Bookcase with numerous foreign languages dictionaries.In IBSA Institut Biochimique v. Teva Pharmaceuticals USA, Inc. a valuable lesson was learned about relying on a translation of a non-English patent application. The IBSA Institut Biochimique (IBSAIB) hired an Italian patent agent to file a patent application in Italian for a thyroid drug formulation. The application was filed in Italy. Within 12 months of filing in Italy, IBSAIB filed a patent application in the United States, citing its Italian patent application under the Paris Convention for Intellectual Property. However, instead of filing the Italian application in the U.S., a poor-quality English translation was filed, and material was added. The translation contained the meaningless term “half-liquid.” Because this term has no established meaning in pharmacology, a district court found the resulting patent to be invalid as indefinite, a finding that was affirmed by the court of appeals.

The Law of Indefiniteness

Section 112 of the Patent Act (as amended by the America Invents Act) requires a minimum level of clarity in the claims of patents. Specifically:

The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.

The courts interpret this section of the act to prohibit claims that are “indefinite.” The Supreme Court further defined this standard in its landmark case of Nautilus v. Biosig: “…we hold that a patent is invalid for indefiniteness if its claims, read in light of the specification delineating the patent, and the prosecution history, fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention.

The IBSAIB Patent

The patent application at issue in this case claimed a drug formulation containing (among other things) “a soft elastic capsule consisting of a shell of gelatin material containing a liquid or half-liquid inner phase comprising said thyroid hormones.” Based on the contents of the patent itself, the testimony of experts, and the contents of scientific texts, the court found that “half-liquid” was not a term whose meaning was reasonably certain. IBSAIB argued that this term should be interpreted to mean “semi-liquid.” It was not disputed that the term “semi-liquid” is an understood term, but the court disagreed that a person skilled in the art would understand “half-liquid” to be synonymous with “semi-liquid.”

IBSAIB’s argument was based in part on the fact that the original Italian patent contained the term “semiliquido,” which properly translates to “semi-liquid” in English. IBSAIB argued that a person trying to interpret the term “half-liquid” would understand that it was meant to be the English translation of “semiliquido” based on the sworn statement by the inventor that the Italian application was cited under the Paris Convention for Intellectual Property. The Paris Convention requires that, when a person applies for a patent in a first country and then in a second country, the second country treat its patent application as having the filing date in the first country, so long as the patent application in the second country is filed within 12 months of that in the first country. An earlier filing date is advantageous for many reasons, so this treaty is widely used.

The Court’s Rebuke

The court was unpersuaded. It reasoned that the Italian and U.S. patents were separate and distinct; although the U.S. patent was largely a translation of the Italian one, it contained additional information as well. There was nothing in the U.S. patent saying that it should be interpreted to be identical as the Italian one, in whole or in part. As a result, the court based its interpretation only on sources that are usually used under U.S. law: the contents of the patent itself, the prosecution history before the USPTO, and the knowledge of persons skilled in the art at the time of filing.

The Lesson on Foreign Filings

While low-quality patent translations abound (and are difficult to detect), IBSAIB’s problems could have been easily avoided. Under U.S. law one may file a patent application in any language, so long as an English translation is filed within a certain time limit. In such a situation the foreign language application is considered the authoritative version, and the translation merely that. As a result, translation errors can be corrected so long as the original non-English documents shows that they are clearly errors. This differs from IBSAIB’s situation, in which the translation itself was filed as the application.

One may also make an explicit statement in the U.S. application that the foreign application is incorporated by reference into the U.S. application. The USPTO officially recognizes that such an explicit statement allows for the correction of translation errors in section 213.02 of the Manual of Patent Examination Procedure. Had IBSAIB included such a statement in its U.S. patent application, it would have had the opportunity to correct translation errors such as the one that sunk its patent.

When a patent application has been drafted in a language other than English, one should not rely on a third-party translator to draft the patent application in the United States. Instead the foreign language application should either be used as the U.S. patent application or explicitly incorporated by reference, in case corrections need to be made or the foreign language application is needed to understand the English claims. Another option is to ask a U.S. patent agent or attorney to draft an application in English from scratch, which may still cite the foreign application for priority if correctly drafted.

We are excited to announce that attorney and Patent 213 blog editor, Nicholas J. Landau, was included in the 2021 edition of The Best Lawyers in America® for Patent Law. Firmwide, seven patent attorneys at Bradley are listed by Best Lawyers. Several of our patent law attorneys also author blog content for Patent 213.

A member of the firm’s Intellectual Property Practice Group and contributing author and editor of the Patent 213 blog, Mr. Landau advises clients in the procurement, protection and litigation of all forms of intellectual property, including patents, trademarks and trade secrets. He is particularly experienced in patent prosecution, having drafted over 150 patent applications in numerous areas of technology. His patent prosecution experience includes multiple successful ex parte appeals. Mr. Landau’s practice also includes the management of large international patent portfolios and coordinating intellectual property strategy at the multinational level. He advises clients on their freedom to operate new products and services in light of the intellectual property rights of others, and how to avoid liability for infringing others’ rights.

Following are the other Bradley attorneys selected by Best Lawyers as “Lawyer of the Year” for Patent Law as well as their additional recognized practice areas:

  • Jeffrey D. Dyess was named Antitrust Law “Lawyer of the Year” in Birmingham. He also is listed for Commercial Litigation, Litigation – Intellectual Property, Litigation – Patent.
  • Stephen H. Hall was named Litigation – Intellectual Property “Lawyer of the Year” in Huntsville. He also is listed for Litigation – Patent, Patent Law and Trademark Law.

The other patent attorneys listed as 2021 Best Lawyers are:

  • Frank M. Caprio (Copyright Law, Litigation – Intellectual Property, Litigation – Patent, Patent Law, Trade Secrets Law, Trademark Law)
  • Angela Holt (Litigation – Intellectual Property, Litigation – Patent)
  • Mark D. Strachan (Litigation – Patent)
  • Phillip E. Walker (Litigation – Intellectual Property, Litigation – Patent, Patent Law, Trademark Law)

We are excited for our attorneys and Patent 213 blog authors on their achievements!

Patenting COVID-19 Tests: Avoiding the Common PitfallsThe impact on human health of the global pandemic of the SARS-CoV-2 virus and the resulting disease termed COVID-19 cannot be overstated. Not since the influenza pandemic of 1918 have so many regions of the world been so acutely impacted by a single pathogen. Society in 2020 has the advantage of a more sophisticated biotechnology industry. Testing is considered crucial in controlling (or at least mitigating) the pandemic, and tests from several companies have become widely available.  However, many of the tests have proven inaccurate, and it is becoming clear that more needs to be invested in validation before tests can be rolled out to the public. It is also becoming clear that this pandemic will persist for months or possibly years — it may even recur periodically like many other communicable diseases. This has created incentives for the development of validated tests for use not only in the immediate future, but possibly for years to come.

The cost of developing and validating diagnostic tests can be efficiently recouped if the test is patented, giving the developer an exclusive market for a finite period. However, one hoping to patent a COVID-19 test must plan to avoid certain foreseeable difficulties inherent in American law in doing so.

Obviousness in the Post-Genomics Age

Under Section 103 of the Patent Act, a patent cannot be obtained if “the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains.” Novelty by itself is not sufficient for patenting. Even an invention that has never existed before can be denied a patent if a judge or a patent examiner deems it to be “obvious.” The American obviousness standard is a vague and subjective standard compared to foreign analogs. This virtually always presents an obstacle to patenting in the United States, and it is a particular concern when it comes to diagnosing COVID-19.

The genome of SARS-CoV-2 has been elucidated and is publicly known, and a great deal has been learned and published about the structural proteins in the virus. Any test that functions just by detecting a sequence in the genome is likely to be considered obvious. The rationale is that a person of ordinary skill would look to sequences in the virus’ genome, determine which are unique to the virus (or at least absent from the human host), and try such sequences as a diagnostic target. The same holds true for structural proteins: If they are known to be part of the virus, it would be obvious to test for them to detect infection in the host. Stated another way, if the analyte is known but has never been used as a diagnostic indicator, it is presumed to be obvious to do so.

However, if it can be shown that testing for a certain target has unexpected advantages compared to other targets, then the test is not obvious. Examples of such advantages can include higher accuracy, higher specificity, less stringent purification steps, etc. In order to obtain a patent, one should be prepared to present evidence of such unexpected advantages, ideally in the patent application itself.

There can be non-obvious aspects of a diagnostic test apart from the analyte. For example, if the invention is a new assay to detect the analyte, or a new instrument to measure the analyte, it does not matter as much that the analyte itself might already be known. However, if the invention is a traditional type of test used on a known analyte (even if for the first time), be prepared to rebut an obviousness challenge.

The Mayo Ban on Patenting Diagnostic Tests

The United States also stands with a small number of countries that consider diagnostic tests as forbidden subject matter for patenting, regardless of how novel or non-obvious. The doctrine (“the Mayo ban”) has been reviewed in numerous earlier blog posts. The Supreme Court has taken the position that any actions that directly result in making a medical diagnosis cannot be patented as a method, because they are nothing more than “laws of nature.” In this case the “law of nature” is that the presence of an analyte is indicative to the presence of the disease. This includes physical steps such as obtaining samples and performing chemical and biochemical tests on the samples.

However, the courts have also opined that including a medical intervention in the method renders it more than just a law of nature. As a result, patents are allowed for combined methods of testing and treatment (or other forms of medical intervention). These usually take the form of a method that involves the act of testing followed by the act of treating if the test has a certain result.

In the context of COVID-19 this poses a specific difficulty: There is only one drug that is thought to be effective to treat the disease, and its effectiveness is still being validated to a great extent. This creates a problem if one tries to draft a patent claim that includes the act of treating COVID-19. A patent can only cover what a person of ordinary skill could successfully make and use based on the state of the art combined with the information in the patent application. It is not clear at present that the disease can be treated given the state of the art.

One possible solution to that dilemma is to claim an intervention that is not limited to treatment or does not include treatment. It could be mere supportive measures. It could be a contagion control measure, such as quarantine. Such measures go beyond simply diagnosing the patient.

Enablement: Are You Sure It Works?

As mentioned above, a requirement for patenting is that evidence must be provided that a person of ordinary skill could make and use the invention (i.e., it is “enabled”). The law allows such evidence to be provided as “paper chemistry” (modelling), in vitro data, animal data, and human trial data. However, the USPTO has a marked preference for animal and human data; they will sometimes accept in vitro results but will infrequently accept paper chemistry models when it comes to methods of medical diagnosis. This poses another problem. Presently there is no universally accepted animal model for COVID-19. A recent review concluded that several animals are permissive of the virus, but none appear to show the same severity of symptoms as humans; this calls into question the applicability of the models to human vaccines and treatments. Of course, human subjects provide the strongest data, but human testing is expensive and time consuming; human data are rarely available at the time a patent application is filed.

It is possible that the USPTO will view in vitro data permissively in light of these acknowledged issues at the present time. However, an accused infringer in court will not, and will take advantage of current limitations in validating COVID-19 tests in animals and humans to argue that patents are invalid because they are not enabled.

Summing Up: Prepare Your Patents Carefully

Under the best of conditions patent procurement can be a long and expensive process. Given the immediate demand for accurate and inexpensive COVID-19 tests and the complicating factors discussed above, patenting COVID-19 tests could be especially challenging unless preparations are made to avoid such challenges. Consideration should be given during the drafting process for ways to avoid rejections for obviousness, banned subject matter, and enablement. A modest amount of effort in the beginning of the process could shorten the patenting process by years and reduce patenting costs by thousands of dollars.