Seyfarth Shaw is pleased to announce The BioLoquitur Bulletin: Drugs Available in 2018 for Generic Competition, published by the Life Sciences team. The BioLoquitur Bulletin provides a brief overview of selected New Chemical Entities (NCE) that were approved by the FDA in the year 2014. While not every NCE will be a target for NCE-1 litigation, the Dissection Guide offers information about the drug products, indications, and Orange Book patents.

In calendar year 2014, the FDA’s Center for Drug Evaluation and Research (CDER) approved 41 novel new drugs as new molecular entities (NMEs) under New Drug Applications (NDAs) or as new therapeutic biologics under Biologics License Applications (BLAs). More than one-third of the novel new drugs approved in 2014 (17 of 41 or about 41%) were identified as First-in-Class and about 41% of the novel new drugs approved in 2014 (17 of 41) were approved to treat rare or “orphan” diseases.

CDER designated 41% as fast track, 22% as breakthrough therapies, 61% as priority review and 20% under FDA’s Accelerated Approval program. Further, a majority of the novel new drugs of 2014 (32 of 41, 78%) were approved on the “first cycle” of review, meaning without requests for additional information that would delay approval and lead to another cycle of review. See The Bulletin for more information.

Seyfarth’s Life Sciences team includes a multidisciplinary group of legal professionals with strong technical backgrounds in biology, biochemistry, organic chemistry, molecular biology, and pharmacology. Our team of experienced trial and appellate lawyers craft and execute comprehensive intellectual property strategies from initial drug development through trial and appeal.

How to Get Your Copy of The BioLoquitur Bulletin

Click here to download the pdf.

 

The Food and Drug Administration (FDA), as part of its Drug Competition Action Plan, published a draft guidance detailing good practices for the submission of ANDAs on January 3, 2018. The guidance highlights common, recurring deficiencies that may lead to a delay in the approval of an ANDA and makes recommendations to applicants on how to avoid such deficiencies. A typical ANDA requires an average of four review cycles before approval. The delay happens when ANDAs are submitted without all the information that the FDA needs to determine whether the ANDA meets FDA standards for approval, which leads to additional review cycles. Continue Reading Good ANDA Submission Practices: Summary of Draft Guidance

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.