Top Three Stories of 2013

by McDonnell Boehnen Hulbert & Berghoff LLP

FireworksReflecting upon the events of the past twelve months, Patent Docs presents its seventh annual list of top biotech/pharma patent stories.  For 2013, we identified fourteen stories that were covered on Patent Docs last year that we believe had (or are likely to have) the greatest impact on biotech/pharma patent practitioners and applicants.  On Tuesday, Wednesday, and Thursday, we counted down stories #14 to #4, and today we count down the top three stories of 2013.  As with our other lists (2012, 2011, 2010, 2009, 2008, and 2007), links to our coverage of these stories (as well as a few links to articles on related topics) have been provided in case you missed the articles the first time around or wish to go back and have another look.  As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with anything we included, please let us know.  In addition, we will be offering a live webinar on the "Top Patent Law Stories of 2013" on January 21, 2014 from 10:00 am to 11:15 am (CT).  Details regarding the webinar can be found here.

3.  Supreme Court Decides Monsanto v. Bowman -- Exhaustion Doctrine Does Not Allow Purchaser to Make New Copies of Patented Invention

In May, the Supreme Court issued its opinion in Bowman v. Monsanto Co., determining that the doctrine of patent exhaustion did not permit a farmer who buys patented seeds to repro­duce them through planting and harvesting without the patent holder's permission, affirming the Federal Circuit's decision that such activities amount to the creation of a newly infringing article.  Writing for a unanimous Court, Justice Kagan began a concise 10-page opinion by noting that "[u]nder the doctrine of patent exhaustion, the authorized sale of a patented article gives the purchaser, or any sub­sequent owner, a right to use or resell that article," but that such sale "does not allow the purchaser to make new copies of the patented invention."  Although the Bowman opinion provided a (rare) favorable outcome for the life sciences sector in 2013, Justice Kagan concluded the opinion by noting that the Court's holding "is limited -- addressing the situation before us, rather than every one involving a self-replicating product."

For information regarding this and other related topics, please see:

• "Organic Seed Growers & Trade Ass'n v. Monsanto Co. (Fed. Cir. 2013)," July 4, 2013
• "Bowman v. Monsanto Co. (2013)," May 13, 2013
• "Bowman v. Monsanto: Oral Argument," February 19, 2013
• "Parties Reiterate Arguments from Certiorari Petitions in Briefs to Supreme Court," February 18, 2013
• "Universities Urge Supreme Court to Affirm in Bowman v. Monsanto," February 18, 2013
• "WLF Files Amicus Brief in Support of Respondents in Bowman v. Monsanto," February 7, 2013
• "U.S. Government Requests Argument Time in Bowman v. Monsanto -- at Monsanto's Expense," February 5, 2013
• "It Ain't Necessarily So Down on the Farm: Not All Farmers Agree with Farmer Bowman in Bowman v. Monsanto," January 31, 2013
• "BayhDol25 Files Amicus Brief in Bowman v. Monsanto," January 30, 2013
• "Government Sticks to Its Guns in Bowman v. Monsanto Amicus Brief," January 28, 2013
• "IPO Files Amicus Brief in Support of Respondents in Bowman v. Monsanto," January 24, 2013
• "House Considers Alternative Patent Royalty Scheme for Genetically Engineered Seed," January 14, 2013

2.  First-Inventor-to-File Provisions of Leahy-Smith America Invents Act Take Effect

On March 16, 2013, the final provisions of the Leahy-Smith America Invents Act took effect, subjecting some (but not all) applications filed on or after that date to the first-inventor-to-file rules of the AIA.  As part of the process of implementing the AIA, the U.S. Patent and Trademark Office began the year by publishing a final rule in the Federal Register setting and adjusting certain patent fees pursuant to the Office's fee-setting authority under § 10 of the AIA.  While most of the fees changes took effect last March, the remaining changes took effect only days ago on January 1.  The fees changes final rule was followed by a February 14 final rule to implement the first-inventor-to-file (FITF) provisions of the AIA.  In the lengthy final rule, which numbered 160 pages in a pre-publication version released on February 13, the Office provided some interesting replies to comments submitted in response to the proposed rule.  The impact of the Office's comments on post-AIA filing strategies is quite complex (readers are advised to review our February 13, 2013 report on the final rule), and we find that the subject continues to foster significant discussion.  Interestingly, the change in the filing date requirements for a patent application brought about by the ratification of the Patent Law Treaty (PLT) and enactment of the Patent Law Treaties Implementation Act of 2012 (PLTIA) (see Top Story #6) have further impacted and altered post-AIA filing strategy.  Finally, in April, the USPTO published two Federal Register notices to implement technical corrections to the AIA.  An interim final rule revised the rules of practice to implement changes to the patent term adjustment (PTA) provisions, and a second final rule implemented changes with respect to the new (and thus far, quite popular) inter partes review proceedings.

For information regarding this and other related topics, please see:

• " The First IPR Decision -- A Win for the Patent Challenger," November 18, 2013
• "Coalition Opposes Expansion of AIA § 18," September 13, 2013
• "Op-Eds in The Scientist Debate Impact of the AIA," September 5, 2013
• "USPTO Issues Rules to Implement AIA Technical Corrections," April 3, 2013
• "USPTO Issues First-Inventor-to-File Examination Guidelines and Final Rule," February 13, 2013
• "USPTO Publishes Final Rule Setting Patent Fees," January 21, 2013

1.  Supreme Court Decides AMP v. Myriad -- Naturally-Occurring, Isolated DNA Excluded from Patent Eligibility

In June, the Supreme Court issued its much anticipated decision in Association for Molecular Pathology v. Myriad Genetics, Inc., holding that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but determining that cDNA is patent eligible because it is not naturally occurring.  In writing for the Court, Justice Thomas provided one caveat with respect to cDNA, noting that "insofar as very short series of DNA may have no intervening introns to remove when creating cDNA," under such circumstance, "a short strand of cDNA may be indistinguishable from natural DNA," and therefore, would likely be patent ineligible.  While the biotechnology industry avoided a categorical ban on patenting DNA (which was the goal of the ACLU) or, worse, on "products of nature" no matter how altered, the Court's carefully focused opinion contained enough worrisome dicta to permit plaintiffs to declare victory even though the Court expressly disclaimed any decision on genetic diagnostic methods (which, after all, was the purported basis for the litigation in the first place).  While the case did not establish a categorical "product of nature" preclusion and thus should not be interpreted as mandating that other products of nature are categorically unpatentable, we warned in one of our posts that those cases are to come.  In July, Consumer Watchdog attempted to pull the Myriad decision into the appeal of an inter partes reexamination involving a Wisconsin Alumni Research Foundation (WARF) stem cell patent.  Reaction to the decision also led Myriad to file patent infringement suits against a number of diagnostic companies, as well as be pulled into declaratory judgment actions by some of these same companies (see Top Story #10).  The Myriad decision also led Sen. Patrick Leahy (D-VT) to send a letter to Dr. Francis Collins, the Director of the National Institutes of Health (NIH), to urge the Director to consider using march-in rights under the Bayh-Dole Act to ensure greater access to genetic testing for breast and ovarian cancer.  While the Myriad case has finally reached a conclusion, and has reclaimed the top spot on our Tops Stories list (the case was #2 in 2012, #2 in 2011, #1 in 2010, and #4 in 2009), the full impact of this case has yet to play out.

For information regarding this and other related topics, please see:

• " In Defense of Patenting," December 19, 2013
• "Genes and Information: The Problem of Disease-specific Databases," October 15, 2013
• "Authors of Genome Medicine Article Form Genetic Testing Company," August 12, 2013
• "NCI Researchers Generate Largest Database of Cancer-specific Genetic Variations," August 6, 2013
• "Consumer Watchdog Argues That WARF Stem Cell Patent Is Invalid under § 101," August 1, 2013
• "Senator Leahy Urges NIH to Use March-In Rights on Myriad BRCA Test," July 17, 2013
• "After Myriad: A Herd of Elephants in the Room," July 3, 2013
• "Consortium Launches Public Database of BRCA Data," July 2, 2013
• "Reaction to Supreme Court's Decision in AMP v. Myriad," July 1, 2013
• "Does the Myriad Decision Presage a Golden Age of Patent-Free Personalized Medicine?" June 19, 2013
• "AMP v. Myriad: A Bad Day At Black Rock," June 16, 2013
• "The Supreme Court's Myriad Decision: Where Does It Leave the 'Inventive Concept' Test?" June 16, 2013
• "Association for Molecular Pathology v. Myriad Genetics, Inc. (2013)," June 13, 2013
• "USPTO Issues Memo on AMP v. Myriad to Examining Corps," June 13, 2013
• "Supreme Court Issues Decision in AMP v. Myriad," June 13, 2013
• "The Myriad Case and "Gene" Patents: Much Ado about Nothing?" May 14, 2013
• "A Perspective on the Cost of the Myriad BRCA Gene Test," May 2, 2013
• "What We May Learn from the Myriad Oral Argument," April 18, 2013
• "PBS NewsHour Examines Oral Argument in AMP v. Myriad -- Patent Docs Author Kevin Noonan Appears on Program," April 16, 2013
• "Myriad Genetic Database Under Siege," April 15, 2013
• "A Response to Dr. Mason's "Rebuttal" to Criticisms of His Genomics Medicine Article," April 11, 2013
• "A Primer on Claim Construction -- Comments on Dr. Mason's Response," April 11, 2013
• "Dr. Chris Mason Responds to Blog Posts on Genome Medicine Article -- Updated," April 10, 2013
• "Revisiting Genome Medicine Article on 'Pervasive Sequence Patents' That 'Cover the Entire Human Genome'," April 8, 2013
• "Genome Medicine Article Calls for Limits on Patenting of Existing Nucleotide Sequences," April 2, 2013
• "Is Lack of Preemption the Key for the Supreme Court to Decide in Myriad's Favor?" March 26, 2013
• "IPO Files Amicus Brief in Support of Respondents in AMP v. Myriad Genetics," March 19, 2013
• "AIPLA Submits Amicus Brief to Supreme Court in AMP v. Myriad Genetics," March 13, 2013
• "Myriad Sets Forth Its Case to the Supreme Court," March 11, 2013
• "News from Abroad: Federal Court of Australia Affirms Patentability of Isolated Nucleic Acids," February 17, 2013
• "News from Abroad: Australian Federal Court Upholds Myriad's BRCA1 Gene Patents," February 17, 2013
• "United States Asks Supreme Court to Affirm on cDNA, Reverse on Isolated, Unmodified DNA," February 12, 2013
• "Is It Time for Myriad to Concede in AMP v. Myriad for the Good of the Biotechnology Industry?" January 23, 2013


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© McDonnell Boehnen Hulbert & Berghoff LLP | Attorney Advertising

Written by:

McDonnell Boehnen Hulbert & Berghoff LLP

McDonnell Boehnen Hulbert & Berghoff LLP on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
Privacy Policy (Updated: October 8, 2015):

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.


JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at:

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.