new type of litigation, “Hatch-Waxman” or “ANDA” litigation. The evolution of the US generic drug industry has been shaped, in part, as a result of such litigation proceedings that unfolded many questions critical to understanding the generic approval process.

Although generic drug usage is over 80% of all prescriptions in the US, as of 2015 the sale of generics were only a quarter as large as those of patented drugs. In the past several years, the number of ANDA litigations has significantly increased. As an active member of the legal community within the ANDA space, we took a look at the latest developments in the field and now share our observations. In the article titled “Hatch-Waxman And Biosimilars Litigation: 2017 Year-in-Review,” we provide a brief overview of the Hatch-Waxman Act, a summary of the recently released FDA Draft Guidance, a general timeline of Hatch-Waxman and Biosimilars litigation, and summaries of some of the related decisions issued by the U.S. Supreme Court and Court of Appeals for the Federal Circuit in the year 2017. If you would like to order a hard copy of the Year in Review, please see our blog post.

U.S. Food and Drug Administration (FDA) Commissioner, Dr. Scott Gottlieb, has made generic drugs and drug pricing an agency priority by emphasizing the critical value of generic drugs to public health. In 2017, 1027 total generic drugs were approved, which was the highest number of generic drugs approved in a single year.[1] Table 1 below illustrates 2017 approvals by month. Continue Reading FDA’s Office of Generic Drugs: 2017 Annual Report Highlights

This webinar is hosted by The Knowledge Group.

On April 17th at 10 a.m. ET, Dr. Dean Fanelli and Dr. Thomas Haag, along with Jens Viktor Nørgaard of HØIBERG, Niklas Mattsson of Awapatent, Mr. Glyn Truscott of Elkington + Fife LLP and Jennifer O’Farrell of Boult Wade Tennant, will present a live webcast on Bridging the Gap Between EU and U.S. Biotech Inventions Protection.

Biotechnology companies both in the U.S. and Europe rely greatly on patents to protect their biotech inventions, especially during the research and development process. However, with the evolving economic landscape, and the rise of complex developments and innovation, protecting biotech inventions has become more difficult.

In this LIVE Webcast, a team of thought leaders and professionals brought together by The Knowledge Group will provide and present and in-depth analysis of the laws and regulations in the EU and U.S. concerning Biotech Inventions Protection. Speakers will also provide practical tips and strategies to maximize legal protection and to avoid risks and pitfalls while complying with applicable laws.

Key topics include:

  • EU and U.S. Biotech Inventions Protection – Laws and Regulations
  • Similarities and Differences
  • Significant Court Rulings
  • Trends and Legal Updates
  • What Lies Ahead in 2018

For more information and to register for the webinar, click here.

This webinar is hosted by The Knowledge Group.

On March 22nd at 12 p.m. ET, Dean Fanelli and Jamaica Szeliga, along with Timothy Shea of Sterne, Kessler, Goldstein & Fox P.L.L.C., will present a live webcast on Biosimilar Litigation and Your BPCIA Compliance: Key Strategies In Light of AbbVie v. Boehringer.

The previous year saw an increase in biosimilar filings in the U.S., including the recent suit filed by AbbVie in the U.S. District Court for the District of Delaware against Boehringer Ingelheim regarding Boehringer Ingelheim’s adalimumab product, Cyltezo®, a proposed biosimilar to AbbVie’s Humira®. The complaint alleges infringement of 8 patents in the initial phase of litigation, as Boehringer Ingelheim was able to cap the scope of litigation by complying with the procedures of the Biologics Price Competition and Innovation Act of 2009 (BPCIA). This case reflects the benefits of complying with the BPCIA’s patent dispute resolution procedure, also known as patent dance.

In this LIVE webcast, a panel of distinguished professionals and thought leaders will discuss the latest legal and regulatory updates that are continuously changing the biosimilar landscape. They will review the on-goings of the AbbVie v. Boehringer Ingelheim litigation and give insights on the benefits and risks of engaging in the BPCIA’s patent dance. Speakers will also provide considerations in adopting appropriate litigation strategies.

Key issues that will be covered in this course are:

  • Biosimilar Litigation Landscape Post Sandoz v. Amgen
  • Complying with BPCIA: AbbVie v. Boehringer Ingelheim
  • The Benefits and Risks of Patent Dance
  • Recent Legal and Regulatory Updates
  • Strategic Considerations for Biosimilar Litigation
  • Significant Trends and Legal Updates

For more information and to register for the webinar, click here.

Seyfarth Shaw Offers Hatch-Waxman And Biosimilars Litigation: 2017 Year-in-Review

Today’s rapid scientific and technological advances demand not only a thorough understanding of the complex technology, but also a meticulous application of intellectual property law to protect the technology.

Seyfarth’s Intellectual Property and Hatch-Waxman Litigation practitioners are pleased to announce the release of Hatch-Waxman And Biosimilars Litigation: 2017 Year-in-Review which provides a brief overview of the Hatch-Waxman Act, a summary of the recently released FDA Draft Guidance, a general timeline of Hatch-Waxman and Biosimilars litigation and summaries of some of the related decisions issued by the U.S. Supreme Court and Court of Appeals for the Federal Circuit in the year 2017.

How to Get Your Desktop Guide:

To request the Hatch-Waxman And Biosimilars Litigation: 2017 Year-in-Review as a pdf or hard copy, please click the button below:



For updates and insight on Hatch-Waxman related issues, we invite you to subscribe to our BioLoquitur Blog.

Continue Reading Now Available! Seyfarth Shaw’s Hatch-Waxman and Biosimilars Litigation: 2017 Year-in-Review

As a special feature of our blog, we include special guest postings by experts, clients, and other professionals—please enjoy this blog entry which includes guest author Rolf J. Haag.[1]

It has been impossible to miss the surreal volatility in Bitcoin’s per unit price—having gone from $1,000 in January 2017 to almost $20,000 (~$750B mkt. cap) toward the end of last year and retracting to under $8,000 (~$500B mkt. cap) in February 2018. Whether these G-LOC-inducing price undulations are reflective of a radical paradigm shift in the mode of financial transactions, history’s greatest pyramid scheme, or some mix thereof, remains to be seen. Continue Reading Will Blockchain Revolutionize Bio/Pharma R&D, Tech Transfer, and IP?

In late December the FDA issued a new guidance, entitled “Best Practices for Communication Between IND Sponsors and FDA During Drug Development.” The purpose of the guidance is to “describe best practices and procedures for timely, transparent, and effective communications between investigational new drug application (IND) sponsors and FDA at critical junctures in drug development.” The hope is the guidance facilitates an earlier availability of safe, effective and high-quality drugs to the American public, including biosimilars.

The IND phase of drug development is the time during which human trials of investigational drugs are conducted. From the FDA’s perspective, the IND phase spans the time from the first IND-related submission (including a pre-IND or Biosimilar Initial Advisory (BIA) meeting request or an original IND) to the submission of a marketing application. The FDA engages in thousands of communication with drug sponsors during the IND phase. As such, the FDA’s guidance encourages efficient, consistent, clear and concise communications.

The new guidance particularly lays out and describes the following: the FDA’s philosophy regarding timely communications with IND sponsors as a core activity; the scope of appropriate interactions between review teams and IND sponsors; the types of advice that are appropriate for IND sponsors to seek from FDA; the expectations for the timing of FDA responses to IND sponsor inquiries; the best practices and communication methods to facilitate interactions with the FDA; and the expectations for appropriate methods of communication with the FDA.

At bottom, the FDA engages in thousands of communications with IND sponsors each year. Given the sheer volume of communications the FDA must review and respond to, facilitating a consistent, complete and concise communication protocol will assist the FDA in reviewing and providing timely and cogent feedback to the sponsors where appropriate. This, in turn, should result in greater efficiency during the drug development process to the benefit of the American public.

The Federal Circuit on Wednesday reversed Court precedent and long held belief that inter partes review (“IPR”) institution decisions were categorically non-reviewable. The Court, sitting en banc, held that the issue of whether a petitioner is time-barred from filing an IPR petition  under 35 U.S.C. § 315(b) is in fact reviewable.[i]

This case arose when the patent owner alleged that an IPR petition was time barred based on the petitioner being privy with parties sued over the patent more than a year before the petition was filed. The IPR was instituted and a final written decision was published.

Congress granted the Director of the USPTO, subject to certain requirements, the sole discretion in whether to institute an IPR.  It is the extent of that discretion that the Court clarified on Wednesday. The Court honed in on two sections of the AIA—§§ 314 and 315. Section 314(a) authorizes the Director to institute an IPR if there is a “reasonable likelihood” that the petitioner will prevail with respect to at least one claim challenged in the petition. Section 315(b) on the other hand is a statutory time bar provision that limits a petitioner’s ability to successfully pursue an IPR proceeding if the “petitioner, real party in interest, or privy of the petitioner” was served with a complaint alleging infringement of the patent more than one year before the IPR petition was filed. The question answered by the court was whether § 314(d), which deems the Director’s decision to institute an IPR “under this section” final an nonappelable, extends to the time bar set out in § 315(b). According to the court, § 314(d) does not extend to § 315(b), but it is unclear if other determinations may soon be reviewable.

In concluding that the time bar determination is appealable, the Court highlighted the “fundamentally different” analysis of § 314 and § 315. On one hand, § 314(a) relates to a substantive analysis of the merits—a “preliminary patentability determination.” On the other hand, § 315(b) is a “condition precedent to the Director’s authority to act.” In other words, § 315(b) is precondition that if met grants the Director the authority to make a determination under § 314(a). According to the Court, the lack of a clear indication that Congress intended to bar appeals related to § 315(b) gave way to “the strong presumption in favor of judicial review of agency actions.”

This decision, although limited to time bar appeals, opens the door for other challenges to the Director’s “sole discretion.” Based on the Court’s heavy reliance on the language of § 314 being directed to preliminary patentability determinations, it is possible that the Court may be amenable to further appeals that do not relate directly to the “patentability merits of the claims.” Other AIA threshold requirements that may be challenged include the requirement that petitioner name all interested parties in the case and the AIA estoppel provisions.

[i] The case is Wi-Fi One LLC v. Broadcom Corp., Nos. 15-1944, 15-1945, and 15-1946 (Fed. Cir. Decided January 8, 2018).

It was a busy year for patent litigation across the broad, including the U.S. Patent and Trademark Office Patent Trial and Appeals Board (PTAB), U.S. District Courts (USDC), Court of Appeals for the Federal Circuit (CAFC), and the Supreme Court of the United States (SCOTUS). A quick look at the number of patent litigation cases filed over the years, particularly the last five years, show that while there has been a decrease in the number of cases filed with the USDC, the filings with the PTAB and CAFC saw a significant increase.

Total Number of Patent Litigation Cases 2008 to 2017

USDC patent case counts include cases addressing the infringement, validity, or enforceability of a U.S. patent that are pending in a U.S. district court or the Court of Federal Claims. This encompasses cases flagged with Nature of Suit (“NOS”) 830 in the PACER system as well as other cases that are known to meet the above criteria. Transferred, consolidated, coordinated, or bifurcated actions may contribute to the number of cases counted.

PTAB cases include applications to the PTAB for inter partes reviews and post-grant reviews pursuant to 35 U.S.C. § 6(a)(4), as reported in the PTAB’s Patent Review Processing System (“PRPS”). The term does not include proceedings conducted pursuant to 35 U.S.C. § 6(a)(1)-(3) such as appeals of adverse decisions of examiners, appeals of reexaminations, or derivation proceedings. Data obtained from Docket Navigator analytics.

SCOTUS was called upon to make important decisions ranging from patent venue laws, patent exhaustion to a U.S. manufacturer’s liability for exporting components later incorporated into an infringing product, including amendments during inter partes review. The year started with predictions as to whether the Supreme Court will consider the issue of whether IPR violates the U.S. Constitution by extinguishing private property rights through a non-Article III forum without a jury, in Oil States Energy Services LLC v. Greene’s Energy Group, LLC, and ended with predictions regarding the outcome of the oral arguments heard by the Court in November. Although faced with the issue before, the fact that Supreme Court decided to hear the issue now is not surprising given the increasing number of IPRs being filed with the PTAB and a slow decrease in the number of IPR petitions being instituted (coupled with increase in the number of IPR petitions being denied).

Institution Rates from FY13 to FY18 (Source: PTAB)

The number of post-grant proceedings filed in the technologies related to Electrical/Computer & Mechanical are much higher than those filed in the Bio/Pharma and Chemical technology areas. However, the rate at which the petitions are instituted is similar in each of the technology areas.

Institution Rates by Technology 09/16/2012 to 11/30/2017(Source: PTAB)

Also, the post- and pre-institution settlement rates have remained the same for the last two years, which are noticeably lower as compared to two years prior to that and significantly lower (at least for post-settlements) compared to five years ago. Although it may be tempting to associate this decrease in settlements to the predictions of Oil States’ challenge for the constitutionality of IPR proceedings, it would not be appropriate to do so given that the issue has been discussed previously.

Pre-Institution Settlements (Source: PTAB)

Post-Institution Settlements (Source: PTAB)

The Supreme Court’s decision in Oil States could have a major impact on the patent world, and is clearly the center of attention as the new year begins. Certainly, the decision in TC Heartland has proved to be a game-changer in patent filings. According to a recently published report by Fried, Frank, Harris, Shriver & Jacobson LLP, a substantial difference was noticed in the patent infringement filings from May 2017 to September 2017 when compared to the same period in 2016 in at least two of the top ten District Courts. The patent filings in the Eastern District of Texas, which is considered a plaintiff-friendly jurisdiction, decreased from 39.61% in 2016 to 15.04% in 2017; while the district of Delaware saw a rise in the filings, which is not surprising given most companies are either based out of, or majorly operate, in Delaware.

Top 10 District Courts: Pre- and Post-TC Heartland

It is not unusual that a decision, even by the Supreme Court, sometimes tends to pose more questions than it answers. The decision in Life Technologies Corp v. Promega Corp. is certainly amongst the top in 2017, wherein the Supreme Court had to address the issue of a U.S. manufacturer’s liability for exporting components later incorporated into an infringing product. While addressing a specific dispute pertaining to diagnostic kits between the parties, the Court raised many questions without providing any guidance as to the answers for those questions. The court held that the term “substantial portion” in Section 271(f)(1) has a quantitative, not a qualitative, meaning. More specifically, the court held that the phrase “substantial portion” in the statute does not cover the supply of a single component of a multicomponent invention. One of the obvious questions this decision raises is what if the invention is a two-component invention?” Would the supply of a single component of a two components invention still be outside the scope of the statute? Given the continuing growth in international commerce, it is fair to predict that the Courts might have to address this issue sooner than later.

This year was also marked by the Supreme Court deciding on its first case related to Biologics Price Competition and Innovation Act (“BPCIA”). The Court was called upon to review an issue regarding the notice requirements of BPCIA. Although, the Court provided clear guidance that biosimilar applicants may provide 180-day notice of commercial marketing prior to the FDA’s approval of the application, it left some questions for the CAFC to decide. The Court held that the Federal law does not provide for an injunction requiring a biosimilar applicant to start the patent dance by providing its application and manufacturing information to the reference product’s sponsor under 42 U.S.C. § 262(l)(2)(A) and remanded the case to CAFC for further proceedings. In December, the CAFC held that BPCIA preempts any state law remedies for failure to comply with § 262(l)(2)(A) and concluded that applying state law would create a conflict with the careful balance struck by Congress in establishing the BPCIA.

The CAFC also had its share (65% of its docket) of intellectual property law cases, including 29% resulting from appeals from the District Court decisions and 33% resulting from appeals from the PTAB.

Appeals Filed, by Category for FY 2017 (Source: CAFC)

A review of filings over the last 10 years reveals that the number of appeals filed with the Federal Circuit resulting from the PTAB have risen significantly in the last 4 years.

Appeals Filed, by Category for FY 2006 to FY 2017 (Source: CAFC)

This increase in the appeals resulting from PTAB is consistent with the number of petitions for post-grant proceedings filed with the PTAB. It will be interesting to see how the trend, particularly in inter-partes review filings, will change once the Supreme Court issues its final written decision.