Stuart R. Gallant, MD, PhD

When I think of patent law, I am reminded of a line from the play A Man for All Seasons.  Discussing the thickets of English law, Sir Thomas More asks Will Roper rhetorically, “And when the last law was down, and the Devil turned round on you where would you hide, Roper, the laws all being flat?”

Patent law provides protection to all of us:  patients, doctors, pharmaceutical companies, investors, and taxpayers.  Without patent protection, a generic company could undercut prices of an innovative pharmaceutical company as soon as a new drug appeared in the pharmacy.  This loss of protection would immediately dry up investment capital and prevent the development of novel, safe, and effective medical treatments.

With that motivation, this post is devoted to patent strategy for innovative pharmaceutical treatments.

Elements of a Patent

To be patentable, an invention must have certain elements:

• Novelty:  The invention cannot have been made public in a journal article, another patent, a presentation, or other communication.  The Europeans are famously fastidious about novelty.  In theory, in Europe, a design for a new boat would not be patentable if the inventor took the boat to a local lake to test the design prior to filing a patent if there were other people present at the lake who saw the invention.
• Non-Obviousness:  There needs to be an inventive step.  The non-obviousness standard is more of a judgement call than the novelty standard.  A person skilled in the art covered by the patent (chemistry, biology, etc.) should not feel that the invention is obvious.
  • The European approach is to examine the two to three closest prior art documents (publications, patents, etc.) and determine if they include the technical features of the invention, as well as the suggestion of how to combine the technical features to create the invention.
  • I know a lawyer who always asks, “What is counterintuitive about this invention?”  I think he feels that, if he can show that a skilled scientist would think the opposite of what is represented in a patent application, he is pretty far along in showing non-obviousness.
• Utility:  The invention needs to provide a tangible benefit to the practitioner.  However, this standard is region specific, so reference should be made to national and regional patent regulations.  For pharmaceuticals, utility is rarely at issue; however, there are limitations on what aspects of analytical methods can be patented in Europe, for example.

An invention is described using lists of prior art, text describing how the invention works, drawings and other exhibits, and a list of claims.  The claims describe what aspects of the invention are to be protected.  Some guidelines for writing claims are:

• It is desirable to make the claims as broad as possible without reaching into prior art.  The claims should be like carpet, covering the entire floor, but stopping at the walls formed by prior publications and patents.
• Developing patent portfolio is based on dividing and grouping claims as appropriate.  Often pharmaceutical companies end up filing several related patents.  USPTO allows 3 independent claims and 20 total claims to a patent.
• Consider what other patents the company would like to file in the future.  It is not desirable to have the company’s first patent form prior art preventing other patents from being filed.  Talk to counsel about filing these further patents prior to the initial patent becoming public.

Intellectual Property Challenges and Defense

The photo below is an African elephant in Rwanda.  You may wonder what an elephant has to do with patent strategy.  In Africa, when confronted with an intruder, elephants often engage in mock charges—they square up on intruder, run forward, then halt while trumpeting, flapping their ears, and sometimes throwing dirt into the air with their trunks.  It’s quite an intimidating sight, but the goal is to avoid combat, rather than engage in it.

Litigation, like fighting lions on the African savannah, can be a costly and bloody business.  A patent portfolio is designed as a kind of threat display, aimed at deterring a courtroom fight.  The effectiveness of the deterrence depends on a number of factors:

• The types of claims in the patent(s) and how they protect the invention.
• The number of patents owed by the inventor.  It’s sad but true that a single patent won’t usually deter a determined infringer.
• The patent environment.  Does a potential infringer have access to other patents and prior art in this area of intellectual property?  It’s also sad but true that some infringers arrive second to a particular area of intellectual property, but they successfully blanket the area with their own patents, ensuring eventual success for their strategy of infringement.
• The determination and resources of the patent owners to defend their intellectual property.

There is a curve of intellectual property risk represented by the following graph:

In the early phase of development, a company operates based on stealth.  Patent applications have been filed, but the information is not public.  Potential competitors are unaware of the claims, and the risk of patent litigation is low.  As patent claims become public, the risk of litigation rises.  A significant aspect of this risk is that startup companies have a small group of investors with limited financial commitment to the company.  So, funds may not be readily available to mount a vigorous defense.  Eventually, with demonstrated clinical success, a pharmaceutical startup typically partners with deep-pocketed investors and funds become available to protect the company’s intellectual property from potential competitors—so the risk of patent litigation goes down.

Patent Timeline

Keeping with the theme of providing the maximum intellectual property at the minimum expense, here is a list of items to consider in defending a pharmaceutical invention.  The perspective is that of a small US startup pharmaceutical company:

• Year 0:
  • File provisional patent in US; best to file as soon as possible—patent review focuses on the date of first filing.  There is a $150 filing fee, and if the company never files the full patent application, the details of the provisional never become public.
• Year 1:
  • In Year 1, at least one patent application will be filed:  1) a US patent application, or 2) a foreign patent application claiming priority, or 3) a PCT (Patent Cooperation Treaty) application.  The USPTO offers this idealized timeline for PCT application [1]:

• PCT covers multiple jurisdictions, including the US, and pushes some of the significant costs down the road a bit.
  • The advantages of filing first in the US are:  1) the applicant will work through the patent issues with US patent examiners, 2) the applicant may be able to file later for PCT (discuss this option with US patent counsel to ensure no PCT dates are missed)—may already have US patent by that time.  Typically, there are initial rejections in foreign countries (figures, lack of clarity, prior art…).  Working through this in US allows foreign applications to move forward more smoothly.
  • The advantages of filing with PCT are:  1) PCT does a search and report at the time of filing which may be a useful adjunct to the prior art search performed by the applicant, 2) By filing with PCT, the process of review for other jurisdictions is begun—which puts the applicant closer to approval in those countries.  The applicant is still obligated to file in the individual countries—most PCT countries require filing at 28 to 32 months.
  • An applicant is not obligated to perform a prior art search, but it greatly behooves the applicant to include relevant prior art in the application.  Having prior art out in the open allows claims to be adjusted early on, rather than being invalidated later.

Patent Families

Pharmaceutical patents commonly fall into the following families:

• Active Ingredient Manufacture:
  • Focus of active ingredient manufacturing patents is often on challenges, such as high purity or production at large scale, which are critical to the success of the drug, but may be difficult for rival firms to achieve without using the particular technical solutions claimed in the patent.
  • Unfortunately, manufacturing patents are the easiest pharmaceutical patents to skirt because there are often ways of achieving the same synthetic result by using altered or alternative conditions.  Nevertheless, manufacturing patents have value by ensuring that the applicant has freedom to operate using its own technology that it invented.
  • The balance between what the applicant choses to protect by patent, versus by maintaining as trade secret, is part of the overall intellectual property strategy.
• Drug Product:
  • The identity, enantiomer, composition, formulation, crystal form, and method of manufacture of the drug product are important intellectual property of the company.
  • The company may consider patenting formulation conditions and methods of drug product manufacture that it has evaluated but chosen not to adopt or formulations that it plans to use in second-generation and third generation drug products.
  • Mode of administration, container closure, and other drug product features which include aspects of novelty and non-obviousness should also be considered.
• Indication(s) and Dosing Regime(s):
  • Therapeutic indication is an example where prior art can be challenging.  If the applicant cites a particular indication in an initial patent, that may qualify as prior art, preventing a subsequent patent for the use of the drug in that indication.  Considering the entire patent portfolio early on is important to avoid such clashes.
  • Dosing regime should be protected.  If there is prior art to be taken into account, consideration should be given to whether the dose is non-obvious (e.g., much lower or higher than prior art suggests would be the correct dose).
  • Given the rapid improvement of medical diagnostics, claims related to subcategories of patients (“patients with X condition, positive for Y gene”) are important to consider.
  • Combination treatments with other agents should be protected.  It is commonly necessary to show a synergistic effect (a stronger effect than would be predicted based on the known effects of the individual agents alone).

Given that intellectual property strategy involves so many diverse aspects of pharmaceutical operations, good communications between IP counsel and all the areas of the company (Management, CMC, Pre-Clinical, Clinical, and Marketing) is critical.  With careful IP planning and good luck in the clinic, a company’s new drug may eventually be able to help patients, their families, and society.

[1] USPTO.  “1842 Basic Flow Under the PCT [R-10.2019],” accessed Sept. 2022.

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