Protecting the Vaccine

By: Dr. Dariush Adli

The devastating impact and disruptive effect of the COVID-19 pandemic on the world economy has prompted an unprecedented drive by pharmaceutical companies, universities, physicians, research institutions and health care professionals in search of vaccines and medical treatments for the illness.  Already, two pharmaceutical companies, Pfizer and BioNtech have concluded Phase 3 studies of a Covid-19 vaccine.

Existing and proposed COVID-19 treatments range from vaccines to medications that may help patients at certain stages of the illness. The treatments may be used  alone or in combination with other medications, and administrative and intervention measures. For example, recently, an antibody cocktail made by the company Regeneron made news when President Trump’s doctors used it to treat the President during his bout with COVID-19.[1]  The U.S. Food and Drug Administration (FDA) authorized use of Remdesivir, an antiviral drug[2] for treatment of those with severe COVID-19 symptoms.  Dexamethasone, a common steroid, has been shown to help patients on ventilators when administered in low doses[3].  Some studies suggest that Hydroxychloroquine, which has long been used to treat malaria, helps patients with mild cases of COVID-19[4].  Another study, combined Hydroxychloroquine with Azithromycin Z-pack and found that it cleared most patients of symptoms in 8 days[5].

Against a backdrop of government coordination and encouragement, much of the effort for finding treatments is funded by private capital, although some of the efforts involve government funding.  Patent protection, and the exclusivity it provides, could deliver a strong incentive for investment in this area. Therefore, a question by many potential investors may question the extent to which the treatments would be eligible for patent protection, or another form of intellectual property protection.

Patents are issued for useful, new and non-obvious inventions. This gives rise to an initial question for COVID treatments is that, as noted above, many of the existing and proposed treatments for COVID-19 involve commonly known medications and medical administration and intervention steps and processes, used for treating other illnesses and health conditions.  Fortunately for investors and the public, patent law provides that “a new combination of steps in a process may be patentable even though all the constituents of the combination were well known and in common use before the combination was made.”[6] Even if a particular combination is known and long used for a particular purpose, its new use, e.g., for COVID treatment, can still be patent protectable.  For example, a court ruled that “Bag Balm,” a product previously used to soften the udders of cows could be protected by a patent when used in an application to the human scalp to promote hair growth and combat baldness[7].

Further, most of the world requires “absolute novelty” for patent protection, which would require that patent protection be sought before an invention is publicly disclosed or used publicly.  However, the U.S. and a handful of other countries allow a grace period for filing patent applications on inventions that have been publicly disclosed for less than a year.  Therefore, treatment methods completed and currently used can still benefit from U.S. patent protection, so long as they have not been publicly disclosed or in public use for more than a year.[8]

 

Basic Requirements of U.S. Patent Law

 U.S. patent law allows patent protection for a “new and useful process, machine, manufacture, or composition of matter.”[9] Once an application is received, the U.S. Patent and Trademark Office (USPTO) appoints an examiner to evaluate and examine the application for compliance with the required criteria for grant of a patent.[10]  Whether an invention falls within a category of patentable subject matter is discussed at greater length later in this article.  Otherwise, the three basic criteria of patentability are: utility, novelty and non-obviousness.  The utility requirement evaluates an invention for specificity and practicality. i.e., that the invention not directed to an abstract idea and have a practical application. The novelty aspect looks into whether the invention is new.  Finally, non-obviousness involves an inquiry into existence of meaning, explainable differences between the invention and what came before it.[11]  Patent law grants owners exclusive ownership of their patented invention for a limited period of time.  A utility patent is valid and enforceable for some 20 years after the initial, non-provisional patent application is filed.[12] An extension of this term may be available, particularly for medical inventions that are delayed from use during evaluation and approval by the FDA.[13]

 

Patents are available in many areas of science, technology and general know-how, including electrical systems and electronics, mechanical devices, software, chemistry, biotech, methods of manufacturing and pharmaceuticals.[14]  With regard to medical treatments, patent protection is available for inventive products and methods that may or may not include an active chemical ingredient or include such ingredient as a component of the treatment. For example, with regard to treatment of an illness, a drug, a method of using the drug, a method and procedure of administering the drug, a method of manufacturing the drug, and a method for testing and diagnosis are all patentable if they meet the basic patentability requirements.[15]

 

Aiming to encourage innovation, patent law gives a patent owner the exclusive right to make, use, sell, and import the patented invention in the United States.[16] The patent owner may choose to exclusively use the invention, to assign or license the owner’s patent rights to others, or to not use it at all.[17]

 

Yet, being on the forefront of COVID prevention and treatment does not provide immunity from patent disputes. Earlier, this past November, Regeneron, alongside vaccine developers Pfizer and BioNTech have found themselves defending a patent infringement lawsuit brought by the company Allele Biotechnology and Pharmaceuticals, claiming that their coronavirus products infringe upon Allele’s patent.  In particular, Allele charges that Pfizer and BioNTech’s COVID-19 vaccine BNT162, and Regeneron’s REGN-COV2, were developed using Allele’s mNeonGreen fluorescent protein without the company’s permission.[18]

 

Pfizer and other companies working on a COVID-19 vaccine are expected to file their own patent applications on their vaccines. Such a vaccine is not, however, entirely new.  Back in 1990, Pfizer filed for a patent entitled “universal Coronavirus vaccine” directed at protecting animals from the coronavirus.  According to the patent description: “The present invention relates to a universal vaccine useful to protect different species of animals against infection by different host-specific coronaviruses.”[19] Another coronavirus patent, issued to Phoenix Biotechnology, Inc. in August, 2020 is entitled “method and compositions for treating coronavirus infection.”[20] Yet another patent, issued in June, 2020 to the University of Miami, “relates to test kits and methods for detecting the presence of coronavirus polynucleotides in a biological sample.”[21]  In 2014, prior to the onset of COVID-19, a patent application prophetically described “methods of treating coronavirus infection,” and has now yielded a patent for the University of Maryland.”[22] Another patent, issued to Molecular Rebar Design, LLC in September, 2020 is directed to a mask for preventing spread of the coronavirus.[23]

Choice of Invention Protection Between Trade Secret and Patent Protection

 

As with patents, trade secrets are a type of intellectual property, capable of protecting valuable inventions as well as sensitive and valuable information.  To qualify for trade secret protection, the information needs to meet the following criteria.  First, is must not generally be known or readily obtainable from legally available sources; next, the trade secret needs to have some economic value.  Finally, for information to be eligible for trade secret protection it must be guarded and protected as a secret.

Patents are different from trade secrets in that they require public disclosure of the invention and enjoy a limited life, usually 20 years from the filing date of the application.  Trade secrets are not publicly disclosed and can be protected so long as they are protected as a secret.  A well-known example of a trade secret is the Coca Cola formula, which has been famously and successfully protected as a trade secret for over 130 years.[24]

 Traditionally, trade secret law in the U.S. is largely based on the Uniform Trade Secrets Act, which has been adopted by all states in very similar, but not identical form and content. The California trade secret statute, codified in section 3426 of the Civil Code, includes the available remedies and required procedures in trade secret litigation.[25]  Despite relative uniformity, the UTSA does differ from state to state as to certain aspects such as the definition of trade secret, remedies available and statute of limitations.  In addition, absent diversity jurisdiction, the UTSA does not provide the option of litigating disputes in federal court.  That situation changed in in 2016, with the enactment of a federal trade secret statute, known as the Defend Trade Secrets Act (DTSA).  Without preempting state laws, the DTSA provides a uniform statute to be applied nationwide in federal court.

The DTSA contains a broad definition of trade secret, as: “all forms and types of financial, business, scientific, technical, economic, or engineering information, including patterns, plans, compilations, program devices, formulas, designs, prototypes, methods, techniques, processes, procedures, programs, or codes, whether tangible or intangible, and whether or how stored, compiled, or memorialized physically, electronically, graphically, photographically, or in writing if (A) the owner thereof has taken reasonable measures to keep such information secret; and (B) the information derives independent economic value, actual or potential, from not being generally known to, and not being readily ascertainable through proper means by, another person who can obtain economic value from the disclosure or use of the information.”[26]

 Medical methods of treatment frequently involve a combination of commonly known medications, medical administration, and intervention steps and processes, some of which have been public knowledge and in use treating illnesses and health conditions.  Nevertheless, case law makes clear that “A trade secret can exist in a combination of characteristics and components, each of which, by itself, is in the public domain, but the unified process, design and operation of which, in unique combination, affords a competitive advantage and is a protectable secret.”[27]  An additional argument raised against trade secret protection for such medical methods of treatment is that even though the steps may not have been specifically known, the concepts for these measures were known.  However, courts have rejected this ground for disallowing trade secret protection to medical methods.  For example, a process of developing viral vaccine was found to be a trade secret even though the theoretical concepts were known.[28]  Another court decision found a process for production of a poultry vaccine to be trade secret eligible even though the individual elements of the process were known.  The court found that the combination production process was unique and unknown to industry competitors.[29]  Courts have stated that trade secret protection is available for “practical problem solving” methods and techniques.[30]  Trade secret protection is even available to a process when the secret could have been learned from public sources. Therefore, a trade secret appropriator can’t necessarily defend against a misappropriation charge just by showing that the information learned is somewhere “published”[31]

Trade secret protection does not require registration or approval by a government office.  Patents, on the other hand, require examination and approval by the USPTO.  Therefore, trade secret protection is broader than patent protection and includes not only patent protectable inventions, but also formulas, programs, methods, processes, devices and techniques, which may not pass scrutiny at the patent office.  Secrecy is the hallmark of trade secret protection, and a trade secret loses its status as soon as the information is no longer a secret, including when someone legally reverse engineers the trade secret or independently derives it from legally available sources. In contrast, patents are protected even if someone does arrive at the patented invention independently or uses the invention without knowledge of the patent.

 

Subject Matter Eligibility Challenges to Patent Protection for Medical Methods of Treatment

A key hurdle to securing patent protection for medical methods of treatment is subject matter eligibility.  Section 35 U.S.C. §101 of the patent code, as interpreted by the Supreme Court, excludes laws of nature, natural phenomena, and abstract ideas from eligibility for patent protection[32]. Medical methods of treatments are subject to scrutiny for subject matter eligibility under this standard because, at their core, they generally concern the human body’s natural reaction to the treatments.  However, the law provides that although laws of nature, natural phenomena, and abstract ideas are ineligible for patent protection by themselves, certain applications of these otherwise unprotectable subject matters can be eligible for patent protection.[33]

In Alice[34] the Supreme Court confirmed a two-step process for determining subject matter eligibility for patent protection.  First, the claims are to be evaluated to determine if they are directed to an ineligible subject matter, i.e., laws of nature, abstract ideas or natural phenomenon.  If not, then the invention satisfies the subject matter eligibility test.  However, even an invention, which is found to be directed to an ineligible subject matter, may still qualify for patent protection if it exhibits an inventive concept.[35]  In that regard, the inquiry focuses on whether there are additional elements present in the claim, which include an “inventive concept” thus rendering the claim patent-eligible.[36]

Likewise, courts have scrutinized medical treatment methods under the Supreme Court’s two step test. As discussed below, properly described and claimed medical treatment methods can pass the subject matter eligibility requirements of section 101.

 

Concern With Preemption

 

One rationale for evaluating subject matter eligibility is the desire to avoid potential to inhibit further innovation by improperly tying up the future use of laws of nature. Thus, in Morse[37] the Supreme Court set aside as unpatentable Samuel Morse’s broad claim for “the use of the motive power of the electric or galvanic current … however developed, for making or printing intelligible characters, letters, or signs, at any distances,” explaining that such a broad claim would inhibit progress of science by covering other methods of “writing or printing at a distance.”[38]

With respect to medical treatment methods, the Supreme Court in Mayo[39] stated that although the patent claims at issue were directed to narrow laws that may have limited applications, they “tell a treating doctor to measure metabolite levels and to consider the resulting measurements in light of the statistical relationships they describe. In doing so, they tie up the doctor’s subsequent treatment decision whether that treatment does, or does not, change in light of the inference he has drawn using the correlations. And they threaten to inhibit the development of more refined treatment recommendations that combine Prometheus’ correlations with later discovered features of metabolites, human physiology or individual patient characteristics. The “determining” step too is set forth in highly general language covering all processes that make use of the correlations after measuring metabolites, including later discovered processes that measure metabolite levels in new ways.”

The Court concluded: “We need not, and do not, now decide whether were the steps at issue here less conventional, these features of the claims would prove sufficient to invalidate them. For here, as we have said, the steps add nothing of significance to the natural laws themselves. Unlike, say, a typical patent on a new drug or a new way of using an existing drug, the patent claims do not confine their reach to particular applications of those laws. The presence here of the basic underlying concern that these patents tie up too much future use of laws of nature simply reinforces our conclusion that the processes described in the patents are not patent eligible, while eliminating any temptation to depart from case law precedent.[40]

 

Treatment Methods, Which Include a Treatment Step Based on Screening Criteria are Patent Eligible


A review of cases decided since Alice shows that medical methods, which include treatment steps based on certain screening criteria are usually found to be subject matter eligible for patent protection.

In Vanda[41] the Federal Circuit Court of Appeal found that a medical dosage regimen based on results of genetic testing was subject matter eligible for patent protection.  The inventive method in Vanda concerned treating schizophrenic patients with a certain drug, with a dosage measure determined based on results of a genetic test.  The claim at issue recited steps of determining the patient’s metabolizer genotype and administering specific dose ranges of the drug depending on the genotype to treat the patient.  The court pointed out that the invention was patent eligible because it was not directed to a natural phenomenon of merely recognizing the underlying relationships revealed by the genetic testing, but rather to a method of using a drug in specific doses, based on the test results for treatment purposes.[42]

Likewise, the Federal Circuit found that an invention directed to use of beta-alanine, an amino acid, as a dietary supplement in a certain dose range, for increasing athletic anaerobic working capacity, passed the section 101 eligibility test of the patent law. [43] The decision explained that the invention was directed to administering certain quantities of beta-alanine to trigger increased production of creatine, which, in turn, increases the working capacity for athletes engaged in intensive exercise.[44]

 

Diagnostic Method Without Medical Treatment Steps are not Patent Eligible


In contrast, decisions since Alice generally show that patent claims that are limited to diagnostic steps, without any form of medical treatment steps, are not subject matter eligible for patent protection.

For example, the court found that an invention concerning a prenatal screening to determine the risk of Down’s syndrome in fetus to not be patent eligible[45].  The patent claims at issue recited the steps of measuring the level of a screening  marker  from  a  first  trimester  of  pregnancy, measuring the level of a second screening marker from a second trimester of   pregnancy, and  determining  the  risk  of  Down’s  syndrome  by  comparing  the  measured  levels  of  the  first  and the second screenings markers.[46]  The court found the invention was not subject matter eligible because it was directed to a law of nature, explaining that the finding of an increased risk of fetal Down’s syndrome producing certain analytical results is a natural process, that “exists in principle  apart  from any human action.”[47] The decision found the “measuring” steps to be insufficient to make the claims patent eligible as they merely inform of the process to measure the screening markers through known methods. Likewise, the court found the “determining” step to be insufficient to make the claims patent eligible as it was merely a mental step.[48]

Likewise, the Supreme Court found that process claims concerning the correlation between blood levels of a drug and optimal dosages of that drug not to be eligible for patent protection[49]. The claim at issue recited administering a certain drug, determining the level of the drug metabolite, and utilizing the determined metabolite level for dose adjustment for treatment purposes. The decision found the correlation between an effective dose of the compound, which, in turn, produced a certain range of metabolite concentrations, to be the result of the natural metabolic process, and patent ineligible as it was not directed to treating patients.[50]

Also, the Federal Circuit found that the medical treatment method involving treatment of infants suffering from low levels of oxygen in their tissue, with nitric oxide gas to be subject matter ineligible for patent protection[51]. The treatment was based on the discovery that babies suffering from this condition who also had a congenital heart condition, were at an increased risk of swelling of lung tissue due to excessive liquid when treated with a certain gas.[52] The claim recited the steps of identifying patients who suffer from low oxygen levels in their tissue, screening the candidates for the heart condition and excluding them from gas treatment.  The Federal Circuit found that by withholding treatment, the claim allowed the body to take its natural course, rendering the claim to be directed to a natural phenomenon and thus ineligible for patent protection.[53]

 

Conclusion:

Potential COVID-19 vaccines and treatment methods, including those which are in the development and testing phase, as well as those existing and in use, as long as they have not been publicly disclosed for more than a year, can benefit from patent protection if described and claimed properly in the patent application.  Trade secret protection is an alternative for securing intellectual property protection for such methods.

 

[1] https://www.washingtonpost.com/health/2020/11/21/regeneron-fda-clearance

[2] https://www.fda.gov/media/137565/download

[3] Dexamethasone in Hospitalized Patients with Covid-19 — Preliminary Report; The New England Journal of Medicine, July 17, 2020; https://www.nejm.org/doi/full/10.1056/NEJMoa2021436

[4] Can Hydroxychloroquine and Chloroquine Be Used to Treat Coronavirus (COVID-19)?, https://www.goodrx.com/blog/coronavirus-medicine-chloroquine-hydroxychloroquine-as-covid19-treatment

[5] Hydroxychloroquine-Azithromycin and COVID-19;  https://www.mediterranee-infection.com/wp-content/uploads/2020/03/COVID-IHU-2-1.pdf

[6] Diamond v. Diehr, 450 U.S. 175, 187 (1981)

[7] In re Cortright, 165 F.3d 1353, 1356 (Fed. Cir. 1999)

[8] See, 35 USC 102(a) and (b).

[9] 35 U.S.C. §§ 101, 111.

[10] Id. § 131

[11] Id. §§ 101, 102-103, 112

[12] 35 U.S.C. § 151, 153

[13] Utility and plant patents issuing on applications filed on or after May 29, 2000 are eligible for the patent term adjustment provisions of 35 U.S.C. 154(b)(effective May 29, 2000 and amended thereafter) and 37 CFR 1.702 -1.705. See MPEP §§ 2710 and 2730

[14] Patent Technology Centers Management, U.S. PATENT & TRADEMARK OFFICE, https://www.uspto.gov/patent/contact-patents/patent-technology-centers-management

[15] Id.

[16] 35 U.S.C. § 271(a).

[17] See, e.g., Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 730 (2002) (characterizing patents as a “temporary monopoly”)

[18] https://www.reuters.com/article/health-allele/regeneron-pfizer-sued-for-patent-infringement-over-covid-antibody-cocktail-vaccine-idUSL1N2GW267

[19] EP0640096A1

[20] U.S. Patent Appl. No. 10,729,735, Newman,  et al., August 4, 2020

[21] U.S. Patent No. 10,689,716, Daunert , et al. June 23, 2020

[22] U.S. Patent Appl. No. 10,434,116, Frieman , et al., October 8, 2019

[23] U.S. Patent Appl. No. 10,757,988, Swogger , et al. September 1, 2020

[24] https://www.coca-colacompany.com/company

[25]  https://leginfo.legislature.ca.gov/faces/codes_displayText.xhtml?lawCode=CIV&division=4.&title=5.&part=1.&chapter=&article

[26] 18 U.S. Code § 1836

[27] Imperial Chem Indus. Ltd. v. National Distillers Chem. Corp. 342 F.2d 737, 742 (2d Cir. 1965)

[28] Merck v. Smithkline Beecham Pharm. Co., No. C.A. 15443-NC, at *15-17 (Del. Ch. 1999)

[29] Salsbury Labs, Inc. v. Merieux Labs, Inc., 735 F. Supp. 1555, 1569 (M.D. Ga. 1989)

[30] In Monovis, Inc. v. Aquino, 905 F. Supp. 1205 (W.D.N.Y. 1994),

[31] Merck Co. v. Smithkline Beecham Pharm. (Del. Ch., Aug. 5, 1999, C. A. No. 15443-NC) [pp. 1]

[32] Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208, 216 (2014)

[33] Id.

[34] Id.

[35] Id. at 217-218

[36] Alice 134 S.Ct. 2347, 2355 (2014) (quoting Mayo, 566 U.S. at 72–73, 75–79, 132 S.Ct. 1289 )

[37] O’Reilly v. Morse, 15 How. 62, 112–120, 14 L.Ed. 601 (1854)

[38] Id., at 113

[39] Mayo Collaborative Servs. v. Prometheus Labs., Inc. (2012) 566 U.S. 66, 85-87

[40] Id.

[41] Vanda Pharm. Inc. v. W.-Ward Pharm. Int’l Ltd., 887 F.3d 1117 (Fed. Cir. 2018)

[42] Id.

[43] Nat. Alternatives Int’l, Inc. v. Creative Compounds, LLC, 918 F.3d 1338 (Fed. Cir. 2019)

[44] Id.

[45] PerkinElmer, Inc. v. Intema Ltd., 496 F. App’x 65, 71 (Fed. Cir. 2012)

[46] Id.

[47] Id.

[48] Id.

[49] Mayo v. Prometheus, 566 U.S. 66, 74–75 (2012)

[50] Id.

[51] INO Therapeutics LLC v. Praxair Distribution Inc., 782 F. App’x 1001 (Fed. Cir. 2019)

[52] Id.

[53] Id.