COVID-19 and Pharmaceutical Patent Law

With the COVID-19 pandemic being an issue that is impossible to ignore in recent months, it comes as little surprise that the race to develop a treatment or a vaccine for this virus is at the forefront of the minds of many innovators.

As individuals, companies, universities and governments across the globe strive to develop treatments and vaccines, several questions loom. If someone does develop a successful vaccine, should they be able to patent it? Or, should the formula be made publicly available around the world to allow even the planet’s poorest citizens to have immediate access to it?

While this debate remains at least partially theoretical in advance of the development of a successful treatment or a vaccine, this is an excellent time to examine pharmaceutical patent laws and their effect on the availability of medical treatments and vaccines.

What Is Pharmaceutical Patent Law?

Many people aren’t aware that new drugs frequently are patented by their creators. This means that the company that developed the drug has the right to prevent their competitors from making an identical product, and this means that the patent owner has reserved the right to earn profits from the formula to himself.

Eventually, all patents expire. At this time, which typically is after approximately 20 years, it becomes possible for other drug companies, including those that produce generic versions of medications, to make these drugs and perhaps offer them at a fraction of the price for which the patent owner was selling it.

Pharmaceutical patents are important to companies because it is risky and expensive for these companies to develop new drugs. Years of research, development and testing may be required, and the exclusive period of being able to claim the profits from sales of that drug help the company to recoup its expenses and turn a tidy profit. Moreover, the patent owner has the option of licensing their rights to other companies, which also can signal enhanced profits.

The downside pharmaceutical patents is that sometimes these drugs are incredibly expensive when they are under patent. Accordingly, people with limited financial means may not be able to afford access to critical medications.

If a treatment or vaccine could save lives, is it right to restrict the manufacture of this medicine to a single innovator or to charge a premium price for it?

Pharmaceutical Patent Law in a Pandemic

Over the years, large pharmaceutical firms have used a variety of more-or-less nefarious schemes in an attempt to extend their exclusive hold over patented drugs. With powerful government lobbying departments, they have sought to prohibit or minimize the manufacture of generic drugs.

Observers are concerned that if a major pharmaceutical company does develop a COVID-19 vaccine, that it will do everything it can to complicate access to it. The problem becomes more complex if more than one treatment or vaccine is developed. Then, there may be competing concerns that will make it even harder to dispense effective medicines to the world’s population.

This is why NGOs and certain pharmaceutical companies, along with biotech communities, are pledging to make public the results of their research and development into the treatment and prevention of the coronavirus. Accordingly, such drugs would be provided inexpensively or even at no cost to people around the world.

Similarly, the World Health Organization is lobbying to make research, treatments and vaccines publicly available, while some countries are proposing limited patent rights for treatments and vaccines that include mandatory licensing.

Vaccine Patent Law

Most of the vaccines that are recommended by medical professionals are far older than the typical 20-year term of a U.S. utility patent. This means that they are no longer subject to patent protection. Accordingly, they can be safely and effectively manufactured by a variety of companies without any of these companies running afoul of another’s patent rights.

However, if the currently hypothetical coronavirus vaccine is developed, should the inventor have the right to patent it? Some parties argue that the developer should have the exclusive right to profit from their achievement while others are convinced that the vaccine should be made publicly available to all.

Currently, various efforts are underway to make the vaccine available for the good of the world’s population. Time will tell if these efforts, and the effort to develop a vaccine, are successful.

If you are an inventor or entrepreneur with an innovative idea, then it makes sense to take essential steps to protect your work. Contact the Williams IP Law for an initial consultation to explore your options.

How COVID-19 in Shaping Patent Law and Important Changes

As the Coronavirus spreads across the globe, scientists realized that this was an unknown virus. The medical tools that might be used to detect, treat and prevent it don’t exist.

Developing new tests and treatments requires time and money. Moreover, it’s necessary for these innovations to be tested and attain approval from the FDA or other agencies.

Here’s a look at some of the patent-related efforts that are underway to fight COVID-19.

What is the Facilitating Innovation to Fight Coronavirus Act?

Recently, a bill was drafted in the U.S. Its goal is removing barriers to inventing medical interventions that may be able to prevent or treat COVID-19.

Legal analysts tend to agree that the proposed legislation is a hodgepodge of laudable ideas and unintended consequences. The proposed act contains two sections, the first of which protects individuals from liability lawsuits arising from Coronavirus treatments.

The second section suspends the patent rights of certain medical products and provides a 10-year patent term extension beginning after the pandemic.

Analysts tend to see little problem with the first section, but the second one is causing concern. Critics feel that it’s just too vague. Biomedical firms heavily invest in new products. They bear these expenses because of the exclusivity that’s granted to them through a patent, which means that they may recoup their costs.

Unfortunately, the proposed legislation is too vague about how a new patent application that covers relevant technology would be treated. Does the clock on its term not start until the end of the pandemic, and then is the patent eligible for an additional 10 years?

If the law passes as written, it would mean that the inventors no longer had “exclusive” rights, which is one of the primary reasons why patents are pursued. Moreover, inventors would have to worry about infringing actions occurring at a time when they should enjoy perfect exclusivity.

How will patent owners re-establish exclusivity when the pandemic is over? The invention will have entered the public domain, making this a potentially impossible task.

Hopefully, this bill will be clarified before being adopted.

Patent Protections and Relaxation During the Pandemic

The relaxation of patent protections is occurring around the world In Israel, the government wants to made use of Abbvie’s drug known as Kaletra to treat COVID-19, but there isn’t enough of it in the country. Abbvie held patents in several countries for Kaletra, many of which have which expired.

Their Israeli patent is still in force, so that government is looking at obtaining generic Kaletra from another country, such as India, where the patent has expired.

In response, Abbvie announced that they would cease patent enforcement with regard to Kaletra, paving a cooperative way forward.

This approach makes sense in the case of a drug that’s near the end of its patentable life. Nonetheless, it’s vital that governments always consult with patent holders before looking for ways around their rights.

Lengthening Patent Terms and its Effect on Innovators

Governments are seeking to prevent innovators from profiteering from Coronavirus. They mainly are accomplishing this by passing legislation that allows them to produce any patented item that might help in the fight.

The U.S. government’s approach is different. The Coronavirus-relief bills provide billions of dollars’ worth of public research money to federal agencies to develop treatments and vaccines. Is it ethical for a government agency to receive an additional 10-year patent term on life-saving treatments or vaccines that should be freely available?

Many critics don’t think so, citing the stance taken by Jonas Salk when he developed the polio vaccine. Salk declared that his innovation needed to be owned by the public, and people say that the same approach should apply here.

Will the thought of not having the exclusive right to profit from a vaccine or treatment stop innovators? It’s possible, but there’s hope that an altruistic spirit will motivate the right inventors to find a cure.

COVID-19 Innovations & Keeping Your IP Safe

Despite the current uncertainty with regard to patent protection for Coronavirus-related technologies, it’s wise to seek patent protection. With shortages of items like face masks and medicines, there’s a proliferation of adulterated or counterfeit goods. Pursuing a patent gives you the right to prevent this.

In the spirit of cooperation, educational institutions, government agencies and biomedical firms are pledging to make their COVID-19 research freely available without enforcing patent rights. Whether your invention helps to stop the pandemic or not, contact Williams IP Law to discuss how to protect your IP.