United States: Life Science Patent

Last Updated: December 19 2014
Practice Guide by Brinks Gilson & Lione

The field of life science patents is an important, emerging area that involves many small and startup companies. Moreover, patents in this area have unique attributes, hence this dedicated section.

A. Definition of a Life Science Patent

Patents claiming subject matter that includes drugs, biological research assay tools, medical devices, agricultural products, biofuels, food, and cosmetics are sometimes described collectively as “life science patents.”

B. Value of a Life Science Patent

Patents are the lifeblood of any innovative life science company. Patents and their licensing play critical roles for organizations as diverse as pharmaceutical companies, medical device companies, and manufacturers of instruments and reagents. Increasingly, universities conducting life science research are using these patents to generate income.

However, patents do not serve the same purpose for all organization.

Specifically,

• Life science startups and smaller companies generally need to raise capital to fund their R&D efforts long before a product is ready for sale. An intellectual property portfolio likely will be necessary to attract investors who want to see some evidence of significant future earnings potential.

• On the other side of the equation, large pharmaceutical companies do not need to garner venture capital, since they use profits from existing products to fund new projects. The investment required to fund these new research efforts and to bring a drug to market is high; current estimates put the cost at around $800 million. A strong patent portfolio is needed to ensure that the innovator company can protect the return on investment necessary to fund those future research efforts.

• There is a trend where these two interests are coming together— large pharmaceutical companies or medical device companies are acquiring or partnering with smaller life science companies to develop new products.

• Universities play a role in generating intellectual property for both life science startups and large companies. Many universities have established or are in the process of establishing technology transfer offices in order to capitalize on the intellectual property generated by their faculty. The universities seek to out-license intellectual property to companies or, in some cases, to develop the intellectual property internally to generate revenue to fund research at their respective institutions. In recent years this effort has been spurred by a decrease in government funding for research.

C. Trends in Life Sciences and Intellectual Property Needs

Trends in this evolving area include:

1. Alliances. More and more large pharmaceutical companies or medical device companies are making alliances with smaller life science companies in order to develop new products. These agreements must be carefully drafted in order to properly allocate intellectual property rights and responsibilities.

2. Biologic Drugs. Biologic drugs are becoming more common, and along with them come unique patent challenges. The Biologics Price Competition and Innovation Act of 2009 (BPCIA), enacted as part of the Patient Protection and Affordable Care Act of 2010 (“PPACA”), created an abbreviated pathway for the U.S. Food and Drug Administration (FDA) to approve biosimilars.

3. Medical Devices. Medical devices are being coupled with drugs in products such as drug-coated stents and drug-nanoparticle delivery systems. In addition to separate drug and medical device patents, patents for the combined systems may provide additional intellectual property protection.

4. Biostrategies. Companies are turning to biostrategies in an effort to cut greenhouse emissions,. For example, companies are using bacteria to transform plant matter into usable fuel. Protection of the intellectual property related to such biostrategies is critical in order to spur investment.

D. Patentability

The requirements for obtaining patents on an invention in the life science area are the same as those for any other patent; the invention must be novel, nonobvious, and useful. However, there are several areas related to the prosecution and patent term of life science patents that may be different and that may require a higher level of disclosure.

1. Utility. As in other technologies, the specification must disclose the invention’s utility. For life science inventions, however, this can be difficult. For example, in order to claim a particular chemical compound as a drug, information about its utility is given, generally in the form of data relating to the compound’s activity. The data does not need to show that the drug is safe and effective; it is enough to provide information that enables one of skill in the art to determine that the compound is useful as a drug. Another example where utility is not immediately obvious is when the invention is directed to a newly discovered DNA sequence. The fact that the sequence is new does not necessarily make it patentable. In addition to being novel, the specification must describe a credible and substantial use for that DNA sequence. Often this requires performing tests to determine the DNA’s function.

2. Detailed Description of the Invention. As with all patents, there is a requirement for a full and clear description of the invention, which enables one of skill in the art to make and use the invention (“enablement requirement”). In general, reduction to practice is not actually required because a full and clear disclosure of the application can be given without actually constructing the invention. In most cases, the provision of drawings is sufficient to show that the inventor had possession of the invention at the time of filing. However, for certain life science inventions the courts have required a heightened level of disclosure (the “written description requirement”). Fulfillment of this requirement may require disclosure of more specific embodiments of the invention than are necessary for other types of invention, and often may require disclosure of data to show that the invention works for its intended purpose.

E. Patent Term

1. Patent Term Adjustment (PTA). As is the case for other patents, the term of a patent may be lengthened to make up for USTPO delays in issuance. This increase in the patent term is referred to as a “Patent Term Adjustment” or PTA.

2. Patent Term Extension (PTE). Patent Term Extensions are available only for patents covering inventions that must be approved by the FDA before being marketed. Generally, life science patents can be separated into two areas depending on whether regulatory approval is required before the invention may be sold. Inventions that are used in the discovery of drugs or biologics, or the development of medical devices, generally do not require FDA approval in order to be sold, whereas drugs, biologics, and medical devices do require FDA approval before being marketed. FDA approval requires extensive testing, which can take approximately three (3) to ten (10) years to perform. Because patents are generally filed well in advance of FDA approval, the patent term is effectively shorted by the delays to gain approval.

To compensate for the delay, the Hatch Waxman Act of 1984 provides for a PTE for a patent covering an approved drug. Subject to certain limitations, the patent term may be extended up to five (5) years for a new drug, depending on the length of regulatory delay. An additional six months of exclusivity may be obtained if the drug developer submits certain FDA-requested information relating to the use of the drug in a pediatric population.

To balance out the benefit to the innovator patent owners, the Hatch Waxman Act also provides a path by which generics companies can enter the market with the same drug immediately upon the patent’s expiration (including PTAs and PTEs) or after the patent is invalidated by a court. The generics company need only show that the approved drug and the generic drug are bioequivalent; that is, that they are identical molecules that act in the same way.

In addition, with the passage of the BPCIA, an abbreviated regulatory pathway is now available by which generic companies can gain approval of biologic drugs such as antibodies, nucleotides, siRN A, etc., often referred to as “biosimilars” or “biogenerics.” Because of the difficulties associated with manufacturing a biologic with exactly the same structure, the FDA’s general stance is that there are no true “generic biologics” but rather biosimilars.

The complete details of the Hatch-Waxman Act and the BPCIA are beyond the scope of this section, but it is worth noting that while the biosimilars pathway is similar to some aspects of Hatch-Waxman, there are differences in several key provisions. For example, the BPCIA sets forth very different provisions governing the notice requirement, the mechanics of challenging patents covering approved biologics, and the length of “data package exclusivity.” Data package exclusivity is the term used for the timeframe after market approval during which the FDA cannot approve the same drug for the same indication if the generic applicant relies on the innovator’s data for approval.

F. Regulatory Protection

In addition to PTEs, a new drug may be eligible for three (3) or five (5) years of data package exclusivity, and a biologic is eligible for twelve (12) years of data package exclusivity regardless of whether a patent is in force. In addition, biologics receive four (4) years of market exclusivity that runs concurrently with the 12-year data exclusivity. Both biologics and drugs that are approved for treatment of a patient population of < 200,000 (i.e. orphan drugs) receive 7-year market exclusivity for the approved indication.

To find out more please access our IP Primer page.

This document is not intended to create an attorney-client relationship. You should not act or rely on any information in this document without first seeking legal advice. This material is intended for general information purposes only and does not constitute legal advice. If you have any specific questions on any legal matter, you should consult a professional legal services provider.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Contact the Author?
Click here to email the Author
View Template
Click to View the Template
Some comments from our readers…
“The articles are extremely timely and highly applicable”
“I often find critical information not available elsewhere”
“As in-house counsel, Mondaq’s service is of great value”

Supporting Documents
Other United States Advice Centers
Advertising and Marketing
Telemarketing
More Advice Centers
Useful Resources
The IP primer provides an overview of the complexities of IP law, is an excellent resource for both new and experienced professionals and available in a number of languages.
A collection of recent and significant publications by the Experts at BGL.
USPTO is the federal agency for granting U.S. patents and registering trademarks.
Administers the U.S. copyright law and advises Congress and other government agencies regarding copyright issues.
WIPO is the global forum for intellectual property services, policy, information and cooperation.
INTA is a global association of trademark owners and professionals.
The Intellectual Property Owners Association is a trade association for owners of patents, trademarks, copyrights and trade secrets.
The AILPA is an innovator, powerful advocate, and visible global leader in intellectual property.
AIPPI is an international organization comprised of business firms, executives, lawyers, educators, patent and trademark agents, intellectual property owners, and other persons interested in the worldwide protection of patents, designs, trademarks, trade names, know how, goodwill, copyright, and other intellectual property rights and the elimination of unfair trade practices.
BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations.
Supports innovation, competitiveness and economic growth across Europe through a commitment to high quality and efficient services delivered under the European Patent Convention.
Upcoming Events
Tools
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
 
Email Address
Company Name
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions