Protecting new treatments and innovations is critical for the drug developers. In this article and its presentation, we provide of an overview of the history of patents, what a patent is, the general process to obtain one today, and some common questions and errors.

What is the origin of the patent?

Patents date back to the 14th century when King Edward II wanted to entice skilled workers from other countries to come to England, teach their skills, and start new industries. Edward II gave the foreign workers letters that protected them and provided them with a monopoly on their trade. These “letters patent” (another name for an open document issued by the government that gives someone rights to something) paved the way for their modern-day namesake: patents.

What is a patent?

A patent is an exclusive right granted by the government (such as the US Patent and Trademark Office, USPTO) for an invention that is new, involves an inventive step, and is capable of industrial application. Contrary to popular belief, patents don’t give you the right to make your product, they just prevent others from making or selling your product. Patents give an inventor the exclusive right to prevent others from making, using, selling, or importing a product or process based on the patented invention without the inventor’s prior permission, such as through a patent license.

A patent’s anatomy includes an abstract, background information, summary of the invention, figures, a “specification” (detailed description about how the invention was made and how it can be used), and the claims (the legal boundaries of protection).

Patent protection is limited to the country or region that it was issued in and limited to a certain amount of time, typically 20 years from the date of patent application filing. Pharmaceutical patents may be extended to compensate for the time spent in review by the US Food and Drug Administration (FDA) or other regulators.

What is patentable?

A patentable invention must be novel, useful, and non-obvious. An invention is defined as a new and inventive solution to a technical problem. Ideas, laws of nature, scientific principles, ‘immoral’ inventions, and human life or its parts aren’t patentable.

In order to be patentable, an invention must have never been publicly disclosed, meaning it was never discussed in a seminar, oral presentation, poster, abstract, paper, or even with your friends or colleagues over a beer.

Once an inventor is granted a patent (and therefore a temporary monopoly over their invention), they must fully disclose enough detail about the invention so that others can understand it. This is the trade-off: patents provide government-backed protection over the monopoly of an invention, but the inventor must fully explain the invention publicly. On the other hand, the inventor could not disclose their invention, but runs the risk of it being unprotected and has a monopoly over it only until the competition figures out how to make it themselves.

How do you apply for a patent?

The process of filing for and being granted a patent can take years. Filing a patent starts with writing a provisional application, which is like a placeholder for the full application that clearly states what the invention is and its limits. Provisional patents don’t need to include specific claims yet (those are included in the full application).

Priority date: Filing a provisional patent is very important because it establishes the “priority date,” or the first date that the patent was filed. This could be crucial if a legal battle erupts between different inventors claiming rights to the same invention or similar inventions; the first patent filed will generally be upheld as it defines what other patents or documents are “prior art,” or what documents and patents already exist prior to that date. The priority date can be thought of as the defining line between old information (prior art) and new information (invention in the patent application).

Once you’ve filed a provisional application, you can say your invention is “patent pending,” meaning you’ve filed an application, but the patent hasn’t been granted yet.

12 Months Later: You must file a full “non-provisional” patent application that includes the full set of claims within 12 months after filing your provisional application. The claims clearly lay out the boundaries of the invention. After filing the full application, you can’t add any additional subject matter (topics or information outside of those specified in the application). Once the full application is filed, the administrative details are reviewed during a formal examination period.

16 Months Later: After publication, the search and substantive examination is conducted where the application is examined to ensure it satisfies the requirements for being patentable. An authorized International Searching Authority (ISA) begins searching for the most relevant prior art documents and compiles them into an International Search Report (ISR).

The patent office also writes a non-binding written opinion on patentability and sends the ISR and opinion letter to the inventor, who can address any objections made and modify the patent application as needed. This iterative process widdles down the scope of the claims to ensure the invention and patent fulfills all patentable criteria.

18 Months Later: During this time, you may also submit the Patent Cooperation Treaty (PCT) application, which allows you to seek patents in 152 countries worldwide (shown on the map) at a later stage in the patent process. The PCT application is published 18 months after the priority date.

22-28 Months Later: If the authority cannot find any prior art (the ISR is negative), the inventor can request an optional International Preliminary Examination to examine the chances of getting the patents granted in the locations being pursued. This is economical because it can give the inventor a better idea of a patents chances before proceeding with the trouble and costs of regional and national examination.

30 Months Later: Once the ISR and opinion letter cycle is complete, the application enters the regional (such as the European Patent Office, EPO) and national (such as the USPTO and Canadian Intellectual Property Office, CIPO) substantive examination phase. This phase is the most expensive because it involves multiple local patent attorneys and business in multiple languages.

More Than 30 Months Later: After the examination phase, the patent office decides whether a patent is granted and published or not. This process varies widely between offices and can take anywhere from a few months to up to five years. If the patent is granted, the inventor must decide which countries the patent will be published in. Each country has its own patent office and translation costs.

Following publication, opposition proceedings allows third parties to voice their opinions where they may oppose the granting of a patent if they think the invention is not new.

Common pharmaceutical patent extensions

There are many different types of pharmaceutical patents, depending on the drug they are protecting. The exclusivity of each patent can be extended by various lengths because drug discovery, validation, and marketing can take more than 10 years.

By extending the patent exclusivity, it encourages companies to study and develop new drugs by derisking the extended time and effort expended during development. This is especially important for drugs in understudied areas, such as rare diseases, antibiotics, and pediatric populations.

Because a large portion (up to 80 percent) of pharmaceutical company’s revenue comes from their patents, they want to extend their patents for as long as possible. Once a patent expires, other companies can manufacture and sell the drug, which is where generic competitors come into play.

Patents for new chemical entities (drugs that contain a portion that has never been FDA-approved) can be extended for five years under the FDA and European Medicines Agency (EMA). Sponsors may also receive up to 11 years of exclusivity for new drugs (eight years of data exclusivity, two years of market exclusivity, and a one-year extension).

Patents for new methods of use (a new use for a drug or drug reformulation via extended-release drug versions, reduced dosing, or increased ease of use) can be extended for three years under the FDA and ten years under the EMA.

Patents for drugs with orphan designation (drugs to treat rare diseases) have an extra seven years of exclusivity on drug sales under the FDA and ten extra years under the EMA.

Patents for drugs with pediatric exclusivity (ones that include pediatric data) can enjoy an additional six months of exclusivity under the FDA and EMA.

Patents for certain new antibiotics can have an extra five years of exclusivity under the FDA.

Common questions about patents and publishing

If you’re considering applying for a patent, you should closely examine the variety of advantages, risks, and alternatives.

There are also a variety of other questions you should ask yourself:

  • Is there a market for the invention?
  • Do the expected profits from an exclusive position in the market justify the costs of patenting?
  • What are the alternatives to your invention and how do they compare?
  • Is the invention useful for improving an existing product or developing a new product? Does it fit with the business strategy?
  • How likely are others, especially competitors, to invent and patent what you have invented?
  • Is it the right time to file an application?

When should you file for a patent? “It’s always too early until it’s too late,” said Alacrita’s consultants. If the competition is thick, filing for a patent early may be crucial as the first-to-file date is dominant when deciding on patent rights – just look at the drama unfolding in the courtroom over CRISPR patents! However, filing a patent too early can turn around to bite the inventor in the butt; if the invention isn’t well fleshed out when the PCT is filed, more subject matter can’t be added to the application, stunting the patent coverage. If you need to withdraw the patent application for any reason, you can do so during the 12-month provisional period, bearing in mind that you will lose the priority date from the provisional patent.

What are the differences between a patent application and a grant or scientific paper? If a patent isn’t the right answer for you, maybe a scientific paper is. While a patent and a grant or scientific paper both discuss novel ideas or entities, they do so in opposing ways. A grant or paper must be an evidence-based, logical, systematic report based on preliminary data that usually speculates about future applications or potential. On the other hand, a patent must be a non-obvious, non-incremental, novel report that no one has done before and does not speculate about future applications or potential (speculation would make those future applications unpatentable!).

When is it safe to publish? Never! There is always a risk when publishing – most novelty-destroying disclosures are made by the inventors themselves! If you’re between provisional application and PCT, you may need to withdraw and re-file, which can’t be done if you’ve published your work in a scientific paper/abstract/poster. Publishing after the PCT can provide ammunition to the Examiner as to why you lack an inventive step because explaining the scientific method in the publication is at odds with the “surprise” element needed to be patentable. After a patent is granted, you may be considering additional patents and don’t want to impact future patents’ novelty. Publication is a strategic issue that balances patent issues and the need to establish credentials through high impact publications.\

 

Navigating the complex world of patents can be challenging. Hopefully this overview is a help with that activity. If we can assist you with anything related to life science patents, please don’t hesitate to contact us.

 

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