April 2013

Dawson v. Dawson: Suing Yourself for a Patent

Patent

By Dennis Crouch

Dawson v. Dawson (Fed. Cir. 2013)

It's a fairly rare case where you sue yourself – especially when that occurs after your death. Dr. Chandler Dawson, now deceased, was a leading eye specialist and is the named inventor of the patent applications at suit in this case. While an employee at UCSF, Dawson began working on a topical azithromycin treatment for trachoma – some of Dawson's notes from UCSF include a statement that 0.5% solution might help overcome low-solubility problems. During the process Dawson sought help from folks at InSite Vision to actually make and test the treatment. And, very quickly, Dawson left UCSF and joined InSite. Later, InSite filed two patent applications naming Dawson as a co-inventor for the use of 0.1 to 1% azythromicin to treat the eye. The InSite applications were filed in 1999 and issued in 2001 and 2003 respectively. In 2007, UCSF filed two applications in Dawson's name (without Dawson's cooperation) claiming priority back to the 1999 (InSite) application date. The PTO then declared two interferences. There is a fairly substantial amount of money at stake because the patents are listed in the Orange Book as covering ophthalmic drops known as AzaSite. An infringement lawsuit is pending between InSite and Sandoz. See InSite Vision Inc. v. Sandoz, Inc., Civil Action 17 3:11-cv-03080-MLC-LHG (Complaint filed: 26 May 2011).

So, this case is largely a battle over patent ownership and that ownership depends upon whether Dawson's conception of the invention occurred early (while an employee at UCSF) or later (while an employee at InSite). The doctrine of conception has remained fairly steady for the past 120+ years requires proof of the "formation in the mind of the inventor, of a definite and permanent idea of the complete and operative invention, as it is hereafter to be applied in practice." Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367 (Fed. Cir. 1986) (quoting Robinson on Patents (1890)).

UCSF as Junior Party: In interference cases (and in future derivation cases) the most important factor is often designation of the "senior" and "junior" parties. Normally, the Senior Party is the party with the earliest effective filing date and the interference (derivation) begins with a presumption that the senior party wins unless unseated by the junior party. Here, we have a filing-date tie because applicants claim priority to the 1999 application date. However, the PTO has a longstanding practice of breaking that tie by saying that the junior party is the one with the latest filing date for its involved application. The UCSF actual application was not filed until 2007 and is thus the junior party.

In the interference, the PTO Board concluded that UCSF had failed to prove Dawson's conception while at UCSF. In particular, the Board held that Dawson "did not fully appreciate how [his] idea was to be implemented in actual practice. . . . What emerges from the facts of this case is that [while at UCSF] inventor Dawson had a general idea for a future research plan to come up with a composition for topical azithromycin to be applied to the eye to treat infection."

On appeal, a divided Federal Circuit has affirmed – holding that substantial evidence supports the Board's conclusion that the invention claimed was not conceived by Dawson as of that early date. The court did suggest that Dawson's lack of testimony in favor of UCSF was a critical factor in its decision.

No Patent Rights to Pre-Conception Innovations: An important take-away from the decision is that the prior employer has no patent rights associated with ideas and innovations that fail to rise to the level of inventive conception. Although this could likely be cured through particular contract language regarding ownership of further developments stemming from work began at the prior employer. This case puts power in the hands of entrepreneurial employees who are not bound by strong contractual limitations on their post-employment activities or patenting.

Writing in dissent, Judge Reyna argued that Dawson's conception occurred while at UCSF. In particular, Reyna walked through the evidence showing that Dawson had conceived of the a process for applying an effective amount of azithromycin to an eye to treat infection in a way that fit the interference count.

Inventorship is perhaps the most fundamental question in patent law. The instant an inventor conceives her invention is the moment in which vests her right to a patent, thus perfecting her constitutional right to exclude. . . .

The majority discounts Dr. Dawson's work at UCSF as failing to achieve a fully developed idea of the invention. This conclusion reflects a misapplication of the law of conception to the facts of this case. To demonstrate conception, the law does not require that Dr. Dawson develop a working physical embodiment of his innovative idea. Indeed,

Invention is not the work of the hands, but of the brain. The man that first conceived the complete idea by representing it on paper, or by clear and undisputed oral explanation, is the first inventor, and to avail himself of the rights or priority the law only requires that he shall use due diligence in embodying his idea in a practical working machine. The sketch need not be a "working drawing." The conception may be complete, while further investigation, and perhaps experiment, may be necessary in order to embody the idea in a useful physical form.

Edison v. Foote, 1871 C.D. 80 (Comm'r Pat. 1871). While conception thus requires "the formation, in the mind of the inventor, of a definite and permanent idea of the complete and operative invention," Mergenthaler v. Scudder, 11 App. D.C. 264 (D.C. Cir. 1897), it does not require reduction to practice. The point of time at which an invention merits protection under the patent law is neither when the first thought occurs, nor when a practical working embodiment is completed. Rather, conception occurs

when the 'embryo' has taken some definite form in mind and seeks deliverance, and when this is evidenced by such description or illustration as to demonstrate its completeness. It may still need much patience and mechanical skill, and perhaps a long series of experiments, to give the conception birth in a useful, working form. The true date of invention is at the point where the work of the inventor ceases and the work of the mechanic begins.

Cameron & Everett v. Brick, 1871 C.D. 89 (Comm'r Pat. 1871). Here, Dr. Dawson's WHO presentation manifested an inventive embryo which thereafter sought deliverance. In his presentation, he provided a description sufficient to illustrate the completeness of his invention. All that was left was the work of the mechanic—that is, reduction to practice. This Dr. Dawson was not required to do.

Responding to the dissent, the majority suggested that the outcome turns on the standard of review since the Board's factual determinations are affirmed based upon the very low standard of substantial evidence. See In re Gartside, 203 F.3d 1305, 1311-15 (Fed. Cir. 2000). The appellate panel does not deal with the reality that conception is a question of law presumably reviewed de novo on appeal other than its fully unsatisfying statement that "UCSF failed to meet its burden of proof as to the legal issue of conception." I ask the court – What is the burden of proof for questions of law?

Do the Wright Brothers Deserve a Patent for their Flying Machine?: Why Eliminating Software Inventions from the Patent System Makes No Sense.

Patent, , , ,

Guest Post by Martin Goetz

Imagine that the digital computer and the stored computer program (software) existed in the late 1800's. If so, there is a high probability that the Wright Brothers would have used a computer program to control the three-axis control system in their 1903 Flying Machine patent application. If they did, we would call the patent they received in 1906 a software patent. Further imagine that today's anti-patent zealots who preach that all software consists of abstract ideas, mental processes or mathematics were thrown back in time to the late 1800's. And finally imagine that they were successful in their stated goal to eliminate all software patents through an act of Congress. Had that really happened, the Wright Brothers would not have received a patent for what is recognized as one of the greatest inventions of the 20th century.

Think of all the great inventions in the 20th century. Many would have used a software program as they implemented and disclosed their inventions. Would we be better off today if there was no patent protection for those software inventions?

For the last 50 plus years, the nature of software and of software products has been significantly distorted by opponents of software patents. But their argument to eliminate all software patents makes no sense unless their goal is to eliminate the entire patent system.

Here's why it makes no sense….

Article 29 of the TRIPS guidelines covering "Disclosure Obligations" states "…An applicant for an invention shall disclose the invention in a manner sufficiently clear and complete for the invention to be carried out by a person skilled in the art and may require the applicant to indicate the best mode for carrying out the invention…." If the best mode includes software (a computer program), then that disclosure would describe the software through diagrams, flow charts, and descriptive text.

According to Wikipedia "there is no legal definition of a software patent". Let's look at two possible definitions.

Definition 1: If the definition of a software patent is that, if in the Disclosure of the invention, there is a description of a computer program (in whole, or in part) then the patent would be called "software patent". A "Software patent", under this definition, would be found in many industries, e.g., Software, Telecommunications, Manufacturing, Transportation, Appliances, Medical, Robotics—to name a few.

Said another way… In many industries inventions contain software programs as part of their disclosures. Take the Robotics/Medical Devices sector, where very sophisticated computer programs can control an artificial limb. How the artificial limbs are designed and constructed may be the invention. Or the invention may be how the computer program(s) interacts with the artificial limb. Or the invention may be a combination of both elements.

A more recent real life invention is the artificial retina, a robotics/medical device which offers partial vision for the blind. It's described as a camera, transmitter, and cable to video processor (software) connected to the brain.

So those that want to eliminate software patents, by design or by ignorance, would eliminate all robotic/medical device inventions where the disclosure includes a computer program.

Definition 2: Anti-Software patent zealots might argue that the definition of a "software patent" is when the disclosure of the invention only describes a computer program and a computer. And then their goal would be to have Congress change the Patent System to eliminate the issuance of "software only patents". But that would be catastrophic for the Software Industry, where many of their inventions are software only. This industry is made up of thousands of companies and is recognized as one of the top three manufacturing industries in the world .With annual worldwide revenues well over $ 300 Billion this industry needs (and wants) just as much patent protection as other industries.

Many software product companies can be thought of as high-technology manufacturing entities. Many of their products are state of the art, developed in a competitive, fast-moving environment that requires rapid response to meet user demand. Some of their products can be all software i.e., Google's search program or they could be a combination of software and hardware circuitry and/or devices i.e., Google's driverless car or the 3-D printer.

If the patent application contains a true invention it should be irrelevant whether or not the invention is disclosed as a "software only" implementation. The following are two examples of inventions from the Software Industry to illustrate my point of view

Back in November 2012 Microsoft stated in a press release "Microsoft researchers have demonstrated software that translates spoken English into spoken Chinese almost instantly, while preserving the unique cadence of the speaker's voice—a trick that could make conversation more effective and personal." Certainly the way Microsoft's researchers accomplished this complex translation is not obvious. And I have is little doubt that Microsoft will try to protect its research investment with a patent application. But its patent claims could not be that it invented "speech recognition" or "language translation", or even "voice to voice translations". Patents for Voice and Speech Recognition patents go back well over 30 years with IBM having over 200 speech recognition patents. And there have been language translation patents for many years But Microsoft could invent a new way to do voice recognition and language translations and at the same time retain the cadence of the speaker's voice. And, let's imagine, the invention would use a standard headphone and the headphone would not be part of the disclosure. Such a patent on that invention would be software only (and a computer) in its disclosure. But what if the invention needed a special set of headphones (a device), was integral to the invention, and was part of the disclosure? Is a speech recognition/translation/cadence and special headphone invention any more innovative than a "speech recognition/translation/cadence" software only invention?

In 2000, a renowned inventor, Ray Kurzweil received a patent named Reading System which Reads Aloud from an Image Representation of a Document. The patent disclosure shows a diagram of a monitor, scanner, speakers, and a PC computer composed of a processor, storage and a keyboard. The essence of the disclosure and the invention is a logic chart describing a machine system which interacts with a speech synchronizer and the various devices.

The first sentence of the abstract in the patent stated "a reading system includes a computer and a mass storage device including software comprising instructions for causing a computer to accept an image file generated from optically scanning an image of a document."

At that time, Ray Kurzweil's company, Kurzweil Educational Systems marketed a special purpose hardware/software system called the Kurzweil 3000 Reading Machine which was marketed to the blind and poor readers. They received a patent on this invention in 2000. Today the company sells a software only system called Kurzweil 3000 and continues to have the protection of the patent system through his original 2000 patent and with additional patents e.g., Reducing processing latency in optical character recognition for portable reading machine — another software only patent.

Few would argue that the Kurzweil 3000 Reading Machine was not an invention and not deserving of a patent.

What these zealots should be arguing is that many software patents issued by the US Patent Office, including most business-method patents, should never have been issued because of their obviousness. With that I heartily agree. To their credit, the Patent Office and the Courts are today grappling with how to recognize obviousness in a patent application. A very difficult challenge, to say the least.

But let's stop calling a true invention that includes a computer program in its disclosure a software patent. In fact, let's eliminate the phrase "a software patent" from our vocabulary.

END

Guest Post: New USPTO Professional Conduct Rules Will Take Effect on May 3

Patent

Guest Post by Lisa Dolak, Angela S. Cooney Professor of Law at Syracuse University College of Law. Professor Dolak has written extensively on professional responsibility issues in the patent law context.

Effective May 3, 2013, the USPTO has adopted new professional conduct rules and has modified some existing rules governing the conduct of disciplinary investigations. The Final Rule is published in today's Federal Register. See Changes to Representation of Others Before The United States Patent and Trademark Office, 78 Fed. Reg. 20179 (April 3, 2013). As discussed in my previous post relating to the corresponding Notice of Proposed Rulemaking, the new professional conduct rules will replace the current ABA Model Code-based USPTO ethics rules with a version of the ABA Model Rules, versions of which have been adopted in 50 jurisdictions (49 states and the District of Columbia).

According to the USPTO, its goal is to "bring standards of ethical practice before the Office into closer conformity with the professional responsibility rules adopted by nearly all States and the District of Columbia, while addressing circumstances particular to practice before the Office." In addition to greater harmonization with state ethics rules, the USPTO indicates that practitioners will benefit from being able to reference interpretive sources applying the corresponding Model Rules, such as the Comments to the Model Rules and state bar opinions and disciplinary decisions (although it notes that "[s]uch decisions and opinions are not binding precedent relative to USPTO rules").

The USPTO reports that it received 19 responses commenting on the October 18, 2012 Notice of Proposed Rulemaking (some of which did not relate to the proposed changes), including "[m]any" that "supported the new rules and their alignment with State bar standards." Several comments related to new USPTO Rule 11.106(c), which expressly reinforces a practitioner's duty of disclosure, notwithstanding his or her confidentiality obligations ("A practitioner shall disclose to the Office information necessary to comply with applicable duty of disclosure provisions."). In particular, according to the Final Rule, "the comments raised concerns about the balance between the practitioner's duty to disclose information to the Office and the duty to protect confidential information of third parties, including that of other clients."

In response, the USPTO noted that ABA Model Rule 1.6 cmt. 12 (2012) states that "If. . . other law supersedes this Rule and requires disclosure, [Rule 1.6](b)(6) permits the lawyer to make such disclosures as are necessary to comply with the law." (Note, though, that the Comment also acknowledges that "[w]hether such [other] law supersedes Rule 1.6 is a question of law beyond the scope of these Rules."). The implication is that the applicable "other law" here is the practitioner's duty of disclosure. By analogy, the USPTO also cites to a North Carolina Ethics Opinion (N.C. Ethics Op. 2005-9 (2006)) for the proposition that a "lawyer for [a] public company may reveal confidential information about corporate misconduct to [the] SEC under [a] permissive-disclosure regulation authorized by [the] Sarbanes-Oxley Act, even if disclosure would otherwise be prohibited by [a] state's ethics rules." The USPTO also emphasizes that the primacy of the practitioner's disclosure obligation is "not a new requirement" (citing current 37 C.F.R. § 10.23(c)(10) and Manual of Examining Procedure, 8th Ed., Rev. 9 (Aug. 2012) Ch. 2000), and states that the express inclusion in new Rule 11.106(c) of the practitioner's obligation to comply with his or her disclosure obligations notwithstanding the duty of confidentiality "may be helpful in responding to any allegation of an ethical violation before a State bar in a situation where the practitioner engaged in particular conduct to comply with this USPTO Rule."

Regarding the possibility that the potential conflict between the duties of confidentiality and disclosure could lead to a prohibited "direct adversity" client conflict, the USPTO cited the client conflicts rules, which, it noted, "would generally prevent a practitioner from accepting clients who may have potentially adverse interests." Finally, it pointed to withdrawal as the ultimate solution ("[i]n certain situations a practitioner may seek to withdraw from representation under § 11.116 to avoid a conflict of interest"). Notably, the Final Rule includes this additional statement on withdrawal as a solution to the potential disclosure-confidentiality conflict:

Solely for the purposes of enforcement under 37 C.F.R. Part 11 (Representation of Others Before The United States Patent and Trademark Office), if a practitioner has a conflict of interest in a given matter, arising from a different client, timely withdrawal by the practitioner from the given matter would generally result in OED not seeking discipline for conflicts of interest under Part 11.

In response to other comments, the USPTO:

  • Declined to institute a mandatory CLE reporting requirement, notwithstanding the fact that patent agents are not subject to state bar CLE requirements.
  • Declined to designate a "default jurisdiction" that would provide a single body of case law for guidance, since the USPTO "is its own jurisdiction", and noted (again) that "State case law and opinions are not binding precedent on the" USPTO.
  • Declined to adopt ABA Model Rule 6.1 (Voluntary Pro Bono Publico Service) and ABA Model Rule 6.5 (Nonprofit and Court Annexed Limited Legal Services Program), citing the USPTO's Patent Ombudsman Program, its cooperation with local bar associations to develop a pro bono services "clearinghouse" operated by the Federal Circuit Bar Association, and the USPTO Law School Clinic Certification Pilot Program as examples of the USPTO's "broad[] support[] and encourage[ment of] pro bono services."
  • Adopted the suggestion that new Rule 11.108(e) be revised to include "proceedings before the Office" (and not just "pending or contemplated litigation"), "ensur[ing] that a practitioner may advance fees to prevent or remedy abandonment attributable to the practitioner."
  • Adopted the suggestion that proposed § 11.108(i)(3) (authorizing a practitioner to take an interest in a patent as part or all of his or her fee) be expanded to include an express authorization to (as part or all of a practitioner's fee) take an interest in a "patent or patent application."
  • Noted that although "a practitioner is prohibited from representing a client if the representation will be materially limited by the practitioner's own interests, unless the practitioner reasonably believes that the representation will not be adversely affected and the client provides informed consent," owning shares in "a diversified mutual fund [which includes stock in a company that competes with the practitioner's client] would ordinarily not be considered [taking] an interest adverse to a client under the USPTO Rules."
  • Adopted a suggestion that § 11.201, like ABA Model Rule 2.1, authorize a practitioner to "refer not only to law but to other considerations such as moral, economic, social and political factors that may be relevant to the client's situation" "[i]n rendering advice."
  • Clarified that § 11.305 (relating to prohibited ex parte communications with, e.g., judges, administrative patent and trademark judges, and "employee[s] or officer[s] of the Office") does not "prevent ex parte communication that is authorized by law, rule or court order, in an ex parte proceeding."
  • Adopted ABA Model Rule 3.6 as § 11.306 relating to trial publicity (except for the provisions relating to criminal cases).
  • Emphasized that the "duty to cooperate with the Office of Enrollment and Discipline" pursuant to § 11.801(b) (which does not appear in the Model Rules) is not a new requirement (having previously been housed in 37 C.F.R. § 10.131), and noted that "there are at least seven jurisdictions that adopted the ABA Model Rules and that have ethics rules regarding cooperating with the respective jurisdiction's disciplinary authority."
  • Affirmed its power to pursue reciprocal discipline against practitioners.

Note that the numbering of the new USPTO rules generally tracks the numbering of the corresponding ABA Model Rules. For example, USPTO Rule 11.107 parallels Model Rule 1.7, USPTO Rule 11.201 parallels ABA Model Rule 2.1, etc. The Final Rule notes that the USPTO has (thus far) decided not to adopt the substantive changes made to the ABA Model Rules in the latest (August 2012) ABA revision, as "most States have not yet done so," but that it "will continue to evaluate the ABA Model Rule changes and adopt them as appropriate."

Timing of First Actions on the Merits

Patent

By Dennis Crouch

The chart below is a bit confusing, but I think that it presents some interesting data. The chart generally shows the timing of first actions on the merits (FAOMs). Most commonly a FAOM is either a non-final rejection or else a notice-of-allowance. The number of applications awaiting FAOM is typically referred to as the backlog of unexamined cases. The PTO has been focusing attention on reducing that backlog as well the timing from filing to FAOM. In addition to calculating the timing of FAOM, the PTO also offers a forward-looking prediction to applicants that estimates how long the wait will be. The chart shows both the average actual timing (red) and predicted timing (blue) of FAOMs. I can only report the predicted timing for recently filed applications (since we don't know how long it will actually take). By late 2015, we could see the backlog reduced to 12-months.

Predicting Patent Issuance

Patent

By Dennis Crouch

One of my patent law students (Marriam Lin) is working on a project that divides patent applications into two sets: (1) Those that are patented and (2) those that are abandoned without being patented. We’re looking to see whether we can identify objective factors found in the original application filing (or at least by the time of publication) correlate with the application being patented or not. This project falls in line with the papers on Valuable Patents and Worthless Patents, but focuses only on pre-issuance issues. We have a few simple measures such as the assignee, type of technology, number of inventors, size of application and claim set, and priority claims. Obviously, our result will have only a limited value since many important factors will elude our measurement. However, I have been surprised at the explanatory power of the model even in our limited approach. If you picked up a patent application, what factors would you think might help predict whether that application will eventually issue as a patent? Is there a way to objectively measure those factors?

Guest Post: The Patent Failure of Novartis with Gleevec

Patent, , ,

Guest Post by Srividhya Ragavan (Professor of Law, University of Oklahoma College of Law)

The Indian Supreme Court’s verdict on the Novartis patent application has garnered a lot of attention as having set a stringent standard of nonobviousness for patents. In India, this litigation is pitched as a battle between big pharma and health aid groups.

This recent saga at the Supreme Court relates to a patent application that was originally filed in 1998 for a cancer drug named Gleevec (or Glivec, in Europe). Gleevec is the beta crystalline form of imatinib mesylate, which is the salt form of the free base and is used to treat chronic myeloid leukemia, a form of cancer. This application in India claimed priority from an earlier application filed in July 1997 in Switzerland. The application was opposed in India on the basis that imatinib mesylate was anticipated by the earlier Novartis US patent No. 5521184. As a side note, Novartis’s US application for the free base of Imatinib -which was the crystalline form —issued as a patent in the United States in 1996 owing to a 1993 filing date. When after losing the mail-box dispute, India opened its doors to a transitional mail-box application facility, Novartis filed a patent application in India in 1996. Overall, Novartis had over 35 patents over this polymorphic form of Gleevec in different countries. The application was reviewed in India in 2006 once India fully transitioned into a patent regime as required under the TRIPS agreement. Notably, even before the application was taken up by the patent office there were 5 pre-grant oppositions filed against the application!

In gist, the argument against Gleevec in India was that this application related to new form of a known substance. In pharmaceutical chemistry, a different crystalline form of the same chemical substance is called a polymorph, the patenting of which is specifically prohibited under § 3(d) in India unless it also results in enhanced efficacy. Now, § 3(d) of the Indian patent statute, the operative section reads as follows:

3. What are not inventions. – The following are not inventions within the meaning of this Act,

…

(d). the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.

Explanation.—For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy;

In gist, India does not allow the patenting of new forms of known substances unless it also results in enhanced efficacy. The assertion in India was that the salt form for which the patent application was filed inherently existed in the original crystalline form. Considering the US patent as a prior art, the Patent Controller concluded that the application was obvious for covering a new form of a known substance under § 3(d) of the Patents (Amendment) Act of 2005.

Soon Novartis pursued an appeal to the High Court of Chennai on the grounds that § 3(d) was unconstitutional and in violation of India’s obligations under TRIPS. The Chennai High Court established that § 3(d) was indeed Constitutional and within the scope of the TRIPS agreement based on the fact that the section deals with all technologies and does not limit itself to pharmaceutical innovations. The explanation to the section becomes applicable to pharmacology inventions and works to strengthen the understanding of the overarching test. The test, the court explained cast a duty on the patent applicant to prove that the discovery had resulted “enhancement of a known efficacy of that substance.” The court added that the explanation creates a “deeming fiction that all derivatives of a known substance would be deemed to be the same substance unless it differs significantly in properties with regard to efficacy.” Thus, was born the higher standard of nonobviousness that India has embraced with such vigor. In its opinion, the Chennai High Court agreed with the patent office that Gleevec was an obvious improvement and that the applicant should prove enhanced efficacy by showing enhanced therapeutic efficacy in order to get a patent. Interestingly, Novartis filed another patent application for the alpha version of the same compound; that application was also denied.

It was during this time that the government of India issued a notification constituting the Intellectual Property Appellate Board (IPAB), which is a tribunal with judicial powers under which all patent appeals were transferred. It is important though to understand that, despite being a tribunal, the IPAB’s judicial pronouncements have gained in reputation and stature over the years. Eventually, the Novartis patent application, like the other patent appeals, landed in the hands of the newly constituted IPAB on transfer from the High Court. The IPAB alluded to the original 1993 Zimmerman Patent facilitated the formation of imatinib mesylate salt by reaction with “aliphatic sulfonic acids, such as methane -,ethane – or – 2-hydroxy ethane -sulfonic acid.” Interestingly, the IPAB clarified when nonobviousness is evaluated for a pharmaceutically active substance, in particular, the application material would finally have to be evaluated to determine whether the compositions fall within the category of “not an invention under § 3(d) of the Act.” This evaluation determined whether the new form/derivative of a known substance displayed significant enhancement in properties with regard to efficacy. Thus, the IPAB gave the impression that the § 3(d) analysis is tied to nonobviousness and not patent eligibility. In considering Gleevec, the IPAB held that the increased bioavailability of the salt of imatinib (application material) and the increased solubility did not result in increased efficacy.

Novartis preferred an appeal to the Supreme Court in 2009, the same year that the IPAB upheld the rejection of Gleevec by the Controller. The Supreme Court considered whether an invention that clears all of the requirements for an invention can be denied on the ground that § 3(d) puts it out of the category of “invention”? The manner of phrasing the question in itself suggests that § 3 is not a threshold question in India. That is, one gets the feeling that whether an application material falls within the category excluded under § 3 is determined only for inventions that cross the § 2 requirements of utility, novelty and nonobviousness. This view is further bolstered by the statement elsewhere by the Supreme Court that “in case of chemicals and especially pharmaceuticals … [of] a new form of a known substance with known efficacy, [] the subject product must pass, in addition to clauses (j) and (ja) of section 2(1), the test of enhanced efficacy as provided in section 3(d) read with its explanation.” That said, elsewhere the court, in denying that § 3 is not a provision ex majore cautela, adds that the vital distinction is between the concepts of invention and patentability. So, the conclusion perhaps is that § 3 is akin to patentability question although in practice in India, it is tagged with the nonobviousness question.

As for the specific constituents of the § 3(d) requirements, the Supreme Court clarified that the term efficacy relates to “therapeutic efficacy.” The court then went on to discuss the test or parameters for providing such efficacy noting that such proof shall be weighed on strict and narrow standards. In the case of pharmaceutical compounds, the Court noted external and internal factors should clearly demonstrate therapeutic efficacy and it should be specifically claimed and established by research data. Thus, “the mere change of form with properties inherent to that form would not qualify as “enhancement of efficacy” of a known substance.”

As for the patent itself, the court adopted a stance similar to the Controller of patents and the IPAB to hold that imatinib mesylate is represented entirely by the Zimmermann patent. It added that after the Zimmermann patent issued, Novartis applied for, and obtained patents on different forms of the substance. But, no application was made on imatinib mesylate on the non-crystalline form. The court concluded that it is because imatinib mesylate is fully a part of the Zimmermann patent and does not call for a separate patent and thus, denied the patent.

Notably, the interest and role of non-governmental organizations in India in access issues as far as intellectual property is concerned is remarkable and distinguished. Further, the country’s interest in hearing and dispensing intellectual property issues has also become notable. The Novartis litigation has showcased India’s interest and ability as far as pharmaceutical patents are concerned. This case reinforces the suspicions for the need of a higher bar to get a patent issued in India. It also proves that the power of lobby groups notwithstanding, businesses needs a dose of local reality especially in countries in India. It must take exceptionally bad market assessment to sell a drug for approximately $ 2400 for a month’s supply (against a cost of $ 160 for the same from a generic manufacturer) in a country where the per capita income is estimated at a low $ 1 to $ 10 per month for a vast majority of the population. To give a perspective, an Indian employee who earns $ 2400 per month would consider himself very well-employed. In fact, in the lower middle class (forming about 300 to 400 million people), one would be considered agreeably employed if they earned $ 2400 in a year. And, big pharma cannot hope to erase away this ground reality with its lobby power.

Excluding Others in the Market for Ranking Lawyers

Patent

Thomson Reuters has a new patent – U.S. Patent No. 8,412,564 entitled System and method for identifying excellence within a profession. The patent was originally filed by the folks at Key Professional Media who later sold their “Super Lawyers” business to Thomson. The basic idea behind the patent is that – using a computer – you do a peer survey to identify a pool of candidates, then evaluate individuals within that pool based upon various objective factors (and store the information in a “data storage device”); next conduct another peer-evaluation of the select group; and finally ranking the professionals.

 

 

 

 

Claim 1 of the patent (prosecuted by) reads like a bear.

1. A method on a processing device for identifying excellent performance of candidates within a profession group, the processing device comprising a processor, a user interface device, and a data storage device, the method comprising:

creating a candidate pool by selecting individuals from a profession group, including:

receiving and processing a survey of peer professionals working within the profession group, wherein the peer professionals nominate other individuals within the profession group, wherein a minimum set of qualifications exist for each of the peer professionals to provide nominations;

performing independent research to identify individuals, the independent research comprising data mining to identify the individuals who satisfy predefined criteria for outstanding performance within the profession group, wherein the data mining includes querying electronic data sources containing relevant biographical information for the individuals within the profession group; and

selecting candidates for the candidate pool based on a combination of the results produced by the survey of peer professionals and the independent research, wherein the combination is performed using a computer operation which removes duplicate candidates;

wherein biographical information about individuals identified via the survey and the independent research is compiled for each individual within the candidate pool and stored in the data storage device;

evaluating the candidates individuals within the candidate pool, including:

performing, by the processor, independent research to evaluate performance of the candidates, the independent research comprising retrieval of performance information for the candidates relevant to objective criteria specific to the profession group, wherein the retrieval of performance information is performed independent of input from the individuals in the profession group and the peer professionals, and wherein the performance information is compiled for each candidate in the candidate pool and added to the information compiled for each candidate stored within the data storage device;

for each candidate within the candidate pool, storing in the data storage device a score for each objective criterion based on the performance information of each candidate stored in the data storage device;

for each candidate within the candidate pool, compiling with the processor a point total from the scores of each objective criterion; and

identifying candidates with point totals in a first predetermined top percentage of candidates in the candidate pool;

conducting peer evaluations of only the candidates with point totals in the first predetermined top percentage of candidates in the candidate pool, including:

selecting peer evaluators from among the candidates having point totals in the first predetermined top percentage of candidates in the candidate pool;

obtaining, from the user interface device, peer evaluation scores from the selected peer evaluators; and

producing, with the processor, an averaged peer evaluation score for each candidate in the first predetermined top percentage; and

identifying, with the processor, candidates in a second predetermined top percentage of candidates in the candidate pool based on a function of the point totals compiled from the scores of each objective criterion and the peer evaluation scores obtained from the selected peer evaluators.

 

The patent includes several technology-focused limitations such as a processor, a user interface device, and a data storage device. Without those limitations, the method could be performed in a room of professionals with nothing other than pencil and paper. So the question is whether this patent is subject matter eligible. Does it matter that the originally filed claim was functionally the same but did not include the tech-specific limitations? Some of these questions will be answered by CLS Bank.

Via Bob Ambrogi

The Federal Circuit Table of Authorities

Patent, ,

By Dennis Crouch

For the following list I parsed through all precedential patent related opinions at the Federal Circuit for the past three years. The resulting list are the fifteen most frequently cited cases in Federal Circuit patent decisions:

  1. Phillips v. AWH, 415 F.3d 1303 (Fed. Cir. 2005) (en banc)
  2. Cybor Corp. v. FAS Technologies, Inc., 138 F.3d 1448 (Fed. Cir. 1998) (en banc)
  3. KSR Intern. Co. v. Teleflex Inc., 550 U.S. 398 (2007)
  4. Graham v. John Deere Co. of Kansas City, 383 U.S. 1 (1966)
  5. Anderson v. Liberty Lobby, Inc., 477 U.S. 242 (1986)
  6. Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576 (Fed. Cir. 1996)
  7. Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co., 598 F.3d 1336 (Fed. Cir. 2010) (en banc)
  8. Lucent Technologies, Inc. v. Gateway, Inc., 580 F.3d 1301 (Fed. Cir. 2009)
  9. Markman v. Westview Instruments, Inc., 52 F.3d 967 (Fed. Cir. 1995) (en banc)
  10. ICU Medical, Inc. v. Alaris Medical Systems, Inc., 558 F.3d 1368 (Fed. Cir. 2009)
  11. Bilski v. Kappos, 130 S.Ct. 3218 (2010)
  12. In re Gartside, 203 F.3d 1305 (Fed. Cir. 2000)
  13. MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118 (2007)
  14. In re Seagate Technology, LLC, 497 F.3d 1360 (Fed. Cir. 2007) (en banc)
  15. Star Scientific, Inc. v. R.J. Reynolds Tobacco Co., 537 F.3d 1357 (Fed. Cir. 2008)

For cases decided within the past year, the only new entrant on the list is Microsoft Corp. v. i4i Ltd. Partnership, 131 S.Ct. 2238 (2011)

Inventorship: Limits of Collaboration

Patent

By Dennis Crouch

Rubin v. General Hospital Corp (Mass. General) (Fed. Cir. 2013)

Back in 2000, Dr. Rubin and his team identified an IKAP Gene mutation as causing a syndrome known as Familial Dysautonomia. Rubin sent his article to the American Journal of Human Genetics who forwarded the abstract to Dr. Gusella at Mass General for peer-review. Dr. Gusella then filed a provisional patent application in January 2001 shortly before Rubin’s article published. Gusella’s team had been working on the same genetic problem as Rubin (that’s why the journal sent him the article for review). Interestingly, Rubin particularly actually asked the journal not to send it to Gusella because of the lab-lab competition, but the journal sent it anyway.

After Gusella’s patent issued Rubin sued under 35 U.S.C. §256 – asking that Rubin be added as a joint-inventor. 35 U.S.C. §116 roughly defines joint inventorship as “when an invention is made by two or more persons jointly.” The statute makes clear that the two individuals do not need to “physically work together or at the same time,” “make the same type or amount of contribution,” or contribute to “every claim of the patent.” Still, the statute requires they acted “jointly.”

The district court dismissed the case on summary judgment – holding that there was no evidence of collaboration between Rubin & Gusella as required for joint infringement.

On appeal, the Federal Circuit affirmed – holding that “the independent relationship between these teams of scientists, and the nature of this communication of information, do not support joint invention in accordance with §116, or warrant change or substitution of inventorship under §256.” The non-precedential opinion by Judge Newman is short on analysis and does not contend with the controlling precedent of Kimberly-Clark Corp. v. Proctor & Gamble Distributing Co., 973 F.2d 911 (Fed. Cir. 1992). In that case, the court identified one form of joint inventorship “such as collaboration or working under common direction, one inventor seeing a relevant report and building upon it or hearing another’s suggestion at a meeting.” See also Mueller Brass v. Reading Industries, 352 F. Supp. at 1357 (E.D. Pa. 1972).

India: Drug Patents for True and Genuine Inventions, but not for Gleevec

Patent

By Dennis Crouch

In the U.S., Gleevec costs around $70,000 per year. In India, that price is only $2,500 (for a generic version). The difference is that the Indian government has refused to grant patent rights over the Swiss-created drug while five different patents cover the drug and its use in the US.

Today’s Indian Supreme Court decision is online here: http://judis.nic.in/supremecourt/imgs1.aspx?filename=40212.

The Indian Supreme Court focused on the question of obviousness:

Does the product for which the appellant claims patent qualify as a “new product” which comes by through an invention that has a feature that involves technical advance over the existing knowledge and that makes the invention “not obvious” to a person skilled in the art?

India recognizes that its inventive step is a higher standard than that of different countries around the world – especially in the area of pharmaceuticals. And pushing in that direction is India’s statute stating that:

(3)(d) the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.

Explanation.—For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.

In reading the statute, the Indian Supreme Court found that section 3(d) “clearly sets up a second tier of qualifying standards for chemical substances/pharmaceutical products in order to leave the door open for true and genuine inventions but, at the same time, to check any attempt at repetitive patenting or extension of the patent term on spurious grounds.”

The active ingredient in Gleevec is a beta crystal form of Imatinib Mesylate. It turns out that Imatinib was already known to be useful for inhibiting BCR-Abl tyrosine kinase (the function of Gleevec) and the court found that the difference between the two insufficient to allow the new patent.

The decision is important because it attempts to offer wide leeway for India’s generic drug industry while also fit within the TRIPS guidelines. The inventors of Gleevec were awarded both the Lasker Award and the Japan Prize for their contributions to medicine and science.