Samuels’ Infamy or Praise review provides an overview of law blawgs within the concept of the mountain representing Purgatory, the place wherein those souls neither condemned to Hell nor raised to Heaven may be purified of their sins so that they might enter Heaven. This is known in my firm as “Of Counsel.”
Samuels shows the terraces of the mountain of Purgatory from Pride through Lust. We especially enjoyed Robert Ambrogi’s post on a handy how-to video that’s not to be missed.
Every now and then I have an application that is subject to a secrecy order by the government that restricts disclosure of the invention and prevents the publishing or granting of a patent. I noticed that a current application being held up really doesn’t seem to contain sensitive information but the application may have triggered the order itself by making a reference in the description that one of its many uses could be by the military. It would be analogous to an invention for an improved water bottle that you might describe as being beneficial to the military (a group that often needs bottled water in far away places) but that really is ordinary, everyday technology.
If you don’t know, the Invention Secrecy Act of 1951 requires the government to impose secrecy orders on certain patent applications that contain sensitive information, thereby restricting disclosure of the invention and withholding the grant of a patent. This requirement can be imposed even when the application is wholly created and owned by a private individual or company without government sponsorship or support.
There are several types of secrecy orders which range in severity from simple prohibitions on export (but allowing other disclosure for legitimate business purposes) up to classification, requiring secure storage of the application and prohibition of all disclosure. A secrecy order withholds the grant of a patent, orders that the invention be kept in secrecy and restricts filing of foreign patent applications.
It seemed to me that the number of secrecy orders has been on the rise. It turns out, I’m not the only one that thinks the government is keeping more secrets since 9/11. At the end of fiscal year 2006, there were 4942 secrecy orders in effect, some of which have been in effect since the 1930s. Even the NSA had nine of its patent applications blocked in the fiscal year to March 2005 against five in 2004, and none in each of the three years up to 2003.
This week, I received a note from a reader about information on secrecy orders posted by the Federation of American Scientists (FAS), a group formed in 1945 by atomic scientists from the Manhattan Project who felt that scientists, engineers and other innovators had an ethical obligation to bring their knowledge and experience to bear on critical national decisions, especially pertaining to the technology they unleashed, i.e., the Atomic Bomb. Endorsed by 67 Nobel Laureates in chemistry, economics, medicine and physics, FAS addresses a broad spectrum of issues in carrying out its mission to promote humanitarian uses of science and technology.
Secrecy orders provide a security procedure to prevent technical data contained in a patent application from being disclosed in a manner that would be detrimental to the national security. Secrecy orders are imposed by the PTO upon specific recommendation by defense agencies, including the Army, Navy, Air Force, National Security Agency, Department of Energy and National Aeronautics and Space Administration.
The PTO conducts an initial security screening of all patent applications. Government-owned applications are not reviewed by the PTO for technical content. It is the responsibility of the cognizant defense agencies to review their own applications and recommend a secrecy order to the PTO where appropriate.
Applications in which there is no apparent government property interest are made available by the PTO to defense agencies for their inspection when, in the opinion of the Commissioner of Patents, disclosure might be detrimental to the national security. If, upon inspection, a defense agency determines that disclosure “would be detrimental” to the national security, it may recommend that the Commissioner of Patents place a secrecy order on the application.
When the Secrecy Order issues, the law specifies that the subject matter or any material information relevant to the application, including unpublished details of the invention, shall not be published or disclosed to any person not aware of the invention prior to the date of the Order, including any employee of the principals except as permitted by the Secrecy Order. The law also requires that all information material to the subject matter of the application be kept in confidence, unless written permission to disclose is first obtained from the Commissioner of Patents and Trademarks except as provided by the Secrecy Order. Therefore, the subject matter under Secrecy Order is to be safeguarded under adequate protection to prevent access by unauthorized persons.
I suppose we should not get too worked up about this given the lengthy history. Concerns about invention secrecy and national security date back to the First World War. In an effort to address the government’s concerns, Congress passed the act of October 6, 1917. The Invention Secrecy Act of 1951 created 35 U.S.C. sections 181 through 188, entitled Secrecy of Certain Inventions and Filing Application in Foreign Countries. Section 181 deals with the conditions set forth by a secrecy order, namely that the order shall last one year, or in the event of war, for the duration of the hostilities plus one year, on in the time of a national emergency (as declared by the president), for the duration of the emergency plus six months, all orders being renewable.
Section 181 also sets out that the applicant may appeal the issuance of a secrecy order to the Secretary of Commerce. Section 182 provides that in the event of an unauthorized disclosure of the contents of a secret patent, the inventor forfeits all rights to a patent to which he might have otherwise been entitled. Section 183 outlines the conditions for an inventor’s right to compensation, which is valid for six years from the date of issue on the patent, and includes compensation for government use, and for damages caused by the secrecy order. Section 184 states that any applicant must not file in a foreign country for six months after filing in the United States, to allow proper review of the invention for its relevance to national security. Section 185 applies the same penalties for foreign filing as for an unauthorized disclosure (as outlined in section 182). Section 186 describes the penalties for any violation of the secrecy order, which are up to $10,000 or two years in prison, or both. Section 187 exempts officers and agents of the United States from these prohibitions. Section 188 lists the persons who may wield secrecy orders, which include the Atomic Energy Commission, Secretary of Defense, Secretary of Commerce, and the heads of any government agencies the President designates.
A month ago, Robert Ambrogi’s LawSites ran a LawSites Poll: Your Top Legal Blog. Deemed “an experiment”, Robert hopes to use the poll to deal with the flood of law blogs.
Robert wanted to know:
What is the one law-related blog you feel you must read as regularly as possible? No fair naming your own. From your responses, I hope to find guidance in deciding which blogs should be on my own must-read list.
To be fair, I must confess that I got busy with a talk I was giving and forgot to vote. What’s worse, the site I was going to vote for was none other than: Patently-O! Sorry ’bout that Dennis.
I don’t know what it is about the recent uptick in conflict issues but now the Washington Post has reported that federal prosecutors have charged a senior scientist at the National Institutes of Health with conflict of interest for taking fees from a drug company that was involved with his government research. Dr. P. Trey Sunderland III is the first official in 14 years to be prosecuted for conflict of interest at the NIH. Sunderland accepted $285,000 in fees from Pfizer from 1998 to 2003 relating to research to identify chemical warning signs of Alzheimer’s disease. (Note to Pfizer: I’m available for consulting.) Prosecutors contend that Sunderland took money from Pfizer without getting the required advance permission from the NIH and did not note the fees and additional expense reimbursements on annual NIH financial reports. Federal law prohibits officials from accepting outside compensation for their government duties.
His services for the company were intimately intertwined with his government duties. Sunderland led efforts for a material transfer agreement on behalf of the NIH, whereby his staff would collect and then pass the spinal-tap samples to Pfizer. As part of the research, Sunderland helped provide Pfizer with hundreds of government-owned tissue samples for analysis. About the same time, in early 1998, “Sunderland initiated negotiations with Pfizer to be paid as a consultant for his work on the same project,” according to the criminal filing.
Sunderland’s not alone. Congressional investigators found that 44 researchers had off-the-books relationships with drug and biotech companies. Conflicts of interest in the pharmaceuticals area may in the news quite a bit lately but they’re not new. I don’t think that it indicates any new trend or that the world going to hell in a handbasket. I think if you want to know the root of the issue, you need look no further than the bottom line for drug sales. The global pharmaceutical market is forecast to grow to $842 billion in 2010. Just the top 16 new blockbuster drugs in 2005 generated combined sales of $18.1 billion. These eye-popping numbers can put a lot pressure on the marketplace – some innocent, some not so innocent.
Sunderland, 55, could get up to a year in prison and a $100,000 fine.
I received the following note from a reader asking if anyone would have suggestions on the following fact pattern:
I am preparing a petition to revive a US application that has gone abandoned, we think unintentionally. There are a number of case specific issues, which are not expressly provided for in MPEP 711.03. In particular, there appears to have been a mis-communication between the agent of record, at the time the application went abandoned, and the Applicant about the importance of a particular limitation in a claim element. The application went abandoned in favor of a subsequently filed CIP to add some limiting language to the specification and claims; this as a result of the mis-communication (and poor advice from the then agent of record). The CIP issued as a patent, but it now turns out that the licensee in charge of manufacturing the product believes that the product covered by the now abandoned application should have been the one to enter the marketplace and not the one covered in the issued patent. Finally, and probably a lost cause in light of MPEP 711.03, the application before it went abandoned went through three rounds of prosecution in which it received numerous 103(a) rejections, all essentially based on the same piece of art. The arguments which were put forth by the agent to address the rejections were inappropriate for this type of rejection, and thus led the Applicant to chose the abandonment route rather than continue prosecution.
Have any of your blog readers encountered such a problem and if so, were they successful in petitioning the Commissioner to revive the application?
A petition to revive must include a statement that the entire delay in filing the required reply from the due date for the reply until the filing of a grantable petition pursuant to this paragraph was unintentional. I’m not sure if this qualifies as unintentional since the application was intentionally abandoned, just on mistaken information about the rejections. It may be that the only recourse that can correct the claim deficiencies is a broadening reissue application.
The broadening reissue application allows you to go back to the USPTO once the patent is issued whenever there has been an error made and the inventor did not get all of the inventions (or the breadth of the invention) that he or she was entitled to. There are some requirements. First, the error must have been made without any deceptive intent. Second, the broadening reissue application, however, must be filed within two years after the patent issues. After that, it is too late. See 35 U.S.C. §251.
A broadened reissue claim is a claim which enlarges the scope of the claims of the patent, i.e., a claim which is greater in scope than each and every claim of the original patent. If a disclaimer is filed in the patent prior to the filing of a reissue application, the disclaimed claims are not part of the “original patent” under 251. A claim of a reissue application enlarges the scope of the claims of the patent if it is broader in at least one respect, even though it may be narrower in other respects.
The Court of Appeals for the Federal Circuit held that the effectiveness of the prior art is not relevant but rather whether it describes the claimed invention sufficiently to enable a person of ordinary skill in the art to carry out the invention.
After Impax sued Aventis in District Court for a declaratory judgment that Impax did not infringe, induce infringement of, or contribute to the infringement of U.S. Pat. No. 5,527,814 by filing an Abbreviated New Drug Application for the sale of riluzole, the district court found that Impax failed to prove the patent as invalid. Impax Laboratories v. Aventis Pharmaceuticals (05-1313).
Riluzole, sold under the name Rilutek, is the chemical compound 6-trifluoromethoxy-2-benzothiazolamine used for the treatment of patients with amyotrophic lateral sclerosis (“ALS”). ALS, commonly referred to as Lou Gehrig’s disease, is a disease of the central nervous system involving the progressive degeneration of the nerves that carry impulses to muscles.
Under 35 U.S.C. § 271(e)(2), it is an act of infringement to submit an ANDA under 21 U.S.C. § 355(j) for a drug claimed in a patent before the patent’s expiration. Therefore, Impax needs to knock out the ‘814 patent.
So, Impax asserted that the claims of the ’814 patent were invalid over the prior art and invalid by reason of incorrect inventorship. Impax later amended its complaint to add allegations of inequitable conduct.
In the district court Impax claimed that claims 1-5 of the ’814 patent were anticipated by the ’940 patent. The ’940 patent, which is owned by Aventis, is directed to a class of compounds disclosed in formula I:
The ’940 patent includes many different compounds, but it exempts 6-trifluoromethoxy-2-benzothiazolamine. That is, 6-trifluoromethoxy-2-benzothiazolamine could fall within the literal scope of formula I but is explicitly exempted from formula I. The ’940 patent states that 6-trifluoromethoxy-2-benzothiazolamine is not new, and thus does not form part of the invention. The ’940 patent goes on to state that the compounds of formula I are useful in treating medical conditions associated with the effects of glutamate such as ALS.
The ’940 patent claims priority from the ’624 application, which has a disclosure similar to that of the ’940 patent. However, the ’624 application does not exempt 6-trifluoromethoxy-2-benzothiazolamine from the family of formula I compounds as a claimed compound.
Impax argued that every limitation of claims 1-5 of the ’814 patent was disclosed by the ’940 patent in describing a class of compounds generally encompassed by formula I, including riluzole, and that the ’940 patent taught that riluzole is useful in treating ALS and also taught effective administration.
Aventis argued that the ’940 patent excluded riluzole from the compounds and that even if the ’940 patent included riluzole, it did not anticipate the ’814 patent because it failed to disclose the invention in the ’814 patent and was not enabling because it did not provide specific instruction for using riluzole and actually taught away from riluzole.
The district court concluded that the ’814 patent was not anticipated because “formula I entails such a large number of compounds . . . [that] one of ordinary skill in the art would not have recognized that riluzole was effective in treating ALS without additional detail or guidance that is not found in the disclosure of the ’940 patent.” Therefore, the court reasoned, formula I was not enabling.
In order to be anticipating, a prior art reference must be enabling so that the claimed subject matter may be made or used by one skilled in the art. Prior art is not enabling so as to be anticipating if it does not enable a person of ordinary skill in the art to carry out the invention.
The CAFC held that:
The enablement requirement for prior art to anticipate under section 102 does not require utility, unlike the enablement requirement for patents under section 112. Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318, 1325-26 (Fed. Cir. 2005) … Significantly, we have stated that ‘anticipation does not require actual performance of suggestions in a disclosure. Rather, anticipation only requires that those suggestions be enabled to one of skill in the art.’” (citations omitted).
“Whether a prior art reference is enabling is a question of law based upon underlying factual findings.” Minn. Mining & Mfg. Co. v. Chemque, Inc., 303 F.3d 1294, 1301 (Fed. Cir. 2002). In Amgen, we stated that, when, as here, an accused infringer asserts that either claimed or unclaimed material in a prior art patent anticipates patent claims asserted against it, the infringer is entitled to a presumption that the allegedly anticipating material is enabled.
The district court found that the ’940 patent did not anticipate the ’814 patent because the disclosure of the ’940 patent was not enabling at least in part because there was no evidence that it would be “effective.” Id. Under Rasmusson, the effectiveness of the prior art is not relevant. Id. Rather, the proper issue is whether the ’940 patent is enabling in the sense that it describes the claimed invention sufficiently to enable a person of ordinary skill in the art to carry out the invention. The CAFC then remanded to allow the district court to make a factual determinations and then reach its own legal conclusion as to whether the ’940 patent is enabled.
The CAFC thought differently, however, of the ‘624 patent holding:
As found by the district court, riluzole is just one of hundreds of compounds included in formula I. When a reference discloses a class of compounds, i.e., a genus, a person of ordinary skill in the art should be able to “at once envisage each member of th[e] . . . class” for the individual compounds, i.e., species, to be enabled. In re Petering, 301 F.2d 676, 681 (C.C.P.A. 1962). If the members cannot be envisioned, the reference does not disclose the species and the reference is not enabling. Here, with the large number of compounds included in formula I and no specific identification of riluzole by the ’624 application, the ’624 application does not disclose riluzole, and therefore, cannot enable treatment of ALS with riluzole. The ’624 application cannot anticipate any of claims 1-5 of the ’814 patent.
Judge Rader, concurring in part, opined that:
[T]he court determined that the language of the ‘940 patent itself created “substantial uncertainty” regarding use of glutamate inhibiting compounds in the treatment of ALS. Id. The court determined that the language in the patent discussing conditions implicating glutamate to be speculative, at best. Id. Thus, I read the district court to have found that the ‘940 disclosure did not put one of skill in the art in possession of the invention at all. Elan Pharms., Inc. v. Mayo Found., 346 F.3d 1051, 1057 (Fed. Cir. 2003). When it found that the disclosure leaves “substantial uncertainty,” the trial court sufficiently supported its holding. Id. The ‘940 disclosure does not make it a potential treatment in any way.
Anticipation does not require proof of “utility,” or (in other words) “actual performance of suggestions in a disclosure,” Bristol-Myers Squibb Co. v. Ben Venue Labs., 246 F.3d 1368, 1378 (Fed. Cir. 2001), but in this case, the district court has found that the disclosure does not make even a suggestion of disclosure to one of skill in the art. Beyond the efficacy question, the ‘940 patent does not even disclose the necessary suggestion to enable one of ordinary skill in the art to look to riluzole for the treatment of ALS in the first place. Thus, I would affirm the district court’s determination of anticipation without requiring a remand in this case.
The Supreme Court today heard oral arguments in the case of KSR International v. Teleflex. Already a group named the Coalition for Patent Fairness sent in a press release that it “welcomes” the Supreme Court review of the case of KSR International v. Teleflex. It states: “By choosing to hear this patent case, the highest court in the land is signaling its belief that there are serious imbalances in our nation’s patent litigation system. The many companies and industries that make up the Coalition for Patent Fairness agree. Inventors, consumers and businesses large and small will benefit from bright legal lines drawn by the court.”
The Coalition for Patent Fairness is a lobbying group backed by a number of high-tech companies in support of S. 3818, the Patent Reform Act of 2006, introduced by Senators Orrin Hatch (R-Utah) and Patrick Leahy (D-Vt.), to reform patent laws. Coalition members include Intel, Cisco Systems and Hewlett-Packard. The Coalition is concerned about the so-called patent trolls – companies that exist primarily to make money from patents through litigation instead of commercialization.
The tech companies want to put a damper on all the patents on all the patents on business methods, designs and undeveloped technologies that casues them to spend lots of money to defend. While Microsoft Corp., Cisco Systems Inc., Intel Corp. and other tech companies have filed amicus briefs calling for a change to the system, Johnson & Johnson, GE and DuPont, have filed their own briefs arguing that major changes to the patent system would jeopardize billions of dollars invested in product innovation. They want to protect pharmaceutical and chemical products from generic manufacturers and counterfeiters.
In the KSR case, KSR manufactures gas pedals that can be adjusted for the height of the driver and uses electronic signals rather than a mechanical cable to accelerate when the pedal is pushed. Both features were developed separately but Teleflex sued KSR claiming that KSR’s combination of the two features infringed on a patent it was issued in May 2001. KSR argues that the patent should be invalidated because the combination of the two features is obvious.
In KSR, the Federal Circuit held that the prior art did not render the claimed invention unpatentable because they had not proven, beyond genuine dispute and by clear and convincing evidence, that there was a suggestion or motivation to combine the teachings of the prior art in the particular manner claimed by the patent at issue (U.S. Patent No. 6,237,565).
The Supreme Court granted cert to answer the following question:
Whether the Federal Circuit has erred in holding that a claimed invention cannot be held obvious, and thus unpatentable under 35 U.S.C. § 103(a), in the absence of some proven “‘teaching, suggestion, or motivation’ that would have led a person of ordinary skill in the art to combine the relevant prior art teachings in the manner claimed.”
Section 103 was first enacted in 1952; it provides that a patent cannot issue on subject matter that would have been “obvious” to a hypothetical “person having ordinary skill in the art” or PHOSITA. Four factual inquiries underlie an evaluation of obviousness: (1) the scope and content of the prior art; (2) the differences between the claimed invention and the prior art; (3) the level of ordinary skill in the art; and (4) any other objective indicia of non-obviousness, such as commercial success of the claimed invention, long felt but unmet need.
KSR argues that under the Supreme Court’s interpretation of § 103, a combination of pre-existing elements does not constitute an “invention”, and does not meet the “condition for patentability” specified in § 103(a), if each element in the claimed combination does nothing more than what it was previously known or designed to do. They argue that the Federal Circuit’s interpretation of § 103 is wrong in holding that a combination of pre-existing elements will always constitute an “invention”, and will always meet the “condition for patentability” specified in § 103, unless there is proven “some ‘suggestion, teaching, or motivation’ that would have led a person of ordinary skill in the art to combine the relevant prior art teachings in the manner claimed.” They argue that the “teaching-suggestion-motivation test” has no basis in the text of § 103 or in any decision of the Supreme Court.
Critics of the test argue that this has made it too difficult to prove that a claimed invention is obvious. This is of particular importance to pharmaceutical and biotechnology research-based companies who are against any change to the test (and might make it difficult to patent known drugs for new uses).
We will probably see some modification to the obviousness test but I don’t think the Court will swing wildly against the “teaching-suggestion-motivation” test.
Earlier, the Court of Appeals for the Federal Circuit affirmed a District Court’s decision that Transkaryotic Therapies Inc. (TKT) and Aventis Pharmaceuticals Inc. infringe Amgen’s erythropoietin (EPO) patent estate. Amgen Inc., v. Hoechst Marion Roussel, Inc. (Now Aventis) and Transkaryotic Therapies, Inc., (05-1157). The court’s decision upheld the validity of two of Amgen’s EPO patents and the infringement by TKT of three patents and 12 claims, including a patent that does not expire until 2015.
Now, Amgen’s petition for a panel rehearing and rehearing en banc has been denied by the Court of Appeals for the Federal Circuit.
The issue remains over the District Court’s findings on the infringement and validity of two patents with claims to the production of erythropoietin, the infringement of one product patent under the doctrine of equivalents, and the validity of one product patent. The Federal Circuit found the production patents valid and infringed (U.S. Patent Nos. 5,618,698 and 5,756,349). The court reversed the District Court’s determination that TKT infringed Amgen’s U.S. Patent No. 5,621,080 under the doctrine of equivalents, and remanded to the District Court for further consideration of the remaining validity issue on one of the other product patents (U.S. Patent No. 5,955,422).
The patents at issue are directed to recombinant DNA technology relating to the production of the hormone erythropoietin (“EPO”). Epogen a form of the protein erythropoietin that is produced outside of the human body and delivered by injection. Transkaryotic’s product Dynepo, however, is a gene. When injected, Dynepo leads to the production of a slightly different form of erythropoietin inside the body.
Transkaryotic uses what it calls gene-activation technology. It relies on the fact that all human cells have a complete set of genes, even though the gene for producing EPO is not active except in kidney cells. So Transkaryotic inserts an on switch into human cells grown in culture, activating the gene for EPO. The switch is surrounded by genetic sequences that match those found upstream of the EPO gene on the chromosome. That guides the switch to the spot where it will turn on the EPO gene and not any other gene.
On remand, the trial court construed “therapeutically effective amount” in claim 1 of the ‘422 patent to require that the claimed EPO increase hematocrit and also be useful in healing or curing certain patients identified in the specification (those with anemia-like disorders). The CAFC held that the language used in the specification indicated that the invention was used in therapy to produce any or all of five identified effects; increasing hematocrit was only one of the biological effects produced by the invention. Thus, the trial court misinterpreted this part of the specification when it read the passage as limiting the invention to products with any or all of the first four effects ascribed in vivo to EPO and also an increase in hematocrit.
The CAFC felt that the trial court made an artificial distinction between the first four effects and the fifth effect (an increase in hematocrit). Also the CAFC believed that “therapeutic utility” was not dependent on the product having an effect in a living being, such as curing disease believing that the patentee used the words “therapeutically effective” in order to broadly claim a pharmaceutical composition with a wide range of effects.
The trial court ruled that claims 2-4 of the ‘080 patent were not invalid and that Amgen was not estopped from asserting infringement under the doctrine of equivalents. The trial court found that the presumption was rebutted because the amendment limiting the claims of the ‘080 patent to EPO with the amino acid sequence of Figure 6 was tangential to EPO having a 165-amino acid sequence and also set forth an alternative rationale based on the “some other reason” language.
The Federal Circuit upheld the trial court’s finding that Amgen failed to show that EPO with a 165-amino acid sequence was not foreseeable at the time of the amendment. However, the CAFC held that the trial court erred when it found that Amgen had met its burden of rebutting the presumption under both the tangentiality and “some other reason” rationales. Amgen’s third preliminary amendment limited the ‘080 patent to EPO having 166 amino acids. As for the “some other reason” rationale, the patentee knew of the 165-amino acid sequence at the time of the amendment, but chose to limit the claims to the 166-amino acid sequence.
Amgen argued that the district court correctly interpreted the term since only amounts of EPO producing effects—particularly increased hematocrit—that counteract these anemia-like diseases are “therapeutically effective.”
Chief Judge Michel, dissenting-in-part, summed up things thusly:
[S]ince the majority holds that other asserted patents are not invalid and are literally infringed by HMR 4396, (and here I agree), the district court likely will enter an injunction … Prolonging this litigation seems futile when, in the end, an injunction will likely issue regardless of how “therapeutically effective” is construed or whether claim 1 of the ‘422 patent is invalid.
In the petition for rehearing, Judge Michel and Judge Rader dissented stating:
In my view, four practical problems have emerged under the Markman-Cybor regime: (1) a steadily high reversal rate; (2) a lack of predictability about appellate outcomes, which may confound trial judges and discourage settlements; (3) loss of the comparative advantage often enjoyed by the district judges who heard or read all of the evidence and may have spent more time on the claim constructions than we ever could on appeal; and (4) inundation of our court with the minutia of construing numerous disputed claim terms (in multiple claims and patents) in nearly every patent case.
Our standard of review of no deference to the trial judge’s claim constructions, expressed in Cybor, rests upon the premise that claim construction is always a purely legal exercise, devoid of factual content. We have likened claim construction to statutory construction. I believe that this analogy is open to serious question. In interpreting statutes, a judge, whether trial or appellate, essentially asks himself/herself, “What does the disputed term mean to me, the judge, as an artisan in the law?” With claim construction, on the other hand, the judge is supposed to inquire, essentially, “How would the average artisan in the relevant field of technology understand the disputed claim terms in the context of the rest of the patent, the prosecution history, and the prior art?”
This petition order also had a dissents from Judges Newman and Moore with concurrences by Judges Lourie, Gajarsa, Linn and Dyk. With such a divided court, we may well see Amgen VI in the Supreme Court. All over a product that Transkaryotic dropped years ago.
Editor-in-Chief Barista Stephen Jenei is a patent attorney and Owner of Jenei LLC. When not serving up patent chat over a steaming cup of java, he's handling a diverse intellectual property practice in the biotechnology, pharmaceutical and chemical fields. More info @ Jenei LLC
