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Kevin DeJong (Senior Editor) and Shweta Kumar (Editor) from the
Big Molecule Watch recently interviewed Rachel Goode, Ph.D. to
discuss an article she recently co-authored, “Biological
patent thickets and delayed access to biosimilars, an American
problem.”1 The article, published in the Journal of
Law and the Biosciences, examines whether patent thickets covering
biological drugs are responsible for delayed biosimilar market
entry.
Dr. Goode currently serves as Senior Vice President of Legal and
Intellectual Property, Biosimilars at Fresenius Kabi, a global
health care and pharmaceutical company. The views expressed herein
do not necessarily reflect the views or policies of Goodwin or the
Big Molecule Watch, and do not necessarily reflect the official
policy or position of Fresenius Kabi.
- Before we dive into your recent article, can you tell
us about your background and how you came to write this
paper?
I’m licensed as a patent attorney, with a background (an
undergraduate degree and Ph.D.) in biochemistry. I have always had
an interest in academia which led to my collaboration with
Professor Chao at the University of Denver Law School. Together we
drew on my industry experience and his academic expertise to gather
global data and publish this paper. Our goal was to shine a light
on certain patent practices of branded drug companies. We concluded
that the patent system needs to strike a better balance between
encouraging development of new drugs and enabling access to
affordable treatments for patients.
- How did you get interested in work on
biosimilars?
Biosimilars are copies of biological drugs that are approved by
the FDA based on demonstrating high similarity to an FDA-approved
originator drug. Biological drugs are larger and more complex than
small molecule drugs so they give rise to interesting inventions
and patent strategies. My day-to-day work at Fresenius Kabi focuses
on obtaining freedom to operate for biosimilars so we can bring
these low-cost medicines to patients and expand access to important
drugs around the world.
- Before we get into the details of your article, what is
a “patent thicket” in your view?
There’s not a single definition, but one common
understanding comes from a 2001 paper by Carl Shapiro. He described
“a dense web of overlapping intellectual property rights that
a company must hack its way through.”2 In my mind,
the definition of a patent thicket is synonymous with
“evergreening.” In other words, it would be any portfolio
of patents that extends the full scope of the monopoly of a branded
drug beyond the expiry of the primary patent on the drug
product.
- What was the objective of your research on patent
thickets, and what did you conclude?
The objective was firstly to prove that patent thickets exist.
Our data showed that, not only do they exist, but they are a
uniquely American problem. We also showed that large patent
thickets correlate with delayed launches of low-cost biosimilars in
the United States.
Our initial findings begged the question, why does the United
States have so many more patents covering branded drugs compared to
other countries? What we discovered was that the large scale of
patent thickets in the United States is fueled by a patent
multiplying maneuver called obvious-type double patenting (OTDP).
Double-patenting is exactly what it sounds like: the practice of
claiming the same or an obvious variation of an invention in more
than one patent.
This practice is restricted by patent offices around the world.
The USPTO, however, will grant multiple patents, covering
non-patentably distinct inventions (“duplicative
patents”), provided the patent owner agrees to link those
patents together with a terminal disclaimer (a common expiration
date). We found that U.S. patent thickets on branded drugs are
overwhelmingly comprised of duplicative patents. In some cases, up
to 80% of the patents in a drug’s portfolio are non-patentably
distinct from each other.
To be clear, I am highly in favor of granting innovative,
high-quality patents. Incremental innovations that improve
therapies for patients are critical. That’s not what is at
issue here.
What is troublesome, however, is the pervasive use of
duplicative patents. It is too expensive for biosimilar companies
to challenge scores of patents via inter partes review
(IPR) or post-grant review (PGR) proceedings, so they cannot
economically use IPR/PGR proceedings to sort the good patents from
the bad. Federal courts cannot effectively litigate scores of
patents either. Branded drug companies are strategically building
thickets around their most profitable drugs to shield most of their
patents from scrutiny.
- Can you give us an overview of the methodology you used
for your research?
We downloaded court dockets and counted the number of patents
litigated against biosimilars in three countries: the United
States, Canada, and the United Kingdom. To make it a fair
comparison, we chose thirty (30) biosimilars because they are all
of the biosimilars that have gone through regulatory review in all
three countries. This is different than some of the studies that
have been called into question recently. The difference in our
methodology comparatively is that we counted the number of patents
that branded pharma actively litigated against each biosimilar.
Therefore, we did not need to make our own assessment of which
patents are relevant and how many of them cover branded drugs.
Across those three countries, we found that twenty-four (24)
patents were litigated in the UK, fifty (50) patents were litigated
in Canada and three hundred and seventy-seven (377) patents were
litigated in the United States. Our analysis showed that biosimilar
litigation in the United States includes far more patents than the
counterpart litigations in Canada and the UK for the same
drugs.
Next, we made a deep dive analysis into the U.S. patent
portfolios of specific branded drugs. We assessed the file wrappers
and counted how many patents were linked together through terminal
disclaimers. Given that terminal disclaimers are voluntarily filed
to overcome a rejection from the patent examiner under OTDP, this
means that the linked patents are claiming non-patentably distinct
inventions. It was disappointing to find that patent thickets on
branded drugs are not comprised of mostly innovatively
different or even incrementally different patents; rather they are
comprised mostly of these duplicative patents.
Our data has been peer reviewed and published in the Journal of
Law and Biosciences, which is a co-venture journal between Duke
University, Harvard University Law School, and Stanford
University.
- Do patent thickets affect entry of generic
small-molecule drugs into the market to the same extent as
biosimilars?
Patent thickets are a numbers game that branded drug companies
know their competitors cannot win. While it costs approximately
$25K to prosecute, grant and maintain a patent, biosimilar/generic
competitors budget $775K on average to file an IPR or PGR against a
single patent. Therefore, the U.S. patent system incentivizes
branded drug companies to amass as many patents as possible. In
other industries, such as the mobile phone industry, competitors
have more options to design around patents. In these industries,
there is inherent interest in designing something new and different
and therefore less incentive to stack duplicative patents on the
same invention. Conversely, biosimilar/generic competitors,
necessarily, have to be the same or highly similar as the branded
drug which unfortunately makes the patent thicket strategy
particularly amenable to the pharmaceutical industry.
For biological drugs there are many more possibilities to create
inventions as compared to the small molecule field. For example,
there are many ways to manufacture each biological drug, and
biological drugs often have many different indications (FDA
approved uses of the drug for treating particular diseases) on
their labels. Some of these innovations will result in quality
patents, but some will result in junk patents. Using terminal
disclaimers, branded companies can duplicate patents around each
invention, making it difficult to sort the good from the bad.
Regarding your question on generic drugs, we are starting to see
more and more “mini-thickets” in the small molecule
field. Although there tend to be fewer opportunities to file
patents on a range of inventions, there is still the same incentive
to branded drug companies to play the numbers game of having as
many duplicative patents as possible.
- Your article touches on some of the features of the
Canadian and UK patent systems that are more likely to give rise to
high-quality patents and prevent patent thickets. Can you elaborate
on those differences?
There’s a lot going on here, but some key themes emerge. The
UK and Canadian patent systems place more restrictions around
obvious-type double-patenting (OTDP). There is no terminal
disclaimer equivalent in Canada or the UK; instead, this type of
objection is overcome by addressing the overlapping claims either
by argument, amendment, or abandonment.
In the United States, we also see a greater use of functional
claim language in the pharmaceutical space as compared to what is
permissible under the patent systems of the UK, Canada, and
Europe.
- What are some features of the Canadian and UK patent
systems that could feasibly be implemented in the United
States?
With respect to OTDP, the USPTO should consider eliminating
terminal disclaimers. We have yet to hear a good argument as to why
a company should need more than one patent on non-distinct
inventions. Patentees should pursue their best claims in the parent
patent.
In Europe, patent examiners are stricter in that they do not
allow claim language that defines a “result to be
achieved” (i.e., functional language) and requires that the
claims include all of the essential features (i.e., structural
features) of the invention. The USPTO could consider moving more in
that direction to address the issue of patent thickets.
- Is there anything the U.S. patent system does better or
more effectively than the patent systems in Canada and the UK, as
it relates to patent thickets?
I appreciate the short timeframes for IPR/PGR procedures. The
PTAB does a very good job of keeping the timelines on track, which
helps our planning and alignment with our FDA approval timelines.
Unfortunately, the Federal Circuit has held that a company that has
not yet filed a regulatory application to the FDA does not have
standing to appeal a negative IPR decision.3 This
becomes a major conundrum for us, as filing an IPR/PGR too far in
advance of filing an aBLA may result in there being no standing to
appeal after an unfavorable decision. The result is that biosimilar
applicants delay the filing of IPRs/PGRs against low-quality
patents, rendering it difficult to obtain a final non-appealable
decision prior to FDA approval of the biosimilar. In addition to
patent thickets, this also leads to delayed launch of low-cost
biosimilar drugs.
- As you know, in July 2021, President Biden issued an
Executive Order on Promoting Competition in the American Economy,
which directed the Secretary of Health & Human Services (HHS)
to “help ensure that the patent system, while incentivizing
innovation, does not also unjustifiably delay generic drug and
biosimilar competition beyond that reasonably contemplated under
the law.” In response, the U.S. Patent & Trademark Office
recently outlined several initiatives. Can you comment on whether
any of those initiatives may help to address patent
thickets?
Fortunately, the Director of the USPTO, Kathi Vidal, seems
poised to tackle what others before her have overlooked or ignored.
On October 4, 2022, the USPTO issued a series of policy proposals
for public comment, aimed at improving patent quality, encouraging
consistency in examinations, and tightening written description
rules.4 Most importantly, though, the request for
comment seeks input on policies that would tackle the issue of
patent thickets. For example, there are policy ideas relating to
capping the filing of continuation and divisional patent
applications, as well as the idea to eliminate terminal disclaimers
all together.
These policies would also incentivize innovation into new drugs.
Afterall, why should branded drug companies invest into research
and development while they can stack patents on their old
“cash cows”?
Footnotes
1 Rachel Goode & Bernard Chao, Biological patent
thickets and delayed access to biosimilars, an American
problem, 9 J. L. BioSci. (2022).
2 Carl Shapiro, Navigating the Patent Thicket: Cross
Licenses, Patent Pools, and Standard-Setting, Innovation
Policy and the Economy, Vol. I 119-150 (Adam Jaffe, Joshua Lerner
& Scott Stern, eds., MIT Press, 2001).
3 See, e.g., Argentum Pharms. LLC v.
Novartis Pharms. Corp., 956 F.3d 1374 (Fed. Cir.
2020).
4 Request for Comments on USPTO Initiatives to Ensure the
Robustness and Reliability of Patent Rights, 87 FR 60130 (Oct. 4,
2022).
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