by Adrian Rivera-Reyes
On November 10th, the
Penn Science Policy Group and the Penn Intellectual Property Group at Penn Law
co-hosted a panel discussion focused on intellectual property and how to patent
scientific research. The panel included Peter Cicala, Chief Patent Counsel at
Celgene Corp.; Dr. Dora Mitchell, Director of the UPstart Program at the Penn
Center for Innovation (PCI) Ventures; and Dr. Michael C. Milone, Assistant
Professor of Pathology and Laboratory Medicine at the Hospital of the
University of Pennsylvania (HUP), and Assistant Professor of Cell and Molecular
Biology at Penn Medicine.
The event started with the introduction
of both groups by their respective presidents and was proceeded by Kimberly Li giving
an introduction of the panelists. Next, Peter gave a short PowerPoint
presentation with a general introduction of intellectual property. Below are
some key points to understand intellectual property/patent law 1,2:
1) In general, patents provide a “limited
monopoly” that excludes others from making an invention, using, offering for
sale, selling, or otherwise practicing an invention, but it does not confer
upon the patentee a right to use the said invention. Thus, patents serve as a
form of protection for the owner.
2) A single invention can only be
patented once; once the patent on that invention expires, others may not file
to patent the same invention again.
3) In order to confer a patent,
the United States Patent and Trademark Office ensures that inventions of
patentable subject matter meet the following legal requirements: i) inventions
must be novel, ii) inventions must be useful, and iii) inventions must be
non-obvious.
4) Utility patents only last for
20 years from the date of filing. After 20 years, anyone can make, use, offer
for sale, sell, or practice the invention. A single invention cannot be
re-patented after the time is done. In contrast, trademarks or trade secrets
last forever, and copyrights last for the lifetime of the author.
5) The United States Patent and
Trademark Office follows the ‘first to file’ rule. Thus, the first person or
entity to file a patent is the assumed owner.
6) Patents can be invalidated by
the United States Patent and Trademark Office.
A clever example discussed by
Peter Cicala was the patenting of a new car feature. If X company has submitted
and received a patent for a car and Y company makes a new feature for the car,
they can patent the new feature (as long as it meets the legal requirements
introduced above). Once the patent for the new feature is conferred to Y
company then they can produce that one feature, but not the car that was
patented by X company, unless a license is provided by X company to Y company.
Thus, the patent for Y company only gives them the power to prevent others from
making that new feature.
Conferring Patents in the US and Internationally
First, there has to be an
invention of some sort. Once there is an invention, a patent is filed. Patents
are drafted free-hand, unlike a tax application where one has a specific form
to fill. For patents, one has to start from scratch. Patents are usually long (some
can reach 500 pages in length) and there are many legal requirements on what to
say in the application and how to say it. Eventually, when one files a patent
application it will go to the patent office. A patent examiner will, as the
name suggests, examine it and deliberate with the patent office over the course
of 3-5 years as they point out sections that need further editing,
clarification, or justification. There is a lot of back and forth, until the
examiner agrees that the invention has satisfied the patent requirements. Then,
one pays fees and the patent is awarded. Fun fact: In the US, patents are granted
only on Tuesdays.
On a global basis, one files a
single international patent and the designated patent offices around the world
examine it locally. If an office grants a patent, such patent will only be
valid in that jurisdiction. That is why submitting patents cost so much,
because one files and pays legal fees for each jurisdiction. For example, if a
patent is filed in Japan for a compound, a different entity can manufacture the
compound freely in the US, but not in Japan. This is one reason why companies
and universities are very careful when filing patents.
Intellectual Property in Industry
Pharmaceutical products start
with a great idea, but for every product in the market there are about 10,000
that fail. Therefore, companies file many patents even though many of those
patents may not have any commercial value in 5-6 years. It costs about $500K to
file (including filing and attorneys’ fees) and receive a single issued patent,
which means companies spend a lot in patents (i.e. 10,000 patent submissions
each worth $500K)! Out of those 10,000 patents, typically one will make the
company about an estimated $5 billion a year in returns.
A student asked, “Is submitting a
patent the same price for a university as it is for a company?” In essence, no!
The patent office makes a distinction between large and small entities. Small
entities, based on requirements provided by the patent office3, pay
half the fees, but attorneys charge a fixed price. In the end, small entities
save just a small percentage of money. Another question asked by an audience
member was “what is patentable in the pharma business?” If one patents a
molecule, no one else can infringe or use that molecule itself. That is how
companies patent drugs or their associated components. One can also patent
dosing regimens, formulations, modes of administration, etc. The compound claim gives the most protection, because it is
very hard to make a knock-off of a molecule.
Intellectual Property in Academia
A student raised the issue that
there is a lot of communication that occurs in science, especially at
conferences, symposia, or amongst colleagues, classmates, etc. That seems to be a big risk in the context of protecting one's
intellectual property, but doing so is an unavoidable risk when one does
scientific research.
Dora, patent analyst from PCI
Ventures, then proceeded to discuss the issues brought up from an academic
perspective. She said, “The question raised here is that when one works in an
academic institution the work is knowledge based and disseminated to others....
How does one draw the line from all that to protect something valuable?” What
most, if not all, academic/research institution do is have their lawyers work
very closely with faculty, so that anytime they are about to publish a paper,
go to a conference, attend grand rounds, or any other such public appearance,
the lawyers will hustle and get an application submitted before such events.
In addition to these more public
forums, problems can arise from talking with friends who are not directly
associated with the work. An example of this pertains to OPDIVO®, a drug
patented by Ono Pharmaceuticals and the Kyoto University in the 90’s, which
later was exclusively licensed to Bristol-Myers Squibb who launched the drug. Recently,
Dana Farber Cancer Institute sued Ono Pharmaceuticals and Bristol-Myers Squibb
because the principal investigator at Kyoto University had periodically consulted
a colleague at Dana Farber for his advice. The professor-consultant at Dana
Farber would send some data he thought was helpful and consult with them. Dana
Farber sued both companies, claiming that the now-retired professor from its
institution should be included as an inventor in the patent. Because an
inventor of a patent is part-owner, Dana Farber is actually claiming ownership
of the patent and will receive compensation from the sales of products under
the patent4,5.
Michael, Penn Med professor who
works intimately with a team of lawyers from PCI because he regularly files
patents, said that balancing confidentiality with science communication is a
difficult task. He commented, “I think it comes down to how important one thinks
the invention is and a lot of the times the patent will not get developed if it
will not bring any money to the owner (company/institution).” Moreover, there
has to be a conversation with the university because the university pays for
the patent, so it decides what to file. It also depends on the resources of the
university. Regarding the work of graduate students or postdoctoral fellows,
there are more considerations. Students and postdocs want and need to publish,
go to conferences, and present their work in order to move forward with their
careers; thus patents can be a rather limiting step for them.
From the industry perspective, Peter
clarified that the rule at Celgene is that no one can talk about anything until
the patent application is filed. Once the patent application is filed,
employees are free to talk to whomever they wish without causing a situation
like the one with Dana Farber and Bristol-Myers Squibb, since the patent
application has been filed prior to any communication.
Thus, a clear difference between
industry and academia is that in industry, things are kept under wraps and then
a patent is filed, whereas in academia patents are filed early to make sure
that the institution does not lose the rights of patenting by making the
information public. Because universities file very early, there is a lot to
deal with afterwards. The costs of prosecution are high, and sometimes the
application does not make it through the full process, because universities
cannot afford to throw $500K for an application if they are not confident on
getting a return on the investment. The reason to file for some universities might
be purely strategic.
Ownership vs. Inventorship
Another interesting topic
discussed, was that of ownership vs. inventorship. There is the notion that
ownership follows inventorship. In most cases, people do not file patents on
their own; they work for companies or universities. Usually, an employment
contract will state that if an employee invents something while employed by
that entity, then ownership to a resultant patent will be assigned to the
employer. Thus, the person is the inventor but not the owner of the patent; the
entity is the owner. For academic research, the Bayh-Dole act was enacted to
allow universities to own inventions that came from investigations funded by
the federal government6. Dora explained that, “Government officials
got together and agreed that they awarded so much money into research and good
stuff came out of it, which the government would own but not file patents or do
anything with it commercially."
A preliminary list of inventors
is written when the patent is filed, but legally the inventors are the people
that can point to a claim and say: "I thought of that one." Inventors
have to swear under oath that they thought of a particular claim, and need to
be able to present their notebooks with the data supporting a claim of
inventorship. Inventors are undivided part-owners of the patent, which means
that any inventor listed in the patent can license that patent in any way,
without accounting for any of the other inventors. Additionally, there is a
difference between the people that think about the claims and the people that
actually execute the subject matter of the resulting claim. If a person is only
executing experiments without contributing intellectually to the idea or
procedure, then that person is not an inventor. For those in academic research,
this often differs from how paper authorship is decided – usually performing an
experiment is sufficient.
Summary
The discussion prompted the
researchers in the room to be on the lookout for ideas they have that can
result in patents, and to be careful when discussing data and results with
people outside of their own research laboratory. Also, the discussion exposed
key differences between intellectual property lawyers working for universities
and industries, as opposed to law firms that have departments working on
intellectual property. Ultimately, students felt they gained a basic
understanding on how intellectual property works, the rules to file patents,
and some intrinsic differences between academic and industry research.
References:
1) United States Patent and
Trademark Office – (n.d.) Retrieved December 11, 2016 from https://www.uspto.gov/patents-getting-started/general-information-concerning-patents
2) BITLAW – (n.d.) Retrieved
December 11, 2016 from http://www.bitlaw.com/patent/requirements.html
3) United States Patent and
Trademark Office – (n.d.) Retrieved December 20, 2016 from https://www.uspto.gov/web/offices/pac/mpep/s2550.html
4) Bloomberg BNA – (2015, October
2) Retrieved December 11, 2016 FROM https://www.bna.com/dana-farber-says-n57982059025/
5) United States District Court
(District Court of Massachusetts). http://www.dana-farber.org/uploadedFiles/Library/newsroom/news-releases/2015/dana-farber-inventorship-complaint.pdf
6) National Institute of Health,
Office of Extramural Research – (2013, July 1) Retrieved December 11, 2016 from
https://grants.nih.gov/grants/bayh-dole.htm
Is a policy without enforcement really a policy, or is it just an aspiration? That question has been on my mind lately, in two different contexts, both related to the air we breathe. First, there’s Penn’s new “Tobacco-free Campus” policy. I first noticed the signs in November, when they quietly popped up here and there around campus. As someone who has spent many a lunch hour going from bench to bench all around campus in an often-vain attempt to find a place to sit and eat my lunch without having to breathe second-hand smoke, I was really excited to see those signs. But I confess I was much less excited when I went online and read the actual policy, particularly the section on enforcement. You can read it here. 
