- PPAC Nominations are due by May 15 – The new PTO director will presumably pick the nominee and will likely have time to suggest a nominee.
- IP Scholars Conference 2009: This annual event will be held at Cardozo Law in NYC on August 6th and 7th, 2009. This is usually a large gathering of IP focused academics and academic minded individuals presenting original works-in-progress. Deadline for submissions is April 30, 2009. Individual submissions and questions should be directed to David Morrison at dmorriso@yu.edu. For more information, visit www.ipscholars.org. Submissions include topic, abstract, author name, & academic affiliation.
- ANDA Infringement: Section 271 of the patent act provides a cause of action for patent infringement based on an unauthorized submission of an abbreviated new drug application (ANDA) for a patented drug or method. In a recent decision, the New Jersey district court found that the submission may still be an act of infringement even if the ANDA itself does not provide sufficient information to conclude that the use would be infringing. Instead, “the Court must look to the whole of the product, which means considering its ultimate useable state, as well as the ANDA-contemplated process and compound.”PDL Biopharma, Inc. v. Sun Pharm. Indus. Ltd., 2-07-cv-01788 (NJD March 31, 2009).
April 2009
Bits and Bytes No. 102
- PPAC Nominations are due by May 15 – The new PTO director will presumably pick the nominee and will likely have time to suggest a nominee.
- IP Scholars Conference 2009: This annual event will be held at Cardozo Law in NYC on August 6th and 7th, 2009. This is usually a large gathering of IP focused academics and academic minded individuals presenting original works-in-progress. Deadline for submissions is April 30, 2009. Individual submissions and questions should be directed to David Morrison at dmorriso@yu.edu. For more information, visit www.ipscholars.org. Submissions include topic, abstract, author name, & academic affiliation.
- ANDA Infringement: Section 271 of the patent act provides a cause of action for patent infringement based on an unauthorized submission of an abbreviated new drug application (ANDA) for a patented drug or method. In a recent decision, the New Jersey district court found that the submission may still be an act of infringement even if the ANDA itself does not provide sufficient information to conclude that the use would be infringing. Instead, “the Court must look to the whole of the product, which means considering its ultimate useable state, as well as the ANDA-contemplated process and compound.”PDL Biopharma, Inc. v. Sun Pharm. Indus. Ltd., 2-07-cv-01788 (NJD March 31, 2009).
Bits and Bytes No. 102
- PPAC Nominations are due by May 15 – The new PTO director will presumably pick the nominee and will likely have time to suggest a nominee.
- IP Scholars Conference 2009: This annual event will be held at Cardozo Law in NYC on August 6th and 7th, 2009. This is usually a large gathering of IP focused academics and academic minded individuals presenting original works-in-progress. Deadline for submissions is April 30, 2009. Individual submissions and questions should be directed to David Morrison at dmorriso@yu.edu. For more information, visit www.ipscholars.org. Submissions include topic, abstract, author name, & academic affiliation.
- ANDA Infringement: Section 271 of the patent act provides a cause of action for patent infringement based on an unauthorized submission of an abbreviated new drug application (ANDA) for a patented drug or method. In a recent decision, the New Jersey district court found that the submission may still be an act of infringement even if the ANDA itself does not provide sufficient information to conclude that the use would be infringing. Instead, “the Court must look to the whole of the product, which means considering its ultimate useable state, as well as the ANDA-contemplated process and compound.”PDL Biopharma, Inc. v. Sun Pharm. Indus. Ltd., 2-07-cv-01788 (NJD March 31, 2009).
Law Student Interns at PTO
The USPTO is maintaining its 8-week summer student internship program and is accepting applications now. The position is likely unpaid and does not provide housing or food. However, many law schools will offer credit to students for completing the internship. The Office of Patent Legal Administration (OPLA) and the central reexamination unit will both be working with summer interns.
To apply for the Summer Volunteer Program (SVP), send a cover letter, resume and transcripts via e-mail to Recruitment@uspto.gov with the subject line “Student Employment: Summer Volunteer Program.”
Written Description: Pioneering Claims Require More Expansive Written Description
Ariad v. Eli Lilly (08-1248.pdf, Fed. Cir. 2009) (Judge Moore; Concurring opinion by Judge Linn)
Ariad sued Lilly for infringing its patent that claims a method of reducing NF-κB (“en eff kappa be”) activity. The listed inventors of the patent include, inter alia, two Nobel Laureates, and the original assignees include Harvard, MIT, and the Whitehead Institute. A jury found that both Evista and Xigris infringe, and the judge denied Lilly’s JMOL motion on invalidity. The resulting judgment was for $65 million in past damages and an ongoing royalty of 2.3% of sales.
On appeal, the Federal Circuit reversed the lower court’s decision – finding the asserted claims invalid for lack of written description. The written description requirement is intended to ensure that the inventors “disclose the technologic knowledge upon which the patent is based [and] demonstrate that the patentee was in possession of the invention that is claimed.” (Quoting Capon). Consequently, the disclosure in the patent document “must clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed” and was in “possession” of the invention at the time of filing including “all elements and limitations.” In other words, Ariad “must describe some way of performing the claimed methods.” The actual level of disclosure depends upon several factors such as the extent of prior art, maturity of the science, and the “predictability of the aspects at issue.”
Here, it was clear that the invention was “extraordinarily creative” in a highly unpredictable field with little prior art available. Ariad’s expert even testified that the invention necessitated the development of a new vocabulary. All these factors indicate that the written description bar will be set high.
Here, Ariad’s description was scant on real examples
The ’516 patent discloses no working or even prophetic examples of methods that reduce NF-κB activity, and no completed syntheses of any of the molecules prophesized to be capable of reducing NF-κB activity.
Without specific examples, Ariad attempted to show that its description was sufficient by bolstering the skill of a PHOSITA. Unfortunately for the Patentee, the Jury found an early effective filing date and much of Ariad’s evidence showed skill in the art after that 1989 date.
Because written description is determined as of the filing date—April 21, 1989 in this case—evidence of what one of ordinary skill in the art knew in 1990 or 1991 cannot provide substantial evidence to the jury that the asserted claims were supported by adequate written description.
Although important, these small date issues probably made no difference because the description was so lacking and the prior art so sparse.
The state of the art at the time of filing was primitive and uncertain, leaving Ariad with an insufficient supply of prior art knowledge with which to fill the gaping holes in its disclosure.
“We therefore conclude that the jury lacked substantial evidence for its verdict that the asserted claims were supported by adequate written description, and thus hold the asserted claims invalid.”
Caveat Vindicor: In its conclusion, the court noted that this result likely turned on clam construction. If Ariad had agreed to a narrower construction in litigation or narrower claim language during prosecution, then the written description requirement might have been satisfied. Of course, if it had pursued that strategy, infringement would have likely been lost.
Although Judge Linn concurred in the opinion, he wrote separately to remind readers of his belief that the written description requirement should be eliminated and enablement be allowed to do its job.
Notes:
- Pioneering inventions are less likely to be found obvious or anticipated. However, one problematic result highlighted by this decision is that those pioneer patents are more likely to be trapped by the formalities of the patent system.
In re Kubin: Federal Circuit Expands Obvious-to-Try Jurisprudence
In re Kubin (Fed. Cir. 2009), 08-1184.pdf (Opinion by Judge Rader)
In a much anticipated biotech case, the Federal Circuit has affirmed a BPAI obviousness decision and in the process expanded the court’s obvious to try jurisprudence. The Kubin opinion found that the Supreme Court’s KSR decision overturned In re Deuel and its admonition against an “obvious to try” test for obviousness.
To be clear, Kubin does not hold that an invention that was “obvious to try” was necessarily obvious under Section 103(a). Going forward, however, the question in this long-running debate will be “when is an invention that was obvious to try nevertheless nonobvious?” (quoting In re O’Farrell, 853 F.2d 894 (Fed. Cir. 1988).
Kubin revives the O’Farrell analysis of obvious to try and carves-out two factual situations where obvious-to-try analysis should not apply.
(1) Throwing darts versus a finite number of Identified, predictable known options:
In such circumstances, where a defendant merely throws metaphorical darts at a board filled with combinatorial prior art possibilities, courts should not succumb to hindsight claims of obviousness. The inverse of this proposition is succinctly encapsulated by the Supreme Court’s statement in KSR that where a skilled artisan merely pursues “known options” from a “finite number of identified, predictable solutions,” obviousness under § 103 arises. 550 U.S. at 421.
(2) Exploring new technology versus improving known and predictable technology:
[An] impermissible “obvious to try” situations occurs where ‘what was “obvious to try” was to explore a new technology or general approach that seemed to be a promising field of experimentation, where the prior art gave only general guidance as to the particular form of the claimed invention or how to achieve it.’ (Quoting O’Farrell).
Again, KSR affirmed the logical inverse of this statement by stating that § 103 bars patentability unless “the improvement is more than the predictable use of prior art elements according to their established functions.”
Application: In this case, the court finds that neither of the O’Farrell exceptions apply. The invention is old-school biotech: isolating and sequencing a human gene that encodes for a protein. People do this in high school now, and the application explicitly states that the DNA and Protein sequence may be obtained through “conventional methodologies known to one of skill in the art.” Likewise, the protein in question had already been identified and the prior art suggested that the protein plays an role in human immune response.
KSR moves to Non-Predictable Arts: Biotech has traditionally been thought of as unpredictable. Here, Judge Rader may have dismantled the art-level distinction in holding that KSR applies to the unpredictable arts. The issue rather is if the particular invention in question was predictable.
Therefore this court cannot deem irrelevant the ease and predictability of cloning the gene that codes for that protein. This court cannot, in the face of KSR, cling to formalistic rules for obviousness, customize its legal tests for specific scientific fields in ways that deem entire classes of prior art teachings irrelevant, or discount the significant abilities of artisans of ordinary skill in an advanced area of art.
Affirmed.
Notes:
- Kevin Noonan provides an important critique of the case – focusing primarily on the court’s mishandling of the factual issues. [Link].
- I should note here that the PTO is well ahead of the Federal Circuit. MPEP 2141 indicates that being “obvious to try” is a proper rationale to “to support a conclusion of obviousness.” The big book does hint that such an application would only be proper if the “trying” means “choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success.”
- This case makes clear that the level of enablement of the prior art is very important to any obviousness conclusion. That result is in contrast to the recent Gleave case that found anticipation absent known utility.
Patents and the Auto Industry Bailout
In 2005, the PTO held a ceremony to commemorate the issuance of design patent number 500,000. The design patent went out to DaimlerChrysler for the design of the Chrysler Crossfire. Then Commerce Chief Gutierrez and PTO Director Dudas were on hand to note the importance of design patent design patents.
The patent has taken an interesting path – as shown by the assignment records at the PTO. Of course, DaimlerChrysler is gone, and Chrysler now owns the patent. In addition, Chrysler has given-up three separate security interests in the design patent. The first and second priority are apparently held in trust by the Wilmington Trust Company. The third priority is held by the US Department of Treasury based on a January 2009 grant and is apparently related to the company’s receipt of bailout money. [Assignment Data]. D500,000 is not the only patent implicated here – the assignment documents show that the US Treasury holds a security interest in more than 2,400 of Chrysler’s patents or pending applications. [More Assignment Data]
One important practice issue is raised: Absent a specific agreement, to what extent must the applicant consult secured creditors during the prosecution of a pending patent application?
Percentage of Patents that were Initially Rejected
This relates to my statements regarding the percentage of applications that receive at least an initial rejection. The graph below shows the percentage of patents issued (2000-2006) that were initially rejected by the PTO broken up into groups of art-units. Thus AU 1630 group actually includes AU 1630 – 1639. Close to 95% of the patents issued through the AU 1630 group during that period were initially rejected before being eventually allowed.
As with the design patent discussion yesterday, the rejection rate above is for applications that eventually issue as patents. For any given application, the effective rejection rate was likely higher because abandoned applications are probably more likely to have been rejected.
This data is now getting a bit old – but it is what it is. This data came from public PAIR before researchers were blocked from accessing it in any substantial way. Since 2006, applicants have complained of increased rejections. My perception that this change is not a shift toward more first office action rejections, but rather a shift toward sustaining more of those rejections in the second and subsequent office actions.
In re Gleave: Reference with Unknown Utility Still Anticipates
In re Gleave (Fed. Cir. 2009)
In 2008, the BPAI affirmed the examiner’s rejection of Gleave’s claims as anticipated. The claims focus on an antisense oligodeoxynucleotide designed to bind two different types of insulin-dependent growth factor binding protein (IGFBP). The prior art included a document that listed the genetic sequence of the complementary sense strands but did not identify any utility of the sequence.
On appeal, the Federal Circuit affirmed the anticipation rejection – basing its decision on the rule that anticipatory prior art does need to be functional, useful, or show actual reduction to practice. Rather, to be anticipatory, the prior art must enable the skilled artisan to make the claimed invention.
In the 1973 Wiggins case, the CCPA ruled that the “mere naming of a compound in a reference, without more, cannot constitute a[n anticipatory] description of the compound.” The Federal Circuit here distinguished Wiggins – noting that in Gleave’s case, the sequence listing was sufficient to allow a skilled artisan to “at once envision each member of this limited class.”
Notes:
- A claim by Gleave with functional language might not have been anticipated by the prior disclosure of the bare sequence.
- Patent Docs review the case
- Patent Hawk has the title “useless but enabling.”
Design Patents: Sailing Through the PTO
Over eighty percent of utility patent applications are initially rejected during prosecution. Some areas of technology – such as semiconductors – have a lower rejection rate while others – such as electronic commerce methods – have an even higher rejection rate.
I wanted to compare the result for utility patents with design patents. I pulled up information on 1000 of the most recently issued design patents (all issued in March, 2009) and parsed through the file histories to see how design patent prosecution compares. As the graph below shows, in my sample, only 25.6% of the recently issued patents received an initial rejection during prosecution. To be clear, this 25% rejection rate is for applications that eventually issue as patents. To get an overall picture of design patent rejections, we need to also consider the applications that are abandoned and never issue as patents. Recent PTO statistics show that a bit under 20% of design patent applications are abandoned. Because design patent file histories are kept secret unless a patent issues, we cannot know why any individual case is abandoned – However, the two most likely situations are that the applicant (a) failed to respond to a rejection or (b) failed to pay the issue fee. Even if we assume that 100% of the abandoned cases are initially rejected, that only pushes the initial rejection rate to about 40%.
As the graph below shows, of the 1000 issued design patents in my sample, only 4.1% received a final rejection during prosecution; and only 0.2% cases (2 out of 1000) included a notice of appeal. None of the 1000 cases included an appeal brief.
The design patents in the study had an average pendency of 15.3 months calculated by finding the number of months between the filing date and the issue date. As may be expected, applications that included at least one rejection took considerably longer to issue (21.5 months) as compared to those that were never rejected (13.2 months). (These means are different at 99.9 CI).
Most design patents (58%) in my sample have only one inventor. However, 69% of the inventors are listed as joint inventors. A number of the muliti-inventor patents included trans-national inventorship with inventors originating from two or more separate countries. About 1% of the applications listed at least one inventor from the US & Great Britain. Another 1% listed at least one inventor from both the US and China.
Guest Post: Ten Reasons the Supreme Court Should Take In re Bilski
Erika Arner is the co-author of the Bilski petition for certiorari challenging the Federal Circuit’s limits on the patentability of method claims. She handles patent prosecution and litigation at Finnegan Henderson in DC. I asked Ms Arner to write this post.
The Time Has Come – Nearly thirty years have passed since the Supreme Court addressed patentable subject matter. The “BFD” cases─Gottschalk v. Benson (1972), Parker v. Flook (1978), and Diamond v. Diehr (1981)─represent modern doctrine on the scope of patentable processes under 35 U.S.C. § 101. Yet these cases were handed down before the Internet and personal computer fundamentally changed the way Americans live, work, and innovate. In their struggle to apply the BFD cases to cutting-edge inventions, the PTO and courts have whittled away at the scope of section 101. The time has come for the Court to reaffirm that the broad, flexible approach to section 101 set forth in the BFD cases applies with equal force in today’s information age.
Third Time’s The Charm – The Supreme Court declined its last two opportunities to update its jurisprudence on section 101 and process claims. In 1999, the Court denied cert. in State Street Bank, which applied the “useful, concrete, and tangible result” test to determine when a claim contains a patent-eligible practical application of a fundamental principle. That same year, the Court declined to review AT&T v. Excel, but indicated that the section 101 issue had garnered at least some interest on the Court. Justice Stevens filed a statement on the denial of cert. in AT&T v. Excel, noting that “[t]he importance of the question presented” made it appropriate to reiterate that a denial of cert. is not a ruling on the merits.
Justice Stevens Is Not Alone – In addition to the statement filed in AT&T v. Excel, several justices have found opportunities to express interest in section 101 issues. When the Court dismissed cert. in LabCorp v. Metabolite, Justice Breyer dissented, joined by Justices Stevens and Souter. In the dissenting opinion, Justice Breyer called into question the “useful, concrete, and tangible result” test for patentable processes, arguing that “if taken literally” the test would conflict with Benson and Flook. These three justices were joined by Justice Kennedy in a concurrence filed in eBay v. MercExchange(2006), criticizing the “potential vagueness and suspect validity” of business method patents. Clearly, there is interest among at least some of the justices in the state of section 101.
The PTO Picked Bilski – When the PTO began examining Mr. Bilski’s patent application, prosecution progressed as usual. Prior art was searched and applied, claims were amended, new prior art was cited, and several claims were allowed. Then suddenly, the examiner changed position, withdrawing the remaining prior art rejections and the claim allowances and instead rejecting all of the claims under the now-obsolete “technological arts” test for section 101. An expanded panel of the PTO Board affirmed the rejection in a 70-page “informative” opinion setting forth a version of the machine-or-transformation test. The PTO seemingly chose Bilski as the vehicle to reverse its position set forth in the prior year’s “precedential” decision in Ex parte Lundgren, which allowed business method claims with no tie to a computer or physical transformation.
The Federal Circuit Picked Bilski – At the Federal Circuit, Mr. Bilski’s case progressed normally at first. Briefs were filed; oral arguments were held. But before the panel rendered its decision, the court ordered that the appeal would be heard en banc “in a long-overdue effort to resolve primal questions on the metes and bounds of statutory subject matter” according to Judge Mayer. In its en banc Order, the court invited briefing from the parties and the public on five questions ranging from whether Bilski’s claims were patent-eligible under section 101 to what standard should govern the patent-eligibility of a process. The court also took the extraordinary step of inviting two representatives of amicus parties to participate in the en banc oral arguments. Clearly, the court decided that Bilski was the case to resolve the very “primal” question of when a process is patentable under section 101.
The Patent Community Picked Bilski – When invited to file amicus curiae briefs to the en banc Federal Circuit in In re Bilski, the patent community and the public at large responded in force. Thirty-eight briefs were filed representing wildly different points of view on the proper interpretation of section 101. Briefs were filed by large organizations and small, by teams of academics and by individuals, by corporate patent owners and patent practitioners, and by industry groups ranging from software and biotechnology to the ACLU. These assorted parties with their divergent points of view seem to agree on one thing: In re Bilski presents the perfect vehicle to address the proper scope of section 101.
The En Banc Bilski Decision Is the Closest We Get to a Patent Circuit Split – Three dissents and a concurrence accompanied the 9-judge majority opinion. Regarding the majority’s machine-or-transformation test, the dissenting opinions varied just as widely as the amicus briefs had. Judge Mayer argued that the court should go farther to restrict section 101 and overrule State Street Bank andAT&T. At the other extreme, Judges Newman and Rader filed separate dissents arguing for a broad, flexible application of section 101 to accommodate the innovations of today’s knowledge economy. The divergence of opinions on the en banc court is akin to the “circuit split” that often signals the need for the Supreme Court to step in.
The Issue in Bilski is Fundamental to the Patent System and the U.S. Economy – The proper scope of patentable subject matter under § 101 is not only important to the nation’s economy, it is “one of the broadest, most sweeping issues in patent law,” according to Judge Moore in her dissent from en banc rehearing in In re Comiskey (2009). The importance of this issue is highlighted by the filing of nine amicus curiae briefs in support of the petition for cert. This level of amicussupport at the cert. stage is the highest in a patent case since Festo, where nine briefs were filed at the cert. stage. For example, only three briefs were filed in support of the petition for cert. in KSR and six were filed at the cert. stage in eBay.
The Machine-or-Transformation Test Conflicts with Supreme Court Precedent – Although the Supreme Court has twice expressly declined to hold that the machine-or-transformation test is the “only test” for patentable processes under § 101, the Bilski court did just that. Indeed, the court acknowledged some doubt about its interpretation of Supreme Court precedent and recognized that the Supreme Court “may ultimately decide to alter or perhaps even set aside this test to accommodate emerging technologies.” In re Bilski.
The Supreme Court Does Not Like Rigid Tests for Patents – When the Supreme Court has set forth a flexible approach to interpreting the Patent Act, they are prone to overruling attempts to define a rigid “bright line” test. Festo and KSR are two examples of the high Court reversing an attempt by the Federal Circuit to establish a bright line test when the flexible approach of earlier Supreme Court cases was difficult to apply. In those cases, the Court instructed the Federal Circuit to return to the flexible, case-by-case analysis required by its precedent. The Federal Circuit’s “definitive” machine-or-transformation test should meet the same fate.