Tag: patents

Bioethics News

How to Protect a Drug Patent?

Sell it to a Native American Tribe. The drugmaker Allergan announced Friday that it had transferred its patents on a best-selling eye drug to the Saint Regis Mohawk Tribe in upstate New York — an unusual gambit to protect the drug from a patent dispute

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Be Very, Very Concerned About What Allergan Just Did

Yesterday, it was announced that Allergan had transferred the ownership of the patents on its billion-dollar drug Restasis, used for the treatment of chronic dry eye, to the Saint Regis Mohawk Tribe. The Tribe then exclusively licensed the drug back … Continue reading

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics News

This Shield of Patents Protects the World’s Best-Selling Drug

September 8, 2017

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Humira, a treatment for inflammatory diseases such as rheumatoid arthritis and psoriasis made by AbbVie Inc., is the planet’s best-selling drug. It’s also been around almost 15 years. Those two facts alone would normally have rival drugmakers eagerly circling, ready to roll out generic versions that could win a piece of the aging medicine’s $16 billion in annual sales. Yet last year, when the patent on Humira’s main ingredient expired, not a single competitor launched a copycat version. Figuring out how to manufacture it wasn’t the obstacle. The real challenge was the seemingly impregnable fortress of patents AbbVie has methodically constructed around its prized moneymaker.

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Image: By Black Stripe at English Wikipedia, CC BY-SA 3.0, https://commons.wikimedia.org/w/index.php?curid=26581981

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The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics News

CRISPR Pioneer Doudna Envisions a World of Woolly Mammoths and Unicorns

If there was one misstep that doomed the long and bitter fight by the University of California to wrest key CRISPR patents from the Broad Institute, it was star UC Berkeley scientist Jennifer Doudna’s habit of being scientifically cautious, realistic, and averse to overpromising.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics News

US Taxpayers Are Funding a Zika Vaccine. Let’s Make Sure US Patients Can Afford It

Last year, the government gave Sanofi, which is one of the world’s largest vaccine makers, a $43 million grant. Another $130 million may follow as research continues. The Army also disclosed plans to award Sanofi an exclusive license to a pair of patents that are crucial to the vaccine

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Contracting to counter gene patents – a 21st Century solution to access and innovation

By Sarah Ali-Khan and E. Richard Gold As Precision Medicine becomes a reality, molecular tests are an increasingly critical part of patient care. While patients and their physicians would like to maximize access, they have confronted a roadblock in the … Continue reading

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Increasing Access to Biosimilar Drugs

The development of ‘specialty drugs’
in the health care industry has created legal, ethical, and public policy
issues because patients are not able to get access to their prescribed
medications based on the expense.  Specialty
drugs are usually biologicals, treat serious conditions, and  are very expensive with no cheap
alternatives.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Increasing Access to Biosimilar Drugs

The development of ‘specialty drugs’
in the health care industry has created legal, ethical, and public policy
issues because patients are not able to get access to their prescribed
medications based on the expense.  Specialty
drugs are usually biologicals, treat serious conditions, and  are very expensive with no cheap
alternatives. Although there is debate
about how much finances should influence medical decision making, it is a
conversation that can not be ignored when patients can not get access to
treatment based on ability to pay. There should be increased access to these
drugs but how to increase access is up for debate.

One posed solution has been the
creation of biosimilar which are the generic version of a specialty drug. A
biological medication is different from a traditional drug in molecular make
up.  “A biologic drug is ‘a substance that is made
from a living organism or its products[,]’”  while a traditional prescription drug is made
up of simple molecules.  This difference means that biologicals are
scientifically more difficult to produce because a more elaborate research is
necessary.  This also means making a generic form, known
as a biosimilar, is more expensive and harder to make.
Generally, a biological is “twenty times more expensive per patient than
traditional small-molecule pharmaceuticals.”
There also are patent infringement concerns when making biosimilar.

 

From ethics perspective, one of the
key aspects of justice is ensuring equal access to healthcare or at least
fairly allocating available resources. For biosimilar drugs, it truly depends
on what insurance company, what insurance plan, and what pharmacy benefit
manager the patient has as to whether the patient will even have a chance to
get these drugs.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

40th Annual Health Law Professors Conference

If you teach health law, come to the 40th Annual Health Law Professors Conference, June 8-10, 2017, at Georgia State University College of Law in Atlanta.  Here is the schedule:


Thursday, June 8, 2017
8:00-12:00 AM Tour of the Centers for Disease Control and Prevention (Separate registration is required. Participants meet in the lobby of Georgia State Law to take a shuttle to the CDC.)


9:45 – 11:15 AM Tour of Grady Health System (Separate registration is required. Participants meet in the lobby of Georgia State Law and will walk over to Grady as a group.)


2:00 – 5:00 PM Conference Registration – Henson Atrium, Georgia State Law


3:00 – 5:00 PM Jay Healey Teaching Session – Knowles Conference Center, Georgia State Law
Experiential Teaching and Learning in Health Law
The format for this session is World Café roundtables, with plenty of opportunity for the collegial exchange of teaching ideas and insights among your colleagues. Come prepared for a lively, interactive workshop.
World Café Hosts:
Dayna Matthew, University of Colorado Law School
Charity Scott, Georgia State University College of Law
Sidney Watson, Saint Louis University School of Law
Invited Discussants and Participants:
Rodney Adams, Virginia Commonwealth University School of Health Administration
Christina Juris Bennett, University of Oklahoma College of Law
Amy Campbell, University of Memphis Cecil C. Humphreys School of Law
Michael Campbell, Villanova University Charles Widger School of Law
Erin Fuse Brown, Georgia State University College of Law
Cynthia Ho, Loyola University of Chicago School of Law
Danielle Pelfrey Duryea, University of Buffalo School of Law, State University of New York
Jennifer Mantel, University of Houston Law Center
Elizabeth McCuskey, University of Toledo College of Law
Laura McNally-Levine, Case Western Reserve University School of Law
Jennifer Oliva, West Virginia University College of Law and School of Public Health
Thaddeus Pope, Mitchell Hamline School of Law
Lauren Roth, St.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Dueling BRCA Databases: What About the Patient?

The news release Monday morning grabbed my attention:

“Study finds wide gap in quality of BRCA1/2 variant
classification between Myriad Genetics and a common public database.”

Myriad Genetics had been exclusively providing tests, for
$3000+ a pop for full BRCA gene sequencing, for 17 years before the Supreme
Court invalidated key gene patents back in 2013. Since the ruling a dozen or so
competitors have been offering tests for much lower prices. Meanwhile, Myriad
has amassed a far deeper database than anyone else, having been in the business
so much longer. And it’s proprietary.

CLASSIFYING GENE VARIANTS

(NHGRI)

Public databases of variants of health-related genes have
been around for years too. The best known, ClinVar, collects and curates data
from the biomedical literature, expert panels, reports at meetings, testing
laboratories, and individual researchers, without access to Myriad’s database.
ClinVar uses several standard technical criteria to classify variants as
“pathogenic,” “benign,” or “of uncertain significance.” (“Likely pathogenic”
and “likely benign” were used more in the past.)

ClinVar lists 5400 variants just for BRCA1. The criteria
come from population statistics, how a particular mutation alters the encoded
protein, effects on the phenotype (symptoms), and other information.
Bioinformatics meets biochemistry to predict susceptibility. The BRCA1 protein
acts as a hub of sorts where many other proteins that control DNA repair
gather. DNA Science discussed the genes behind breast and ovarian cancers here.

As gene sequences accumulate in the databases and troops of
geneticists and genetic counselors annotate them, the proportion of pathogenic
and benign entries will increase as that of the unsettling “variants of
uncertain significance” — VUS — will decrease.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.