Teva Pharm. Indus. v. Apotex, 2008 U.S. Dist. LEXIS 60418 (D.N.J. 2008)
In 2007, Teva sued Apotex infringing its carvedilol patents. Apotex counterclaimed with charges of inequitable conduct – alleging that Teva had failed to disclose “any of the English language counterparts” of a submitted prior art reference.
The examiner actually found the withheld references in his search, and Teva argued no harm, no foul, no materiality. Apotex disagreed and argued that the examiner’s serendipity “does not, as a matter of law, absolve an applicant from a charge of inequitable conduct.”
New Jersey District Court Judge Brown agreed with the patentee Teva – holding that a reference cannot be considered “withheld from the examiner” if it is actually before the examiner.
“In Scripps Clinic & Res. Found. v. Genentech, Inc., 927 F.2d 1565, 1582 (Fed. Cir. 1991), the Federal Circuit stated that “[w]hen a reference was before the examiner, whether through the examiner’s search or the applicant’s disclosure, it can not be deemed to have been withheld from the examiner.”
. . .
The duty to disclose all information known to be material to patentability is deemed to be satisfied if, all information known to be material to patentability of any claim issued in a patent was cited by the Office or submitted to the Office in the manner prescribed by §§ 1.97(b) -(d) and 1.98.
. . .
It is undisputed that the document allegedly withheld by Teva was found by the examiner. Therefore, in light of the fact that the alleged failure to disclose the English language counterparts of EP 0 127 099 is the only basis for Apotex’s inequitable conduct counterclaim, the Court concludes that Apotex’s inequitable conduct counterclaim should be dismissed with prejudice.”
A Debate on Patent Policy: Obama (representatives) vs. McCain (representatives). August 28 in Denver (on the last day of the Democratic convention). See Professors Sprigman and Rai defenda Obama against Reines and Gifford. [LINK]
Stanford’s IP Scholars Conference included lots of interesting academic works in progress. Here are a few examples [LINK].
Chiang (George Mason): Ex Post Claiming – “Patent law permits moving the fence to enclose the neighbors’ new house, and then evicting the neighbors for trespassing.” Chiang proposes a rule to eliminate any claim amendments made after a patent has issued (i.e., no continuation amendments). Pre-allowance amendments would be given the priority date of the amendment.
Chien (Santa Clara): The Cold War is not over. Discussing how the arms-race justification of filing patents is alive and well.
Cotropia (Richmond): Proposing a requirement that inventions be reduced to practice before patent filing.
Crouch (Missouri): Considering the justification of design patent protection as an alternative rule of evidence for protecting trade dress rights.
Greenbaum (Stanford): Explaining why University Tech Transfer offices should be abolished and university inventors should get to keep their rights.
Hemphill (Columbia): Empirical work on generic drug settlements in the shadow of Hatch-Waxman.
Kapczynski (Berkeley): India’s progress in implementing TRIPS obligations for pharmaceutical inventions.
Liivak (Cornell): Examining ways of modifying patent law to encourage competition without relying solely on granting anti-competitive rights.
Masur (UChicago): Discussing the positive value of costly patent prosecution. It serves as a screen to block many worthless patents.
Pulsinelli (Tennessee): Proposing that new matter restrictions be softened to allow the addition of best mode information. This is important for international applicants who do not face the best mode requirement in their home countries.
Sichelman (Berkeley): Proposing a new form of intellectual property based on commercialization of new technology.
Vermont (George Mason): Narrowing the doctrine of equivalents over time.
Non-patent, but really interesting:
Bartow (South Carolina): Counterfeits, Copying, Class, and Confusion.
Oliar and Sprigman (Virginia): IP norms in Stand-up Comedy.
Rowe (Florida): New Generation Employees and Trade Secrets
Dr. Serdarevic v. Advanced Medical Optics (Fed. Cir. 2008)
In 2006, Dr. Serdarevic filed an inventorship claim against Advanced Medical (AMO). She argued that AMO’s patented inventions were hers that she had developed during her ophthalmology residency at Columbia Presbyterian. Two of her attending physicians are listed as the inventors of the six patents in suit. Unfortunately for Serdarevic, all her witnesses died before she filed suit.
The district court dismissed Serdarevic’s claims – finding the inventorship claim barred by laches. It turns out that Serdarevic claimed to have invented back in the early 80’s. She learned of the patents in 1998, but waited until 2006 to file suit.
Inventorship Laches: The 1993 Scimed case held that a “delay of more than six years after the omitted inventor knew or should have known of the issuance of the patent will produce a rebuttable presumption of laches.” Here, Serdarevic knew of the patent for more than eight years before filing suit – creating a presumption that laches applies.
Reexamination Does Not (Necessarily) Reset Laches: One of the patents had undergone reexamination during the eight-year period. Serdarevic argued that the laches clock should be restarted at that point. The CAFC rejected the notion of any such rule:
“One thing is clear, and accordingly we so hold: there is no rule that the issuance of a reexamination certificate automatically resets the six-year clock for the presumption of laches in each and every case.”
In one older case, the CAFC allowed reset the laches clock after a reissue. Vaupel (Fed. Cir. 1991). The CAFC distinguished that case because the excluded inventor had participated in the reissue and had given notice that it would pursue its claim after the reissue.
Most design patents are based on the work of a single inventor. Although the average “inventor count” per design patent is still under two a time series appears to show that the lone-mind story of inventing continues to shift to a collaborative effort. Two additional points of information: design patents associated with an assignee have a higher average inventor count as do design patents that list a law firm as handling the patent. Part of the story may be that patent attorneys are getting better at ferreting out the true inventor. However, I suspect that the trend does reflect a shift in the process of invention and product development.
Notes:
This data is based on an analysis of all 300,000+ design patents issued since 1976.
I’ll redo this graph for utility patents. I suspect that the results will be similar – especially the continued trend toward more inventors per patent.
In response to a comment, I parsed the number of inventors by country of assignee. Outcome: Amongst the 10 countries with the most design patent holders, US assignees have the highest average number of inventors per patent. (Non-assigned patents are left out of this analysis). (Click on graph to expand)
In response to another comment, I looked at the patent with the most inventors. U.S. Patent No. Des. 563,280 has ten inventors listed. The patent covers the “ornamental design for a car” and is owned by the Chinese auto company Shenyang Brilliance Jinbei Automotive Co. The company manufactures BMW’s Chinese 3 and 5 series. (Image below).
By Prof. Paul M. Janicke, HIPLA Professor of Law, University of Houston Law Center< ?xml:namespace prefix ="" o ns ="" "urn:schemas-microsoft-com:office:office" />
In the 1980s patent practitioners were being pressed by clients to keep costs down. At the same time they were seemingly presumed by courts to understand right away any prior-art reference that made its way into their offices, and how that reference might relate to patent applications they were writing or prosecuting. They were rather upset with the drift of the law on inequitable conduct. It seemed the courts were allowing something short of intentional deception to make out that defense and to ruin a client’s otherwise solid case for validity and infringement. Language like “gross negligence” had crept into some of the appellate decisions. With enough time and funding by the challenger, many non-cited things in a patent practitioner’s possession could be made years later to look important to patent prosecution, and explanations for non-citation always seemed at that late date a little lame. All the challenger needed to do is find one of those things and persuade the judge to label the non-citation as gross negligence.
The Federal Circuit recognized the problem and in 1988 handed down Kingsdown Medical Consultants Ltd. v. Hollister Inc.,[1] wherein the court reiterated that intent to deceive the PTO had to be proved by clear and convincing evidence. In an in banc section of the opinion labeled “Resolution of Conflicting Precedent,” the court held that gross negligence could not alone suffice to make out inequitable conduct.[2] The profession breathed a little easier. They were perhaps out of the frying pan.
However, shortly after Kingsdown a number of other cases rightly pointed out that deceivers seldom come forth and say they acted with intent to deceive. “Such intent usually can only be found as a matter of inference from circumstantial evidence.”[3] Through the 1990s the Federal Circuit appreciated the continuing need to make an actual finding that a particular person acted to mislead the PTO in a particular way. It told us “a finding of intent to deceive the PTO is necessary to sustain a charge of inequitable conduct.”[4] In a withholding-type accusation, reaching that conclusion of course requires a subsidiary finding that the person appreciated the significance of the withheld item. Without that appreciation, he can hardly be trying to deceive the examiner about the item.
In the last three years Federal Circuit panels have slipped back into “should have known” language to arrive at the conclusion of intent to deceive or mislead the PTO.[5] That is the language of simple negligence. Even more troublesome, they seem to have reached the “should have” finding by reference to the importance (materiality) of the item to the prosecution proceeding, the logic of which is somewhat elusive. In 2008 a number of cases have now explained how all this is consistent with Kingsdown. Negligence alone might not be enough, but when material information is found in the hands of persons connected to patent prosecution, they need to provide a “credible explanation” or suffer a finding of bad intent.[6]
The trouble with this approach is that it allows even simple negligence (“should have known”) to shift the burden of persuasion on intent to the patent owner. This shift will happen in just about every case, because the finding of materiality in a combative courtroom setting will nearly always generate the “should have known” prong, shifting the entire burden of credibly showing benign intent onto the patentee. In the dynamic of actual patent litigation years after the events in question, that burden is indeed a fearsome one. In life, consider how often we ask ourselves when bad situations arise: “Why did I do that? Why didn’t I see the connection?” Credible-sounding explanations are not that easy to come by, even when we know we are innocent. Explanations on the ground of human fallibility feel hollow, and this is especially so in the majestic setting of a court proceeding. The patent bar and their clients have gone out of the frying pan and into the fire.
Some rays of hope have appeared for rectifying the situation. Judge Newman dissented in Nilssen, the small-entity status case.[7] And Judge Rader has seen the problem in what I regard as its proper light. In May of this year two panel judges sitting with him upheld a district court’s finding of inequitable conduct in a withholding-of-information case. The two were unwilling to reverse the lower court’s conclusion that the explanation given for non-citation was not credible.[8] Dissenting, Judge Rader said: “[M]y reading of our case law restricts a finding of inequitable conduct to only the most extreme cases of fraud and deception. . . Although designed to facilitate USPTO examination, inequitable conduct has taken on a new life as a litigation tactic. The allegation of inequitable conduct opens new avenues of discovery; impugns the integrity of patentee, its counsel, and the patent itself; excludes the prosecuting attorney from trial participation (other than as a witness); and even offers the trial court a way to dispose of a case without the rigors of claim construction and other complex patent doctrines.”[9] Amen to that. This is not the place to try to rectify perceived weaknesses in the patent examination process or to make amends with district judges by according more weight to their rulings. Worthy and important goals those may well be, but shifting burdens on inequitable conduct is not the way.
Inequitable conduct burdens have in the past rightly been placed on the challenger. Establishing this defense has required a finding not about what a person should have known, but that the person involved actually did appreciate of the significance of the information to the prosecution process. Now the burden on the intent prong has de facto shifted. Hopefully it will return to where it was. I have always thought the relative importance of the item as seen years later has little to do with finding an intent to mislead. Most of the time it is just as easy in life to fail to connect important dots as unimportant ones.
[4]RCA Corp. v. Data General Corp., 887 F.2d 1056, 1065 (Fed. Cir. 1989), emphasis in original.
[5] See Ferring BV v. Barr Labs. Inc., 437 F.3d 1181, 1191-92 (Fed. Cir. 2006) (applicant should have known non-disclosed relationships of affiants to assignee company were important); Cargill Inc. v. Canbra Foods Ltd., 476 F.3d 1359, 1367-68 (Fed. Cir. 2007) (applicant should have known lab tests on a property were important); Bruno Indep. Living Aids Inc. v. Acorn Mobility Services Ltd., 394 F.3d 1348, 1351 (Fed. Cir. 2005) (from what was said to FDA, applicant should have known prior powered staircase was important to PTO).
[6] See Nilssen v. Osram Sylvania, Inc., 528 F.3d 1352, 1359-60 (Fed. Cir. 2008) (inequitable conduct finding upheld based on wrongful claiming of small entity status, where explanation testimony was not credible); Pfizer Inc. v. Teva Pharms. USA, 518 F.3d 1353, 1367 (Fed. Cir. 2008) (finding of no inequitable conduct in non-citation of reference showing similar structure affirmed where explanation was credible); Monsanto Co. v. Bayer Bioscience N.V., 514 F.3d 1229, 1241 (Fed. Cir. 2008) (inequitable conduct finding upheld where explanation for non-citation of meeting notes was not credible).
Research Corporation Technologies v. Microsoft (Fed. Cir. 2008)
In the third of a trio of inequitabe conduct opinions by Judge Rader, the CAFC reversed the lower court’s ruling that RCT’s digital halftoning patents were unenforceable. Amazingly, the appellate panel found instead that it was storied district court judge Manny Real who was guilty of bad behavior. [Discussion of the district court case.]
The panel – Judges Newman, Rader, & Freeman – could not have been better for a patentee accused of inequitable conduct. Here, the CAFC held that the lower court clearly erred by failing to establish the materiality of RCT’s actions during prosecution.
“The trial judge found inequitable conduct because the inventors did not disclose [the inventor’s] post-filing K factor tests to the USPTO. Because [the inventor’s] work occurred after she and Dr. Parker had filed the patent application, these K factor experiments were not material to their inventive activity. In the circumstances of this case, therefore, the inventors had no obligation to report their later tests to the USPTO.”
The next quote will be taken out of context and often used:
“Importantly, [the inventor] and her coauthors published the K factor tests to the scientific community. Publication is an act inconsistent with an intent to conceal data from the USPTO.”
In re Freescale Semiconductor (Fed. Cir. 2008) (non-precedential)
Although this case arises from an ITC action, it still serves as a good example the difference between a court deciding whether to stay a proceeding versus the decision on preliminary injunctive relief. Both decisions are within the discretion of the lower court. However, only the preliminary injunction decision is immediately appealable.
In an ITC Section 337 action begun by patentee Tessera against Motorola, Freescale, Quallcom and others, the Administrative Law Judge (ALJ) granted a stay of its proceedings pending reexamination of the patent. On appeal, the Commission rejected the stay and ordered the proceedings reinstated. Freescale filed a petition for a writ of mandamus asking the CAFC to stay the proceedings.
Tessera’s 6,465,893 patent broadly covers a semiconducter chip arrangement:
a) a first semiconductor chip having a front surface, a rear surface and contacts on said front surface;
b) a second semiconductor chip having a front surface, a rear surface and contacts on said front surface, said rear surface of said second semiconductor chip being juxtaposed with said front surface of said first semiconductor chip;
c) a first backing element having electrically conductive first terminals, said first backing element being juxtaposed with said rear surface of said first semiconductor chip so that at least some of said terminals overlie said rear surface of said first semiconductor chip, at least some of said contacts on said first and said second semiconductor chips being electrically connected to at least some of said terminals; and
d) a substrate having contact pads thereon, said first terminals being connected to said contact pads of said substrate, said substrate being adapted to connect the assembly with other elements of a circuit, at least some of said first terminals overlying said rear surface of said first semiconductor chip.
The CAFC rejected Freescale’s request for mandamus — holding that the accused infringer had not shown any special need for a stay.
“The Commission provided a sufficient basis for denying the stay. Furthermore, that a petitioner may suffer hardship, inconvenience, or an unusually complex trial does not provide a basis for a court to grant mandamus.”
On Friday, I’ll be speaking at a Stanford Conference. The topic is the Quasi-Trademark Properties of Design Patent Protection. A recent lawsuit filed by Simply Orange Juice (Coca-Cola) is typical of the approach. SOJ’s design patent covers its recognizable orange juice bottle. These days, design patents are regularly obtained more easily, cheaper, and quicker than the accompanying trade dress registration. The design patent can then be used as evidence of non-functionality in the future trade dress proceedings.
The IP Dispute Resolution Blog (IP ADR) hosted “Blawg Review #171” with dozens of links to recent interesting IP articles. [LINK]
Today’s Washington Post includes info on “A Junket that is Patently Enviable.” [An all expense paid trip to Copenhagen for PTO Officials and Congressional Staffers]
Proveris Scientific Corp v. InnovaSystems, Inc. (Fed. Cir. 2008)
Innova’s optical spray analyzer is used in connection with FDA regulatory submissions. In particular, the device can be used to measure the quality of aerosol sprays used for drug delivery. In a pre-trial order, much experienced Judge Young of Massachusetts ruled that the safe harbor of 35 USC 271(e)(1) does not immunize Innova’s activities.
Section 271(e)(1) is designed to facilitate FDA regulatory approval process by immunizing submission related activity from charges of patent infringement. In particular, the safe harbor immunizes activities associated with a patented invention “solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.”
On appeal, the CAFC affirmed Judge Young’s decision – holding that “the Section 271(e)(1) safe harbor does not immunize the OSA from infringement.”
“In short, Innova is not a party seeking FDA approval for a product in order to enter the market to compete with patentees. Because the OSA device is not subject to FDA premarket approval, and therefore faces no regulatory barriers to market entry upon patent expiration, Innova is not a party who, prior to enactment of the Hatch-Waxman Act, could be said to have been adversely affected by the second distortion. For this reason, we do not think Congress could have intended that the safe harbor of section 271(e)(1) apply to it. Put another way, insofar as its OSA device is concerned, Innova is not within the category of entities for whom the safe harbor provision was designed to provide relief. We thus agree with the district court that Innova is not entitled to the benefit of the section 271(e)(1) safe harbor.”
Note:
Jeff Light of “Patients not Patents” filed an amicus brief in this case.
Editorial by Arti Rai, Elvin R. Latty Professor of Law, Duke University
From the perspective of a candidate running for President, articulating a position on the subject of patent reform might appear a fool’s errand. For many (perhaps most) voters, the subject will be impossibly arcane. Within the small group that closely follows the highly divisive debate (e.g. patent litigators and prosecutors, stakeholders in the various industries most affected by patents), virtually any position a candidate takes will alienate a significant percentage.
Complicating the situation further is the reality that the patent system has so many moving parts. In particular, for better or for worse, a large chunk of patent policy is currently made through Federal Circuit decisions. For good reasons, the Constitution insulates Article III judges from direct Presidential control. But the result of this lack of control means that reform proposals that a President can readily implement, and that might appear sensible on first examination, can be undermined by judicial action. For example, requiring disclosure of prior art by applicants (who presumably know a lot about their area of invention) might seem sensible. But the reasoning behind the policy is undermined if the Federal Circuit decides to invoke a highly aggressive doctrine of inequitable conduct.
So ignoring the subject – as Senator John McCain has done, at least thus far, may be the politically expedient course. (We will see if the McCain technology plan, about which McCain advisor Michael Powell has been dropping hints and which is supposed to be unveiled formally soon, talks about patents.) But politically expedient behavior on an issue as important to innovation, and our country’s future, as sound patent policy is hardly what we want from our next President.
What is striking about Senator Barack Obama’s approach is that he has not only articulated a position, but that he did so back in November 2007, as the patent reform wars were raging in Congress. (Senator Obama’s position appears in the technology platform that he released at Google last November.)
Senator Obama’s approach reflects a nuanced understanding of the concerns of the various stakeholders. It also reflects an ability to rise above narrow interest group politics and suggest creative solutions not contemplated by the interest groups most active in the latest round of the Congressional reform wars.
For example, the Senator says that when "dubious patents are being asserted, the PTO could conduct low-cost, timely administrative proceedings to determine patent validity." Thus he comes out in favor of a "second window" for post-grant administrative review of patent validity at the time the patent is asserted. As IT firms that are faced with constant litigation threats have pointed out (and as other countries’ experience with post-grant review shows), this option could represent a real savings relative to expensive litigation over patent validity. Moreover, at least in the long term, the availability of this option might reduce the incentive to file dubious patent applications in the first instance (and hence might reduce the current backlog of over 700,000 patent applications).
At the same time, Senator Obama’s plan accommodates the interests of those firms (e.g. biotechnology and pharmaceutical firms) that have made reasonable arguments about their need for early certainty about patent validity. It provides for an option not contemplated in the Congressional debate – self-selection ex ante into "rigorous and public peer review that would produce a ‘gold-plated’ patent." Under default principles of administrative law, gold-plated patents would be much less subject to future administrative or judicial challenge.
Of course, much of the devil will be in the details. For example, as the GAO has recently pointed out, management and personnel practices at the PTO need to be improved substantially in order for the PTO to retain the qualified examiners necessary for implementing even existing procedures. New procedures will require even more attention to reform of internal PTO practices.
A Presidential candidate’s policy proposals cannot include all of the details he might contemplate. But Senator Obama’s willingness to stake out some clear reform positions early in his campaign, and at a time of great sensitivity over the issue, performs what economists call a signaling function. The Senator has sent a signal that he would take patents seriously, both in terms of substantive proposals and in terms of the people he would appoint to formulate and implement these proposals.
Bill Patry has decided to stop his popular copyright law blog. He gives two reasons:
Although the blog is his personal work, most folks who quote the blog draw some link to Google policy. (I’ll do it here: Patry is Google’s top copyright attorney).
Copyright law is too depressing:
“[W]e are well past the healthy dose stage and into the serious illness stage. Much like the U.S. economy, things are getting worse, not better. Copyright law has abandoned its reason for being: to encourage learning and the creation of new works. Instead, its principal functions now are to preserve existing failed business models, to suppress new business models and technologies, and to obtain, if possible, enormous windfall profits from activity that not only causes no harm, but which is beneficial to copyright owners. Like Humpty-Dumpty, the copyright law we used to know can never be put back together again: multilateral and trade agreements have ensured that, and quite deliberately.
It is profoundly depressing, after 26 years full-time in a field I love, to be a constant voice of dissent. I have tried various ways to leaven this state of affairs with positive postings, much like television news shows that experiment with “happy features.” I have blogged about great articles others have written, or highlighted scholars who have not gotten the attention they deserve; I tried to find cases, even inconsequential ones, that I can fawn over. But after awhile, this wore thin, because the most important stories are too often ones that involve initiatives that are, in my opinion, seriously harmful to the public interest. I cannot continue to be so negative, so often. Being so negative, while deserved on the merits, gives a distorted perspective of my centrist views, and is emotionally a downer.
So between the inability or refusal of some people to accept the blog for what it is — a personal blog — and my inability to continue to be Cassandra, I decided it was time to pull the plug.”
The only patent reform bill to make it through both the House and Senate in 2008 may well be the “Duffy Provision.” In an article first published in Patently-O on July 23, 2007, Professor John Duffy of GWU Law School argued that current provisions for appointing members of the Board of Patent Appeals and Interferences are unconstitutional. According to Duffy’s article, the constitution requires that these inferior officers (BPAI judges) must be appointed by either the President of the US or a “Head of Department” such as the Secretary of Commerce. I conducted a study in June 2008 and found that 83% of recent BPAI decision panels included at least one panel member that had been illegally appointed under the Duffy construction. In my study, a significant number of panels (44%) included a majority of illegally appointed judges, and about half of the opinions were authored by illegally appointed judges. John Welch, an expert on the Trademark Trial & Appeal Board suggested that TTAB judges would fall in the same category. [LINK]
The House and Senate have acted on the issue and have now sent a Bill to the President that would correct the appointment process for both the BPAI and the TTAB by placing the appointment duty in the hands of the Secretary of Commerce.
The Bill also includes a “defense to challenge appointment.” In particular, the new statute would read that “It shall be a defense to a challenge to the appointment of an administrative patent judge on the basis of the judge’s having been originally appointed by the Director that the administrative patent judge so appointed was acting as a de facto officer.”
Debra Anderson recently published her checklist for ensuring that the PTO is notified of all relevant prior art and public uses of an invention. What is on your checklist?
Remind your client of the duty to disclose relevant prior art, including related copending applications (and make sure to file this prior art with the United States Patent and Trademark Office).
Make sure that the examiner at the patent office is aware of activity in related cases, if handled by other examiners.
Ask [inventors and in-house attorneys] about attendance at conferences [including notes taken], posters, and abstracts submitted to journals.
Remember to file prior art uncovered in foreign searches.
Ask about offers for sale or other public disclosures through use or publication.
If you are filing a declaration, make certain that it is clear to the PTO where the interests of the declarant lie. Do not conceal from the PTO facts known to you that are adverse to your client’s position (such as negative data), in order to advance your client’s case.
Discuss the date of invention and related evidence with your client.
Novo Nordisk v. Sanofi-Aventis (Fed. Cir. 2008) (nonprecedential)
Novo sued Sanofi alleging infringement of its patent covering an insulin pen. In a Feb 19, 2008 order, the district court denied Novo’s request for a preliminary injunction – finding that Sanofi has a strong non-infringement argument. On appeal, the CAFC quickly affirmed.
The decision to not issue a preliminary injunction rests within the discretion of the district court.
We will reverse such a decision only when an appellant demonstrates that the “factors relied on by the district court [were] clearly erroneous” and “that a denial of the preliminary relief sought would amount to an abuse of the court’s discretion upon reversal of an erroneous finding.” New Eng. Braiding Co. v. A.W. Chesterton Co., 970 F.2d 878 (Fed. Cir. 1992).
In this case, the district court did not construe the claims prior to denying the PI request. It did note, however, that “questions exist” as to whether the patented invention requires direct gearing and a non-rotatable piston — elements not found in the accused product.
In its appellate decision, the CAFC found that the lower court had acted properly in denying the PI request without deciding the claim construction issue:
At the preliminary injunction stage, however, it is irrelevant whether this case presents greater issues of claim construction or validity—the existence of one or both of these issues is sufficient to justify the district court’s decision to deny a preliminary injunction.
Affirmed
Note: My former firm, MBHB, represents Sanofi-Aventis in this appeal.
Late Requests for Patent Term Extension: An earlier post noted that the PTO had rejected AstraZeneca’s request for a patent term extension because it was filed one day late. Interestingly in its filing, Astra found 14 other PTE requests that were filed on the 61st day and were still granted: 5,827,937 (RESTYLANE); 5,639,639 (Luveris); 5,532,221; 5,441,745; 4,941,093; 4,874,749; 4,836,217 (ALLERGEN PATCH); 4,830,010; 4,702,253; 4,513,006; etc.
The following histogram shows the distribution of patent term extensions granted by the PTO. The average extension is just over 2 1/2 years. The PTE list includes about 100 patents that would have expired already, but are still in force due to the extension. See http://www.uspto.gov/web/offices/pac/dapp/opla/term/156.html.
Question: The CAFC reviews BPAI factual findings for substantial evidence. If an applicant appeals a Board ruling to a district court, how does that court treat the BPAI’s facutal findings? (Please cite a case or give your experience)
SC Law Review: When I was born, my dad was attending USC — that’s right the Gamecocks of South Carolina. The South Carolina Law Review transforming to a a peer review journal and is looking for help & comments. http://www.sclawreview.org/peerreview/index.php.
Summary: The USPTO has rejected AstraZeneca’s request for an extension of its patent term on Symbicort. In its decision, the office gave two reasons: (1) new combinations of old drugs do not receive extensions; and (2) AstraZeneca missed the filing deadline by a day.
Intro: AstraZeneca’s drug Symbicort has two active ingredients: formoterol fumarate dihydrate and budesonide. Global Symbicort sales were $1.6 billion in 2007. The original patent application covering the combo invention was filed in 1991 by two of Astra’s Swedish scientists. The US version issued in 1997.
“Human drug products” require pre-market FDA approval – a long and expensive process. The FDA approved Symbicort in July 2006 – some 15 years after the original patent application was filed. This long delay is common, and the Hatch-Waxman provision of 35 USC 156 provides for an extension of the patent term based on these delays.
In this case, however, the USPTO has rejected Astra’s extension petition — finding the patent ineligible.
Combo Drugs: Under the statute, extensions are only granted if the patented “product … is the first permitted [and FDA approved] commercial marketing use of the product.” 35 USC 156(a)(5)(A). It turns out that each active ingredient in the Symbicort has been previously marketed – although the combination was new to the market. Applying the rule to the facts, the PTO found that the “product” had been previously marketed:
“Because both active ingredients in SYMBICORT have been previously approved for commercial marketing or use before the approval of SYMBICORT, Applicant’s approval of SYMBICORT does not qualify as the first permitted commercial marketing or use of either active ingredient, as required by section 156(a)(5).”
Synergy is Irrelevant: Importantly, the PTO rejected the argument that the relevant “product” must include both active ingredients because they have synergistic value when combined.
“The term “product” as used in 35 U.S.C. 156 includes any new drug or antibiotic drug, “as a single entity or in combination with another active ingredient.” 35 U.S.C. 156 (f)(2). Section 156(f)(2) says nothing about whether a combination is synergistic.”
This decision follows the CAFC precedent found in Arnold Partnership v. Dudas, 362 F.3d 1338 (Fed. Cir. 2004). In that case, the court rejected a PTE extension for Vicoprofen (hydrocodone/ibuprofen) announcing that the statute requires a component-by-component analysis for PTE extension:
“This statutory language requires this court to examine a drug product patent’s eligibility for extension on a component-by-component, or an ingredient-by-ingredient basis.The final phrase in subsection (f) –“including any salt or ester of the active ingredient, as a single entity or in combination with another active ingredient” – emphasizes this point.This final phrase of subsection (f) shows that the statute refers to a drug product on a component-by-component basis, not as a whole.” Arnold Partnership.
MPEP 2751 includes the interesting statement that “an approved product having two active ingredients, which are not shown to have a synergistic effect or have pharmacological interaction, will not be considered to have a single active ingredient made of the two active ingredients.” The PTO in its decision rejected the negative implication of this statement.
One Day Late: As an alternative reason for its decision, the Commissioner found that the PTE Petition had been filed one day late. It is always a trick to figure out whether the first day of a time period “counts.”
Section 156 announces that the due date is: “within the sixty-day period beginning on the date the product received [FDA] permission.” PTO rules spell this out more particularly – requiring the application be submitted “within the sixty day period beginning on the date the product first received permission.” 37 C.F.R. 1.720(f). Based on a “plain language” reading of the statute and rule, the PTO decided that the day that permission was granted counts as day one rather than day zero.
Because the FDA granted permission on July 21, 2006, PTO found that the sixty-day period ended on September 18, 2006. Astra filed its petition on September 19.
Astra can appeal “within TWO MONTHS of the mailing date of this letter.” The PTO’s letter was sent on June 13 – query whether the reply is due on the 12th, 13th, or 14th?
Margaret Peterlin has announced that she will be leaving the PTO in August. She has sparked resistance from the patent community ever since her appointment as deputy director of the USPTO in May 2007. She is considered an expert at legislative tactics at a time when the PTO was asking for legislation opposed by many patent practitioners. In late 2007, a DC District dismissed a lawsuit against the USPTO requesting that Peterlin be removed from office. The complaint alleged that she lacked the intellectual property law experience required by statute for her position. In many ways, the negative reaction to Peterlin was simply a reflection of frustrations felt by many patent practitioners. In an internal message to PTO employees, Director Jon Dudas indicated that Peterlin is also expecting her first child later this year. Congratulations and Good Luck!!(more…)
This is a nice idea: A device for automatically printing out caller ID records. What I prefer (and have used in the past) is to receive an e-mail receipt for all incoming calls and with messages attached in an mp3.
SEI (the party in interest) has a simple enough claim:
1. A caller ID printing device, comprising:
a controller configured to detect caller ID information from an incoming call; and a printer configured to automatically print the caller ID information; and a message template onto a call record immediately after the first receipt of a first ring signal and without user intervention.
The BPAI rejected the claim as obvious. On appeal, the CAFC reminded the applicant that the BPAI’s underlying factual determinations need only be supported by “substantial evidence.”
‘Substantial evidence is evidence that “a reasonable mind might accept as adequate to support a conclusion.” In re Gartside, 203 F.3d 1305 (Fed. Cir. 2000). “[W]here two different inconsistent conclusions may reasonably be drawn from evidence in the record, an agency’s decision to favor one conclusion over the other is the epitome of a decision that must be sustained upon review for substantial evidence.” In re Jolley, 308 F.3d 1317 (Fed. Cir. 2002). This court will not determine that a decision made by the Board is unsupported “simply because the Board chose one conclusion over another plausible alternative.” Id.’
In this case, the panel easily found that two references combined teach each element of the invention and render it obvious.
Secondary considerations are most often used by patentees as circumstantial evidence that an invention was nonobvious. “Negative” secondary considerations – those used as circumstantial evidence of obviousness – have received less attention and less support in the case law. However, Brent Yamashita discusses the potential use of one negative secondary consideration: the simultaneous invention factor. Brent gave his permission to publish this short article on the topic.
By Brent Yamashita*
Introduction: In nearly every patent litigation, the accused infringer will argue that the asserted patent claims are obvious (if not anticipated) by the prior art and therefore should be ruled invalid. The U.S. Supreme Court substantially altered the law of obviousness in KSR when it held that an accused infringer does not necessarily need to show “a teaching, suggestion, or motivation” (“TSM”) in the prior art to combine known elements in order to show that the combination was obvious. SeeKSR Int’l Co. v. Teleflex Inc., 550 U.S. ___, 127 S. Ct. 1727, 1741 (2007). Now that proving obviousness no longer requires establishing TSM, the secondary considerations of obviousness and nonobviousness have taken on greater importance in obviousness determinations, as KSR left that doctrine fully intact.
The concept of secondary considerations originated in Graham, where the Supreme Court stated that secondary considerations can serve as relevant “indicia of obviousness or nonobviousness” and might be utilized “to give light to the circumstances surrounding the origin of the subject matter to be patented.” See Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 17-18 (1966). The Court further stated that secondary considerations can include commercial success, long-felt but unsolved need, and the failure of others. See Id. Other factors recognized by the Federal Circuit after Graham include whether the prior art teaches away from the invention, whether others have copied the invention, and whether the invention has received industry acclamation. See, e.g., Ecolochem, Inc. v. Southern California Edison Co., 227 F.3d 1361 (Fed. Cir. 2000), cert. denied, 532 U.S. 974 (2001).
The Simultaneous Invention Factor: Another secondary consideration-and one which appears to have been discussed and applied much less frequently by the Federal Circuit than the other secondary considerations-is the simultaneous invention consideration. The Federal Circuit has stated that, “[T]he possibility of near simultaneous invention by two or more equally talented inventors working independently,… may or may not be an indication of obviousness when considered in light of all the circumstances.” Ecolochem, 227 F.3d at 1379 (quoting Lindemann Maschinenfabrik GMBH v. American Hoist and Derrick Co., 730 F.2d 1452, 1460 (Fed. Cir. 1984)). In other words, the fact that another person simultaneously and independently created the same invention claimed in the patent-in-suit can serve as an indication that the invention was obvious.
Every accused infringer should consider this often-overlooked secondary consideration in preparing its obviousness defense. This factor can be particularly useful in a situation where the simultaneous inventions occurred shortly after an enabling technology was introduced. Some inventions only become possible-or relevant-once a foundational technology becomes known. For example, tires could not have been invented before the wheel and would have been meaningless before the wheel. An enabling technology can serve as a chronological starting point for the simultaneous inventions that follow, which can be useful in gauging obviousness of the invention.
In this particular context, I propose that the simultaneous invention factor be modified as follows: Simultaneous invention by a first inventor and a second inventor is indicative of obviousness when the development by the two inventors occurred independent of one another in a simultaneous manner shortly after an enabling technology emerged and where there is a nexus between the enabling technology and the development by the two inventors. Applying the simultaneous invention factor in this manner would reflect the fact that if more than one person develops the claimed invention quickly once all of the necessary enabling technology becomes available, then the invention arguably was obvious.
As an example, imagine the following sequence of events:
March 1, 1925: Company A introduces the world’s first TV. The TV includes an antenna for receiving broadcast signals. (Admittedly, TV content is hard to come by at this time.)
May 1, 1925: Inventor B develops a TV antenna that improves the reception of Company A’s TV. Inventor B files a patent application on his invention and eventually obtains the patent.
May 15, 1925: Inventor C, independently of Inventor B, develops a TV antenna that improves the reception of Company A’s TV. Inventor C’s antenna practices the claims of Inventor B’s patent when it ultimately issues.
Under the simultaneous invention factor, an accused infringer in a lawsuit brought by the owner of Inventor B’s patent could argue that the fact that Inventor B and Inventor C each independently created a TV antenna shortly after an enabling technology (i.e., Company A’s TV) emerged suggests that the claimed invention was obvious once the enabling technology existed and that the invention would have been invented sooner had the enabling technology been available sooner. In addition, the simultaneous invention factor in this context would counteract the ability of the patent holder to argue that a long-felt but unsolved need for the claimed invention shows that the patent was nonobvious, since the “long” aspect of the long-felt need in this context was a result of the amount of time that elapsed before the TV emerged and was not a result of the amount of time taken to develop the invention once the enabling technology existed.
From a litigation strategy standpoint, in most instances the accused infringer under this proposed rule would do whatever it could to find technology that preceded the invention and argue that it was enabling and that the invention occurred only once that technology existed. The proposed modification of the simultaneous invention rule potentially could become a “knee-jerk” obviousness argument by every accused infringer, and courts therefore must be diligent about identifying and rejecting spurious arguments. In that regard, requiring litigants to establish a nexus between the simultaneous inventions and the enabling technology will help to prevent the abuse of this secondary consideration. The nexus will be most apparent if both inventors began their work only after the enabling technology emerged and if the inventions never could have been developed or built without that enabling technology in place. In this sense, the enabling technology must be a genuine prerequisite or foundation for the invention.
Conclusion: In appropriate circumstances, litigants should utilize the often-overlooked simultaneous invention factor in its obviousness defense. If applied in the manner proposed in this article, the simultaneous invention factor properly recognizes the fact that in some instances inventions do not occur after years and years of toiling in a laboratory, but rather, after a minimal effort (executed by others independently and simultaneously) after a breakthrough in an enabling technology that is not itself the subject of the invention.
Notes:
* Brent Yamashita is a partner in the patent litigation group of DLA Piper US LLP’s Silicon Valley, California office.
Teva Pharm. Indus. v. Apotex, 2008 U.S. Dist. LEXIS 60418 (D.N.J. 2008) 
Dr. Serdarevic v. Advanced Medical Optics (
The Federal Circuit recognized the problem and in 1988 handed down 
Research Corporation Technologies v. Microsoft (
On Friday, I’ll be speaking at a Stanford Conference. The topic is the Quasi-Trademark Properties of Design Patent Protection. A recent lawsuit filed by Simply Orange Juice (Coca-Cola) is typical of the approach. SOJ’s design patent covers its recognizable orange juice bottle. These days, design patents are regularly obtained more easily, cheaper, and quicker than the accompanying trade dress registration. The design patent can then be used as evidence of non-functionality in the future trade dress proceedings. 
Proveris Scientific Corp v. InnovaSystems, Inc. (
The only patent reform bill to make it through both the House and Senate in 2008 may well be the “Duffy Provision.” In an article 
Novo Nordisk v. Sanofi-Aventis (
In re Patent Term Extension for Patent No. 5,674,860 (
Margaret Peterlin has announced that she will be leaving the PTO in August. She has sparked resistance from the patent community ever since her appointment as deputy director of the USPTO in May 2007. She is considered an expert at legislative tactics at a time when the PTO was asking for legislation opposed by many patent practitioners. In late 2007, a DC District dismissed a lawsuit against the USPTO requesting that Peterlin be removed from office. The complaint alleged that she lacked the intellectual property law experience required by statute for her position. In many ways, the negative reaction to Peterlin was simply a reflection of frustrations felt by many patent practitioners. In an internal message to PTO employees, Director Jon Dudas indicated that Peterlin is also expecting her first child later this year. Congratulations and Good Luck!! 
By Brent Yamashita* 
As an example, imagine the following sequence of events: