Top Three Stories of 2013

By Donald Zuhn --

Reflecting 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

Comments

[Skeptical]

Regarding Justice Kagan’s ‘limitation,’ I am struggling to envision what form of distinguishing fact pattern (for any other self-replicating product) might exist that would lead to a different conclusion based on the law as rendered in the Bowman case.

It seems pretty clear that a reasonably foreseeable use of a patented item (in fact, the number one use for seeds is planting; let alone when one considers that the particular Monsanto invention for these seeds necessarily entailed planting – use of the seed as food directly by humans or animals has no nexus whatsoever with the invention). What possible ‘use’ set of facts can be dreamed up that would yield a different result?

[Skeptical]

In your Myriad write-up I see two items I would seek to clarify or challenge:

One: “or, worse, on ‘products of nature’ no matter how altered”

Clearly the driver of the case was the notion of change in kind versus change in degree. This was pivotal in understanding what the term Product of Nature includes. Thus, there was NEVER a concern that the Court would render a decision based on a thought of “no matter how altered.”

Two: “While the case did not establish a categorical “product of nature” preclusion….”

Sorry, but that is exactly what the case did establish. If you constrain the understanding of what is a product of nature (as in not enough change to effect a change in kind), the result of the case very much should be interpreted as mandating that other products of nature (correctly defined) are indeed categorically unpatentable (as in not patent eligible). That is precisely the law TO take away from the case.

[EG]

Skeptical,

I agree with you that the holding/ruling in Myriad is based squarely (explicitly or at least implicitly) on the "product of nature" doctrine. And we at least know from that case that at least some of the claimed cDNA was considered a "difference in kind rather than degree." But we're still left with no general definition from Myriad as what is a difference in "kind" versus "degree."

[Skeptical]

EG,

Sounds like you want more brightline than what one would ever expect from the Supreme Court.

[EG]

"Sounds like you want more brightline than what one would ever expect from the Supreme Court."

Skeptical,

You're correct, but is why we've currently got "chaos" in patent-eligibility determinations under 35 USC 101. (Do I also detect a note of sarcasm in your comment directed at SCOTUS?)

[IP]

The impact of Myriad is huge. The PTO currently interprets Myriad to cover primers, primer compositions and kits with primers, even if the compositions or kits include non-natural components. And don't try to add "synthetic" because that will get rejected too. Try explaining that to your client

[Skeptical]

The explanation to the client is rather straightforward, IP.

Just because you can duplicate something does not mean that you can have exclusive rights to that thing.

Do you understand the warehouse of nature analogy? I am...