In a 2-1 decision, the Federal Circuit upheld that companies can patent genes but decided that they cannot patent methods to compare the gene sequences.

The Federal Circuit handed down a decision on the Myriad Genetics appeal from the decision of the US District Court holding that a gaggle of medical organizations, researchers, genetic counselors, and patients have standing to challenge Myriad’s patents. See:  Assoc. for Molecular Pathology v. U.S. Patent & Trademark Office, 669 F. Supp. 2d 365 (S.D.N.Y. 2009). Myriad also appealed the district court’s decision granting summary judgment that all of the challenged claims are drawn to non-patentable subject matter under 35 U.S.C. § 101.

  1. On the issue of jurisdiction, the Federal Circuit concluded that at least one plaintiff, Dr. Harry Ostrer, has standing to challenge the validity of Myriad’s patents.
  2. On the merits, the Federal Circuit reversed the district court’s decision that Myriad’s composition claims to “isolated” DNA molecules cover patent-ineligible products of nature under § 101 since the molecules as claimed do not exist in nature.
  3. The Federal Circuit also reversed the district court’s decision that Myriad’s method claim to screening potential cancer therapeutics via changes in cell growth rates is directed to a patent-ineligible scientific principle.
  4. The Federal Circuit did, however, affirm the court’s decision that Myriad’s method claims directed to “comparing” or “analyzing” DNA sequences are patent ineligible; such claims include no transformative steps and cover only patent-ineligible abstract, mental steps.

Association For Molecular Pathology v. US Patent And Trademark Office and Myriad Genetics

This whole brouhaha has to do with U.S. Patent Nos. 5,747,282; 5,837,492; 5,693,473; 5,709,999; 5,710,001; 5,753,441; 6,033,857.

The composition claims cover two “isolated” human genes, BRCA1 and BRCA2 and certain mutations in these genes associated with a predisposition to breast and ovarian cancers. Representative composition claims include claims 1, 2, and 5 of the ’282 patent:

1.  An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.

2.  The isolated DNA of claim 1, wherein said DNA has the nucleotide sequence set forth in SEQ ID NO:1.

5.  An isolated DNA having at least 15 nucleotides of the DNA of claim 1.

SEQ ID NO:2 depicts the amino acid sequence of the BRCA1 protein, and SEQ ID NO: 1 depicts the nucleotide sequence of the BRCA1 DNA coding region.

All but one of the challenged method claims cover methods of “analyzing” or “comparing” a patient’s BRCA sequence with the normal, or wild-type, sequence to identify the presence of cancer-predisposing mutations. Representative method claims include claim 1 of the ’999:

1. A method for detecting a germline alteration in a BRCA1 gene, said alteration selected from the group consisting of the alterations set forth in Tables 12A, 14, 18 or 19 in a human which comprises analyzing a sequence of a BRCA1 gene or BRCA1 RNA from a human sample or analyzing a sequence of BRCA1 cDNA made from mRNA from said human sample with the proviso that said germline alteration is not a deletion of 4 nucleotides corresponding to base numbers 4184-4187 of SEQ ID NO:1.

The final method claim challenged by Plaintiffs is directed to a method of screening potential cancer therapeutics. Specifically, claim 20 of the ’282 patent reads as follows:

20. A method for screening potential cancer therapeutics which comprises: growing a transformed eukaryotic host cell containing an altered BRCA1 gene causing cancer in the presence of a compound suspected of being a cancer therapeutic, growing said transformed eukaryotic host cell in the absence of said compound, determining the rate of growth of said host cell in the presence of said compound and the rate of growth of said host cell in the absence of said compound and comparing the growth rate of said host cells, wherein a slower rate of growth of said host cell in the presence of said compound is indicative of a cancer therapeutic.

The challenged claims relate to isolated gene sequences and diagnostic methods of identifying mutations in these sequences.

Declaratory Judgment Jurisdiction

The first question addressed was whether the district court correctly exercised declaratory judgment jurisdiction over this suit:

Although no bright-line rule exists for determining whether a declaratory judgment action satisfies Article III’s case-or-controversy requirement, the Supreme Court has held that the dispute must be “definite and concrete, touching the legal relations of parties having adverse legal interests,” “real and substantial,” and “admi[t] of specific relief through a decree of a conclusive character, as distinguished from an opinion advising what the law would be upon a hypothetical state of facts.” MedImmune, 549 U.S. at 127 (quoting Aetna Life, 300 U.S. at 240-41). “Basically, the question in each case is whether the facts alleged, under all the circumstances, show that there is a substantial controversy, between parties having adverse legal interests, of sufficient immediacy and reality to warrant the issuance of a declaratory judgment.”

Myriad challenged jurisdiction on the grounds that Myriad and the Plaintiffs do not have adverse legal interests and that Plaintiffs failed to allege a controversy of sufficient immediacy and reality to warrant the issuance of a declaratory judgment.

The Plaintiffs responded that they have standing because, not only are they undisputedly prepared to immediately undertake potentially infringing activities, but also Myriad took sufficient affirmative acts with respect to the patents in suit. Regarding the latter, the Plaintiffs cried that Myriad sued, threatened to sue, or demanded license agreements from every known institution offering BRCA clinical testing, including university labs directed by plaintiffs Kazazian, Ganguly, and Ostrer.

Under the facts alleged in this case, we conclude that one Plaintiff, Dr. Ostrer, has established standing to maintain this declaratory judgment suit. All Plaintiffs claim standing under the Declaratory Judgment Act based on the same alleged injury: that they cannot undertake the BRCA-related activities that they desire because of Myriad’s enforcement of its patent rights covering BRCA1/2.3 Only three plaintiffs, however, allege an injury traceable to Myriad; only Drs. Kazazian, Ganguly, and Ostrer allege affirmative patent enforcement actions directed at them by Myriad. Of these three, Dr. Ostrer clearly alleges a sufficiently real and imminent injury because he alleges an intention to actually and immediately engage in allegedly infringing BRCA-related activities.

The court said that Dr. Ostrer could have proceeded with his BRCA-related clinical activities without taking a license from Myriad because he thinks that the patents are invalid since  genes are patent ineligible products of nature. This put Myriad and Dr. Ostrer in adverse legal positions regarding whether or not Ostrer can engage in BRCA genetic testing without infringing any valid claim to “isolated” BRCA DNAs or methods of “analyzing” or “comparing” BRCA sequences, as recited in Myriad’s patents.

 The Supreme Court has required only that it is “likely,” rather than “merely ‘speculative,’” that the alleged injury will be “redressed by a favorable decision.” Lujan, 504 U.S. at 561. The Court has not required certainty.

Patentable Subject Matter

Under the Patent Act, “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.” 35 U.S.C. § 101.

The Supreme Court has consistently construed § 101 broadly, explaining that “[i]n choosing such expansive terms . . . modified by the comprehensive ‘any,’ Congress plainly contemplated that the patent laws would be given wide scope.” Bilski v. Kappos, 130 S. Ct. 3218, 3225 (2010) (quoting Chakrabarty, 447 U.S. at 308).

Supreme Court  precedents provide three judicially created exceptions to § 101’s broad patent-eligibility principles: “laws of nature, physical phenomena, and abstract ideas.”

Here, the Plaintiffs challenge Myriad’s composition claims directed to “isolated” DNA molecules and method claims directed to “analyzing” or “comparing” DNA sequences under § 101.

Composition Claims: Isolated DNA Molecules

Myriad argued that the district court found the claims unpatentable by (1) misreading Supreme Court precedent as excluding from patent eligibility all “products of nature” unless “markedly different” from naturally occurring ones; and (2) incorrectly focusing not on the differences between isolated and native DNAs, but on one similarity: their informational content.

Myriad argued that an isolated DNA molecule is patent eligible because it is, as claimed, “a nonnaturally occurring composition of matter” with “a distinctive name, character, and use.”

The Plaintiffs argued that claims to isolated DNA molecules fail to satisfy § 101 because such claims cover natural phenomena and products of nature. The Plaintiffs assert that to be patent eligible a composition of matter must also have a distinctive name, character, and use, making it “markedly different” from the natural product.

In sum, although the parties and the government appear to agree that isolated DNAs are compositions of matter, they disagree on whether and to what degree such molecules fall within the exception for products of nature. As set forth below, we conclude that the challenged claims to isolated DNAs, whether limited to cDNAs or not, are directed to patent-eligible subject matter under § 101.

Because isolated DNAs, not just cDNAs, have a markedly different chemical structure compared to native DNAs, we reject the government’s proposed “magic microscope” test, as it misunderstands the difference between science and invention and fails to take into account the existence of molecules as separate chemical entities.

Method Claims

The district court’s decision predated the Supreme Court’s decision in Bilski, which rejected this court’s machine-or-transformation test as the exclusive test for determining whether an invention is a patent-eligible process under§ 101, although the test remains “a useful and important clue.”

Methods of “Comparing” or “Analyzing” Sequences

Myriad argued that its claims to methods of “comparing” or “analyzing” BRCA sequences satisfy the machine-or-transformation test as applied in Prometheus because each requires a transformation–extracting and sequencing DNA molecules from a human sample–before the sequences can be compared or analyzed.

The Plaintiffs argued that these method claims are drawn to the abstract idea of comparing one sequence to a reference sequence and preempt a phenomenon of nature–the correlation of genetic mutations with a predisposition to cancer.

We conclude that Myriad’s claims to “comparing” or “analyzing” two gene sequences fall outside the scope of § 101 because they claim only abstract mental processes. The claims recite, for example, a “method for screening a tumor sample,” by “comparing” a first BRCA1 sequence from a tumor sample and a second BRCA1 sequence from a non-tumor sample, wherein a difference in sequence indicates an alteration in the tumor sample.

This claim thus recites nothing more than the abstract mental steps necessary to compare two different nucleotide sequences: look at the first position in a first sequence; determine the nucleotide sequence at that first position; look at the first position in a second sequence; determine the nucleotide sequence at that first position; determine if the nucleotide at the first position in the first sequence and the first position in the second sequence are the same or different, wherein the latter indicates an alternation; and repeat for the next position.

Method of Screening Potential Cancer Therapeutics

The Plaintiffs challenged Myriad’s method claim directed to a method for screening potential cancer therapeutics via changes in cell growth rates as directed to the abstract idea of comparing the growth rates of two cell populations and as preempting a basic scientific principle — that a slower growth rate in the presence of a potential therapeutic compound suggests that the compound is a cancer therapeutic.

The Federal Circuit disagreed:

Starting with the machine-or-transformation test, we conclude that the claim includes transformative steps, an “important clue” that it is drawn to a patent-eligible process. Bilski, 130 S. Ct. at 3227. Specifically, the claim recites a method that comprises the steps of (1) “growing” host cells transformed with an altered BRCA1 gene in the presence or absence of a potential cancer therapeutic, (2) “determining” the growth rate of the host cells with or without the potential therapeutic, and (3) “comparing” the growth rate of the host cells. The claim thus includes more than the abstract mental step of looking at two numbers and “comparing” two host cells’ growth rates.

 

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Welcome to another Blawg Review, hosted this week by the Patent Baristas.  We’re always glad to have people over to visit so grab a cup of joe and we’ll see what’s been going on around the blogosphere.

It’s the Dog Days of Summer, the name for the most sultry period of summer from about July 3 to Aug. 11. As is typical here, it’s currently a sultry 95 degrees in beautiful, downtown Cincinnati, Ohio, with the humidity hovering somewhere near steam bath.  Bear with us if we sometimes seem incoherent due to the heat.

This week we celebrate the slow life that comes with scorching weather.  So, unload a few burdens, give yourself the luxury of slowing down and looking for that elusive cooling breeze.

Keep It Simple, Real Simple.

“Keep It Simple”

Y’all know it’s crazy
Drivin’ me insane
I don’t wanna be a superman
I just wanna’ go somewhere and use my hands And keep it simple, real simple

~Keb’ Mo’

Keep It Simple - Keb' Mo'

Without further ado, here is this week’s review, in no particular order:

 

Proving You Wrong

Scott Greenfield, over at Simple Justice, writes about the felonization of just about everything.  Eddie Leroy Anderson, 68, and his son each plead guilty to a misdemeanor and got a year’s probation and a $1,500 penalty after trying to dig for arrowheads near a favorite campground of theirs (they didn’t actually find any).  Unfortunately, they were on federal land and the Archaeological Resources Protection Act of 1979, doesn’t require criminal intent and makes it a felony punishable by up to two years in prison to attempt to take artifacts off federal land without a permit.  Harvey Silverglate, notorious civil rights lawyer, says we commit three felonies a day, If you don’t believe it, see the Wall Street Journal.

wiredGC has a post by John Wallbillich on 7 Rules in a series about Zen and the Art of Legal Pricing for those who are value-billing and want the quickest bang for the buck.

Gene Quinn at IP Watchdog laments the problem of the patent troll — one who is abusing the patent right by pressing specious claims in order to shake down a defendant for payment.

Law.com’s Legal Blog Watch longs for when flight plans were simpler and continued its series of Things You Can’t Do on a Plane (vol. 4).

Simple Justice ponders Kevin O’Keefe’s view of the inevitable, unconditional surrender to social media as our Overlord  Kevin says: “You’re going to lose lawyers and other professionals to competitors. Per a study by American Express, 39 percent of younger workers won’t even consider working for a company that blocks Facebook. Facebook has become the communication tool of choice for many young professionals.”

 

 Let Your Light Shine

Mark Bennett, at Defending People, gives a detailed and thoughtful response to the Department of Education’s “Dear Colleague Letter” stating that, under Title IX, “a school’s grievance procedures must use the preponderance of the evidence standard to resolve complaints of sex discrimination.” Sex discrimination, says the DOE, includes sexual violence.

The Volokh Conspiracy outlines the case of a woman being prosecuted for displaying plastic testicles on her car because South Carolina bans obscene or indecent bumper stickers and similar “device[s].”

zen habits points out that it is fairly simple how you can make a living doing something you’re passionate about.  Do one thing really well.  It’s really that simple. Narrow down what you do, and do it repeatedly. Learn, grow, improve, read, watch, do it some more. When you’re really good at that one thing, people will want to pay you for it, or to learn how you do it.

The Blawg Review editor is passionate about down-sizing.  mnmlist shares that when we start out with something, we usually will try everything. But as we learn, we can pare down ideas that we find out don’t matter.  We’re left with the essentials.

Head of Legal points out that the Culture, Media and Sport select committee will not be able to compel answers from Rupert and James Murdoch and Rebekah Brooks. In a sense, no one can ever compel anyone to answer questions – even by the use of torture (a power not even Parliament claims for itself). The real question is, what sanctions will you take against a silent witness?

 

One Friend

The UK law blog Charon QC shows us that that 70% of the population in Britain would welcome a return of the death penalty – the argument of the ‘executioneers’ is that Parliament must impose the will of the majority.  To that, Charon simply says “5 million flies eat shit, but it does not follow that shit is good for us to eat” .

Dennis Crouch at Patently-O notes that over the past year-and-a-half, 52 utility patents have issued that each cite more than 2,500 references.  It turns out that the vast majority of those patents are owned by one company –  Personalized Media Communications. PMC needs to learn to simplify.

Jackie Wright Bonilla writes on the Personalized Medicine Bulletin that the Federal Circuit decided the “ACLU/Myriad” gene patenting case, formally known as Assn. Molec. Path. et al. v. USPTO et al.  In a majority opinion by Judge Lourie, the court addressed the case on the merits, after finding that at least one plaintiff — out of a cast of thousands — had standing to sue.

Patent Docs‘ Kevin Noonan talks about the latest case in which the Federal Circuit assessed the scope of foreseeability for rebutting prosecution history estoppel, Duramed Pharmaceuticals, Inc. v. Paddock Laboratories, Inc., followed a trend started in Festo X and applied in several other doctrine of equivalents decisions by the Federal Circuit in the nine years since the Supreme Court established foreseeability as a basis for rebutting the presumption of prosecution history estoppel.

IPKat Jeremy Phillips walks us through the laborious court dealings of the Star Wars copyright litigation brought  by Lucasfilm Ltd, Star Wars Production Ltd and Lucasfilm Entertainment Co Ltd against the evil empire consisting of the man who produced military uniforms for the Star Wars movie and the company he owned.

Seattle Copyright Watch likewise has a very detailed account of the Lucasfilm case and the right to keep others from making vacuum-molded plastic Stormtrooper helmets.  Apparently, the defendant made versions of the Imperial Stormtrooper helmet and armor, some of which he sold in the U.S. at a price of between $8,000 and $30,000.


Walk Back In

In the legal credit crunch, babybarista wonders if various solicitors’ firms could begin selling off their future earnings to loan sharks.

Hugh McLeod, guest post on Copyblogger, thinks It’s the Simplicity, Stupid.  Make it easy  One thing he’s learned:  “I cannot make my subscriber list tell their friends about the newsletter, no matter how hard I try to apply my Jedi mind tricks.  All I can do is make it easy for them to share. All I can do is make it as friction-free as possible.”

HR Ninja Todd Bavol suggests keeping it simple when creating job titles in recruiting ads.   When a UK company advertised for a “nail technician”, not surprisingly the employer found himself wading through dozens of applications from beauticians when what they were actually seeking was someone to sort nails (the metal variety!) on a building site.

The WSJ Law Blog gives some social media advice in Tweeting for Lawyers 101.  A good rule of thumb for attorneys is that “if you can’t do it off-line, you can’t do it online.”

Lawyerist.com says that the next time you find yourself struggling to get things done, or taking too long to accomplish menial tasks, attack your distractions to simplify things and increase productivity.  “I have not seen anyone effectively simultaneously use a laptop and a desktop, or a desktop and a iPad. If your desk is cluttered with four different pieces of technology, your mind will be just as cluttered.”

The Gender & Sexuality Law Blog notes that at the same time that “being tough on rape” seems a losing strategy for many prosecutors, they can’t be tough enough on human trafficking.

 

I’m Amazing

gapigvoid‘s Hugh Macleod writes about simpler times while watching Neil Armstrong stepping down the ladder of lunar landing module.  “Watching that one small step on the static-ky, shaky black and white TV, with the tinfoil on the antenna to get a slightly better reception, I realized I had been inspired in small ways to live a life that would always push against the limits of my own fears.”

Eric Turkewitz of the New York Personal Injury Law Blog writes about Watching a massive Saturn V rocket blast off to the moon can leave quite an impression on an 11-year-old.  “I think about that now as kids of the same age as I was back then are getting cell phones and iPads, texting, sexting, twittering and facebooking. Friends are now some type of amorphous concept as we live in the age of information overload.”

An Associate’s Mind thinks about how integrity is not that popular of word in the 21st century.  “Look at the general mess available on TV: reality shows, celebrity divorces, and back-stabbing politicians. Integrity has seemingly faded from the daily lexicon. But for anyone looking to develop a reputation that matters, integrity is essential.”

The Men’s Divorce Blog writes about the fatherhood-gap. The marriage-gap works as follows: couples who are wealthier and better educated tend to marry later, and stay married longer. Couples who have less education and less professional success tend to not marry and to divorce more often. Because a fragmented family is more expensive to maintain than an intact one, they tend to then get poorer still. The married thus end up much wealthier than the unmarried and the gap between them is getting wider.  The “Fatherhood-gap,” is a similar gap where Fathers from intact families are spending more time with their kids than their own fathers did. So those who have dads in the home are getting more time with those dads. Thus the gap in actual fathering time between those whose fathers live with them and those whose fathers don’t is getting wider.

With the Blawg Review editor heading to Greece soon it seems only natural to mention Koehler Law’s reminiscing about drinking Ouzo in Greece.  “There, behind the door, was a vat that must have been three feet tall.  When either Ouzo bottle was empty, the owner brought it back to the kitchen and re-filled it with the cheapest stuff he could buy.”

The Time Blawg educates us about the various forms of law blogging, including the ‘flawger’ — someone who flawgs (A legal blog without any substantive legal content that is created, monetized and promoted exclusively for profit.). Usually, a non-lawyer/social media law marketer, (but also a disbarred/suspended/unemployed/underemployed/retired/or failed lawyer who quit) who writes blawg posts about how to write blawg posts, SEO, ROI, iPads, cloud computing, top ten lists, and enjoys attending law marketing conferences and twittering about using #hashtags.

 

Prosperity Blues

In a a guest post by Michael Samsel, SimplyForties has a thing or 2 to say about office chairs.  “Sitting and working, hours on end, staring at the monitor, while minding the mouse and keyboard.  As this has come to define the workaday world, office furniture manufacturers seized the opportunity, quite effectively I might add, to fill the void… offering you comfort and ergonomic correctness… in such a cool way as to become fashion. ”

At the SPC Blog, Jeremy Phillips explains why Brazil should be the next country to be included in the Bucknell Book, the new Oxford University Press publication, Pharmaceutical, Biotechnology and Chemical Inventions: World Protection and Exploitation, a massive two-volume work covering no fewer than 12 jurisdictions which is edited by Duncan Bucknell (for details click here).

Jeremy also looks at pharmaceutical repackaging cases in which one case holds never mind the technicalities as to whose name appears on the packaging — look at the reality. The trade mark owner’s interest in preserving the integrity of its trade marks is unaffected and the consumer is not threatened or misled,  End of story.

If you’re passionate about downsizing but need a fixed address, you may consider the ”Keret House‘ the thinnest house in the world that will be built predominantly using a steel frame, plywood, and Styrofoam.

Think IP Strategy’s weekly selection of top Pharma & Biotech intellectual property news breaking in the blogosphere and internet includes corporate self-interest and strategic choices: Gilead licenses to Medicines Patent Pool (IP Watch) (KEI).

Spicy IP notes that the Indian Patent Act bars patents on traditional knowledge (TK), stated in very broad terms that any invention based on TK is not patentable. It appears to suggest that no patent shall be granted even if the patent application happens to be from the community owning the TK in question.

Dice noted that the law firm Proskauer has equipped more than 500 of its 700 attorneys with iPad 2’s. “At law firms, the technology spend ranks as the third-largest line item behind people and office space. Its place on the budget sheet, though, is well justified: Lawyers rely heavily on computers to deliver services that are at the core of a law firm’s business. All of this underscores the huge risk Proskauer took to adopt the newfangled iPad as a lawyer’s go-to computer.”

At Centsational Girl, Courtney Lake gives his monthly contribution on the topic of how to stage a simple and stylish brunch for your friends and family.

 

Keep It Simple

Profit and Laws shows why more lawyers don’t write books that try to explain the world of law to the rest of the world. And why writing it was such a challenge and why debating it is so delightful. Because law is complex and consequential and fascinating. Hard as you try to summarize and simplify, nuance gets lost in clarity. Lawyers love nuance and distrust clarity.

The EPO blog writes about the EPO’s invitation for an informal meeting with the heads of the US and Japanese Patent Offices to explore possible ways of moving towards international patent law harmonization.

Alan’s blog discusses John Maeda’s book, “The Laws of Simplicty,” which includes many gems not least those arising from Maeda’s roots in Japanese design culture, including aichaku, the “sense of attachment one can feel for an artifact” (p.69) and omakase meaning “I leave it to you”, which asks the sushi chef to create a meal especially for you (p.76).

China Law Blog discusses what you should be reading on China politics, China travel, China food, China this and China that. The quick answer is to look at the CLB blogroll.  But that’s not all.  “Just today I realized how much I enjoy and for how long I have enjoyed the Beijing Daze blog, and yet I have not once mentioned it on this blog.  Until now. Beijing Daze describes itself as “ramblings and comments about Beijing Live Music Scene, Chinese Restaurants in Beijing as well as any weird and quirky cultural ditties that i might come across!” It is heavily skewed toward Beijing’s music scene.

Legal Rebels Patrick Lamb thinks some law firm leaders are hitting a mental wall when confronted with a chance to change.  Lamb compares the situation with the Discovery Channel’s new show “Surviving the Cut.”  The shows have tracked the training of Navy Seals, Green Berets, Army Rangers and other elite units. The training is designed to separate the über-elite from the mere elite. Some who do not make it are interviewed, and almost to a person, they describe the feeling of “hitting the wall” and being able to go no further. For some, the wall is physical. For many, it is mental.  Is there a similar wall in law firms?

Next week, the ABA Journal is hosting Blawg Review #314.  IP.com Blog plugs the 2011 ABA Annual Meeting and is headed to the world-class city of Toronto this summer!  The Section of Intellectual Property Law will feature an international panel examining recent actions on ACTA.

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We hope you’ve enjoyed this week’s edition of Blawg Review. Nothing herein should be construed as an endorsement of any product or service. The decision on any inclusion (or not) in the review was completely arbitrary and capricious. Past performance does not guarantee future returns.

Thanks for dropping by and visiting our place. We’ll meet at your place next time.  And we won’t ask you to wear a swimsuit.

Blawg Review has information about next week’s host, and instructions how to get your blawg posts reviewed in upcoming issues.

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The effervescent Blawg Review Editor has asked Patent Baristas to host the next Blawg Review .  Having to follow the last review with the theme Nelson Mandela Day, everything I say will seem slightly more trite.

In the interest of God, Country and mercy, please send me your suggested additions to Blawg Review #313, which will be held next Monday.  Keep in mind that this week’s blog theme is “Keep It Simple”  so it would be helpful to have additional suggestions that continue that thread.

Send in your submissions via the submissions and recommended posts button: Blog Carnival submission form - blawg review

Or just send an email addressed in standard form to: post at blawgreview dot com

Submit your own best post or a recent law blog post that you would like to recommend for consideration by the host of the next issue of Blawg Review.  I’d especially like to hear from/about sites that are not perennials on Blawg Review.

Deadline for submissions shall be 11:59 p.m. Pacific Time on Saturdays for publication on Mondays.

Your email should include this info about your submission:

Email Subject Line: Blawg Review

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*  It helps the host, sometimes, to know upfront how the writer would present the submission. The host shall be at liberty to present the submission, or not, or make another presentation of the post as seems appropriate to the host for that Blawg Review, with unfettered discretion.

I think we shall now go and enjoy a simple cup of tea whilst we ponder our task ahead.

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The Sherley v. Sebelius lawsuit challenging U.S. funding for human embryonic stem-cell studies was dismissed by a federal judge after an appeals court found the government-backed research is probably lawful.

U.S. District Judge Royce Lamberth, chief of the federal court in Washington, last year said the lawsuit was likely to succeed and ordered a stop to the research while the case was pending. But, the injunction was yanked by the U.S. Circuit Court of Appeals who thought the case was likely to fail.

The original suit was brought by two doctors who sought to block the U.S. Health and Human Services Department and the National Institutes of Health from spending federal funds on research involving human embryonic stem-cells.  The plaintiffs in this case, Dr. Sherley and Dr. Deisher, are scientists who conduct research using only adult stem cells. They assert that the NIH violated the Dickey-Wicker Amendment by funding ESC research projects.

Lamberth last year temporarily barred the government from funding the research, finding it probably violated the so-called Dickey-Wicker Amendment. The 1996 law bars government spending on research that damages or destroys a human embryo. Now, the United States Court of Appeals for the District of Columbia overruled, by 2-1, the district court judge’s preliminary injunction on federal funding of research using embryonic stem cells (ESCs).

The Dickey-Wicker Amendment is an appropriations rider that bars the NIH from funding:

  1. The creation of a human embryo or embryos for research purposes; or
  2. research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 C.F.R. 46.204(b) and section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)).

The court’s analysis turned on the ambiguity of the Dickey-Wicker Amendment, specifically, a lack of definition for the word “research.” The court determined that the present tense of the Amendment, with no reference to embryos that “were destroyed,” implied that the Amendment did not ban ESC research on stem cell lines in existence at the time of the Amendments enactment.

Judge Ginsburg also pointed out that Congress has continued to leave the Dickey-Wicker Amendment unchanged every year since 1996 even though Congress has had “full knowledge” that the Department of Health and Human Services has been funding ESC research since 2001.

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The Indian patents system, having its seeds laid in the British era (1852) and undergoing sporadic replantations (the 1912, 1970, 2005 Patents Act & amendments), was appearing to grow tall and bear fruits until a noticeable downfall last year. It was surprising and interesting to note the sudden decline in the patents filed, examined and granted with the Indian Patent Office as highlighted in the Annual Report 2009-10 of the Intellectual Property Office India.

In hindsight, we had a heavy backlog of pending examination cases, need for transparency in the system, controversies over pharmaceuticals and software patents and a longer list to deliberate upon.

On the other side of the coin, we could use a periscope to notice some of the positive changes that have happened over the last couple of years. A significant one would be the drive to digitalize the patent documents to a respectable extent, because of which patent practitioners worldwide can easily access Indian patent data on a click, instead of waiting for weeks together. Another feather in the cap was the appointment of the IPO as an International Search Authority, for which of course the IPO will have to use all their muscles.

It was also noteworthy to have the IPO initiate the drive to increase the pool of their patent examiners, which will be a significant step in filling the gaps of the years gone behind. The man leading the ship for most of these positive crusades, Mr. Khurian, in a sudden turn of events resigned as the Controller General of Patents, Designs & Trademark, only to keep us all guessing on his decision’s implications.

In light and support of the above comments, closer2patents, an India based patent services firm would like to share, an analysis conducted on the Annual Report (’09-‘10) of the IPO. The analysis aims to summarize the key points and statistics highlighted in the Annual Report, and make a few comparisons with other countries on those lines. The analysis can be accessed at the closer2patents blog.

Comments and questions are always welcome.

Today’s post is by guest barista Abhishek Pandurangi, Founder at closer2patents, B.Tech (Chem), LL.B, Patent Agent-India

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The India-US Business Network (IUSBN) was created in April, 2010 as a non-profit, membership-based entity, and is based in Cincinnati, Ohio.

The vision of the IUSBN is to create profitable and sustainable commercial alliances, and to foster business transactions between socially responsible enterprises in India and the United States.  Please visit our website www.iusbn.org to learn more.

The IUSBN has an opening for an Executive Director.  The job responsibilities and qualifications are described be.

Interested applicants are requested to email a cover letter delineating why you would be perfect as the IUSBN Executive Director, and a current CV to information@iusbn.org.

Closing Date:  August 15th, 2011

More Info:  Executive Director Job Opening

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A Practitioner from a Leading U.S. Law Firm sent in a screen capture of the U.S. Patent and Trademark Office’s login screen for Patent Application Information Retrieval (PAIR) system.

I find some interest that the site shows a bit of an international flavor in the use of Arabic characters.  The full image is here:  PAIR reCAPTCHA.

Thinking this might be a spoof, I contacted the Electronic Business Center and inquired about the alternate characters.  I received the following reply:

Hello,

ReCAPTCHA images are generated automatically from scanned documents.  It is possible that a CAPTCHA could contain non-English characters, such as Arabic letters or mathematical symbols. 

If you receive an unreadable CAPTCHA on the Public PAIR site, simply click the refresh button next to the CAPTCHA text box.

If you have additional questions about the reCAPTCHA system, please contact Google using the following page:  http://www.google.com/recaptcha/contact

If you have any other questions or concerns about the PAIR system, please let us know.

Thank you,

EBC

I also looked at the function of reCAPTCHA.  A CAPTCHA is a program that can tell whether its user is a human or a computer. You’ve probably seen them — colorful images with distorted text at the bottom of Web registration forms. CAPTCHAs are used by many websites to prevent abuse from “bots,” or automated programs usually written to generate spam. No computer program can read distorted text as well as humans can, so bots cannot navigate sites protected by CAPTCHAs.

reCAPTCHA is a free CAPTCHA service that helps to digitize books, newspapers and old time radio shows at the same time! To archive written information, physical books are being photographically scanned, and then transformed into text using Optical Character Recognition (OCR).

reCAPTCHA improves the process of digitizing books by sending words that cannot be read by computers to the Web in the form of CAPTCHAs for humans to decipher. More specifically, each word that cannot be read correctly by OCR is placed on an image and used as a CAPTCHA.

Each new word that cannot be read correctly by OCR is given to a user in conjunction with another word for which the answer is already known. The user is then asked to read both words. If they solve the one for which the answer is known, the system assumes their answer is correct for the new one. The system then gives the new image to a number of other people to determine, with higher confidence, whether the original answer was correct.

About 200 million CAPTCHAs are solved by humans around the world every day, representing more than 150,000 hours of free work each day for Google Inc. (GOOG).

Hmmmmm…perhaps lawyers should join in the lawsuit against Google by the Authors Guild and the Association of American Publishers over the company’s digital reproduction of books.

The company’s plan to digitize every book ever published and make them widely available was derailed when a federal judge in New York rejected a $125 million legal settlement the company had worked out with groups representing authors and publishers. Google has already scanned some 15 million books.

See:  Authors Guild v. Google Inc., 05-CV-8136, U.S. District Court, Southern District of New York (Manhattan)

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At an event co-sponsored by the US Patent and Trademark Office, The Biotechnology Industry Organization and the Biojudiciary Project,  David J. Kappos, Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office gave a speech on “From Chakrabarty to Today.

Kappos remarked that there is no question that the Chakrabarty pivotal decision had a seismic effect on US patent policy, giving birth to a new mode of thinking at the United States Patent and Trademark Office.

In part, Kappos connected the past changes to the patent system with the now proposed patent reform act:

And while we gather here in the light of this case’s 30th Anniversary and reflect on its history to infer guidance for the road ahead—

Today, we also stand at the precipice of a new history.  One that, through Congressional patent reform legislation, will historically redefine the nexus of patenting and innovation.

Just last week the U.S. House of Representatives demonstrated significant leadership in passing the American Invents Act—representing a major step towards transforming our patent laws to account for the modern stresses and expectations of a fast-moving 21st century global economy.

While we are diligently working to reconcile the bill with a version passed earlier this Spring in the Senate—we are stand at the threshold of major change and a truly “Jeffersonian moment.”

Recognizing that innovation is at the heart of human progress and patents are how we drive that progress forward, Kappos believes that changing the patenting process, small and independent inventors to move their ideas to the market place faster and enable all of you to do your jobs more easily.

And if we get this right, we can foresee resolutions to post-grant review processes that take shape in less than one year.

If we get this right, we can equip our agency with the thousands of additional examiners it will require to tackle the backlog—which for far too long as been an enemy of progress.

If we get this right, we can confirm the strength of patents efficiently or even promptly let businesses know that their claims are in fact not strong enough.

Either way, efficient processing grants independent inventors and large biotech firms alike the assurances you need to move your technologies and services forward. That way, if we get this right, business can conduct business…without constant speculation or endless arbitration.

Let me be clear—should patent reform be signed into law, implementing a robust IP infrastructure around it will not be easy—but we are up for the challenge.

30 June 2011

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