The four principles of ethics discussed in Part 1 of this series are not always binding, but rather, should be applied in all circumstances unless there is a more important factor that must be considered for the greater good. While ethical codes are established as principles that a consensus of medical professionals believe in, they often do not address situations that occur on an individual basis. Two main issues in bioethics today are euthanasia and religious liberty in health care.

Euthanasia
There is an ethical dilemma in the choice of caring for individuals nearing the end of life for prolonged periods of time when there may be little benefit in doing so. Euthanasia is the process of a doctor ending someone’s life by painless means, which provokes debate about whether doctors should be able to deliberately end someone’s life with their consent. There are two main types of euthanasia: active euthanasia and passive euthanasia. Passive euthanasia is the less controversial type: it allows the patient or their family to withhold life-sustaining treatment such as opioid medications, a ventilator, or a feeding tube. Active euthanasia occurs when medical professionals or another person deliberately gives lethal drugs that end the patient’s life. In classical ethics, there is a moral difference between actively killing a patient and refraining from actions that would sustain the life of the patient. However, others argue that because both types of euthanasia are done with the intent of the patient’s death, there is no substantial difference between the two types if they are administered with proper consent. In 1990, the United States Supreme Court approved the use of passive euthanasia, and some states have adopted Death with Dignity Acts, allowing physicians to assist terminal patients in ending their life if they are expected to die within six months.

Religious Liberty in Healthcare
Addressing a patient or caregiver’s religious beliefs that may conflict with certain medical practices is also an ethical problem. This can involve a patient’s religious objection to procedures such as vaccination, or a doctor’s religious objection to treating someone whose lifestyle violates their religious beliefs. Many state laws include conscience clauses, which protects the rights of doctors and medical professionals to withhold treatment that violates their religious or moral values, such as abortion, sex reassignment, and euthanasia. In 2014, the Supreme Court ruled in Burwell vs Hobby Lobby that the government cannot force private companies to provide insurance that covers birth control methods if it violates the employer’s religious beliefs. Some activists and ethics professionals disagree with this Supreme Court decision and with the wide use of conscience clauses: they believe that the expansion of religious liberty for doctors could endanger some groups from receiving emergency care and decrease the availability of contraception for women.

To better address these ethical issues, many healthcare facilities establish an ethics committee that creates formal policies to better resolve issues. However, these ethical dilemmas will continue to be hotly contested at the personal, federal, and global levels.

Books About Ethical Dilemmas and the Practice of Ethics
For further exploration, here are four books widely acknowledged as innovative or informative in developing a more-complete understanding of medical ethics:

• Medical Apartheid: The Dark History of Medical Experimentation on Black Americans from Colonial Times to the Present by Harriet Washington
• The Spirit Catches You and You Fall Down by Anne Fadiman
• The Immortal Life of Henrietta Lacks by Rebecca Skloot
• Bioethics: Principles, Issues, and Cases by Lewis Vaughn

Situations that create conflict between bioethical principles show how the study of bioethics is not always clear cut and has many contrasting opinions within the field. However, the improvements to health care that have resulted from the adherence to these principles show that bioethics is an integral part of creating a better and more equitable healthcare system. The study of bioethics may appear abstract and theoretical, but the forms, practices, and procedures you encounter at the doctor’s office or hospital are governed by the special standards of bioethics to ensure the best care and future for you and all patients.

References:

• https://medicine.missouri.edu/centers-institutes-labs/health-ethics/faq/euthanasia#:~:text=Passive%20euthanasia%3A%20intentionally%20letting%20a,but%20then%20removed%20from%20it

• https://www.medicalnewstoday.com/articles/182951#history

• https://www.thehastingscenter.org/briefingbook/conscience-clauses-health-care-providers-and-parents/

Part 1: The Foundation of Ethics in Healthcare

Determining ethical standards is a priority in any field that involves choices, experimentation, and human interaction. The healthcare industry is no exception. Medical staff aim to establish standards that encourage humane, morally-sound patient care and research. Implementing a system of ethics, or moral principles that determine what is right and wrong, is one way to regulate medical practices. However, creating one consistent ethical code across national healthcare is difficult, given that beliefs often differ across societies and cultures. So how does one determine the role of ethics in the healthcare field?

Bioethics refers to the ethics involved in medical and biological research and is often applied to healthcare settings as well. These are commonly used to guide professionals when they must make choices that cross into potentially subjective territory. Below, we explain the basics of bioethics and how they can be applied in healthcare settings.

Principles of Medical Ethics

Though bioethics researchers differ on the exact ethical standards healthcare professionals should follow, four principles from Thomas Beauchamp and James Childress explain common understandings of bioethics: respect for autonomy, non-maleficence, beneficence, and justice.

Respect for autonomy refers to the idea that a patient has the right to control their own body and the ability to make informed, voluntary decisions. This means that a patient’s decisions should be respected so long as they are able to think freely. For example, if individuals that follow certain religions refuse to undergo procedures like blood transfusions, this principle argues that their wishes should be respected given the assumption that they are rational individuals.

Nonmaleficence means that healthcare providers cannot intentionally harm a patient and any potential danger must be minimized as much as possible. In situations where harm is inevitable, it is the responsibility of the professional to choose the option that causes the least injury. This principle ties in with respect for autonomy when a patient makes the decision to abstain from life-saving treatment if the treatment would cause too much suffering or pain.

Beneficence states that medical staff members serve as a benefit to patients and are tasked with preventing the patient from experiencing harm. This principle differs from nonmaleficence in that although providers should never directly harm anyone, they can choose the patients they wish to benefit through permitting specific individuals into their practices or prioritizing the care of one over another. At times, beneficence can take precedence over respect for autonomy in situations when the patient cannot think independently, and medical providers must make the decision to help them without their consent.

The fourth principle, justice, asserts that individuals are equal and should be treated as such. This means that quality medical care and resources should be distributed evenly so that a certain demographic is not deprived of medical assistance and treatment. It also refers to the responsibility of healthcare professionals to adhere to legislation in their decisions. However, it can be argued that the principle of justice is not always applied in healthcare, as individuals who are of lower socioeconomic status or identify with minority races may receive unequal treatment.

The Hippocratic Oath

Another source medical practitioners use as a basis for ethics is the Hippocratic Oath. Originating from Ancient Greece, the oath emphasizes for those who swear by it to uphold ethical standards, including the popularized phrase to “first do no harm.” While many adaptations have been made, the 1964 version rewritten by Tufts University Academic Dean Louis Lasagna is used in many medical schools today. In this version, individuals swear to respect privacy, prevent disease, protect the environment, and view patients as human beings, among other criteria. The Hippocratic Oath remains a reminder in the medical community to uphold high standards of patient care and practice medicine ethically.

The study and practice of bioethics through its main principles of autonomy, non-maleficence, beneficence, and justice have improved the standards and quality of healthcare in all settings. In the next part of this Ethics in Healthcare series, we will explore how ethical issues in healthcare often arise when there is a conflict between the four principles.

2020 marks the 30th Anniversary of Michael Creighton’s epic novel Jurassic Park. This book directed the trajectory of my first career as a technical research specialist and my current pursuit of intellectual property licensing professional.

First published in 1990, Creighton’s novel intercalated burgeoning genetic engineering techniques with science fiction to produce an intellectually stimulating tale respected by both scholars and Sci-Fi aficionados. The story’s premise: extinct dinosaurs are reintroduced into present-day existence using DNA extracted from fossilized material. Not surprising, the dinosaurs are unsuccessfully assimilated into a zoo-like habitat on a remote island^[1]. While some (not me) have criticized Creighton for employing scientific poetic license to enhance the literary and cinematic drama of Jurassic Park, few have scrutinized the legal latitude taken within the novel. The intellectual property implications involving the fictitious R&D company, International Genetic Technologies, Inc (InGen) begs to be examined!!!

First Edition Cover; Artist: Chip Kidd, Publisher: Alfred A. Knopf

The novel closed with InGen filing for Chapter 11 bankruptcy protection on October 5, 1989. Because cataclysmic mayhem broke out on Isla Nublar (Site 1) in August of the same year, company lawyers attempted to mitigate their losses by liquidating assets before the Park officially opened. Given this information, it is fair to hypothesize that both the technological capabilities in genetic engineering as well as U.S. laws regarding intellectual property owned or licensed by the parent company were those applicable to the mid and late1980’s.

Noteworthy legal embellishments were taken regarding InGen‘s “patented” dinosaurs. I feel it is safe to speculate that before the mythical law firm of Cowan, Swain, and Ross engaged InGen as a client, the firm would have comprehensively appraised the company’s assets and liabilities and evaluated the commercial potential of the proposed patentable technology. The Firm would have mobilized their IP Management team and probably engaged outside counsel to provide a comprehensive patentability analysis to assess among other things if the tech satisfied 35 U.S.C.101, 102, 103, and 112 requirements e.g.

1. whether the invention created by John Hammond and Dr. Henry Wu (company chief geneticist) was patent-eligible
2. if the technology to regenerate extinct animals from fossilized DNA could be described as useful, novel, and non-obvious
3. whether a patent could be enforced, and if so, the potential scope of the claims, and
4. whether the product and process of InGen would infringe the enforceable rights of a third party.

Herein lies a conundrum in the storyline and the slippery slope of subject matter eligibility.

Laws of nature, natural phenomena, and abstract ideas are patent ineligible

Creighton alludes to “patented” dinosaurs. As a U.S. company (headquartered in Palo Alto, CA), InGen would have been bound by the prevailing laws regarding patents. The Constitutional statute governing patents is codified in Sections 100 – 105 of Title 35 of the United States Code. At a minimum, a patent may be conferred to:

Caveats to the exclusivity of patent rights is that the invention must be novel, non-obvious, and not directed toward a judicial exception i.e. laws of nature, physical phenomena, and abstract ideas.^[3] With one or more patents, InGen could prevent others from making, selling, using, or manufacturing the product or process they invented.

Realistically speaking, could any of the dinosaurs regenerated from fossilized DNA in Jurassic Park skirt the law of nature judicial exception or the novelty requirement for a method of acquiring dinosaur DNA?

Yes and No!

In the 1980s, a radical change to laws governing subject matter eligibility occurred. In the strictest sense, Dr. Henry Wu’s groundbreaking work at InGen would have fallen within the realm of a judicial exception i.e., law of nature, and therefore be considered patent ineligible. But, the precedential Supreme Court decision of Diamond v. Chakrabarty, 447 U.S. 303 issued June 16th, 1980 made living, man-made micro-organisms patent eligible as a “manufacture” within the meaning of the 1952 Patent Act.^[4] This decision would have given InGen counsel and executives the green light to embrace the avant-garde technique of cloning dinosaurs.

In 2013, the US Supreme Court nullified in part the range of patentable material previously allowed by Diamond v. Chakrabarty with the Molecular Pathology v. Myriad Genetics^[5] ruling. But, since this would not be relevant for 24 years from InGen’s initial discovery, their right to exclusivity would have expired!

Anticipation and Obviousness

What if InGen’s “patented dinosaur” technology was a method of extracting DNA from fossilized material as opposed to the animals per se? Would the method be patent-eligible?

Yes (maybe) and No!

In the1980’s, DNA extraction was not a novel technique. Isolation of genomic DNA, plasmid DNA, and RNA, while laborious, was regularly performed. If InGen were patenting a specific method of extracting DNA from fossilized material, sequencing and aligning said DNA, supplementing un-interpretable codons with commensurate Xenopus laevis DNA sequence, using said manipulated DNA to asexually fertilize a recipient ovum, and incubating the resulting embryo in a surrogate host until parturition, that might be considered novel, un-obvious, not anticipated by the prior art and therefore patent-eligible.

Description

An issued patent on InGen’s dinosaurs would have necessitated that enough information be publically made available so that someone, skilled in the art, could make or use the invention without undue experimentation.^[6] Without a detailed description, the USPTO would have rejected Ingen’s patent application with a 35 USC 112 rejection. In light of the requisite public disclosure, why would the nefarious Dennis Nedry (Park computer programmer/industrial spy) and Lewis Dodgson (unscrupulous product development chief at a rival company, Biosyn) have needed to steal the technology?^[7]. We know all too well how that turned out!

Epilogue

Sharon Begley of STAT has asserted that “[d]e-extinction” efforts are on the horizon^[8]. The practical utility of regenerating dinosaurs … is arguable. As of 2020, one or more of the 15 species of dinosaurs created in the original Jurassic Park could possibly be patent-eligible. An IP expert could reasonably argue that InGen’s de-extinct creatures are not exact recreations of those animals that roamed the earth 235 million years ago and represent a totally man-made manufacture. While someone “skilled in the art” could probably find the method of extracting dinosaur DNA from the blood of ancient insects preserved in amber as experimentally flawed, it still makes for a totally enjoyable story 30 years later.

— Renee Shaw

Citations:
^[1] Crichton, Michael. Jurassic Park. New York: Ballantine Books, 1990.
^[2] USPTO https://www.uspto.gov/about-us/news-updates/us-patent-system-celebrates-212-years via @USPTO
^{>[3]</sup https://en.wikipedia.org/wiki/United_States_patent_law
[4] Diamond, v. Chakrabarty, PhD 447 U.S. 303 (1980) Supreme Court Decided June 16th, 1980 Citations: 447 U.S. 303, 100 S. Ct. 2204, 65 L. Ed. 2d 144, 1980 U.S. LEXIS 112
[5] U.S. Supreme Court,
ASSOCIATION FOR MOLECULAR PATHOLOGY ET AL. v. MYRIAD GENETICS, INC., ET AL. 12-398
[6] MPEP
[7] “The Science of Jurassic Park and the Lost World” by Rob DeSalle and David Lindley; 1997; Basic Books publisher
[8] Scientists Have Reconstructed the Genome of a Bird Extinct for 700 Years
By Sharon Begley, STAT on February 27, 2018}

Creativity and inventiveness don’t stop because it’s mealtime. As many patents show, there are always problems to be solved, regardless of how big or small the issue is. In this season of Thanksgiving, we want to say thanks to the inventors and patent holders of intellectual property that has made Thanksgiving better, easier, or just more interesting… read to find out more about 6 patents that can help you have a fantastic Thanksgiving from start to finish!

“Cranberry harvesting method and apparatus”
Ever wondered about how cranberries move from the field to your table? If so, then U.S. Patent #5375402 is for you. Called the Cranberry harvesting method and apparatus, the patent includes a “frame movable through a field of plants, a revolvable surface carried by the movable structure and supported to revolve about a horizontal axis, and resilient, rubbery fingers mounted rigidly on the revolvable surface and projecting outwardly therefrom.”Happy Harvesting!

“Animated wildfowl decoy”
While harvesting cranberries is one way to put Thanksgiving dinner on the table, some of you may prefer to play a more active role in acquiring your Thanksgiving delicacy. If you plan to go hunting for fresh meat on Thanksgiving, you may want to check out U.S. Patent #5289654, described as “an animated decoy simulating the external appearance and certain head and neck movements of a wild turkey.” Essentially hollow, the animated turkey neck includes interconnected, longitudinal segments.

“Disposable cooking pan”
After using the Animated Wildfowl Decory and Cranberry Harvesting Method and Apparatus—or just heading out to the grocery store—you’ve gathered up all of your ingredients for a delicious Thanksgiving meal. Next up, you’ll need cooking supplies, and U.S. Patent #5628427 has got you covered. You’ve probably used this disposable cooking pan a time or two, and it’s easy-to-use, “single sheet of metal” design with a bottom panel, continuous wall panel, and continuous rim are perfect for cooking up a Thanksgiving treat!

“Cooking jacket”
If you want to keep your turkey comfortable and stylish while it cooks, be sure to dress it with U.S. Patent #4942809. Actually, this fashionable finery for our formerly feathery friend is to make lifting it out of the pan less difficult. Used for cooking large pieces of meat, the cooking jacket “enables turkey or other pieces of meat to be retained in a jacket structure and easily lifted from the cooking pan, pot, vessel or the like.”

“Turkey baster”
After all of your hard work preparing your feast, you’ll certainly want to make sure that your turkey doesn’t go dry! You can keep it juicy and flavorful with U.S. Patent #D390070, known as the turkey baster.

“Method and apparatus for molding fruits”
Let’s say that, sadly, Aunt Gertrude is unable to make it this year. No worries! With enough notice, you can use U.S. Patent #4827666, designed for “growing squash, cucumbers and other fruits in desired shapes.” It can even create “long-lasting sculptural items!” Use U.S. Patent #4827666 to create a sculpture of Aunt Gertrude and it’ll be like she’s with you the entire meal…until you finish eating.

Happy Thanksgiving!