Patent Primer

UNeMed Map Patentability Avenue
Patents are documented rights granted by the government that give the owner the power to prevent others from using the invention. Below is additional information.

Why patent?
The short answer is that a patent gives an invention the best chance to reach the most people. That might sound counterintuitive because a patent is, in essence, a legal monopoly to restrict others. But the founders built that gem into the U.S. Constitution for good reasons, not the least of which is allowing an inventor enough opportunity to recover costs, and perhaps even profit from the fruits of their labor and ingenuity.

Then, after about 20 years, a patent’s legal protection goes away. The invention—requisitely described in mundane detail in the publicly accessible patent—becomes the property of anyone who has the means or inclination to build it. Even if imperfect, it’s a clever system that all at once protects, encourages and disseminates innovation.

The notion of ownership in academic biomedical research is a thorny one. Presumably, most researchers pursue future cures, treatments and medical devices for nothing less than noble purposes. They want to help those who need it most. They want to cure the incurable. They want to demystify the unknown.

A patent, it would seem, flies in the face of those noble aims. Biomedical discovery and innovations should be shared with the world, should they not? Yes, in a perfect world.

But in our less-than-perfect world, it can take more than a billion dollars to develop a new discovery into a new treatment. That development only happens if the technology is properly protected, giving the developer the opportunity to at least recover that jaw-dropping expense.

What that usually means for UNeMed and our inventors is finding an industrial partner who can pay for the needed development in exchange for certain rights to use the patented invention. (It should be noted that all patents UNeMed secures are on the behalf of, and owned by, the University of Nebraska Board of Regents.)

Without a patent, it’s exceedingly rare to see a novel technology go much further than the pages of an academic journal. The patent, however, encourages industrial partnerships that finance additional development and discovery. That alone should be reason enough.

No detail is too small when determining who should—or should not—be listed among a patent’s inventors. An error at this stage can later invalidate an issued patent.

To be a listed inventor on a patent, the individual must have contributed something in the way of an idea, concept or feature on the invention. Even if a friend, colleague or associate contributed large amounts of time and energy in support of the work, if they didn’t conceive of the idea or contribute some small intellectual part of it, then they cannot be listed as an inventor.

No matter the size of the intellectual contribution, all contributions are viewed as equal in the eyes of the U.S. Patent and Trademark Office. There is no special importance attached to who is listed first or last. It’s UNeMed’s practice to list the inventors in the same order as they are listed on the New Invention Notification form.

At the earliest stages we also must determine if a new technology meets the USPTO’s criteria for a patent, which has nothing to do with the scientific value of the invention. Even if an invention does not meet patent criteria, it still may represent a significant contribution to science.

Determining patentability can be accomplished by asking three questions:

  1. Is it new?
  2. Is it useful?
  3. Is it non-obvious?

A new, or novel, invention must be different in some way from all other ideas that have already been publicly disclosed in any form. The invention must perform a useful function and somehow benefit society. And the invention can’t be merely an obvious improvement to existing technologies in the eyes of those knowledgeable in the area.

Though these may seem like simple questions, they are serious and require extensive research. A lack of thoroughness at this point could amount to a costly mistake. If the USPTO rejects a patent application because it did not meet one or more of those three criteria, UNeMed will have squandered somewhere between $12,000 and $22,000.

Publications greatly impact the novelty and non-obviousness factors of patentability. It may be impossible to patent an invention if different publications so much as mention each of the separate elements of an invention. It doesn’t matter if the mention appeared in the most widely read journals or the most obscure of niche publications.

Even an earlier public disclosure from the inventor can prohibit a patent. U.S. patent law allows for patenting an invention up to one year after disclosure, but nearly all foreign countries prohibit patenting once a public disclosure has occurred. Losing the ability to protect an invention overseas can make an invention less attractive to potential industrial partners.

Types of Patents
The overwhelming majority of UNMC inventions are filed as utility patents, which cover new and useful processes, machines, articles of manufacture or compositions of matter. The two remaining categories for U.S. patents are plant and design. Plant patents cover new, asexual plant varieties, and design patents cover the appearance of an article for manufacture.
Provisional Patent Applications
Provisional patent applications are less costly, but they have only a one-year lifespan and are never prosecuted or issued as full patents. They essentially act as a protective placeholder while notifying the Patent Office an invention. The provisional application allows the inventor more time to gather important data, if needed, and build a more robust patent application. The protection a provisional provides also allows UNeMed to open discussions with potential partners without the risk of damaging an invention’s patentability. These early discussions play a crucial role in gaining a better understanding on the marketability and patentability of a new invention.
Foreign Patents
Patents are territorial, meaning a US patent only provides rights in the US and a Chinese patent only provides rights in China. For world-wide patent coverage, one would have to secure a patent in every country in the world. There is one major difference between U.S. patent law and most other countries in that it provides a one-year grace period to seek patent protection after public disclosure of an invention. Most other countries consider all rights lost immediately after a public disclosure.
Patent Cooperation Treaty
Most countries participate in the World Intellectual Property Organization and its Patent Cooperation Treaty application, or PCT. The application process provides some insight about an invention’s patentability before committing financial resources to filing costly individual patent applications in numerous countries. Additionally, the PCT application process provides additional time for forming relationships with industrial partners before the expensive patent fees are due for filing patent applications in multiple countries.
Patent Process
The process of obtaining a U.S. patent for a biomedical or biotech invention is a long road, lasting anywhere from three to seven years. After the patent application has been filed, it might be 2-4 years before the USPTO reviews the applications. It will take another 1-3 years of back-and-forth with the USPTO before a patent will be issued.

Once issued, a U.S. utility patent expires 20 years after its earliest, non-provisional priority date, but there are extensions available to offset any USPTO delays. However, the patent holder must pay maintenance fees, 3.5, 7.5 or 11.5 years after the patent issues to keep the patent alive for its full term.

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