COVID/Intellectual Property

Pfizer and BioNTech recently asked the Southern District of California to dismiss a patent infringement claim from Allele Biotechnology related to Pfizer and BioNTech’s Covid-19 vaccine.

Allele holds a patent for a fluorescent protein called mNeonGreen, which causes some cells to glow when exposed to certain kinds of light.  Allele does not claim that mNeonGreen is used in the vaccine or was used by Pfizer and BioNTech to develop the vaccine, but rather that mNeonGreen is used in one of the clinical tests to detect the presence of antibodies in a patient that was given the Covid-19 vaccine.  A third party created a pseudo Covid-19 virus containing mNeonGreen, which then introduced to a sample of a patient’s blood cells.  If the patient has no antibodies to Covid-19, the pseudo virus will infect the blood cells and the cells will fluoresce, allowing the detection of the virus.  No fluorescence means that the cells were not infected with the virus, and that the patient therefore has antibodies to Covid-19.

Allele claims that mNeonGreen was used repeatedly throughout Pfizer and BioNTech’s vaccine trials and was referenced multiple times in their Emergency Use Application to the FDA.  At the same time, Allele filed suit against Regeneron, the maker of an experimental antibody cocktail found to be successful in treating Covid-19 (and was famously given to President Trump just days before Allele filed suit against Regeneron).  Allele claims that its product was infringed by both the antibody cocktail and the vaccine.

Pfizer and BioNTech argue that they fall within the safe harbor in 35 U.S.C. 271(e)(1), which allows the use of patented inventions for “uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs….”  Citing Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 671 (1990), Pfizer and BioNTech claim that they are permitted to “engage in otherwise infringing activities necessary to obtain regulatory approval,” including under their Emergency Use Application to the FDA.  Because Pfizer and BioNTech used mNeonGreen only in the context of clinical trials to asses the presence of Covid-19 antibodies, Pfizer and BioNTech argue that they fall within the safe harbor provision of the statute.

The hearing on Pfizer and BioNTech’s motion to dismiss is set for May 3.  Given the high stakes of the Covid-19 testing and vaccine market, it will certainly be closely watched.

The United States Patent and Trademark Office has established a new program for prioritized examination for patent applications for inventions related to COVID-19 and for trademark applications for marks used for certain medical products and services used in connection with COVID-19.

On May 7, 2020, the Director of the PTO announced the program for patent applications.  The program applies to products and processes related to the COVID-19 pandemic, specifically, to those subject to FDA approval for COVID-19 use, including investigational new drug applications, investigational device exemptions, new drug applications, biologics license applications, pre-market approvals, and emergency use authorizations.

To participate in the program, the patent applicant must be a small or micro entity.  The fees typically charged by the PTO for prioritized examination will be waived for qualifying patent applications.  If the patent application qualifies, the PTO will examine the application and reach a final determination within 12 months, and, in some cases, within six months.  The patent application program is limited to the first 500 applications, although the program may be extended.

On June 15, 2020, the Director of the PTO announced a similar PTO program for trademark applications.  The program applies to marks for a product or service that is subject to FDA approval for COVID-19 use or a medical or medical research service for the prevention or treatment of COVID-19.  An applicant must file a petition to qualify for the prioritized examination.  The PTO will waive the fees for these petitions.

According to the Director, the goal of the prioritized examination programs is to “help to bring important and possibly life-saving treatments to market more quickly.”

And we can all hope for that!

On March 31, 2020, the U.S. Patent and Trademark Office announced that, pursuant to the Coronavirus Aid, Relief, and Economic Security Act, certain deadlines for patent and trademark applications would be extended.  The CARES Act authorizes the PTO to toll, waive, or modify any patent or trademark deadline in effect during the COVID-19 emergency.  The announcements were made in written Notices of Waiver, one each for patents and trademarks, posted on the PTO’s website.

In order to exercise the power under the CARES Act, the PTO Director must determine that the COVID-19 pandemic materially affects the functioning of the PTO; prejudices the rights of patent applicants, trademark registrants, or patent/trademark owners; or prevents patent applicants, trademark registrants, or patent/trademark owners from making a filing or paying a fee in the PTO.

The President declared a national emergency on March 13, 2020.  The PTO Director has determined that the emergency has prejudiced the rights of applicants, registrants, and owners, and has prevented applicants,  registrants, and owners from making filings and paying fees in the PTO.  The Director has found that “the spread of the virus has significantly disrupted the operations of numerous businesses, law firms, and inventors.”  The Director specifically noted that small businesses and independent inventors are especially likely to face difficulties.

The Director has extended for 30 days certain patent deadlines that were due between March 27, 2020 and April 30, 2020.  The deadlines include the due dates for replying to a PTO notice or office action; paying a patent issue fee or maintenance fee; filing a trademark statement of use or affidavit of use; filing a notice of opposition; and filing a notice of appeal, appeal brief, or reply brief.

In order to obtain an extension under these provisions, the applicant/registrant/owner must file a statement that the delay was due to the COVID-19 pandemic.  The statement may properly be submitted if the applicant/registrant/owner, attorney, or other person associated with the filing was personally affected by the COVID-19 pandemic, such as because of office closure, inaccessibility of documents, cash flow problems, or illness.

Applicants/registrants/owners may also request that the PTO, PTAB, or TTAB grant extensions of other deadlines that are not covered in the Notices of Waiver.

At this time, the PTO’s offices are closed to the public, but are open for the filing of documents and payment of fees, and the examiners are continuing to work.  Filings and fee payments maybe made as usual, by the PTO’s electronic filing system, U.S. mail, fax, or hand delivery.   However, the Director has noted that these practices could change.

The U.S. Copyright Office has also similarly extended deadlines under the same authority.

It is possible that the PTO may further extend deadlines beyond May 30.  Any further extensions are expected to be announced on the PTO website.

Call me a pessimist, but it was surprising to me when I recently checked the USPTO trademark database that I did not find an application to register “Social Distancing” for some other novelty item.  (It is also surprising that the tag #socialdistancing has only 159,000 uses on Instagram.) Nevertheless, I am sure some entrepreneurs will use it on a t-shirt or coffee mug, file a trademark application for “Social Distancing” and then try to prohibit others from using the term.  Chances are, however, that this entrepreneur will not be successful.

The trademark examiner assigned to an application to register SOCIAL DISTANCING will likely refuse registration because it fails to function as a trademark because it merely conveys an informational message. Where a term is merely informational, the context of its use in the marketplace would cause consumers to perceive the term as merely conveying an informational message, and not a means to identify and distinguish goods/services from those of others.

A “trademark” is a word, name, symbol, or device, or any combination thereof used by a manufacturer or merchant to identify their goods and distinguish them from goods manufactured or sold by others, and to indicate the source of manufacturer’s or merchant’s goods. Determining whether a term or slogan functions as a trademark depends on how it would be perceived by the relevant public.

Under trademark law, “widely used messages” fail to function as a trademark. A “widely used message would include slogans, terms, and phrases used by various parties to convey ordinary or familiar concepts or sentiments, as well as social, political, religious, or similar informational messages that are in common use or are otherwise generally understood. The more a term or phrase is commonly used in everyday speech, the less likely consumers will perceive the term as a trademark.

Some examples of proposed marks that have been denied registration on the grounds of being merely information or a widely used message are: ITS TACO TUESDAY for clothing, I LOVE YOU for jewelry, BLACK LIVES MATTER for a wide variety of goods and services, THINK GREEN for products advertised to be recyclable and to promote energy conservation, and DRIVE SAFELY for automobiles.

The trademark examiner would contend that the proposed mark, SOCIAL DISTANCING, merely conveys an expression of support for the ideas embodied in the message, that maintaining a certain distance between individuals is a measure people can take to slow the rapid spread of the coronavirus, as opposed to rather than an indicator of a single source of goods or services. In support of the refusal to register, the trademark examiner would introduce evidence from the CDC and other sources discussing the benefits of social distancing in slowing down the spread of coronavirus.

So feel free to use #socialdistancing on your favorite social media platform to highlight your contribution as a thoughtful and considerate member of society as we deal with these most interesting times.