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Patents in Medicine
HMB401H1
Course Syllabus Winter 2016
HMB401H1 - COURSE SYLLABUS ?1
Drug Eluting Stent - Wikipedia commons image
Welcome to Patents in Medicine HMB401H1
Course Syllabus Summary 2016
HMB Course Coordinator: Dr. Melanie Woodin
Lecture date & time: Winter term; 11:00AM - 1:00PM
Lecture location: Sydney Smith 2111
Arts & Science Calendar Course Overview: HMB401H1 This course introduces life
sciences students to the application of patent law in medicine. Patents will be introduced
to note their application in different product lines covering drugs, medical device implants,
diagnostics and medical device software including medical smartphone apps. Key
emphasis will also be given to the limitations of patent protection in commercializing
medical products.
Prerequisite: 4th year status; 2 credits in biology courses
Course Description: The course starts with an overview of medical biotechnology and the
current trends in new product offerings in medicine. A basic framework to understand
patent law is introduced and then applied through a series of cases involving different
kinds of medical products. Readings will be drawn from both medical and law literature
that are peer reviewed. Product lines reviewed will include, but will not be limited to:
drugs, medical device implants, diagnostics, life science software and medical smartphone
apps. Students will perform assignments in teams and individually. Team assignments
will involve developing competing patent claims around a new medical discovery.
Student Learning Outcomes:
By the end of this course, students will understand how to
1. Patent law application in medicine
2. Understanding key products in medical treatment today
3. Claim construction
HMB401H1 - COURSE SYLLABUS ?2
Course Instructor
Dr. Jayson Parker is an Assistant Professor,
teaching stream, in the Department of Biology and
is cross-appointed to the Institute of Biomaterials
and Biomaterial Engineering (IBBME), at the
University of Toronto. He also lectures for the
Faculty of Law. Trained in neurobiology, he
worked in investment banking as a biotechnology
analyst for several years and then moved into the
pharmaceutical industry, before returning to
academia. A self professed nerd who is passionate
about Dungeons and Dragons.
Detailed list of publications can be found at:
https://www.researchgate.net/profile/
Jayson_Parker/
For his current views on health technology:
Twitter: @Jayson_Parker
Dr. Parker’s research areas are listed below involve a range of undergraduate, graduate and alumni
across a range of departments at the University of Toronto.
CLINICAL TRIAL FAILURE RATES: We have published a large body of research here that
examines the risk of a drug failing during clinical trial testing and the factors that appear to impact the
risk. We are constantly developing improved risk estimates for specific patient populations and believe
this data will inform both public policy and research funding choices. Does personalized medicine
reduce the risk of drug failure? What kind of data is the best indicator of the future success of a drug
during testing?
MEDICAL DEVICE ANCESTRY: The regulation of the safety and performance of new medical
device innovations is plagued with oversight problems that may threaten patient safety. This research
traces specific medical devices back in time and reconstructs the history of their design evolution.
HMB401H1 - COURSE SYLLABUS ?3
Have small incremental changes over time to some medical devices lead to large design changes that
have escaped proper safety oversight?
BIOTECHNOLOGY PATENTS: We are looking at a range of patent issues surrounding the use of
new medical technologies. For example, patent strategies for new classes of drugs such as biosimilars.
More recently, we are looking at the standards of evidence exercised by the patent office. Under what
conditions are biosimilars patentable? How often are patent claims for a drug later to be found wrong?
How often are erroneous patent claims actually corrected in the intellectual property landscape?
DARK DATA & WEARABLE HEALTH TECHNOLOGY: We are exploring several
cutting edge issues with wearable technology in the digital health space that includes health
(e.g. iWatch TM or Hexoskin TM ) and medical wearables (e.g. glucose pumps). Can we come up
with a common data format for these devices that clinicians and manufacturers can agree upon
as useful? Can we curate a database of user experience from these devices to explore new
predictions of health and wellness? “Dark data” refers to data with no useful purpose. Can
such biometric data be predictive of health and wellness issues? How is this technology
currently regulated and how does that impact product design choices?
MACHINE LEARNING & NEURAL NETWORKS: This is a new area that overlaps with
2 research areas above. For both our clinical trial database and the impending biometric
database we will build, we are starting to use machine learning to interrogate these data sets.
Neural networks will be deployed against the biometric database.
STRATIFYING HOSPITAL TECHNOLOGY BY MEMORY DEMANDS: We are stratifying
hospital technologies based on their demands on temporary memory storage in humans. There are
limits to how much temporary memory any person can handle at once. Have we created bottlenecks in
hospital care where memory loads of health technologies, are too much for healthcare providers to
realistically track to avoid catastrophic errors?
HMB401H1 - COURSE SYLLABUS ?4
Week,
Date
Week Modules Due Dates
Jan 11 I Intellectual Property & What can be
patented Part I
*Team formation *
*Instructor Twitter feed
active *
*Course Patent OfXice Open
for Claim submission *
Jan 18 II What can be Patented Part II *Patent Searches - Bring
laptop/tablet *
Jan 25 III Understanding the case for and against
patenting genes Part I: Charkarbarty
* First Tutorial *
Feb 1 IV Understanding the case for and against
patenting genes Part II: BRCA genes
* Tutorial *
Feb 8 V Tests of Anticipation in Patent Law:
SanoXi vs. Apotex (2008) in Canada
*Tutorial *
*Gene Patent Essay Due *
Feb 15 VI Reading Break (no class)
Feb 22 Claim Construction - Epogen case * Tutorial *
Feb 29 VII Understanding Patenting Families of
Inventions and Sound Prediction
*Tutorial *
*Infographic Due *
*Team Patent Claims
Published to Class - no
further claims can be
submitted *
Mar 7 VIII Are Biosimilar Drugs Patentable? * Tutorial *
Mar 14 IX Patent litigation with Drug Eluting
Stents
* Tutorial *
Mar 21 X Student Team Talks *Major Project Report Due
start of class *
Mar 28 XI Student Team
Talks; student evaluations
Bring a laptop or tablet
HMB401H1 - COURSE SYLLABUS ?5
Required Course Material & Preparation
1. Industry Updates During Course – Instructor Twi9er Feed
Students are required to follow industry updates, which will identify press releases
pertaining to changing products or regulatory conditions. These announcements will be
made via Twitter. All tweets during the course constitute testable material. All you need to
know about a tweet is the company name, product name, and “so what” where applicable.
Students are required to create a Twitter account and follow:
twitter.com/Jayson_Parker
@Jayson_Parker
If a student does not wish to create a Twitter account - see the instructor for alternatives.
2. Online Storage Access
The instructor will send invitations to Dropbox storage. If your folder is not updating, click on
the link for the original invite email. If you already have a Dropbox account linked to your UofT
account that is creating problems, send the instructor an alternate email address in which to
invite you.
Course Evaluation
Participation 15%
Gene Patent Essay (Indvidual) 10%
Team Based Learning Tutorials 10%
Team Major Project Report 25%
Team Presentation 5%
Team Gun Deck 5%
Team Infographic 5%
Final exam 25%
April 4th XII Course Wrap up / review Bring laptop /tablet for
student online evaluations
Final Exam
HMB401H1 - COURSE SYLLABUS ?6
Late assignments: 10% per day penalty, including the day the assignment is due if
received after the speciVied time. See the tutorial section, for penalties for missing such
sessions.
Why Teams? Because everything you will do your life, of any real importance, will almost always
be team based. The course is structured to reXlect the reality of your future challenges in your
career path. Some assignments are individual.
Gene Patent Essay (Individual; 2 pages length)
For this deliverable you will write a short essay in which you will talk about any aspect of
patenting genes you Xind interesting (the future implications, whether or not patents make sense
and so on). You must follow formal essay structure for this assignment - if you do not do so you will
receive a failing grade. We are looking at how you think and structure scholarly arguments.
Proper citation is required to back-up your points as appropriate. Look at the science behind the
issue. You will develop your own thesis on the topic and argue for your position as you look into
the subject at hand. All arguments must be grounded in scholarship as appropriate (e.g. peer
reviewed sources).
Deliverable length: 12 point Palatino font, 1.5 line spacing, 2 pages of text (excluding title page,
references and any Xigures). For citation format, follow the format in the New England Journal of
Medicine. A title page is required and pages should be numbered. Penalties apply for not
following his format. Any Xigures or analysis you may have go into an appendix - your appendix is
of unlimited length. As this assignment is very short, it is naturally understood you cannot cover
many angles to the topic.
Source Material: Based your topic you will go the relevant sources as appropriate to back-up
facts in your paper. Scholarly citations are obvious to examine regarding the science but in cases
where you are attempting to cite views held by the public you may cite newspapers / website
sources as appropriate for public expressions of opinion.
Warning: This is a formal essay. Proper paragraph, sentence, thesis and essay structure is
required. If you do not adhere to formal essay structure, this will result in a failing grade. Seek
help from the writing centre as required. There is also a short video on Dropbox the instructor
created showing the structure of a formal essay.
Submission: Email the instructor before the start of class for the relevant due date (table above)
with the email title “HMB401 Gene Patent Essay”. The format can Apple Pages or Microsoft Word
(up to 2011 version), not PDF.
Students are also required to submit their essays into Turn it In.
HMB401H1 - COURSE SYLLABUS ?7
Team Infographic
Each New Product Team will create an infographic pertinent to some aspect of their major
project.
You can visit the MBiotech website for examples of infographics that convey facts on life
science topics in a visual manner.
MBiotech infographic link: https://www.utm.utoronto.ca/mbiotech/seminar-infographics
The infographic should be 1 page in size but can be
longer as required.
Your infographics must be copyright compliant.
Most students create their own graphics to avoid any
concerns about copyright.
Your copyright permissions should be listed on your
infographic as appropriate or may be listed on a page
of text you can send along with your infographic.
Copyright compliance will be a major part of the
evaluation of the infographic.
Your infographic should have very little text and
convey data trends and concepts visually. It should
not be crowded. Convey a few key concepts, or one,
from your major project. Don’t try to convey too
much. Your infographic should be understandable to
your peers without reading your report or seeing
your presentation (that’s your target audience).
Your choice for content, in addition to the layout of
that content, will be evaluated. A rough guide for
evaluation: copyright compliance 40%, content 30%,
visual layout 30%.
The infographic is sent by EMAIL to the course
Teaching Assistant in PDF format by the deadline for
this assignment.
HMB401H1 - COURSE SYLLABUS ?8
Infographic reproduced with
permission from student team.
Copyright Compliance Requirements & Resources for this Course
Two deliverables for this course, your slides for your team presentation and the infographic for this
course.
What is copyright compliance? In operational terms, it means you could show your work
publicly and not be exposed to any risk of accusations from other parties that you have used their
material without their permission (pictures, songs, text, data etc). This is a requirement in many
areas of professional life and thus you are introduced to it in this course.
Required Viewing: A introduction on how to produce copyright compliant material:
http://www.utm.utoronto.ca/mbiotech/biopartnering-seminar-series-creating-
copyright-compliant-talks-reports
Biopartnering Seminar Series - Creating Copyright Compliant Talks & Reports
Tuesday, September 16, 2014 - 6:30pm
Creating Copyright Compliant Talks & Reports with Shelley Hawrychuck, Copyright
Librarian, UTM Library. Tuesday, September 16th, 2014, 6:30pm.
Here are some weblink to images that are available in the public domain, which can you get you
started to create copyright compliant slides / images (note the “requires attribution”):
Little Visuals http://littlevisuals.co/
Unsplash http://unsplash.com/
Death to the Stock Photo http://join.deathtothestockphoto.com/
New Old Stock http://nos.twnsnd.co/
Superfamous (requires attribution) http://superfamous.com/
Picjumbo http://picjumbo.com/
The Pattern Library http://thepatternlibrary.com/
Gratisography http://www.gratisography.com/
Getrefe http://getrefe.tumblr.com/
IM Free (requires attribution) http://imcreator.com/free
Jay Mantri http://jaymantri.com/
Public Domain Archive http://publicdomainarchive.com/
Magdeleine http://magdeleine.co/
Foodiesfeed http://foodiesfeed.com
Picography http://picography.co/
Raumrot http://www.raumrot.com/10/
ISO Republic http://isorepublic.com/
HMB401H1 - COURSE SYLLABUS ?9
Also, Wikipedia can be a good source of images that can be used. Check their terms of use on the
bottom of their webpage.
If you have questions about copyright - the library is a good resource. We will have a short
tutorial on copyright in class.
Team Major Report (10 pages length)
Students teams that will be responsible for putting together a short patent summary for
mock submission, writing a paper discussing the team’s application strength compared to
competing teams, and oral presentation and defence of the team’s submission.
The Scenario. Your team is a lab that has just made a discovery (described in the
“discovery paper”). Other teams (labs) are working on the same problem and also made
the same discovery (“discovery paper”). You are now in a race to Xile patent claims. If
other teams post claims before you do - that’s okay - you can post claims as well but must
ensure they do not infringe/ overlap with prior claims.
Evaluation and Purpose. While teams will compete to come up with the best claims and
be Xirst to post, the real goal of this assignment is to see how you defend the claims you
post and your ability to attack the claims by competing teams. The paper you write will
explain your claims and speciXication, and will spend time defending your claims (against
expected attacks) and attacking the claims made by the teams.
Data Universe for this Assignment. The patent application will be based on a “universe”
of 2 peer-reviewed papers that will be introduced in class. No other papers exist beyond
these papers - you will not be allowed to cite any paper other than these 2 papers for the
purposes of this assignment.
One paper will be designated as prior art, while the other paper will constitute “new
discoveries” from the lab of each student team, which we will assume have not yet been
published. Each team will draft a patent application, that includes a “speciXication” and up
to three “claims”. Try your best with the speciXication - let’s set an arbitrary limit of 2
pages - you can have Xigures in an appendix - if this is a drug you will be allowed to cite the
structure of the drug in the literature (the only exception here for going beyond our 2
paper universe).
Student teams will be able to submit their patent claims at ANY time during the course up
until the deadline on the table above.
Report Content Details. Each team will have to submit a paper discussing the strength of
the team’s patent compared to competing teams. You can attack teams with a later Xiling
date by arguing their patents are invalid with reference to your own claims as prior art.
You can argue that patents Xiled earlier than yours are invalid due to obviousness, lack of
novelty, or other grounds for invalidity that will be discussed in the course.
HMB401H1 - COURSE SYLLABUS ?10
Team members are encouraged to utilize their members’ strengths; for example, by letting
law students write the claims, and non-lawyers write the speciXication.
Claim Submission Process to Course “Patent OfVice”. Once instructors have received
this Xiling, it becomes part of the prior art in the course, which other teams must consider
in submitting their patent Xilings. Students may still submit their claims ignoring claims
posted by teams with an earlier time stamp, and instead argue that their claims are valid
because the earlier claims do not constitute prior art that jeopardizes their claims.
While it is fun to be the Xirst to submit, our evaluation will be based on the strength of
your patent in the context of class prior art, and your ability to attack other patent
submissions from competing teams in the class.
Team Claim Publication. Patents will be submitted to the Instructor – who will put a
time stamp on the patent application and post the PDF in Dropbox folder for all teams to
see.
The last 2 sessions in the class will involve teams as they brieXly present their claims and
discuss in the context of other group declarations the possible infringement by others, the
strength of their claims, freedom to operate and experimental support.
A folder containing the invention information will be posted by the second week of
class.
Paper target reader. Explain concepts and terminology speciXic to your project that a biology
undergraduate student would not be familiar with.
Appendix: This can be as long as you like and will contain your Xigures / tables / analysis. Do
NOT embed Xigures in your document, rather put them in your appendix at the end of your paper.
These Xigures do not need to be copyright compliant.
Source Material: All teams are limited to a “universe” of papers that are found in the dropbox
folder for this course. There will be 2 papers in the folder - one for prior art and a second for
discovery. Citations in the prior art document do not exist in this exercise (this is to put
boundaries on the data for this assignment so it does not balloon to unmanageable proportions).
Warning: This is a formal essay. Proper paragraph, sentence, thesis and essay structure is
required. If you do not adhere to formal essay structure, this will result in a failing grade. Seek
help from the writing centre as required. There is also a short video on Dropbox the instructor
created showing the structure of a formal essay.
Format: 10 pages 1.5 line spacing 12 point Palatino font. No embedded Xigures - all Xigures in
the appendix.
HMB401H1 - COURSE SYLLABUS ?11
Submission: A copy of the paper must be emailed to the instructor by the deadline, with the
subject title of the email as “HMB401 Team Final paper”. The format can Apple Pages or
Microsoft Word (up to 2011 version), not PDF. Students are also required to submit their essays
into Turn it In.
Team Major Report Presentation
Team presentation is to be no longer than 15 minutes in length. Plan for 1 slide per minute for
your talk – you can spend more time explaining a slide but not less (this excludes your title
slide). Your slide decks must be copyright compliant. All students in a team must present.
Citations should be visible on the bottom of each slide as relevant to the content for the slide in
question. Show all claims you talk about - don’t expect us to remember them.
An example of a good talk for pacing and slide layout can be found at:
http://www.utm.utoronto.ca/mbiotech/biopartnering-seminar-hexoskin-wearable-fitness-
technology-minimal-design
Biopartnering Seminar - Hexoskin Wearable Fitness Technology: Minimal Design
Modifications For Market Success. Tuesday, November 4, 2014 - 6:30pm
“Gun Deck” - Critiquing Team
During the presentations of this course there
will be teams assigned to “Gun Deck” roles.
Following each presentation there will be a
question period with the class. At the start of
the question period, the team assigned the
role of the Gun Deck will have the “floor”
and will be able to ask questions of the
presenting team. It is expected that everyone
in the Gun Deck team will have a few
questions to ask the presenting team.
Your questions can seek clarification but you
should try to challenge or critically evaluate
what the team has said in their presentation.
Critical questions or questions that explore
issues the team has not discussed, will the
focus of the evaluation by the instructor in
evaluating the effectiveness of the Gun Deck
team.
HMB401H1 - COURSE SYLLABUS ?12
The Gun Deck team should all sit together near the front of the room, in a “panel” arrangement.
Evaluation Details
All written assignments are due at the start of class by 1:10 PM in hardcopy form.
All essays - hardcopy to the instructor
Turn it In Submission of Essays for all Assignments
Students will be required to submit their course essays to Turnitin.com for a review of textual
similarity and detection of possible plagiarism. In doing so, students will allow their essays to
be included as source documents in the Turnitin.com reference database, where they will be
used solely for the purpose of detecting plagiarism. The terms that apply to the University's
use of the Turnitin.com service are described on the Turnitin.com web site.”
Turnitin ID: 11383924
Turnin password: 401-medpat
Late penalties:
10% per day for all course assignments. This includes the Wirst day if the deliverable is
received after 1:10 PM on the day it is due.
Missed Assignment/Test Policy:
This course follows the Human Biology Program’s and the University of Toronto’s Policies on
missed tests and assignments:
1. Students that fail to submit assignments or sit term tests for medical reasons must submit a
valid UofT Verification of Student Illness or Injury Form. Note that it must be signed by a
physician and the report must establish that the patient was examined and diagnosed at the time
of illness, not after the fact. For non-medical causes, please refer to the complete HMB Policy
on the website.
2. Within five business days of the missed test or assignment due date, the original copy of
completed the UofT Verification of Student Illness or Injury Form must be submitted to the
Human Biology Program Offices in Wetmore Hall.
3. The HMB Program office verifies all medical notes. If the note is valid, the instructor will be
informed. The student will not be contacted if the missed item was an assignment/tutorial quiz.
The office will only contact the student if the missed item was a term test.
HMB401H1 - COURSE SYLLABUS ?13
4. If the note was submitted for an assignment, the assignment is still due.
Final Exam
The Xinal exam will cover the entire course (yes it is cumulative - including the Twitter feed and
readings). The focus of the exams will be on lecture content. Assigned readings, tutorials, videos
and the Twitter feed are all testable material. There will always be at least a few questions from
the Twitter feed.
Question format for the Xinal exam: short answer questions and there may be some multiple
choice questions.
Course Structure
Generally there will be a 1 hour lecture followed by a 1 hour tutorial. There will be some
deviations from this format, especially at the start and end of the course. This is a senior level
undergraduate course so students are encouraged and expected to ask questions and engage in
discussion (which is also part of your participation mark).
Student Teams
The instructor will assign students into teams. You work in student teams because as young
scientists usually you have very little experience with teams. Most of what you do professionally
will involve your membership in multiple teams. Therefore, as part of your training, you need to
become more comfortable with working with your peers. Very little in life is a solo endeavour.
Students are encouraged to sit among their team members, especially for tutorials.
Teams are formed from those students in attendance in class, early in the course.
For each team assignment such as the major project, there will be a page in the appendix where
each team member will describe his or her “contributions” to the project. Usually, this is a short
paragraph by teach team member.
Tutorials
There will be a short problem posed to the class with the information presented on a single slide.
Don’t bother racing to the Internet for hints, you can only martial the evidence on the slide to
provide your answer, data provided from external sources will be ignored. There can be more
than one “right” answer in many cases - it depends on more on your logic than conclusion (unless
you are way off base).
Working in your teams, you will give your answer to the instructor by email or a paper hardcopy
3:40 PM. Please CC your entire team and send to my attention. No attachments please. Time
permitting, answers will be reviewed and discussed.
Students not present for the tutorial receive a grade of zero for the assignment in question.
Teams are required to only list team members present during the tutorial in submitting their
HMB401H1 - COURSE SYLLABUS ?14
assignment. Absent students are required to provide a doctor’s note for illnesses, if they expect
to make up the grade they missed while absent.
Module Descriptions
Reading load will be uneven. The Xirst 2 modules will ask for considerable reading while other
modules will require far less, so don’t get discouraged by the reading load!
Some articles are not available in Dropbox due to copyright. Use Pubmed or Medline to
retrieve the article. If you have not done this before - seek help from the library.
Week I
Intellectual Property & What can be Patented Part I
An introduction to patent law and the role it plays in commercialization in the context of
biotechnology. By analogy, consider this your introduction to the rules of the game “chess” -
there are not many rules, but betting comfortable with their application will be the focus of this
course.
Learning objectives:
- type of intellectual property
- role of patents
- limitations of patents
- basic criteria for patentability
- understanding prior art
Required Readings:
Required readings: What can be patented. In Patents for Chemicals, Pharmaceuticals and
Biotechnology. By Philip Grubb, Oxford University Press, Oxford, 2004: 57-74. (in
DropBox)
Note: Legal writing even at a basic level can be difXicult to follow - give yourself time - you
will get the hang of it. This chapter will be revisited in the course repeatedly.
Week II
What can be Patented Part II
A continuation of the Xirst lecture - the same reading applies. This will be our Xirst tutorial, which
will focus on prior art relevance in a patent application.
Week III
The Case for Patenting Genes Part I: The patenting of Organisms in the Charkarbarty Case
HMB401H1 - COURSE SYLLABUS ?15
There is considerable confusion around the patenting of genes. This confusion takes two forms -
legal controversy and public misperception of patenting. We will review the landmark case in
this lecture that was the cornerstone defence for the patenting of genes in later years: the
patenting of the world’s Xirst engineered organism, a form of oil eating bacteria.
Learning objectives
- What constitutes an invention?
- What does it mean to patent an invention that can also be found in some form in nature?
- applying the rules of patentability to this case
Required Reading:
Chakrabarty AM . Bioengineered bugs, drugs and contentious issues in patenting.
Bioeng Bugs. 2010 Jan-Feb;1(1):2-8. doi: 10.4161/bbug.1.1.9850.
(Due to copyright, this article is not in Dropbox so you must retrieve it via Pubmed or Medline)
Week IV
The Case for Patenting Genes Part II: BRCA Genes in Breast Cancer
A continuation of our prior lecture, where in this session we build in the Charkbarty decision to
see how we arrived at patenting genes. This decision is still in Xlux, some changes are taking
place and it will take new patent litigation to really see how this issue is shaping up. The
evidence of inventiveness to patent genes appears to be changing.
Learning objectives:
- Current thinking on the patenting of genes
- problems with changes in technology in molecular biology impacting inventiveness
- application of patent rules to genetic patenting and material from nature
Required Readings:
Required reading: Gene Patenting – The Supreme Court Finally Speaks (2013). New England
Journal of Medicine, 369(9): 869-875
(Due to copyright, this article is not in Dropbox so you must retrieve it via Pubmed or Medline)
Week V
Tests of Anticipation in Patent Law: SanoVi vs. Apotex (2008) in Canada
In this session, we’ll talk about how anticipation is determined when talking about whether an
invention is novel. This is was a deXining case in Canada that gave us a clearer understanding of
how to test the notion of obviousness. We will be looking at 2 global pharmaceutical companies
and their dispute in Canada.
HMB401H1 - COURSE SYLLABUS ?16
Learning objectives:
- Tests of anticipation
- “obvious to try” test
- “ought to try” test
Required Reading:
- None.
Reading Break (no classes)
Week VI
The Epogen Patent Dispute - Understanding Claim Construction
In this session we look at one of the most successful drug therapies on the market, which is sold
by Amgen. A dispute arose between Amgen and a start-up called Transkaryotic Systems that had
a work around solution to manufacturing the protein that threatened the recombinant DNA
technology industry. In this context, we will take a closer look at claim construction.
Learning objectives
- the science behind Epogen
- the basis of the case dispute
- claim construction for drugs
Required Readings:
M. A. Liebert. Patent litigation. Biotechnology Law Report. June 2001, 20(3): 421-433
(due to copyright not available in Dropbox - retrieve from Pubmed/ Medline)
Week VII
Understanding Patenting Families of Inventions & Sound Prediction
To understand how patenting of entire families of inventions work we will look at a patent on a
large group of drugs in the patent case of GlaxoWellcome vs. Apotex & Novopharm. The drug
under dispute will be HIV drug azidothymidine. Claiming a family of inventions can be a
considerable time safer avoiding multiple patent Xilings and strong barrier to entry against
competitors. But if not done incorrectly, it can jeopardize the inventor’s patent position. Key to
this whole process is the use of a Canadian convention of “sound prediction”.
Learning objectives
- patenting invention families
- selection patents
- sound prediction
Required Readings:
HMB401H1 - COURSE SYLLABUS ?17
(Review) What can be patented. In Patents for Chemicals, Pharmaceuticals and Biotechnology. By
Philip Grubb, Oxford University Press, Oxford, 2004: 57-74. (in DropBox)
Week VIII
Are Biosimilar Drugs Patentable?
Biosimilars are a controversial new drug technology that offers low cost drug alternatives for
protein based therapies that historically have only been available for small molecule drug
therapeutics. However, biosmilars may have more patentable options than what has historically
been the case with small molecule drugs. In this session we introduce what a biosmilar is and
whether it is patentable. This will require some introduction to drug regulation for safety and
performance testing. This will draw upon a position paper the course instructor is working on
with the intellectual property lawyer that will be made available for reading in draft form.
Learning objectives
- What is a biosimilar?
- Very basic drug regulation
- patent issues around biosimilars
Required Readings:
To be posted in Dropbox - the Patentability of Biosimilars.
Note: this paper is in the process of journal submission
Week IX
Drug Eluting Stents Patent Disputes
Drug eluting stents represent one of the most important products in medical devices over the
past 20 years. They are hybrid devices that combine both drugs and medical devices. This forces
us to revisit the idea of what an invention really is, and to what extent the assembled components
of that invention can render it obvious.
Learning objectives:
- basic science of drug eluting stents
- understanding patents on technology improvements
Required Reading:
Abizaid A1, Costa JR Jr. New drug-eluting stents: an overview on biodegradable and polymer-free
next-generation stent systems. Circ Cardiovasc Interv. 2010 Aug;3(4):384-93. doi: 10.1161/
CIRCINTERVENTIONS.109.891192.
(Due to copyright, not available in Dropbox)
HMB401H1 - COURSE SYLLABUS ?18
Week X
Student Presentations & Course Evaluations (bring a laptop or tablet)
Week XI
Student Presentations
Week XII
Course Wrap Up & Review
HMB401H1 - COURSE SYLLABUS ?19
