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Top Adding - Texas Non-competes Easy to Enforce Under New Ruling
The Texas Supreme Court issued a decision Friday that will make non-compete agreements significantl
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
y easier for employers to enforce. An employer may now enforce its non-compete restrictions even i
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
f it did not provide anything of value to the employee at the time the agreement was signed.
The S
The S
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
upreme Court criticized lower courts and lawyers for reading too much into its 1994 decision which
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
as long governed non-competes. The requirements that non-competition agreements arise out of enfor
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ceable agreements between the employer and employee were not meant, the court said, to create the “
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
overly technical disputes” that have occurred since the Court issued that 1994 decision.
“This cha
“This cha
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
ges the playing field completely,” said Dallas lawyer Matt Hill, who advises and represents employe
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
es concerning their non-competes. “Under the previous standard, most of the non-compete agreements
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
I saw were unenforceable. Now, almost all will be enforceable.”
The decision will most affect at
The decision will most affect at
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
will employees who have no guarantee of continued employment. “It used to be a two-way street,” Hi
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
ll said. “Employers had to give employees something of value to bind them. Now, it’s not clear th
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
at is still true.”
The new decision will make it much more difficult for employees to invalidate t
The new decision will make it much more difficult for employees to invalidate t
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
heir non-competes. The focus now, Hill said, will be whether the restrictions placed on the employ
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
e are reasonable.
“This decision really undercuts the ability of employees to make a living in Tex
“This decision really undercuts the ability of employees to make a living in Tex
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
as,” Hill said. “If an employee isn’t willing to risk being sued, he can be frozen out of the fiel
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
d he’s worked in all his life.”
The main lesson for employees from the decision, Hill said, is to
The main lesson for employees from the decision, Hill said, is to
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
now what they are getting into when they sign an agreement with the company. “On the front end, if
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
an employer wants you, they’re willing to work with you to make the restrictions reasonable. Once
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
you’ve signed, though, you’re stuck. And now the court is saying it won’t save you from yourself.
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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