Welcome to the Weintraub Tobin Resources Page

Browse below for news, legal insights, information on presentations and events, and other resources from the Weintraub Tobin legal team.


Upcoming Speaking Engagement: Healthcare Reform, The Law & Wellness: It’s Still Crunch Time

Labor & Employment attorney Beth West will speak at this SACTO workshop, which will equip you with the resources, tools, and knowledge you need to get your business ready for a healthier, more productive, and compliant workplace. Learn more about the recent changes and new timeline for Healthcare Reform as well as successful wellness programs that have been implemented across companies of all sizes in the Sacramento Region.

Be Smart, Be Ready, Be Compliant

2015 will be here before you know it. It’s time to start preparing as we embark on a new era of healthcare opportunities. Please join us for a panel discussion that will ultimately save you time, money and energy in the future as we start to ask the questions:

Who:

Who is going to be impacted by Healthcare Reform?

What:

What will happen if you are compliant with the new regulations?

Why:

Why is Healthcare Reform beneficial?

Why are wellness programs becoming so popular?

Are they mandatory?

How:

How do I get compliant before 2015?

Panelists:

Insurance:
Liliana Salazar, Senior Vice President of Compliance, Wells Fargo Insurance Services and Vinny Catalano, Area Vice President,
Arthur J. Gallahger & Co., Inc.

Law:
Beth West, Shareholder, Weintraub Tobin Coleman Grodin Law Corporation

Tax:
Brian Conner, Partner, Moss Adams LLP

Wellness:
Alex Lara, President & Co-Owner, Thrive – Educate. Train. Inspire.

Event Details:

Tuesday, August 27, 2013
8:00 – 11:00 a.m.
24 Hour Fitness
1020 7th Street
Sacramento, CA

Healthy breakfast will be provided by Whole Foods.

Register Today!

No cost to attend. To register yourself or other employees of your company, contact Ashley Brown at SACTO at (916) 441-2144 or abrown@sacto.org by August 20, 2013.

Overcoming Proscrastination – Tips for Starting and Completing Your Estate Plan

Are you having trouble completing or updating your estate plan, although you are convinced you should? Maybe you have a referral to an attorney recommended by a friend or other advisor, but you haven’t yet scheduled the first meeting? Or you have attended the first meeting with your estate planning attorney, but you can’t quite seem to finish your action list for the next meeting?

Estate planning is not the top of anyone’s “to do” list. As an estate planning attorney, part of my job is to help my clients complete their estate plans. No one intends to delay the process, but many times the process stalls.

Here are some ideas that have helped my clients cross the finish line and enjoy the relief that a completed plan brings. See if they work for you!

Prop 65 Revisions are Ongoing, Public Meeting on July 30, 2013

This is from OEHHA’s website; the colored comments are ours.

On July 30, 2013, the Office of Environmental Health Hazard Assessment (OEHHA) will hold a public pre-regulatory workshop for the purpose of gathering input from interested parties on the content of a regulation that would address Proposition 65 warnings. Such a regulation, if formally proposed and adopted, would either supplement or replace existing OEHHA regulations governing Proposition 65 warnings and conform to any statutory changes if enacted.

The workshop will take place from 10 am to 3:30 pm in the Coastal Hearing Room at the Cal/EPA Headquarters Building, 1001 I Street, Sacramento, CA. The workshop will be webcast. The URL for the webcast (not active until the day and time of the meeting) is: http://calepa.ca.gov/Broadcast/.

Potential Regulatory Action OEHHA is considering a rulemaking that would provide for more informative and meaningful warnings to individuals concerning exposures to carcinogens and reproductive toxicants. The regulation would offer a variety of options for businesses that are required to provide these warnings, and would provide businesses with greater certainty that their warnings comply with Proposition 65.

At this time, OEHHA believes the regulation should include the following:

  1. A requirement that a warning inform an individual that he or she will be exposed to a listed chemical.
  2. The minimum information that must be included in all warnings, including the health effect (cancer, male reproductive toxicity, female reproductive toxicity, developmental toxicity) for which the chemical(s) involved in the exposure was listed; information on how a person will be exposed; and, where applicable, simple information (such as washing hands) on how to avoid or reduce an exposure.

This will make warnings more difficult and present additional avenues for litigation, particularly if there are more than one Prop 65 chemical present and more than one avenue of ingestion

  1. Approved warning methods and content for use by product manufacturers and retailers regarding exposures to listed chemicals from consumer products, including products sold at retail establishments and products sold via the internet. These approved methods may include alternatives to on-product warning.

This may be adequate although previous attempts to make this change have been unsecessful, as many parties have asserted that warnings need to be at the point of sale.

Approved warning methods and content for use by manufacturers and retailers regarding exposures to listed chemicals in foods, including foods sold at retail establishments and food products sold via the internet. These approved methods may include alternatives to on-product warnings.

Same as above, there is a prejudice by the AG for having the warning at the point of sale, in the store. It would be useful to have specific standards set to ease compliance questions.

  1. Approved warning methods and content for environmental exposures, including exposures an individual may experience when entering or spending time in an area where listed chemicals are present. OEHHA intends to provide specific warning language and methods for some common environmental scenarios, such as parking structures, food courts, hotels, apartments and other businesses, to provide greater clarity and certainty where appropriate.

Makes Sense

  1. Requirements and approved methods for providing additional contextual information to persons concerning exposures to listed chemicals. Such information would allow individuals to learn more about some or all of the specific chemicals involved in the exposure, and the applicability of other state and federal laws to these exposures. This information would not have to be provided prior to the exposure, but instead would have to be available to the public on a web site or other generally accessible location.

Makes sense, although it will cause manufactures and retailers to engage in additional efforts prior to sale.

  1. Reasonable transition times for businesses to come into compliance with this regulation and recognition of existing warnings that are included in court-approved settlements.

We try to draft our settlement agreements to include this time.

Upcoming Seminar: Overtime or No Overtime: How to Properly Analyze the Exempt Status of Employees

Summary of Program
The ever increasing number of claims filed with the Department of Labor and California Labor Commissioner for unpaid overtime, and the increasing number of wage and hour class action lawsuits, highlight the importance of correctly classifying employees as exempt or non-exempt. This seminar is designed to help employers and HR professionals gain a more thorough understanding of the various exemptions available under California law and learn how to conduct an exemption analysis in order to reduce potential liability.

Program Highlights

  • A discussion of the exemptions available.
  • Checklists for determining if your employees are exempt.
  • How to conduct a self-audit to ensure that employees are properly classified.
  • What to do if your employees have been misclassified.

Seminar Program
9:00 a.m. Registration and Breakfast
9:30 a.m. – 11:30 a.m. Seminar
Approved for 2 hours MCLE credit; HRCI credits available upon request.
There is no charge for this seminar.

RSVP
Ramona Carrillo
400 Capitol Mall, 11th Fl.
Sacramento, CA 95814
916.558.6046
rcarrillo@weintraub.com

FDA Proposes Arsenic Action Level for Apple Juice

On July 12, 2013 the FDA announced a proposed action level of 10 ppb (parts per billion) for arsenic in apple juice. The 10 ppb is the same as EPA arsenic in drinking water standards.

“The FDA is committed to ensuring the safety of the American food supply and to doing what is necessary to protect public health. “We have been studying this issue comprehensively, and based on the agency’s data and analytical work, the FDA is confident in the overall safety of apple juice for children and adults.” “While the levels of arsenic in apple juice are very low, the FDA is proposing an action level to help prevent public exposure to the occasional lots of apple juice with arsenic levels above those permitted in drinking water,” said Michael R. Taylor, the FDA’s deputy Commissioner for Foods.

The FDA is establishing this threshold to provide guidance to industry however the agency may take the action level into account when considering an enforcement action, if it finds a food product exceeds the threshold.

The FDA indicated that it has been monitoring the presence of arsenic in apple juice for the last 20 years and has found that most samples contain levels of arsenic that are low. Last year the FDA released findings from an analysis of 94 samples of arsenic in apple juice. 95 percent of the apple juice samples tested were below 10 ppb total arsenic; 100 percent of the samples were below 10 ppb for inorganic arsenic, the carcinogenic form of arsenic. The assessment is based on lifetime exposure. Inorganic arsenic may be found in foods because it is present in the environment, both as a naturally occurring mineral and because of activity such as past use of certain pesticides.

Of interest for Prop 65 practicioners, will be how this number impacts Prop 65 levels. Currently there is a NSRL (No Significant Risk Level ) for inorganic arsenic of 10 micrograms per day. The NSRL for Proposition 65 is the intake associated with a lifetime risk of one in 100,000 for cancer.

The agency will accept public comments proposed action level for 60 days.

Upcoming Seminar: The Intricacies of Wage and Hour Laws for Non-Exempt Employees

Summary of Program
Unfortunately, both single-plaintiff and class-action wage and hour lawsuits continue to plague California employers. Often employers are sued because of technical violations that occur simply because the employer is unaware of its legal obligations. Come join the Labor and Employment Group at Weintraub Tobin as they discuss the “Ins and Outs” of wage and hour compliance for “nonexempt” employees – there’s more to it than merely paying overtime and providing meal periods.
Some Program Highlights:

  • Actual hours worked” and problems with “off the clock” work –
    ○ 24/7 connectivity through computers and mobile devices may create compensation issues.
  • Is your overtime rate correct?
    ○ It depends on whether you’ve properly calculated the employee’s “regular rate.”
    ○ What is and is not included in the “regular rate?”
  • Are you “providing” a meal period to your employees?
    ○ If your answer is “No” because you have an “on duty” meal period agreement with your employees – Is it valid?
    ○ If your answer is “No” because the Brinker case says you don’t have to – You’ll be surprised to learn that this is not so.
  • “Flex-time,” “make-up time,” and “alternative work” schedules.
    ○ What’s legal and what’s not?
    ○ What are the courts saying – highlights of recent decisions regarding non-exempt wage and hour issues in California.

Seminar Program
9:00 a.m. Registration and Breakfast
9:30 a.m. – 11:30 a.m. Seminar
Approved for 2 hours MCLE credit; HRCI credits available upon request.

There is no charge for this seminar.

Location
Weintraub Tobin
400 Capitol Mall, 11th Floor
Sacramento, CA 95814

RSVP
Ramona Carrillo
400 Capitol Mall, 11th Floor
Sacramento, CA 95814
916.558.6046
rcarrillo@weintraub.com

This seminar is also available via webinar. Please indicate in your RSVP if you will be attending via webinar.
If attending via webinar, MCLE and HRCI credits will be provided upon verification of attendance for the entirety of the webcast.

Parking validation provided. Please park in the Wells Fargo parking garage, entrances on 4th and 5th Streets.

Character Copyright — Is Sherlock Holmes in the Public Domain?

Currently pending before the United States District Court for the Northern District of Illinois is a case that will determine whether the Estate of Sir Arthur Conan Doyle has any remaining copyright interest in the iconic character of Sherlock Holmes, and his friend and companion in sleuthing, Dr. John Watson.

The fictional detective and his sidekick first made their appearances in “A Study in Scarlet,” published in 1887. By 1923, Doyle had written and published some fifty-six short stories and four novels wherein Holmes and Watson solved numerous cases through Holmes’ unique analytic and deductive methods, all the while interacting with various supporting characters, including Scotland Yard’s Detective Lestrade, their landlady Mrs. Hudson, Holmes’ brother Mycroft, and his arch-nemesis Professor Moriarty. Each of those pre-1923 works is now in the public domain in the United States. Approximately ten Sherlock Holmes stories, published after 1923, remain protected by copyright.

Malibu lawyer, and Sherlock Holmes aficionado, Les Klinger, is the author of numerous books and articles regarding the Sherlock Holmes canon. In 2011, he published, as co-editor, a collection of new short stories by contemporary writers featuring Sherlock Holmes and some of his supporting characters, titled “A Study in Sherlock.” In connection with that publication, the Doyle Estate demanded, and Klinger’s then-publisher paid under protest, a license fee for the use of Holmes and the other characters in the story collection.

Klinger recently compiled and edited, and is ready to publish, a second collection of new Sherlock Holmes stories by contemporary writers, tentatively titled “In the Company of Sherlock Holmes.” The Doyle Estate has once again demanded a license fee, but Klinger’s new publisher would not agree to pay it. Neither would it publish the new story collection while the Doyle Estate’s claim of copyright ownership remained unresolved.

Accordingly, Klinger has filed a single cause of action complaint against the Estate, seeking a declaration that the Sherlock Holmes character, as well as the other characters that first appeared in the pre-1923 works, are in the public domain, and can freely be used by Klinger or anyone else in new literary or audio visual works without infringing on any of the Estate’s copyrights.

Klinger’s position is that Holmes and Watson (as well as the other supporting characters) were fully delineated characters, with all of their respective well-known characteristics, by 1923, and accordingly the characters fell into the public domain along with the works in which they first appeared. The Estate’s position, as expressed by its attorney to the New York Times shortly after the filing of the lawsuit, is that “Holmes is a unified literary character that wasn’t completely developed until the author laid down his pen.” Since Doyle included the Sherlock Holmes character in ten stories published after 1923 – that are still within the term of copyright protection – the Estate apparently is arguing that the copyright in the character will remain with the Estate until the last of those post-1923 works falls into the public domain.

This case highlights an interesting issue – that of the copyrightability of a character as separate and distinct from the work in which that character appears. It was first addressed in 1930 by Judge Learned Hand in Nichols v. Universal Pictures, and Judge Hand’s description of the issue remains to this day the touchstone for determining when a character becomes copyrightable:

“If Twelfth Night were copyrighted, it is quite possible that a second comer might so closely imitate Sir Toby Belch or Malvolio as to infringe, but it would not be enough that for one of his characters he cast a riotous knight who kept wassail to the discomfort of the household, or a vain and foppish steward who became amorous of his mistress. . . . It follows that the less developed the characters, the less they can be copyrighted; that is the penalty an author must bear for marking them too indistinctly.” 45 F.2d 119, 121 (2d Cir. 1930).

In 1954, in a case involving Dashiell Hammet’s Maltese Falcon, the Ninth Circuit applied a rigorous test for granting copyright protection to a character – namely, whether the character “constitutes the story being told.” If so, then he is protected by copyright. If, on the other hand, “the character is only the chessman in the game of telling the story he is not within the protection afforded by copyright.” Warner Bros. Pictures, Inc. v. Columbia Broadcasting System, Inc., 216 F.2d 945 (9th Cir. 1954).

The factual circumstances of that case – which no doubt influenced the court’s conclusions – were unusual: Warner Bros. had been assigned the copyright in the Maltese Falcon in order to produce a motion picture based on the novel. When Hammett then assigned the Sam Spade character to CBS for use in different stories, Warner sued for copyright infringement. The Court found that Hammett – the original author – had the right to put his characters in other works and assign them to other parties, notwithstanding the fact that Warner had the rights to the original story, because the character was not itself copyrightable:

“We conclude that even if the Owners assigned their complete rights in the copyright to [Maltese Falcon], such assignment did not prevent the author from using the characters used therein, in other stories. The characters were vehicles for the story told, and the vehicles did not go with the sale of the story.” Id.

Cases from other Circuits, and later Ninth Circuit cases, have applied a less stringent test, requiring only that character in question be sufficiently distinctly delineated, with consistent, identifiable traits, in order to warrant copyright protection independent of the story in which he appeared. See Walker v. Time Life Films, Inc., 784 F.2d 44, 50 (2nd Cir. 1986); Rice v. Fox Broadcasting Co., 330 F.3d 1170, 1175 (9th Cir. 2003).

Under any analysis, however, it would appear that at least the great Sherlock Holmes was, within the first handful of stories, highly delineated, perhaps even to the point of constituting “the story being told.” As noted by another court, “[i]ndeed, audiences do not watch Tarzan, Superman, Sherlock Holmes, or James Bond for the story, they watch these films to see their heroes at work.” Metro-Goldwyn-Mayer, Inc. v. American Honda Motor Co., Inc., 900 F.Supp. 1287, 1296 (C.D. Cal. 1995).

If the Sherlock Holmes and Dr. Watson characters in fact reached copyrightable status in the earlier works, then it should follow that when those works fell into the public domain, so did the character. Accordingly, it will be interesting to see how the Estate defends the action, and what the ultimate ruling of the Northern District of Illinois will be. Given the significant number of Sherlock Holmes works currently being produced and distributed, it is undoubtedly a matter of substantial financial import to the Estate.

Attorneys’ Fees For “Bad Faith” Trade Secret Claims: How Pre-Discovery Disclosures Can Help

A central issue in all trade secret litigation is the adequacy of a plaintiff’s pre-discovery disclosure of the alleged trade secrets required by California Code of Civil Procedure section 2019.210. Section 2019.210 provides that a plaintiff suing for misappropriation of trade secrets must identify the alleged trade secrets with “reasonable particularity” before commencing discovery. The disclosure requirements of section 2019.210 can also be a valuable tool for a successful defendant seeking attorneys’ fees under the California Uniform Trade Secrets Act (“CUTSA”) for trade secret misappropriation claims brought in “bad faith.” California Civil Code section 3426.4 authorizes the trial court to award attorneys’ fees as a deterrent to specious trade secret claims. (FLIR Systems, Inc. v. Parrish (2009) 174 Cal.App.4th 1270, 1275.) Compelling a plaintiff to disclose the alleged trade secrets with “reasonable particularity” can be the first step in proving “bad faith.”

The purpose of section 2019.210 has been outlined in Advanced Modular Sputtering, Inc. v. Superior Court (2005) 132 Cal.App.4th 826. (See also, Perlan Therapeutics v. Superior Court (2009) 178 Cal.App.4th 1333.) These four purposes include: (1) promoting well-investigated claims and discouraging the filing of meritless trade secret complaints; (2) preventing plaintiffs from abusing the discovery process to learn about defendants’ trade secrets; (3) framing the issues in order to place reasonable limitations on discovery from defendants; and (4) allowing defendants to formulate well-reasoned defenses and not have to wait until the eve of trial. (Advanced Modular, supra, 132 Cal.App.4th at 833-34.

The Perlan court analyzed what has been described as the “’ubiquitous’ problems of litigating the appropriate scope and timing of trade secret identification.” (Id. at 1344.) Plaintiffs rarely provide detailed descriptions of the alleged trade secrets without a court order. They do so for numerous reasons, some more legitimate than others. Plaintiffs do not want to be tied down early in the litigation in the hope of amending or refining their contentions as the litigation and discovery progress. Plaintiffs also have the legitimate concern that, in the event defendants did not successfully misappropriate all their trade secrets, a detailed description in the section 2019.210 statement might somehow be leaked to the public, thereby depriving plaintiffs of the economic value of the trade secret. Conversely, defendants are legitimately interested in tying a plaintiff down early in the litigation for numerous reasons – the first of which was acknowledged by the Court in Advanced Sputtering: “[to promote] well-investigated claims and discourage the filing of meritless trade secret complaints.” (Id. at 833-34.)

A defendant must establish that a plaintiff brought a trade secret misappropriation claim in “bad faith” to obtain an award of attorneys’ fees. The courts have determined that “bad faith” consists of both “objective speciousness of the plaintiff’s claim . . . and . . . subjective bad faith in bringing or maintaining the claim.” (Gemini Aluminum Corp. v California Custom Shapes, Inc. (2002) 95 Cal.App.4th 1249, 1262; see, also, FLIR Systems, supra, 174 Cal.App.4th at 1275.)

The disclosure requirements of section 2019.210 help define whether there was any merit to the claim. “Objective speciousness exists where the action superficially appears to have merit but there is a complete lack of evidence to support the claim.” (FLIR Systems, supra, 174 Cal.App.4th at 1276.) The standards of Code of Civil Procedure section 128.7, subdivision (b) do not apply. Section 128.7, subdivision (b) does not allow sanctions if the plaintiff can establish that, at the time of filing the complaint, there was a belief the allegations would have evidentiary support after a reasonable opportunity to conduct discovery. That is not the definition of “bad faith” under CUTSA.

Accordingly, the plaintiff, to avoid a finding of “bad faith” under CUTSA, must point to some evidence of trade secret misappropriation. It is simply not sufficient to show that the plaintiff believed that, at the time of filing the complaint, discovery would uncover some evidence of misappropriation. The initial disclosures under section 2019.210 help define the alleged secrets to which evidence of misappropriation must pertain.

You Need an Estate Plan (Even in Your 20s and 30s)

In my two previous posts, I discussed the value of comprehensive estate planning even if you have a small estate or you want everything to go to your spouse. In this last installment, I will address the most common reason I hear from clients who say they don’t need an estate plan, which is, “I don’t need an estate plan because I have everything in beneficiary designation accounts.”

People often try to create a “do-it-yourself” estate plan by creating beneficiary designations on all of their assets. This is typically done by titling assets with another person “with right of survivorship,” holding assets jointly, or creating “payable on death” (POD) or “transfer on death” (TOD) accounts. I caution against using this approach for several reasons.

In California, you can have $150,000 in total assets (subject to a few exclusions) outside of a trust or without beneficiary designations without triggering a probate. Additionally, the threshold amount for transferring real property without a probate in California is $50,000. With TOD/POD accounts, if the designated beneficiary is deceased at your death and if no successor is named, the account goes back to your estate and counts toward the $150,000. The same is true if you are the surviving owner of property that had been owned “with right of survivorship,” which often happens with real property. If enough beneficiary designations fail or were never created, it is possible that a probate will be required.

Second, without a will, if any asset lacks a beneficiary or the beneficiary you have named does not survive you, that asset will be distributed according to the intestacy system. With an estate plan in place, you can name your “back-up” beneficiaries for any of these assets and avoid this default option.

Finally, a common problem is that people forget to change their beneficiary designations as time goes on, particularly if they have many accounts. It is not uncommon to have ex-spouses or estranged relatives named as beneficiaries because a person either forgot who the named beneficiary was or forgot about the account entirely. Beneficiary designation accounts require consistent monitoring to make sure that you have (a) named the correct beneficiaries and (b) the financial institution has processed your beneficiary designation forms correctly.

For these reasons, even the simplest estate plan is a worthwhile investment at any age. A proper plan will make provisions for managing your affairs if you become incapacitated and provide for an orderly distribution of assets upon your death, and it will fully reflect your wishes, rather than the judgment of a court or the California Probate Code.

(Natural) Genes are not Patentable

In Association For Molecular Pathology v. Myriad Genetics, Inc., decided on June 13, 2013, the United States Supreme Court held that isolated natural genes (DNA) are not patentable. Thus, genes that exist in a living organism, such as the human breast cancer genes BRCA1 and BRCA2 at issue in this case, are not made patentable because the inventor isolates them from the other genomic DNA. The Court was careful to explain that other inventions related to genes, however, are patentable. In particular, the Court held that the synthetic copy of a gene known as “complimentary DNA” (cDNA) is patentable, as well as methods of isolating genes and methods of using cDNA.

The decision was not surprising. The law has long been that naturally occurring biological compositions are not patentable subject matter. The Court applied that rule logically to find that a gene as it exists in a living organism is not patentable just because someone discovers it. In contrast to natural DNA, cDNA is not found in the living organism. The Court found that cDNA is a copy of the natural gene, synthesized in the lab; it is different from the natural gene in that it does not include the non-coding portions of the DNA that are present in the natural gene. The Court concluded that the cDNA is therefore patentable as a man-made composition.

BRCA1 and BRCA2 genes are associated with an increased risk of breast and ovarian cancer. A woman with specific mutations in these genes has a 50% to 80% chance of having breast cancer, compared with 12% to 13% risk for women without these mutations, and a 20% to 50% chance of having ovarian cancer. Myriad discovered the location of these genes and sequenced the most common mutations. They used this information to develop a screening test to determine if a woman has a high risk of cancer due to the presence of the BRCA1 and BRCA2 gene mutations.

Myriadobtained patents on the natural genes and on the cDNA. Other companies developed genetic tests to determine the presence of the BRCA1 and BRCA2 mutations, and offered genetic services to the public. Myriad then threatened its competitors with patent infringement suits. In response, all of the other test providers ceased offering their tests, and Myriad became the sole provider of BRCA genetic testing.

After several years, a group of cancer patients, physicians, and patient advocacy groups sued Myriad for a declaratory judgment of invalidity under 35 USC § 101 on the grounds that the patents on the genes covered products of nature. The district court granted summary judgment for the plaintiffs, finding that the claims were not valid. On appeal, the Federal Circuit Court of Appeals reversed the district court. The Supreme Court granted the plaintiffs’ petition for certiorari, vacated the judgment, and remanded the case back to the Federal Circuit. The Federal Circuit then decided that both natural DNA and cDNA were patentable. Plaintiffs again appealed to the Supreme Court. In this decision, the Court affirmed in part and reversed in part.

The Court described Myriad’s discovery as follows:

“The location and order of the nucleotides existed in nature before Myriad found them. Nor did Myriad create or alter the genetic structure of DNA. Instead, Myriad’s principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes within chromosomes 17 and 13. “

Myriad argued that the Supreme Court’s decision in Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980) was controlling. Chakrabarty was the Court’s leading case holding that phenomena of nature and products of nature are not patentable, but that a man-made bacterium was patentable. The Court correctly pointed out that the invention in Chakrabarty was man-made, as it was not a naturally occurring bacterium, while the genes that Myriad had patented were not man-made and exist in nature. The Court acknowledged the importance of Myriad’s discovery, stating that “groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the section 101 inquiry.” The Court held that the genes that Myriad had discovered are clearly products of nature, and therefore not patentable.

The Court reached the opposite conclusion with respect to Myriad’s claims directed to the cDNA it had synthesized. Because the cDNA is not naturally occurring, the Court held that it is patentable.

The Court emphasized the limitations of its holding, pointing out that it was not ruling on the patentability of methods of making genes, method of applying the discovered knowledge, or natural DNA whose sequences had been altered by the inventor.

Even though the Court’s decision was well reasoned, the reaction in the biotechnology community has been mixed. Some experts are concerned that biotechnology companies have lost significant value because their gene patents can and will be invalidated. Others believe that most biotechnology companies will not really be affected because they have also patented their cDNA compositions and methods of using those genes. What is certain is that the Court has made a clear rule, even if narrow: if you want to patent a gene, it had better not be the naturally occurring DNA.

The reaction of the public has been favorable. Many scientists view the decision positively because it confirms that genes (as they exist in nature) do not belong to anyone, but are in the public domain, giving them the freedom to conduct basic genetic research. Patients and doctors are happy because the BRCA genetic test should now be less costly and more accessible to patients.