Timing the filing of an inter partes review for companies in the early stage of developing a biosimilar product should be carefully considered based on the recent Federal Circuit case, Momenta Pharmaceuticals, Inc. v Bristol-Myers Squibb Co., Appeal No. 2017-1694 (February 7, 2019). Momenta filed an IPR before the PTAB to challenge the validity of a BMS patent covering Orencia® (abatacept) while in its Phase I trials for its own biosimilar product. The PTAB instituted review, conducted trial, and sustained the validity of the BMS patent claims. During this period, however, Momenta’s own product failed its Phase I trials and subsequently decided to terminate its pursuit of the biosimilar to the abatacept product at that time. As an Article III court, the Federal Circuit held that Momenta’s decision to no longer pursue its biosimilar product rendered its standing to appeal the PTAB’s decision moot as there was no judiciable injury. Nevertheless, the question of when to file an IPR remains largely unanswered for a biosimilar manufacturer. Given the expense, duration, and uncertainty of getting approval, biosimilar companies will want to retain its right to appeal an adverse IPR decision. In contrast, an adverse IPR decision for the brand company is retained regardless of the status of the biosimilar. While the Court did not specifically address whether Momenta could have met its standing requirement if it remained actively pursuing its biosimilar, it is clear that the position of brand vs. biosimilar companies vastly contrast as the amici clearly established in this case.  According to BIO and PhRMA, the earliest time for a biosimilar company to have standing is upon the filing of its Biologics Licensing Application under the Biologics Price Competition and Innovation Act. Irrespective of the holding of Momenta, timing the filing of an IPR by a biosimilar company is a decision that may be best addressed by future cases that are directly on point.

The FDA Reauthorization Act of 2017 (FDARA) created a new type of 180-day exclusivity for ANDA applicants applying for approval of certain drugs designated as Competitive Generic Therapies. The FDARA, according to FDA commissioner, Scott Gottlieb, “is part of our broader effort to foster generic competition and help address the high cost of drugs […] key step in making safe and effective generic drugs available to patients quickly and ensuring there’s adequate competition so patients have affordable access to the treatments they need.” Continue Reading Teva Sues FDA Alleging Unlawful Interpretation of the Definition of “First Applicant”

The test for patentable subject matter under Section 101 lies at the heart of patent system. However, very little guidance is provided in the actual statutory language. It comes as no surprise that the “seemingly’ simple provision of patent eligible subject matter has caused a great deal of confusion among inventors, patent attorneys, district court judges, and even the Justices on the U.S. Supreme Court.

Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.

Continue Reading USPTO Director Proposes New Patent Eligibility Guidance

Indian tribes ability to shield patents from review at the United States Patent and Trademark Office’s (“USPTO”) Patent Trial and Appeal Board (“PTAB”) took another blow at the Federal Circuit.  The Federal Circuit in a precedential decision, affirming the decision of the PTAB, held that tribal sovereign immunity cannot be asserted in inter partes review (“IPR”) proceedings before the PTAB.[1]

The Federal Circuit based the decision on two principles extrapolated from Supreme Court decisions.  First, the general proposition that “immunity does not apply where the federal government acting through an agency engages in an investigative action or pursues an adjudicatory agency action.”[2]  Second, the Supreme Court’s recognized distinction between adjudicative proceedings brought by a private party against a state, on the one hand, and federal agency-initiated enforcement proceedings, on the other.  According to the Federal Circuit, immunity may generally be invoked in the private party actions, but not in the federal agency-initiated enforcement proceedings. Continue Reading Tribal Immunity Cannot Be Asserted to Escape IPR Proceedings

On June 25, 2018, the Food and Drug Administration (“FDA”) approved Epidiolex (cannabidiol), the first marijuana derived drug for use in the United States, to treat two rare forms of epilepsy. This decision for the FDA could have sweeping effects for the marijuana industry. While the FDA has previously approved drugs comprising synthetic (manufactured) cannabinoids, this is the first FDA approved drug comprised of an active ingredient derived from marijuana. Even with FDA approval, further action is required before Epidiolex can enter the market in the United States.

Epidiolex will be the first pharmaceutical form of the cannabinoid cannabidiol, or “CBD.” CBD is a chemical component of the Cannabis sativa plant commonly known as marijuana. Unlike tetrahydrocannabinol or “THC” (a different and highly discussed cannabinoid found in marijuana), CBD is not known to have psychoactive affects. However, because CBD derived from marijuana is considered part of the marijuana plant, it is currently listed as a Schedule I controlled substance and illegal for all uses in the United States.

The Drug Enforcement Administration (“DEA”) must reclassify CBD in order for Epidiolex to be cleared to enter the market in the United States. This process will likely take months and is currently the topic of much speculation. There are five schedules for controlled substances and each controlled substance is scheduled based on whether there is a current acceptable medical use in the United States, their relative abuse potential, and the likelihood of causing dependence when abused. Schedule I drugs have no accepted medical use. Thus, CBD’s classification as such is clearly contrary to the FDA’s recent decision. It is unclear how the DEA will reschedule CBD or if it will expand reclassification to include the entire marijuana plant (this latter option is highly unlikely).

Once Epidiolex enters the market, it may be prescribed beyond the few FDA approved uses. Epidiolex has been approved for the treatment of two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome. Doctors, however, generally have the ability to prescribe drugs for unapproved, or “off-label” use. The FDA has generally accepted such procedures for various reasons.

While Epidiolex’s approval is significant, FDA Commissioner Scott Gottlieb made clear in a press release that it is not an approval of marijuana or all of its components. That said, the federal government, through the FDA, has now officially recognized that there are some medical benefits to the marijuana plant, suggesting that there is a path forward leading to the legalization of marijuana at the federal level for healthy, medical-based use of marijuana. Of course, such use has been backed by thorough research, which is essential to any future approvals of similar or new marijuana derived products. In sum, as a result of the FDA’s decision, we are likely to see the DEA reclassify CBD, which may pave the way for more developments and subsequent approval of products with CBD.

The U.S. Patent and Trademark Office (“USPTO”) has renewed the hopes of applicants looking to patent method of treatment claims. A recent memo from the USPTO (the “Memo”) provides guidance on method of treatment claims, suggesting that when correctly drafted, such claims should generally be considered patent eligible subject matter.

The Memo comes in direct response to the Federal Circuit’s decision in Vanda v. West-Ward, issued on April 13, 2018. In Vanda, the Court, inter alia, distinguished certain method of treatment claims as patent eligible from those deemed ineligible by the Supreme Court in the infamous Mayo decision in 2012. The Court in Vanda found that the method of treatment claims at issue passed the first prong of the Mayo test, i.e., they were not directed to patent ineligible subject matter, and thus the claims did not need to be analyzed for an inventive concept under the second prong. To support its decision, the Vanda panel highlighted the specificity of the claims at issue:

At bottom, the claims here are directed to a specific method of treatment for specific patients using a specific compound at specific doses to achieve a specific outcome. They are different from Mayo. They recite more than the natural relationship between CYP2D6 metabolizer genotype and the risk of QTc prolongation. Instead, they recite a method of treating patients based on this relationship that makes iloperidone safer by lowering the risk of QTc prolongation. Accordingly, the claims are patent eligible.

For the reader’s convenience, an illustration from the USPTO on the Mayo test is reproduced to the left and a side-by-side comparison of the claim terms in Vanda and Mayo is set forth in the table below.

In analyzing the Vanda decision, the memo highlights three points:

  • First, claims should be evaluated as a whole. Thus, a claim should not be deemed patent ineligible simply because a claim requires a conventional step.
  • Second, patent eligible claims apply a natural relationship rather than claim such a relationship. For example, the claims in Mayo were deemed to be “directed to” the natural relationships of how the body interacts with certain drugs – “[a] method of optimizing therapeutic efficacy” – while the claims in Vanda apply a natural relationship through specific actions to treat a specific disease – “[a] method for treating a patient with iloperidone, [for treating] schizophrenia” and lowering adverse risks of such treatment.
  • Third, if a method of treatment claim is patent eligible under the first prong, of the Mayo test, the Court should not further proceed to the second prong of the Mayo test, i.e., analyzing the claims for something “more,” also known as the illusive “inventive concept.”.

With respect to the second point above, the Memo further explained that correctly drafted claims claim the application of a natural relationship rather than being directed to The Memo highlighted the order of the “primary steps” of “determining” the natural relationship then “administering” a specific quantity to “treat a particular disease.” A rule of thumb thus could be whether the following can be stated after reading a method of treatment claim: “The claim is directed to a method of using _______ [drug] to treat _______ [condition] comprising the following steps . . .”

The claims in Mayo, however, administered a drug and then analyzed the body’s natural reaction in order to provide advice on whether to increase or decrease dosage. In contrast, the claims in Vanda first determined the body’s natural reaction to a drug, then administered the drug in a specific dosage range to treat a particular disease.

While the Memo and the Vanda case signal good news for patentees, there is still a chance, as there always is with the Federal Circuit and the Supreme Court, that future decision may change these interpretations yet again. The Vanda decision was not unanimous. Chief Judge Prost of the Federal Circuit dissenting in Vanda believes that the claims were merely “drafting efforts designed to monopolize the law of nature itself.” According to Chief Judge Prost, “[t]he fact that a reduction of iloperidone dosage in poor metabolizers to the [sic] may reduce QTc prolongation is both the means and the ends of this claim..” A petition for rehearing en banc is currently pending before the Federal Circuit; a Supreme Court petition will likely follow.

Mayo: US Patent 6,355,623
Vanda: US Patent 8,586,610
1. A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:

(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and

(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,

wherein the level of 6-thioguanine less than about 230 pmol per 8×108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and

wherein the level of 6-thioguanine greater than about 400 pmol per 8×108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

1. A method for treating a patient with iloperidone, wherein the patient is suffering from schizophrenia, the method comprising the steps of:

determining whether the patient is a CYP2D6 poor metabolizer by:

obtaining or having obtained a biological sample from the patient;


performing or having performed a genotyping assay on the biological sample to determine if the patient has a CYP2D6 poor metabolizer genotype; and

if the patient has a CYP2D6 poor metabolizer genotype, then internally administering iloperidone to the patient in an amount of 12 mg/day or less, and

if the patient does not have a CYP2D6 poor metabolizer genotype, then internally administering iloperidone to the patient in an amount that is greater than 12 mg/day, up to 24 mg/day,

wherein a risk of QTc prolongation for a patient having a CYP2D6 poor metabolizer genotype is lower following the internal administration of 12 mg/day or less than it would be if the iloperidone were administered in an amount of greater than 12 mg/day, up to 24 mg/day.

Per Senator Orrin Hatch, the America Invents Act has disrupted the “careful balance” he struck with Senator Waxman in the development of the decades-old Hatch-Waxman Act governing the adjudication of generic drug litigation. On June 13, 2018, Senator Hatch filed an amendment in the Senate Judiciary Committee to remedy the perceived conflict between the “carefully calibrated requirements” of Abbreviated New Drug Application (“ANDA”) litigation under the Hatch-Waxman Act and the “much blunter instrument” of post-grant proceedings before the United States Patent Trial and Appeal (“PTAB”).   According to Senator Hatch, the amendment “will ensure that Hatch-Waxman continues to operate as originally intended by protecting the ability of generic drug companies to develop low-cost drugs while at the same time ensuring brand-name companies have sufficient protections in place to recoup their investments.”  A press release of Senator Hatch’s remarks is available here.

The “Hatch-Waxman Integrity Act” by Senator Hatch is an amendment to the Creating and Restoring Equal Access to Equivalent Samples Act (CREATES Act), legislation designed to help generic drug companies acquire the samples they need to develop generic drugs, particularly for products subject to a risk evaluation and mitigation strategy (“REMS”). The CREATES Act advanced to the Senate from the Judiciary Committee on June 14, 2018, and was been placed on the Senate Legislative Calendar on June 21, 2018.

The Amendment would add to the CREATES Act a section entitled “Preventing the Inter Partes Review Process for Challenging Patents from Diminishing Competition in the Pharmaceutical Industry and with Respect to Drug Innovation; Preventing the Manipulative and Deceptive Use of Inter Partes Review.” The section has three parts and targets both generic drug manufacturers and biosimilar companies.

In the first portion of the Amendment, an ANDA applicant must certify that they have not and will not file an Inter Partes Review (“IPR”) or Post-Grant Review (“PGR”) or forfeit the ability to participate in the Hatch-Waxman litigation procedures.  Additionally, the ANDA applicants must certify that they are not relying in whole or in part on any decision reached by the PTAB in an IPR or PGR proceeding.

Second, the Amendment forces a similar choice for biosimilar applicants.  Those who file an abbreviated Biologics License Application (“aBLA”) must decide, with respect to any patent that is or could be included in the lists of patents that are exchanged as part of the “Patent Dance,” whether to challenge patents in an IPR/PGR or take the path outlined in the Biologics Price Competition and Innovation Act (“BPCIA”).

Third, the Amendment aims to end certain market practices and appears to apply broadly to all parties filing for post grant proceedings. To “prevent[] the Manipulative and Deceptive Use of Inter Partes Review,” the Hatch-Waxman Integrity Act amends the Securities Exchange Act of 1934 to address market manipulation tied to inter partes review petitions, such as that attempted by the Coalition for Affordable Drugs.  Specifically, “a person shall be considered to be using a manipulative or deceptive device” if they file a petition for an IPR and engage in a short sale of any publicly traded security of the owner of the patent at issue in the IPR for the 90 days before and after the filing of the petition.

We will continue to monitor the CREATES Act and the Hatch-Waxman Integrity Act in the future. For more information, please feel free to contact Jamaica Potts Szeliga at any time.

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.


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