On May 3, 2018, the U.S. Department of Agriculture (“USDA”) released its much-anticipated proposed rule to establish a national standard for the disclosure of bioengineered ingredients in certain food products. The public comment period on the proposal has begun and runs through July 3, 2018. The proposed rule sheds light on certain aspects of the disclosures that food manufacturers and others will be required eventually to provide. But the USDA’s proposal leaves significant questions unanswered, providing an opportunity for the public to shape the final rule in critical ways.

Background

The USDA’s rule is promulgated under the 2016 National Bioengineered Food Disclosure Standard Act. It preempts the GMO labeling regimes of several states, including Vermont, and requires the USDA to issue a final rule on the disclosure of bioengineered ingredients in food products by July 29, 2018. You can read more about the background of the Act and the actions undertaken by the USDA prior to the release of its proposed rule here.

Definition of “Bioengineered” Ingredients

The proposed rule requires disclosure of “bioengineered” ingredients. Under the Act, “bioengineered” (or “BE”) means food “(A) that contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques; and (B) for which the modification could not otherwise be obtained through conventional breeding or found in nature.”

The proposed rule is silent as to whether ingredients that are genetically modified through other techniques, such as gene editing, are covered. But the USDA does provide some clarifying guidance on what constitutes a “bioengineered” food or ingredient. Its proposed rule offers a list of “Commercially Available BE Foods” that have been “highly adopted” in the food industry, and a list of “Commercially Available BE Foods” that are “not highly adopted.” Only food products containing ingredients on these lists will be subject to the anticipated disclosure rules.

Foods are “highly adopted” where 85% or more of the crop produced in the U.S. is “bioengineered”—including canola, field corn, and soybeans. Foods are “not highly adopted” where less than 85% of the U.S. crop is bioengineered—including apples with non-browning cultivars, sweet corn, papaya, potato, and summer varieties of squash. The proposed rule provides a process by which the lists can be updated depending on changes in technology and food cultivation.

Disclosure Options

Except for certain exemptions (more on that below), if a food product appears on, or contains an ingredient on, either the “highly adopted” or “not highly adopted” list, regulated entities will be required to make a disclosure on the label of that food product or not make a disclosure if they have documented verification that the food is not a bioengineered food or that it does not contain a bioengineered food ingredient.

The proposed rule allows regulated entities to choose from at least three disclosure options for non-exempt foods: a text disclosure on a food label, a symbol disclosure, or an electronic link disclosure. The USDA is considering a text message disclosure option as well. Under this proposed option, the company would be required to include a statement on the food label directing the consumer to a number to text for more information about the food. The number must provide an immediate response with only the required text disclosure.

If a regulated entity uses a text disclosure on a food label, the disclosure requirement would vary depending on which list the food or food ingredient appear. For food products made from ingredients on the “highly adopted” list, the regulated entity would disclose that the food product “Contains a bioengineered food ingredient.” For food products made with ingredients on the “not highly adopted list,” USDA proposes to give regulated entities the discretion to use the disclosure “May contain a bioengineered food ingredient” instead.

For the symbol disclosure option, the USDA proposes three symbols for public comment (along with black-and-white versions of each).

For the electronic link disclosure option, the USDA proposes to allow regulated entities to include a link on food packaging that can be scanned by a smartphone, at which point the user’s smartphone will open a website containing the required disclosures. The USDA seeks comments on text statements that would accompany the digital link—for example, “Scan icon for food information.” Regulated entities that use digital link disclosures would also be required to include a telephone number on the food label that would allow consumers to call at any time of day and receive the required disclosure.

The possible text message disclosure option would allow regulated entities to provide a number on food packaging and an instruction to send a text message to that number “for more food information.” After sending a text message to that number, the consumer would receive a text message in response containing the required disclosure for that food product.

Entities responsible for disclosure would be required to maintain records necessary to substantiate compliance with the standards for individual disclosure options, including the type and wording of the disclosure used, and to substantiate the claim included in the disclosure or implied by the absence of a disclosure statement.

Exemptions from the Labeling Requirements

The proposed rule exempts a number of foods and food manufacturers from the labeling requirements. Exempted foods include animal products (e.g., meat or eggs) from animals that consume feed containing bioengineered ingredients; food certified as organic under the USDA’s national organic program; and food served in restaurants or similar retail food establishments, including cafeterias, food stands, and bars.

The USDA is weighing different options for two categories of additional exemptions: an exemption based on the relatively low level of bioengineered ingredients in a food product, and an exemption for small food manufacturers based on the manufacturers’ annual receipts. The USDA seeks public comment on the appropriate thresholds for these exemptions, and proposes several different options for consideration.

Proposed Compliance Dates

The USDA proposes a compliance deadline of January 1, 2020, with a delayed compliance date of January 1, 2021 for small food manufacturers. The USDA’s proposed deadlines for bioengineered food disclosures are intended to align with the Food & Drug Administration’s extension of the deadlines to comply with updated Nutrition Facts, Supplement Facts and Serving Size labeling requirements to the same dates.

Final Thoughts

The USDA’s statutory deadline to issue a final rule, July 29, 2018, is fast approaching. But it likely will not meet it because the proposed rule contains a number of unanswered questions, many relating to critical issues such as how the presence of “bioengineered” ingredients will be disclosed and which foods and food manufacturers will be exempted from the labeling requirements.

These unanswered questions also mean that the final rule is likely to be influenced significantly by public comments. Food manufacturers, retailers, consumers, industry groups, and other interested parties have an important opportunity to shape the final contours of the USDA’s bioengineered food labeling rules.

The USPTO announced today proposed rulemaking for changing its policy related to claim interpretation in Patent Trial and Appeal Board (“PTAB”) proceedings (not including patent examination). Currently, the broadest reasonable interpretation (“BRI”) standard is applied when analyzing claims. The proposed new rules would result in “the same as the standard applied in federal district courts and International Trade Commission (“ITC”) proceedings;” i.e., “ordinary and customary meaning” according to “a person of ordinary skill in the art in question at the time of the invention,”[1] and “reasonable certainty” for definiteness analysis[2]. In addition, it is proposed that the USPTO/PTAB “will consider any prior claim construction determination concerning a term of the involved claim in a civil action, or an ITC proceeding, that is timely made of record in an IPR, PGR, or CBM proceeding.” Continue Reading USPTO Announces Notice of Proposed Rulemaking for Claim Construction Standard used in PTAB Proceedings

SAS Institute Inc. v. Iancu

As we recently noted in our companion piece Part 1 of 2: Supreme Court and Inter Partes Review, the Supreme Court issued decisions in two intellectual property appeals relating to inter partes review (“IPR”) before the U.S. Patent and Trademark Office. In Oil States Energy Services LLC v. Greene’s Energy Group LLC, No. 16-712, the Court decided 7–2 that the inter partes review process does not violate Article III of the Constitution or the Seventh Amendment. In SAS Institute Inc. v. IANCU, No. 16-969, the Court decided that the Patent Trial and Appeal Board (“PTAB”) must decide the patentability of all of the claims the petitioner has challenged rather than selectively picking and choosing which claims to review. In response to the Court’s decision in SAS, the PTAB has already issued new guidance regarding the institution of IPRs. Continue Reading Part 2 of 2: Supreme Court and Inter Partes Review

Oil States Energy Services LLC v. Greene’s Energy Group LLC

On April 24, 2018, the Supreme Court issued decisions in two intellectual property appeals relating to inter partes review (“IPR”) before the U.S. Patent and Trademark Office. In Oil States Energy Services LLC v. Greene’s Energy Group LLC, No. 16-712, the Court decided 7–2 that the inter partes review process does not violate Article III of the Constitution or the Seventh Amendment. In SAS Institute Inc. v. IANCU, No. 16-969,  the Court decided that the Patent Trial and Appeal Board (“PTAB”) must decide the patentability of all of the claims the petitioner has challenged rather than selectively picking and choosing which claims to review.  In response to the Court’s decision in SAS, the PTAB has already issued new guidance regarding the institution of IPRs. Continue Reading Part 1 of 2: Supreme Court and Inter Partes Review

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.