Kevin Collins has written a new Patently-O Patent Law Journal essay discussing the recent decision in King Pharmaceuticals. [Read the full essay]
On August 2, 2010, the Federal Circuit affirmed the district court’s summary judgment of patent invalidity in King Pharmaceuticals, Inc. v. Eon Labs, Inc. King Pharmaceuticals is most notable for its extension of the printed matter doctrine from objects claims that recite written texts as limitations to method claims that recite speech acts as limitations.
This Essay proceeds in three parts. Part I summarizes the King Pharmaceuticals opinion. Part II argues that the opinion was correctly decided, and it offers an original thesis about the role that the printed matter doctrine should play to enforce patentees’ disclosure obligations and preserve the deep structure of the Patent Act. Assuming that King Pharmaceuticals was correctly decided, Part III addresses the necessary next step in the continuing refinement of the printed matter doctrine. The Federal Circuit must explain why claims like the claim at issue in Prometheus Laboratories v. Mayo Collaborative Services are novel.
Cite as Kevin Emerson Collins, An Initial Comment on King Pharmaceuticals: The Printed Matter Doctrine as a Structural Doctrine and Its Implications for Prometheus Laboratories, 2010 Patently-O Patent L.J. 111 at /media/docs/2011/10/Collins.KingPharma.pdf.
Kevin Collins is a professor of law at Washington University in St. Louis.
When patent litigators hear the term “rocket docket”, they usually think of the U.S. District Court for the Eastern District of Virginia, long-known for its dedication to accelerated justice. The term doesn’t usually call to mind the U.S. Court of Appeals for the Federal Circuit, though its docketing-to-disposition time has averaged a reasonable 9-10 months. The recent case of Beer v. United States, however, shows that it is possible to have the Federal Circuit decide your appeal on the merits and rule on your en banc hearing petition in a mere 85 days, docketing to disposition.
Beer concerns a newsworthy issue dear to the hearts of federal judges: their pay. Eight current and former federal judges seek to recover cost-of-living adjustments Congress promised federal judges in 1989, but failed to deliver in 1995-97, 1999 and 2007. While the Beer parties disagreed on whether this deprivation of COLAs was an unconstitutional diminishing of judicial pay, they all agreed that the Federal Circuit rejected this exact position in Williams v. United States (Fed. Cir. 2001). In 2002, the Supreme Court denied cert. in Williamsover the dissent of Justice Breyer, joined by Justices Scalia and Kennedy.
With the issue resolved in Williams, why did these federal judges raise the same pay issue again in a 2009 U.S. Court of Federal Claims case? The answer rests not with any changes in the law, but instead with changes in the makeup of the Supreme Court. All four justices who joined the court since 2002 (Chief Justice Roberts and Justices Alito, Sotomayor and Kagan) replaced justices who voted to deny cert. in Williams. Assuming the Beer judges still have the three Williams dissenters on their side, they can win on the merits with two of the four newest justices.
Of course, before they could even file their cert. petition, the Beer judges needed to work their way through the Claims and Federal Circuit courts. To expedite that process, the judges conceded that both the Claims court and the Federal Circuit panel were bound to follow Williams. Their purpose was to overturn Williams, which could only be done by the Federal Circuit sitting en banc, or by the Supreme Court.
On Nov. 3, 2009, thirteen days after filing their notice of appeal at the Federal Circuit, the Beer appellants filed a Petition for Initial Hearing En Banc or, in the Alternative, Motion for Summary Affirmance. Alas, the clerk’s office rejected this filing since the appellants included a copy of their trial court complaint, and that apparently is not okay. [Side note to Judge Beer, et al: none of your court clerks can hold a candle to Federal Circuit clerks when it comes to finding a way to reject a filing]. Appellants’ counsel, Christopher Landau of Kirkland & Ellis, resolved this problem the following day, and the case was then before all 12 active Federal Circuit Judges.
On Jan. 15, 2010, the court denied the petition for initial hearing en banc over the dissent of then-Chief Judge Michel, joined by Judges Lourie and Moore, and the separate dissent of Judge Newman. With that denial of the en banc petition, a three-judge panel granted the Beer appellants’ motion for summary affirmance, with a concurrence by Judge Mayer, who reiterated his previous view that Williams was wrongly decided, but that “neither Congress nor the Supreme Court has done anything in the interim that would warrant this court taking the matter up again.” The Federal Circuit had thus resolved Beer on the merits, en banc, only 85 days after docketing.
So what, you ask? How could this possibly be of interest to you, a patent litigator? Well, you have a point – you probably won’t have occasion to stipulate at the district court or the BPIA, and on appeal, that your client is toast due to applicable, binding Federal Circuit case law. But some patent litigants are out to make a big, precedential splash (e.g. ,the ACLU in its challenges to the BRCA gene patents). Perhaps in some of these “big picture” cases, a litigant has no realistic hope on the merits, absent the overruling of a Federal Circuit panel decision. [This was not the case for the ACLU, which actually won at the district court].Or perhaps obliterating a binding precedent would be so valuable to a litigant (e.g., a “frequent defendant”) that it would be willing to concede away weak but non-frivolous arguments on the merits in order to directly attack the harmful precedent, post haste.
Maybe you’ll never have a Beer, but in the right, highly-exceptional patent case, you might want to use the Beer strategy.
As the title suggests, I argue that trademark theory offers the best modern justification for ongoing design patent rights. I suggest that design patents serve as an alternative rule of evidence for trade dress rights and are especially useful when trade dress rights are unavailable (or not yet available).
The Abstract: In a series of cases spanning more than one hundred years, courts and the US patent office have made clear that design patents are not to be justified by a fact that the newly invented ornamental design aids in distinguishing a company's product from those of its competitors. This article reverses that conclusion and argues instead that the trademark-like distinctiveness function that helps eliminate customer confusion is the most compelling policy justification for the continued protection of design patent rights in the US. In cursory language, a number of courts have suggested that the foundation of design patents policy follows the same incentive-to-create approach of copyright and utility patent law. I tentatively reject this traditional incentive model as unlikely to be important in most situations involving ornamental designs. Rather, I suggest the better justification for design patent doctrine lies in the notion that design patent rights serve as an alternative rule of evidence for trade dress protection. However, design patents are not merely a parallel alternative to trade dress. Rather, the existence of practical differences between the doctrines means that design patents rights are available in situations where trade dress protection is unavailable or uncertain.
This article presents a new set of empirical results to support the theoretical construct that design patents fill a gap in trade dress law protection. Based on the data, I tentatively reject the oft-stated conventional wisdom that design patents are worthless for many because procurement is too slow, expensive, and difficult. Rather, based on an analysis of the prosecution history files of a large sample of recently issued design patents, I conclude that the current design patent examination system operates as a de facto registration system. Notably, more than ninety-eight percent (98%) of the patents in my study were issued without the Patent Office challenging their inventiveness. The dramatic rise in the number of design patents being issued indicates that designers find value in design patent protection, and a study of parallel design patent and trade dress litigation suggests that design patents are serving as a back-up or replacement for trade dress rights.
If you think my conclusions are obvious, it may be because I have been making similar suggestions on Patently-O for the past few years. Or else your standards are too high. 🙂
Thirty Percent (30%) of all USPTO patent correspondence is now communicated electronically. Up to three e-mail addresses can be identified for each pending application. Rather than sending paper, applicants receive an e-mail notification of an office communication that can then be accessed via Private PAIR.
The e-Office Action system can help streamline docketing. In addition, attorneys receive the communication a few days earlier and in a form that can be easily communicated to their clients.
Patent Think by David Feigenbaum of Fish & Richardson
Recent Patently-O Job Posting:
In Seattle, the Miller Nash firm is seeking a medical devices patent attorney with at least four years of IP practice experience. [Link]
The DC Area firm McGinn IP (located in Tysons Corner, Virginia) seeks an experienced patent attorney with an electrical engineering background. [Link]
The Denver based firm Holland & Hart is seeking a licensing and technology transactional attorneys. Potential to join any of the H&H offices (Denver, Boulder, Salt Lake, Boise). [10+ years Experience][5+ years Experience]
Holland & Hart is also seeking an associate for their trademark enforcement practice. Must have outstanding academic record, superior writing and communication skills. [Link]
Pfizer is seeking an Assistant General Counsel for Patents to support its Vaccines Research Unit and Center for Integrative Biology and Biotheraputics. [Ph.D. J.D. and 10+ years Experience]
The bio/pharma company Gilead Sciences seeks a patent attorney to work with it respiratory therapeutics area in Seattle, Washington. 8+ years IP experience including in-house experience. [Link]
Kroger is looking to hire a patent counsel to help develop a corporate patent strategy, oversee Kroger’s patent portfolio and manage liability. [Link]
Thirty Percent (30%) of all USPTO patent correspondence is now communicated electronically. Up to three e-mail addresses can be identified for each pending application. Rather than sending paper, applicants receive an e-mail notification of an office communication that can then be accessed via Private PAIR.
The e-Office Action system can help streamline docketing. In addition, attorneys receive the communication a few days earlier and in a form that can be easily communicated to their clients.
Patent Think by David Feigenbaum of Fish & Richardson
Recent Patently-O Job Posting:
In Seattle, the Miller Nash firm is seeking a medical devices patent attorney with at least four years of IP practice experience. [Link]
The DC Area firm McGinn IP (located in Tysons Corner, Virginia) seeks an experienced patent attorney with an electrical engineering background. [Link]
The Denver based firm Holland & Hart is seeking a licensing and technology transactional attorneys. Potential to join any of the H&H offices (Denver, Boulder, Salt Lake, Boise). [10+ years Experience][5+ years Experience]
Holland & Hart is also seeking an associate for their trademark enforcement practice. Must have outstanding academic record, superior writing and communication skills. [Link]
Pfizer is seeking an Assistant General Counsel for Patents to support its Vaccines Research Unit and Center for Integrative Biology and Biotheraputics. [Ph.D. J.D. and 10+ years Experience]
The bio/pharma company Gilead Sciences seeks a patent attorney to work with it respiratory therapeutics area in Seattle, Washington. 8+ years IP experience including in-house experience. [Link]
Kroger is looking to hire a patent counsel to help develop a corporate patent strategy, oversee Kroger’s patent portfolio and manage liability. [Link]
Golden Hour Data Systems, Inc. v. emsCharts, Inc. and Softtech (Fed. Cir. 2010)
Opinion by Judge Dyk and joined by Judge Friedman. Dissent by Judge Newman.
After trial, Judge Ward (E.D.Tx.) rejected the jury verdict of infringement and granted JMOL for the defendants — holding that no single party had infringed each element of the asserted claims. The lower court also held the asserted patent unenforceable due to inequitable conduct during prosecution.
Joint Infringement: EMS delivers web-based medical charting. Softtech’s software coordinates air-flight information. The two companies formed a “strategic partnership” and signed a distribution agreement that would allow their two products to combine as a package. The products were then sold as a package.
Patent law doctrine allows a finding of direct infringement only when a single entity is responsible for practicing each element (or step) of a claimed invention. Federal Circuit law holds that two or more entities can avoid liability for infringement so long as (1) each entity is responsible for practicing only a subset of the claimed elements and (2) no single entity exercises “control or direction” over the entire infringing process. Here, as in other Federal Circuit cases, such as Muniauction v. Thomson and BMC v. Paymentech, the Federal Circuit continued this doctrinal line — holding that the claim against emsCharts must fail because the plaintiff presented insufficient evidence for the “jury to infer control or direction.”
In BMC, Judge Rader acknowledged that strict adherence to the “control or direction” requirement highlighted an easy avenue for avoiding infringement. “This court acknowledges that the standard requiring control or direction for a finding of joint infringement may in some circumstances allow parties to enter into arms-length agreements to avoid infringement. Nonetheless, this concern does not outweigh concerns over expanding the rules governing direct infringement.”
Dissenting from this opinion, Judge Newman argued that, despite Muniauction and BMC, the law of joint infringement does not strictly require that a single entity have control of the operation. Rather, a “collaborative effort as here . . . is not immune from infringement simply because the participating entities have a separate corporate status.” Here, the two companies “combined their procedures into an integrated system that met all of the limitations of claims 1, 6-8, and 15-22, thus finding joint infringement and inducement to infringe these claims. The panel majority acknowledges that the defendants in collaboration infringed the claims, but without discussion overturns the jury verdict.”
Inequitable Conduct: The court also addressed inequitable conduct. Golden Hour had failed to submit an un-dated brochure that included undisclosed information that contradicted statements made by the applicant regarding a prior art AeroMed system.
Golden Hour first suggested that it had no duty to disclose the brochure because it was not clearly prior art. The Federal Circuit rejected that argument because the duty of disclosure is not limited to prior art. As stated in the MPEP, “[t]here is no requirement that the [submitted] information must be prior art references in order to be considered by the examiner.” MPEP § 609 (2008).
On materiality, the court held that the brochure was clearly material because it contradicted a statement made by the applicant in the specification. In finding the contradiction, the court looked to English grammar. The specification stated that the AeroMed system “does not” provide comprehensive integration. According to the court, the present-tense representation indicates the applicant’s contention that the AeroMed system will not provide comprehensive integration at any time “throughout the pendency of the application.” (DDC Says: What is Judge Dyk thinking?).
On intent to deceive the PTO, the court held that intent could be inferred if there was evidence that either of the prosecuting attorneys actually read the brochure (but if they did not read the reference then they would only be guilty of gross negligence). Here, the court did not find evidence that the attorneys actually read the reference and therefore vacated the inequitable conduct decision for lack of intent to deceive. (The appellate court suggests that inequitable conduct will likely be found again on remand.).
In Dissent, Judge Newman wrote:
As for materiality, I do not share the conclusion that the undated AeroMed brochure, obtained at a trade show (the Association of Aeromedical Services) a few weeks after this patent application was filed, and found not to be invalidating prior art, was so clearly and convincingly “material to patentability” that failure to provide a copy of the brochure while quoting its front page, invalidates the patent that was found valid over the entire content of the brochure. The record does not show that the brochure was published before the Golden Hour patent application was filed. The defendants provided no documentary evidence of any publication date, and the district court did not find the brochure to be prior art; their only evidence was the “uh-huh’s” of the brochure’s author, quoted at footnote 1 of the majority opinion.
The record showed that when the brochure came into Golden Hour’s possession at the trade show, it was given to Golden Hour’s patent attorney, who referred to it in the Invention Disclosure Statement filed with the PTO, including quotation of the cover page but not the inner page. At the trial, the full brochure was in evidence, and stressed by the defendants, and the jury found that it was not invalidating. In view of the majority’s ruling that deceptive intent was not established in the district court, and the jury’s verdict of validity despite the brochure, the charge of inequitable conduct should be laid to rest.
Briefing continues in the en banc appeal of TheraSense (Abbott) v. BD and Bayer. That case stems from a district court finding that the TheraSense patent was unenforceable due to inequitable conduct during prosecution of the patent. The Federal Circuit is taking the case as a vehicle for re-evaluating the judge-made-law of inequitable conduct. I have collected the majority of merits briefs filed thus far in the en banc rehearing. Becton Dickinson & Bayer’s opposing brief is due October 8, 2010. Amici-briefs in support of BD/Bayer are due the following week. Oral arguments are scheduled for November 9, 2010 in Washington DC. (This post merely provides briefs. Analysis to follow.)
Although the court ultimately reversed the determination of inequitable conduct based on a lack of intent, its discussion of materiality is significant because the misrepresentation at issue occurred in the patent itself, in the form of statements about a prior art reference. Prosecutors may want to take special note of this opinion in crafting their Background of the Invention sections.
Ring Plus is the assignee of Patent No. 7,006,608 (the '608 patent), which relates to a software based algorithm and method for generating and delivering messages over a phone line that replace or overlay a ring-back signal.
After granting summary judgment of noninfringement, the district court held a bench trial on the unenforceability of the '608 patent. Following the bench trial, the district court concluded that the '608 patent was unenforceable due to inequitable conduct. Ring Plus appealed both determinations, along with the denial of its motion to disqualify Cingular's counsel.
Inequitable conduct: Materiality but no Intent The district court's inequitable conduct determination was based on two alleged misrepresentations concerning the substance of two prior art references, Strietzel and Sleevi. The district court found that the first misrepresentation was in the Background of the Invention section of the '608 patent, which asserted that both references proposed hardware based systems but no software to operate those systems. Contrary to this assertion, the district court found, one of skill in the art would have understood the references to disclose software-based algorithms.1
The panel agreed that this was a material misrepresentation. Although neither reference explicitly disclosed software, the panel could not say that the district court clearly erred in finding that a person of ordinary skill in the art would have understood the references to disclose software-based algorithms.
In arriving at the conclusion that the statement about the contents of the prior art constituted a misrepresentation, the panel rejected the contention that it was merely attorney argument. The court did not address this issue in any depth, merely stating that because the statement was a misrepresentation, it "was outside the boundas of permissible attorney argument." Slip Op. at 9.
Comment: I am a troubled by the court's cursory statement on this point because of the ambiguity it creates. These types of sweeping assertions, made without addressing the substance of the argument or citing relevant authorities, are the kinds of things that are likely to tie attorneys and judges in knots. Indeed, the court's quotation from Rothman is particularly perplexing, as Rothman reached the opposite conclusion on similar facts. At a minimum, one would expect the court to explain why Rothman does not apply.
Ultimately, however, the panel concluded that Cingular had failed to present clear and convincing evidence of intent to deceive. In arriving at this conclusion the court noted that the references were ambiguous as to operating software, and the prosecuting attorney's testimony gave rise to the inference that the applicants believed that the two references did not disclose software for operating a telephone system. Because this inference was as reasonable as the district court's inference of deceptive intent, the district erred in its finding of deceptive intent.
Other holdings The panel also addressed Ring Plus's challenge to the district court's construction of two claim terms, which formed the basis of the noninfringement ruling. The court affirmed the district court's construction, relating to the sequence of steps in the '608 patent. In addition, the court rejected Ring Plus's argument that Cingular's counsel should have been disqualified for ex parte contact with a Ring Plus director and officer. The court concluded that there was no evidence of impropriety under Fifth Circuit law.
1The district court also found that the applicants made a misrepresentation about these references during prosecution; the panel concluded that this statement was not a misrepresentation.
Judge Paul Michel and Hank Nothhaft (Tessera CEO) have written an important OP-ED for the New York Times. They argue that an important way for the US government to stimulate entrepreneurship and job growth is by giving the USPTO a large bolus of money ($1 billion) to put its affairs in order:
This would enable the agency to upgrade its outmoded computer systems and hire and train additional examiners to deal with the threefold increase in patent applications over the past 20 years. Congress should also pass pending legislation that would prohibit any more diverting of patent fees and give the office the authority to set its own fees.
. . . .
To be sure, not every patent creates a job or generates economic value. Some, however, are worth thousands of jobs — Jack Kilby’s 1959 patent for a semiconductor, for example, or Steve Wozniak’s 1979 patent for a personal computer. It’s impossible to predict how many new jobs or even new industries may lie buried within the patent office’s backlog. But according to our analysis of the data in the Berkeley Patent Survey, each issued patent is associated with 3 to 10 new jobs.
In addition, the pair suggests an “innovation tax credit” for each patent received by a small business:
To encourage still more entrepreneurship, Congress should also offer small businesses a tax credit of up to $19,000 for every patent they receive, enabling them to recoup half of the average $38,000 in patent office and lawyers’ fees spent to obtain a patent. Cost, after all, is the No. 1 deterrent to patent-seeking, the patent survey found.
For the average 30,000 patents issued to small businesses each year, a $19,000 innovation tax credit would mean a loss of about $570 million in tax revenue in a year. But if it led to the issuance of even one additional patent per small business, it would create 90,000 to 300,000 jobs.
Taken together, fully financing the patent office and creating an innovation tax credit could mean as many as 2.5 million new jobs over three years, and add up to 600,000 more jobs every year thereafter.
It only makes sense to help innovative small businesses make their way to the patent office and, once there, find it ready to issue the patents that lead to new jobs.
I have quibbles with the numbers used by the authors. However, I do think that they are on the right track in a few respects — especially with the idea that investing in incentives to innovate is a much more cost-effective and stable policy approach as compared with hiring folks to do government work.
The statement that “each issued patent is associated with 3 to 10 new jobs” cannot be derived from the Berkeley Patent Survey. However, I don’t see that figure as unreasonable or unlikely. It would be helpful to see how the authors calculated this figure.
In addition, it is important to recognize that patents are just one step along the road toward job creation. The idea is that patents can provide confidence and stability in business potential ventures. That confidence and stability leads to investment and job creation.
When I wrote about the Doctrine of Equivalents (DOE) yesterday, I made a mental note that the Federal Circuit has not decided many DOE cases recently. To confirm this notion, I searched Westlaw for all Federal Circuit decisions that mention the “Doctrine of Equivalents.” Those results are presented below:
Notes:
Of course, a decision's mention of the words "doctrine of equivalents" does not suggest that the appellate decision involved the DOE. However, the majority of these cases did at least involve allegations of infringement under the DOE.
The rise in the late 1990’s and early 2000’s revolves around Festo.
For the past decade, the number of Federal Circuit patent infringement appeals has remained relatively steady.
To find the number of reported patent decisions, I searched Westlaw’s database of Federal Circuit decisions for the terms “patent /2 (infring! valid! invalid! obvious!)”.
In 2006, Intervet filed a complaint against Merial — asking the DC District Court for a declaratory judgment that Intervet’s Porcine Circovirus vaccine (PCV-2) did not infringe Merial’s gene patent. Merial’s patent claims both the isolated DNA molecule of PCV-2 and a vector that contains the DNA. The application includes a listing of several different sequences that all fall within the PCV-2 category.
Although Intervet also uses a PCV-2 vector. The DJ plaintiff argues that its DNA molecule is different from the one described and deposited by Merial. The district court agreed — holding that the Intervet product was only 99.7% homologous to the closest deposited sequence and therefore outside of the literal claim scope. The district court also applied prosecution history estoppel to rejected Merial’s claims of infringement under the doctrine of equivalents (DOE). On appeal, the Federal Circuit reversed on both claim construction and DOE.
Genus Not Limited to Examples: The asserted claim includes a limitation of a “PCV-2” DNA molecule. The District Court limited that term to cover only the DNA sequences that were deposited with the PTO. On appeal, the Federal Circuit rejected that construction as overly limiting. Rather, the appellate panel held that the deposited sequences serve as a representative sample of PCV-2 DNA sequences. “Sequences are representative of the scope of broader genus claims if they indicate that the patentee has invented species sufficient to constitute the genera. Here, the deposited strains are representative species of the larger ‘type II’ genus, where the genus is identified and claimed as the invention.” In describing its invention, the specification noted that the PCV-2 desposited sequences had a 96% homology and that the invention did not cover PCV-1 sequences that at most shared 76% homology with the deposited sequences. Taking those quantitative limits from the specification, the Federal Circuit ruled that the claimed PCV-2 molecule should be construed as being “about 96% or more homologous with the … sequences disclosed in the present specification, and about 76% or less homologous with the [disclosed PCV-1] sequence.”
What is Equivalents are Surrendered by a Narrowing Amendment: An accused infringer may still be liable even though its product does not literally infringe every element of an asserted patent claim. Under the doctrine of equivalents (DOE), a patentee may be able to provie infringement by showing that one or more elements of the accused product are equivalent to elements in the claim. Under the limiting doctrine of prosecution history estoppel (PHE), a patentee will ordinarly be estopped from claiming DOE over a claim element that was narrowed during prosecution. (A narrowing amendment made for purposes related to patentability creates a rebuttable presumption that estoppel applies.)
Here, one of Merial’s original claims was directed to a markush group of open reading frames (ORFs) that had been described in the specification as “ORFs 1–13.” In an initial rejection, the examiner suggested that the limitation could refer to ORFs of non-PCV-2 molecules. Although the patentee argued that the claim was clear, it still added the limitation that the claimed ORFs were PCV-2 ORFs. The Federal Circuit held that this was a narrowing amendment substantially related to patentability. That narrowing amendment therefore created a presumption that the patentee had surrendered all equivalents that relate to non-PCV-2 ORFs. The district court erred, however, in holding that this narrowing amendment would estopp the the patentee from asserting that the claims cover a non-claimed PCV-2 ORF as an equivalent. “Such a draconian preclusion would be beyond a fair interpretation of what was surrendered. The rationale for the amendment was to narrow the claimed universe of ORFs down to those of PCV-2, and bore only a tangential relation to the question of which DNA sequences are and are not properly characterized as PCV-2.”
Dissenting-in-part, Judge Dyk discussed his argument that the claims directed toward the isolated form of a naturally occurring gene are likely unpatentable under 35 U.S.C. § 101.
[T]he isolated DNA claim raises “substantial issues of patentable subject matter under 35 U.S.C. § 101. . . . Neither the Supreme Court nor this court has directly decided the issue of the patentability of isolated DNA molecules. Although we have upheld the validity of several gene patents, none of our cases directly addresses the question of whether such patents encompass patentable subject matter under 35 U.S.C. § 101. . . .
I think that such patents do in fact raise serious questions of patentable subject matter. The Supreme Court’s recent decision in Bilski v. Kappos has reaffirmed that “laws of nature, physical phenomena, and abstract ideas” are not patentable. No. 08-964, slip op. at 5 (U.S. June 28, 2010) (quoting Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980)); Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948). Just as the patentability of abstract ideas would preempt others from using ideas that are in the public domain, see Bilski, slip op. at 13, so too would allowing the patenting of naturally occurring substances preempt the use by others of substances that should be freely available to the public. Thus, “a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter. Likewise, Einstein could not patent his celebrated law that E=mc2; nor could Newton have patented the law of gravity.” Chakrabarty, 447 U.S. at 309. These aspects are properly conceptualized as representing a public domain, “free toall men and reserved exclusively to none.” Id. (quoting Funk Bros., 333 U.S. at 130) (quotation mark omitted).
In Funk Brothers, the Court considered the patentability of a mixture of several naturally-occurring species of bacteria. 333 U.S. at 128-31. The patented product was a mixture of bacteria used in agricultural processes, enabling plants to draw nitrogen from the air and convert it for usage. The inventor discovered that certain strains of the bacteria were effective in combination with one another, and contrary to existing assump-tions, did not exert mutually inhibitive effects on each other. The Court held that the invention was not pat-entable subject matter. Id. at 131. The inventor “did not create a state of inhibition or of non-inhibition in the bacteria. Their qualities are the work of nature. Those qualities are of course not patentable.” Id. at 130. The Court furthermore noted:
The qualities of these bacteria, like the heat of the sun, electricity, or the qualities of metals, are part of the storehouse of knowledge of all men. They are manifestations of laws of nature, free to all men and reserved exclusively to none. He who discovers a hitherto unknown phenomenon of na-ture has no claim to a monopoly of it which the law recognizes. If there is to be invention from such a discovery, it must come from the applica-tion of the law of nature to a new and useful end.
Id.
In Chakrabarty, the Court considered whether a human-made microorganism is patentable subject matter under section 101. 447 U.S. at 305. The microorganism in question was a bacterium that had been genetically engineered to break down crude oil. In concluding that the man-made bacteria was patentable, the Court observed that the claim “is not to a hitherto unknown natural phenomenon, but to a nonnaturally occurring manufacture or composition of matter.” Id. at 309. The Court went on to distinguish Funk Brothers on the ground that the Chakrabarty bacterium possessed “markedly different characteristics from any found in nature. . . . His discovery is not nature’s handiwork, but his own; accordingly it is patentable subject matter under § 101.” Id. at 310 (em-phasis added).
Thus, it appears that in order for a product of nature to satisfy section 101, it must be qualitatively different from the product occurring in nature, with “markedly different characteristics from any found in nature.” It is far from clear that an “isolated” DNA sequence is qualita-tively different from the product occurring in nature such that it would pass the test laid out in Funk Brothers and Chakrabarty. The mere fact that such a DNA molecule does not occur in isolated form in nature does not, by itself, answer the question. It would be difficult to argue, for instance, that one could patent the leaves of a plant merely because the leaves do not occur in nature in their isolated form.
Over the past few weeks, I have been enjoying PriorSmart’s new “patent complaint alert” service. Each day, I receive an e-mail listing the most recent patent litigation complaints filed in US courts. I like this particular service because it is free (Rubin Anders is their corporate sponsor) and because it provides direct links to PDFs of the complaints and the patents-in-suit.
Justia (Free, but does not provide the actual complaint or patent number listing);
Docket Navigator (Great service and includes same-day summaries of many decisions, but not free). Normally, their service runs about $30 per month. Darryl Towell who runs Docket Navigator just e-mailed with an offer to Patently-O readers: “Patently-O readers who send an email to patentlyo_offer@docketnavigator.com before September 1, 2010, will receive the discounted rate of $14.95/month. That discounted rate is for new subscribers and will be good through the end of 2011.”
Let us know (in the comments) if you have other good sources for this info.
Patent Tools: While I’m talking about patent information tools, I should also mention the new patent analysis tools offered by the company Patent Calls. http://tools.patentcalls.com/. Interestingly, the tools were developed by well known patent plaintiff Erich Spangenberg (and his team). Spangenberg then sold them to Patent Calls who decided to offer them as a free service. (Patent Calls makes its money by providing more detailed analysis of patents, patent infringement, and patent markets). One feature that I enjoy from the Tools is that, for each patent, the main-page provides a direct link to additional information such as maintenance fee payments, certificates of correction, and patent family information. For published applications, the Tools also do a mark-up comparing the published claims with the issued claims. Spangenberg’s team created a pretty good algorithm for automatically finding similar patents. However, at this point, that feature is not available for free. Of course, I should be careful in distinguishing Patent Calls “Tools” from another free service PatTools. http://www.pattools.com/.
Association for Molecular Pathology (AMP) and the American Civil Liberties Union (ACLU) v. United States Patent and Trademark Office (USPTO) and Myriad Genetics (Myriad) (Fed. Cir. 2010)
In a May 2010 decision, Judge Sweet of the Southern District of New York issued an opinion that would render most gene patents invalid for failing to claim patentable subject matter under 35 U.S.C. 101. That high-profile case is now on an appeal, and has the potential of shifting US patent law both by its in-court and out-of-court impact.
Even before filing a substantive brief on the merits, the declaratory judgment plaintiffs (AMP & ACLU) filed a motion asking that Chief Judge Rader recuse himself from potentially hearing the decision. AMP argues that the Chief’s public statements regarding this case “have created an appearance of partiality that calls into question his ability to engage in impartial legal analysis.”
Notably, while attending a BIO meeting, Judge Rader reportedly responded to a comment by Professor Whealan (and former Rader clerk) that there are no real “legal standards for making [a Section 101] decision. . . [U]sing Section 101 to say that the subject matter is unpatentable is so blunt a tool that there is no neutral step to [draw] a line here [between what is and is not patentable].” In Judge Rader’s construct, the lack of a clear legal standard means that the decision will then be based on “politics. It’s what you believe in your soul, but it isn’t the law.” In another conference (this time at Fordham Law School), AMP’s attorney Dan Ravicher was speaking and Chief Judge Rader asked Ravicher a question “hinting at disagreement” with Ravicher’s position. In particular, the Ravicher-Rader colloquy was quoted as follows:
Ravicher (pointing to a bottle of water): "Was that [purification] sufficient intervention between what God gave us … and what man created to merit a patent?"
Chief Judge Rader: "How many people have died of water pollution over the course of human events? Probably billions."
Two responses to the ACLU motion have been filed.
First, Myriad responded that the cited statements by Chief Judge Rader “do not even suggest how Chief Judge Rader might vote, were he a member of the panel assigned to decide this case.”
The second filing is by the Federal Circuit Bar Association (FCBA) as amicus. The FCBA argues strongly that Judges should be encouraged to participate in educational conferences such as the BIO meeting and Fordham Law School. The FCBA makes the important point that “Just as it is important that judges recuse themselves when the rules require it, it is equally important that judges refuse to recuse themselves where the rules do not require it.” Granting recusal on the thin-evidence presented here would have the two primary effects of (1) discouraging sitting Federal Circuit judges from participating in public conversations and (2) encourage more strategic recusal motions. The FCBA motion was a joint effort by former Deputy Solicitor General Thomas Hungar (Gibson Dunn) and the oft-paired team of Ed Reines & Amber Rovner (Weil Gotshal).
This particular motion may never be decided. Since the panel has not yet been assigned for this appeal, the CAFC has refrained from deciding the motion. In a letter to AMP, the court indicated that “[i]n the event that Judge Rader is assigned, the motion will be transmitted to him.”
Mundi Fomukong is a co-inventor of the patents-in-suit. At the time of the invention, Fomukong was married to Fonda Whitfield. Sometime after the first patents issued, Fomukong and Witfield divorced. Later, the second patent issued; Fomukong formed Enovsys; and he (along with his co-inventor) assigned their rights to the new company. Later, when Enovsys sued Sprint-Nextel, the defendant challenged the case on standing. Sprint's argument is based on the rule that any patent infringement actions must be brought jointly by all co-owners of the patent. Specifically, Sprint argued that Ms. Whitfield retained an interest in the patent rights even after the divorce and, without Ms. Whitfield's support, Enovsys lacked standing. (Ms. Whitfield assigned her rights to Sprint.)
In the US, patent ownership rights are primarily controlled by state laws. At times, patent attorneys are called to understand their local laws of contracts, employment, inheritance, and (here) divorce. Thus, in deciding this case, the court looked first to the law of California — the site of the marriage, invention, and divorce.
California is a "community property" state and “all assets acquired during a marriage are presumptively community property.” In their divorce filings, however, Fomukong and Whitfield checked the box next to the statement that “We have no community assets or liabilities.” Without citing specific California law, the Federal Circuit held that that the final divorce decree coupled with this box-checking stripped Whitfield of her community property rights in the patent. "[A]lthough the final divorce decree was silent as to particular property, it nevertheless adjudicated the parties’ rights with respect to that property because it was based on an uncontested complaint which alleged that there was no community property."
With the issue of ownership settled, the court then affirmed the lower court's claim construction and infringement verdict.
The Federal Circuit offers some clues to its post-Bilski patentable-subject-matter jurisprudence, but leaves that fight for another day. Instead, the court held the claims anticipated by explicitly ignoring novel claim elements.
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King Pharmaceuticals, Inc. v. Eon Labs, Inc. and Elan Pharmaceuticals, Inc. (Fed. Cir. 2010)
King’s patent claims a method of increasing oral bioavailability of the muscle relaxant metaxalone by putting metaxalone in food eaten by the patient. Claim 21 includes a step of “informing the patient that the administration [of the drug with food] results in an increase [in absorption]. This step likely has two benefits: (1) increasing patient compliance with the drug regimen and (2) taking advantage of any placebo effect that may exist. The drug metaxalone itself was already a known muscle relaxant well prior to King’s 2001 application date.
Patenting Methods of Treatment: The district court held claim 21 invalid under 35 U.S.C. 101 based on the Federal Circuit’s machine-or-transformation test from Bilski. On appeal, the Federal Circuit rejected the lower court analysis — noting that when examined “as a whole”, the claim requires treatment and “methods of treatments ‘are always transformative when a defined group of drugs is administered to the body to ameliorate the effects of an undesired condition.’” (quoting Prometheus Labs., Inc. v. Mayo Collaborative Serv., 581 F.3d 1336, 1346 (Fed. Cir. 2009), cert. granted and vacated, 78 U.S.L.W. 3254 (U.S. June 29, 2010)).
Although the appellate panel rejected the lower court’s Section 101 analysis, it stopped short of providing any positive position on the patentability of medical treatment methods — presumably saving that battle for the pending remands of Prometheus and Classen.
Instead, the appellate court held that a Section 101 decision was not necessary because the claims of interest are anticipated under Section 102.
Ignoring Non-Patentable Elements: Here, the novelty question is interesting because the “informing” step was not specifically identified in the prior art. On appeal, the Federal Circuit held that claiming a step of “informing someone about the existence of an inherent property” of a method cannot render the claim patentable. “[I]n light of our holding that the method of taking metaxalone with food to increase the drug’s bioavailability, as recited in claim 1, is not patentable, it readily follows that claim 21, which recites the same method with the sole additional step of informing the patient about this increase in bioavailability, is not patentable.”
In its decision, the court ties its case to the precedential foundation of “printed matter” cases that have barred the patentability of known products by the inclusion of printed matter describing the product.
In some ways, this decision may be seen as reviving the suggestion found in the now vacated 2007 In re Comiskeydecision. There, the court suggested that, during nonobviousness analysis, any portion of an invention that constitutes nonstatutory subject matter will be considered de facto obvious.
Panel: Judges Bryson, Gajarsa, and Prost. Authored by Judge Gajarsa.
Double-patenting issues arise when two commonly owned applications cover the same or similar inventions. The issues in this appeal revolved around an earlier patent claiming a composition of matter and describing a method for using that composition, and a later patent claiming that method of use.
Both of the patents in this case, Patent No. 4,808,614 (the '614 patent) and Patent No. 5,464,826 (the '826 patent) relate to gemcitabine, the active ingredient of Lilly's Gemzar® product. The '614 patent claims both gemcitabine itself, as well as a method of using it to treat viral infections. In addition, the '614 patent's specification discloses using gemcitabine to treat cancer. The '826 patent claims a method of treating cancer comprising administering a therapeutically effective amount of gemcitabine. The difference was important: the '614 patent expired on May 15, 2010, while the '826 patent does not expire until November 7, 2012.
Note: The applications leading to both the '614 and '826 patents were filed on the same day, December 4, 1984. The '614 was a continuation-in-part of application No. 473,883 ("the '883 application"), which did not disclose using gemcitabine to treat cancer. That information was added as part of the continuation-in-part.
After filing an Abbreviated New Drug Application ("ANDA") for a generic version of Gemzar®, Sun Pharmaceuticals, sought a declaratory ruling that the '826 patent was invalid and not infringed. Lilly counterclaimed for infringement of the '826 and '614 patents. The '614 patent was not at issue in this appeal.
Obviousness-type double patenting applies Applicants are barred from obtaining multiple patents covering the same invention by the doctrine of double patenting. There are two types of double patenting: statutory double patenting, which prohibits a later patent from covering the identical invention, and obviousness-type double patenting, which prevents a later patent from covering a slight variation of an earlier patented invention.
On appeal, the panel agreed with the district court and Sun that the latter type of double patenting occurred here, thus invalidating the asserted claims of the '826. The basis for the court's decision were two prior opinions, Geneva v. GlaxoSmithKline, 349 F.3d 1373, and Pfizer v. Teva, 518 F.3d 1353. In Geneva, the earlier patent claimed a compound and the specification disclosed its effectiveness for inhibiting beta-lactamase. The later patent claimed a method of using the compound to affect beta-lactamase inhibition. Similarly, in Pfizer, the earlier patent claimed several compounds and the specification disclosed their use in treating inflamation; the later patent claimed a method of using these compounds for treating inflammation. In both cases, the court ruled that the claims were not "patentably distinct," and thus the latter claims were invalid for obviousness-type double patenting.
While Lilly argued that Geneva and Pfizer did not apply because "the specification of the earlier patent disclosed a single use for the claimed compound, which was an essential part of the patented invention and thus necessary to patentability," Slip Op. at 8, the court rejected that argument for two reasons. First, the court disagreed that the specification in Pfizer disclosed more than one utility for the claimed compound. In addition, the court read the rule of Pfizer as simply that "obviousness-type double patenting encompasses any use for a compound that is disclosed in the specification of an earlier patent claiming the compound and is later claimed as a method of using that compound. Pfizer never implies that its reasoning depends in any way on the number of uses disclosed in the specification of the earlier patent." Slip Op. at 10.
The court also rejected Lilly's argument that the specification of an earlier application should have been consulted, as opposed to the specification of the '614 patent. Drawing upon its claim construction precedent, the court noted that the specification is relevant to determining the coverage of the claims, which is at the heart of the obviousness-type double patenting analysis. The court further noted that "consulting the specification of the issued patent, as opposed to an earlier version, is consistent with the policy behind double patenting," which rests "on the fact that a patent has been issued and later issuances of a second patent will continue protection, beyond the date of expiration of the first patent of the same invention or an obvious variation thereof." Slip Op. at 14-15.
Becton, Dickinson and Co. v. Tyco Healthcare Group (Fed. Cir. 2010)
Tyco appealed a jury verdict that its safety needles infringed BD’s US Patent No. 5,348,544. The claims require a “spring means” that is “connected to said hinged arm” and is designed “for urging said guard along said needle cannula.”
On appeal, the Federal Circuit reversed the infringement decision based on claim construction — holding that as a matter of English-language-logic, the claims require a spring and hinged arm that are structurally distinct.
The unequivocal language of the asserted claims . . . requires a spring means that is separate from the hinged arm. . . . Where a claim lists elements separately, “the clear implication of the claim language” is that those elements are “distinct component[s]” of the patented invention. (Quoting Gaus v. Conair Corp., 363 F.3d 1284, 1288 (Fed. Cir. 2004)). . . There is nothing in the asserted claims to suggest that the hinged arm and the spring means can be the same structure.
If the hinged arm and the spring means are one and the same, then the hinged arm must be “connected to” itself and must “extend between” itself and a mounting means, a physical impossibility. A claim construction that renders asserted claims facially nonsensical “cannot be correct.”
Because the hinged arm of the Tyco needles performed the spring function themselves (as opposed to having a separate spring), the court ruled that those needles could not infringe.
In dissent, Judge Gajarsa provides a de-construction of the majority opinion — writing that:
The majority avoids the critical issue upon which this decision turns; i.e., whether 35 U.S.C. § 112, ¶ 6 governs the claim construction of the “spring means” limitation. In a brief footnote, the majority sweeps and brushes aside the means-plus-function analysis as unnecessary in light of the “plain language of the claims.” Without having analyzed the scope of the claims, the majority somehow concludes that the claim language covers only devices having separate “spring means” and “hinged arm” structures. Then applying this simplistic claim construction to analyze the sufficiency of the evidence, the majority improperly overturns the jury’s verdict finding infringement.
By Dennis Crouch
