Posted on Friday, September 7 2018 at 7:11 pm by

Safe Harbor Provision of 35 U.S.C. § 271(e)(1) – Implications of Intent and Continued Use

By: Alyson L. Wooten, Pharm.D.

The safe harbor defense has been of issue in two recent cases in which the bounds of the protection has been analyzed. Section 271(e)(1) carves out an exception to patent infringement liability when otherwise-infringing activities are solely for uses reasonably related to obtaining FDA approval. Read the rest of this entry »

Posted on Tuesday, May 22 2018 at 1:21 pm by

NIST Revises Intellectual Property Rights Offered to Federally Funded Inventions and Licensing of Government Owned Inventions

For complete details please click here.

Posted on Wednesday, April 4 2018 at 6:10 pm by

Judge Stark (D. Del.) Holds Generic Label is Insufficient to Prove Induced Infringement

By: Alyson L. Wooten, Pharm.D.

GlaxoSmithKline v. Teva, No. 14-878-LPS-CJB (D. Del)


Following a seven-day trial last year, a jury found that Teva willfully induced infringement of claims of U.S. Patent No. RE40,000 from January 2008 to April 2011 (“skinny label period”) and from May 2011 until June 2015 (“full label period”), and awarded $234 million in lost profits and $1.4 million in reasonable royalty damages to plaintiff. Teva filed a motion for judgment as a matter of law, which was granted in part, in an opinion issued last week by Judge Stark finding that plaintiff failed to present sufficient evidence to support a jury verdict of induced infringement. The product at issue, generic carvedilol, was originally launched by Teva with a section III carve out (which was in effect from January 2008 to April 2011) and then later, in May 2011, Teva amended its label to include the carved out indication for congestive heart failure (“CHF”), making the label essentially a copy of the plaintiff’s full label.

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Posted on Tuesday, February 13 2018 at 7:05 pm by

Will Kratom Be Restricted?

By: Alyson L. Wooten, Pharm.D.


Kratom, a popular alternative medicine used as a home remedy for opioid addiction, is now classified by the Food and Drug Administration (“FDA”) as an opioid – a step that may lead to the classification of the substance as a restricted drug under the Controlled Substance Act.

Kratom-e1518403746740-600x350Kratom lies at the intersection of the debate between natural product and drug of abuse. Thousands of people around the world have taken kratom, which grows naturally in areas of tropical Southeast Asia. The plant is part of the coffee family and is commonly crushed for use as an herbal supplement and traditional remedy for pain relief and as a stimulant.

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Posted on Friday, December 22 2017 at 9:08 pm by

FDA Proposes a New Risk-Based Enforcement Approach for Certain Categories of Homeopathic Drug Products

By Carolina M. Wirth

More than 2 years after the Food and Drug Administration (FDA or agency) held a public hearing to obtain input from both the public and industry stakeholders regarding its current regulatory framework for homeopathic drug products, the agency has issued a draft guidance proposing a new, risk-based enforcement approach for drug products labeled as homeopathic.  Following the public hearing, FDA received more than 9,000 comments in response to its request for “broad public feedback on its enforcement policies related to drug products labeled as homeopathic.”[1]

According to FDA, after considering the information obtained from the public hearing, as well as the comments submitted to the public docket, it determined that

it is in the best interest of the public health to issue a new draft guidance that proposes a comprehensive, risk-based enforcement approach to drug products labeled as homeopathic and marketed without FDA approval.[2]

While the draft guidance provides a risk-based enforcement framework for products labeled as homeopathic, it leaves open the question as to how the agency will address the marketing of homeopathic drug products in the future considering that the draft guidance, when finalized, will withdraw FDA Compliance Policy Guide (CPG) 400.400, Conditions Under Which Homeopathic Drugs May be Marketed,[3] which was issued by the agency in 1988. Read the rest of this entry »

Posted on Monday, December 4 2017 at 5:39 pm by

Menu Labeling Update: Plans On-Track for Implementation in May 2018

By: Alyson L. Wooten, Pharm.D.

On November 7, 2017, the U.S. Food and Drug Administration (FDA or the Agency) released the much-anticipated draft supplemental guidance, “Menu Labeling: Supplemental Guidance for Industry” (Draft Guidance). The Draft Guidance provides further details on the Menu Labeling Final Rule (Menu Labeling Rule) and responds to comments the Agency received on the interim final rule, which was released in May 2017.

The Agency’s Menu Labeling Rule has had a long history. The rule requires restaurants and “similar retail food establishments”, such as grocery stores and convenience stores that are part of a chain of 20 or more locations, doing business under the same name, and offering similar food menu items from a menu or menu board to provide: (1) calorie information; (2) a statement on suggested daily caloric intake; and (3) a statement with written nutrition information (which must be provided if requested).

After release of the interim rule in May 2017, which was originally presented in 2015, a number of restaurants and stores in New York City filed suit seeking to prevent New York City from enforcing its substantially similar rule against nutritional information (read here). The City agreed to delay enforcing the rule until March 7, 2018, and the parties reached a settlement agreement contingent upon implementation of the rule by this date. Following the settlement, Scott Gottleib, FDA Commissioner, announced that the Agency planned to release a practical guide on the rule before the end of 2017. The November 7 Draft Guidance seeks to fulfill this promise of a “practical guide”, and appears to continue to suggest that the Menu Labeling Rule will be implemented in May 2018.

While many support the overall goal of the Menu Labeling Rule, many organizations such as the National Restaurant Association are concerned about the patchwork of state and local menu requirements, and the burden created by different store formats attempting to comply with varied rules and regulations. The newly issued Draft Guidance attempts to address these issues has been met with mixed reactions.

As an example of the concerns over this rule, a big issue for many pizza chains is the burden of addressing the thousands of topping combinations people may want on their pizza in calorie counts posted on menu boards in the store. Many pizza chains have been pushing for FDA to allow calorie information to be posted on their website instead of in the store location, with the rationale that the majority of customers order their pizza online rather than in-store. The Agency has rejected this approach in the Draft Guidance, noting that calorie count information may appear online but, if they have in-store menu boards, the calorie information must also appear on the board.

The Agency has indicated that it is willing to continue considering feedback and questions concerning the Draft Guidance. Comments on the proposal are due January 8, 2018.


Posted on Friday, September 22 2017 at 8:51 pm by

Menu Labeling Litigation Between the FDA and Public Interest Groups May Be On Hold

By: Alyson L. Wooten, Pharm.D.

Following the announcement that the Food and Drug Administration (FDA or Agency) had decided to delay the compliance deadline for the menu labeling regulations (see our previous blog post here), two public interests groups sued the FDA over the decision seeking to have the delay vacated and an immediate compliance date ordered.  Both of these groups, the Center for Science in the Public Interest (CSPI) and the National Consumers League (NCL), have agreed to stay the litigation if FDA will issue additional guidance before the end of the year and confirm that it will not provide another extension to the deadline.

CSPI and NCL sued FDA in June shortly after FDA extended the deadline for compliance asserting that the extension of time was unlawful because the Agency did not provide a rational explanation for the delay or provide for public comments before the delay took effect. In August, the government filed a motion to dismiss for lack of jurisdiction.  A few days later, on August 25, the Agency issued a statement that they would issue “additional guidance” about menu labeling before the end of the year and that the new guidance “should allow covered establishments to implement the requirements by next year’s compliance date.”

On September 15, prior to the deadline for Plaintiffs to file an opposition to Defendant’s motion to dismiss, the parties (CSPI, NCL and FDA) filed a joint motion to stay the case. If granted by the court, the case will be stayed until May 7, 2018, as long as the FDA issued new their guidance by the end of the year and confirmed a compliance date with the Menu Labeling Rule by no later than May 7, 2018.  If FDA does not confirm May 7, 2018 as the compliance date, gives any indication that the compliance deadline could be or will be extended beyond May 7, 2018, or fails to publish the additional guidance before the end of the year, the stay may be lifted and the litigation will proceed with “expedited consideration.”  However, the parties agree that if the compliance date goes into effect on May 7, 2018, the parties will dismiss the case.

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Posted on Tuesday, July 25 2017 at 2:24 pm by

FDA Issues New Guidance on IRB Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations

By: Carolina M. Wirth

As July comes to an end, the Food and Drug Administration (FDA or agency) has issued a new guidance document for “immediate implementation” entitled “IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More than Minimal Risk to Human Subjects.”  The guidance document outlines FDA’s new enforcement policy with regard to IRB waivers or alterations of informed consent requirements for certain minimal risk clinical investigations.

According to FDA, the agency has received numerous inquiries over the years “from sponsors and investigators about conducting important minimal risk clinical investigations for which obtaining informed consent was not practicable[i].” However, FDA did not have the statutory authority to allow for a waiver of informed consent for these types of investigations until the recent passing of the 21st Century Cures Act (Cures Act).

The Cures Act, which was signed into law on December 13, 2016, amended the Federal Food, Drug and Cosmetic Act and provided FDA with the authority to “permit an exception from informed consent requirements when the proposed clinical testing poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of the human subject.[ii]”  Currently, FDA regulations only allow an exception from the informed consent requirements in life-threatening situations (21 CFR 50.23) or for emergency research (21 CFR 50.24).  Thus, FDA intends to publish regulations to reflect this statutory change, including any appropriate human subject protection safeguards.

Until the new regulations are published, FDA does not “intend to object to an IRB approving a consent procedure that does not include, or that alters some or all the element of informed consent set forth in 21 CFR 50.25,” as long as the IRB finds and documents that:

  • The clinical investigation involves no more than minimal risk (as defined in 21 CFR 50.3(k) or 56.102(i)) to the subject;
  • The waiver or alteration will not adversely affect the rights and welfare of the subjects;
  • The clinical investigation could not practicably be carried out without the waiver or alteration; and
  • Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

According to FDA, it intends to “withdraw th[e] guidance after [it] promulgate[s] regulations to permit a waiver or alteration of informed consent under appropriate human subject protection safeguards consistent with Section 3024 of the Cures Act.[iii]”  However, the agency does not provide a timeframe for when it plans to issue these regulations.  In the meantime, while the guidance is for immediate implementation, the agency “will consider all comments received and will revise this guidance when appropriate.[iv]


[i] Guidance at 1.

[ii] Guidance at 2.

[iii] Guidance at 4.

[iv] Guidance at 2.

Posted on Wednesday, July 12 2017 at 9:19 pm by

The Deadline for Submitting Comments to USDA as it Prepares to Draft a Proposed Rule on GMO Labeling is Quickly Approaching – Submit your Comments Now.

On June 28, 2017, the U.S. Department of Agriculture (USDA or agency) Agricultural Marketing Service (AMS) posted a list of 30 questions for consideration by stakeholders in order to assist the agency in developing a Proposed Rule setting national standards and procedures for the labeling of bioengineered foods  (i.e., GMO labeling).

As you may recall, AMS has two years to implement the National Bioengineered Food Disclosure Standards Law which was enacted by Congress on July 29, 2016, and charged the agency with developing a national mandatory system for disclosing the presence of bioengineered material in foods. The law also preempted future and existing state laws attempting to establish GMO labeling requirements for foods containing bioengineered materials. See our previous blog post on the Vermont GMO Law here.

With about a year left to publish a final rule (AMS is mandated to publish a final rule by July 2018), AMS is publishing this list of questions in the hopes that it will use any input to draft the proposed rule. The questions cover an array of topics from the terms that AMS should consider as interchangeable with “bioengineering,” to the text that manufacturers should be required to use when it chooses to use text to disclose a bioengineered food.

AMS is only providing stakeholders until Monday, July 17, 2017 to submit any comments.  Comments may be submitted to the following email address:

Interested parties will also have an opportunity to submit any comments once a proposed rule is published by AMS. We will be closely following this rulemaking, as it may directly impact the compliance deadline for the new Nutrition Facts Label and Serving Size Final Rules published by the Food and Drug Administration in May 2016.  FDA recently indefinitely delayed the compliance date for these Final Rules (see our blog post here), and that decision may have been in part in order to avoid having industry update food labels twice within a short period of time.



Posted on Wednesday, June 14 2017 at 3:26 pm by

U.S. Supreme Court Finds that Dancing with Biosimilars is NOT Mandatory

By: Alyson L. Wooten, Pharm.D.

imagesThe U.S. Supreme Court had a busy day on Monday (June 12, 2017) issuing four unanimous decisions in recently argued cases.  Of particular note is the final decision in the Supreme Court’s 2016 term – the consolidated case of Sandoz Inc. v. Amgen Inc. and Amgen Inc. v. Sandoz Inc., which interpreted the Biologics Price Competition and Innovation Act (BPCIA).  As we reported here, this case originated out of the U.S. District Court for the Northern District of California where Amgen sued Sandoz for failure to engage in the BPCIA’s patent dance[1] and for inadequate notice of commercial marketing of Sandoz’s biosimilar version (Zarxio®) of Amgen’s Neupogen® product.

The Supreme Court decided that Sandoz had not violated the BPCIA by failing to engage in the patent dance. The justices found it compelling that the BPCIA expressly sets forth the consequences for failure to provide a copy of the FDA application and manufacturing information as required under 42 U.S.C. § 232(l)(2)(A).  This initial exchange of information sets into motion the patent dance.  The consequences, found in 42 U.S.C. § 232(l)(9)(C), permit the sponsor to bring an immediate declaratory judgment action for patent infringement.  Thus, the Supreme Court found the BPCIA does not require a biosimilar applicant to share its abbreviated biologics application and associated data, and, in the absence of voluntary sharing, a branded biologics developer must use injunctive relief to enforce its patents.  As such, the Supreme Court determined there is no requirement that a biosimilar applicant participate in the patent dance.  However, the Court remanded to the Federal Circuit to determine whether California state law may provide for injunctive relief to enforce 42 U.S.C. § 232(l)(2)(A) based on failure to comply with California’s unfair competition statute.

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