Patent Baristas

In celebration of Earth Day, IAmBiotech and their “sister site” WhatCanBiotechDoForYou are spreading the word about the many ways biotechnology is helping save our environment.  The evolution of biotech has resulted in developments and new technologies that are helping to feed, fuel and heal the world.  Through sustainable agriculture and renewable fuels and products, the biotech community is working to create a greener future for all of us.

Now, you can just text your way to green answers:

We need your help! Ask your friends, family, colleagues, that guy sitting next to you on the bus to TEXT  “BIOTECH” to 77513 to find out the top 10 ways biotech is helping save the earth.

In talking to people about how biotech is helping us lessen our footprint on the earth, WhatCanBiotechDoForYou will be working over the next week to bring you some of their comments about what they’d like biotech to tackle next.  So, what questions have been asked and answered so far?  Q&As include:

• Can biotechonology help to make specific foods more healthy?
• What does biotech have to do with algae-based fuels?

Of course, plenty of questions remain to be answered, including ”

• Can biotech make a wine that doesn’t give me hangovers?
• Can biotech help me clean my room when I’m too lazy to? [Can it improve grammar?]
  

If you are working on a technology or product that is helping the environment, you are being asked to please share your work in the “Green Room” on: www.IAmBiotech.org/Forum.

WhatCanBiotechDoForYou.com is part of a project sponsored by the Biotechnology Industry Organization (BIO), designed to foster a conversation with the general public about biotechnology and further educate people about the contributions of this innovative sector.  For more in-depth information on biotech and the people behind the science, please visit their sister site – www.IAmBiotech.org.

The Board of Patent Appeals and Interferences (BPAI) of the U.S. Patent and Trademark Office has combined three patent interferences into a single interference between Sepracor and Wyeth. The interference was declared to determine the priority of inventorship of claims directed to racemic O-desmethylvenlafaxine (ODMV) succinate.

Wyeth markets racemic ODMV succinate in the U.S. under the brand name Pristiq® for the treatment of major depressive disorder in adults. Sepracor, if it wins the interference, could end up owning the patent rights that would then be infringed by Wyeth’s sale of Pristiq.

The U.S. is — at least for now — a “First to Invent” country, rather than “First to File” as is the case in most other countries. While other countries set up a race to the patent office, inventors in the U.S. can file second but still prevail if they can show proper documentation that they invented first.

An inventor can trace back to the date of conception for the earliest date of invention that you can rely on as long as the inventor works diligently on it (no gap in effort) until either filing a patent application for the invention (constructive reduction to practice) or making it (actual reduction to practice).

The interference is between Wyeth’s U.S. patents 6,673,838 and 7,291,347, the two patents listed in the FDA’s publication entitled Approved Drug Products With Therapeutic Equivalence Evaluations (the Orange Book) for Pristiq, and three of Sepracor’s pending U.S. patent applications, 10/720,134, 11/091,518 and 12/011,083.

The earliest application filing date asserted by Sepracor (April 6, 1999) is approximately 22 months earlier than the earliest application filing date asserted by Wyeth for its claims (February 12, 2001). The BPAI has set January 6, 2010 for oral arguments in this interference.

The Board combined the actions and added Count 5 showing an interference between the compound of claim 1 of U.S. Patent 6,673,838 (Hadfield) and claim 60 of application 10/720,134 (Jerussi), both of which read as:

A compound which is O-desmethyl venlafaxine succinate.

Other counts include oral dosage forms comprising O-desmethyl venlafaxine succinate. The Jerussi application was accorded an earlier constructive reduction to practice (i.e., benefit for the purpose of priority) of Application 09/527,442, filed 17 March 2000.

Sepracor filed motions to get the benefit of earlier filed provisional applications 60/167,906 (filed 30 Nov. 1999) and provisional application 60/127,938 (filed 6 Apr. 1999).  In the interference, Wyeth has raised an objection that (at least some) claims by Sepracor are invalid for failing to meet the written description requirement under §112 as well as objecting to the priority claims of the earlier filed Jerussi applications.

An interference occurs when an application claims subject matter that is the “same patentable invention” found in the claims of another application or issued patent. The Board of Patent Appeals and Interferences decides which entity invented the common invention first and that party wins the interference.

As part of the procedural mechanism for resolving interferences, the PTO prepares one or more “counts.” These counts define the scope of the subject matter (invention) in dispute. In general, priority of invention then goes to the first party to reduce an invention to practice unless the other party can show that it was the first to conceive of the invention and that it exercised reasonable diligence in later reducing that invention to practice.

That is, priority goes to the party that has either: (1) the earlier date of conception and the earlier date of reduction to practice or (2) the earlier date of conception, but a later date of reduction to practice, coupled with a reasonably diligent effort to reduce the invention to practice from just before the other party’s date of conception until reduction to practice.

Note, however, that during the course of the proceedings both parties will have an opportunity to knock out or to limit the other party’s claims in the patent or application regardless of who invented first. For example, one party may show that the other party was not entitled to a patent in the first place because its claim or claims were not valid. In various circumstances, patent claims are often limited or thrown out if it is shown that a party did not have grasp of the invention as claimed at the time of filing.

These tactics have to be wielded carefully since an attack on patentability of an opponent’s claims corresponding to the count can also end up being an attack on the patentability of your own claims. In such cases, the parties thus have an opportunity to enact a type of mutually assured destruction by arguing that neither party should have a patent because the invention was already in the public domain.

Unlike the discovery available in federal district courts, the scope of discovery in interferences before the USPTO is fairly narrow. In the trial phase, the parties can present evidence in the form of testimony of various witnesses, which can be with exhibits, consisting of documents of all kinds, including laboratory notebooks, internal reports, publications, etc. Anything relevant to the issues in the interference may be introduced as an exhibit.

Generally, the parties will reach some state in the game where they decide to resolve the conflict through a settlement agreement. In settling, the parties will have to decide who would be entitled to priority under U.S. patent law. Usually, the parties give each other documents showing conception and reduction to practice and then they try to decide whether someone has enough evidence to prove an earlier date of invention.

In settlement, the parties can also try to resolve questions of patentability such as §112 issues. Often, a settlement will include licensing or cross-licensing, which may or may not include payment of royalties.

in·no·va·tion \ËŒi-nÉ™-ˈvā-shÉ™n\.  noun.   1 : the introduction of something new 2 : a new idea, method, or device

It should be obvious to anyone that innovation is crucial to our lives and to our economy.  The question some have raised is whether or not the U.S. legal system is a driver or a damper on innovation. That is, are intellectual property (IP) and antitrust laws being used most effectively to foster innovation?

Michael Carrier, a Professor of Law at Rutgers University School of Law – Camden has now addressed this question in his new book “Innovation for the 21st Century: Harnessing the Power of Intellectual Property and Antitrust Law” (Oxford University Press, 2009).

From the author:

Innovation in the 21st Century: Harnessing the Power of Intellectual Property and Antitrust Law aims to reverse this trend. It offers ten revolutionary proposals to foster innovation. The proposals address generic drugs, pharmaceutical mergers, peer-to-peer (P2P) software, statutory damages, the Digital Millennium Copyright Act (DMCA), BlackBerry devices, biotechnology research tools, valid patents, and countless other cutting-edge challenges.

The proposals cover our patent system, our copyright laws and our antitrust laws, particularly as they apply to the pharmaceutical industry.  In the introduction, Carrier first delves into just what is innovation’s role in society.  The author then weaves together the relationship between IP laws and innovation and how each may be changed to increase innovation:

Copyrights

• Relating to P2P software and other dual-use technologies:, Prof. Carrier calls for a return to protections for technologies “capable of substantial non-infringing uses” as described in Sony v. Universal City Studios;
• Changes to statutory damages to eliminate the remedy for technology manufacturers (presumably because under willful infringement, certain technologies could rack up damages into the billions); and
• Limit the Digital Millennial Copyright Act (DMCA) to only the creative acts the drafters envisioned, i.e., not devices with embedded software like printer ink cartridges.

Patents

• A post-grant opposition system that provides a quicker and cheaper determination of validity;
• Limiting the availability of using injunctions to shut down an infringer à la eBay v. MercExchange;
• Broaden access to patented research tools in the biotech industry (plagued by what Prof. Carrier deems a disconnect between “law on the books” and “law on the ground”); and
• Model agreements for material transfer agreements (MTAs) to increase access to materials needed for research.

Antitrust

• A new framework to prevent mergers between firms in “Innovation Markets” like the pharmaceutical industry where such mergers could suppress R&D when there are not products on the market yet;
• Adoption of standards via standards setting organizations (SSOs); and
• Making settlements between brand and generic drug companies with reverse payments deemed presumptively illegal.

As you can imagine, there is enough in this book to make sure everyone comes away peeved with something.  Whether you find some of the proposals to be pure genius or pure foolishness, we think you’ll find this publication thought provoking on many levels.

To get more insight into these proposals, the book was the subject of a blog symposium by Truth on the Market with articles by various authors on their thoughts on the book as well as Professor Carrier’s response.  Each of the participants was asked to read the book and prepare a thoughtful and engaging post.

You can purchase “Innovation for the 21st Century: Harnessing the Power of Intellectual Property and Antitrust Law” from Amazon.  If that gets your blood boiling, you may also like Richard Susskind’s The End of Lawyers?: Rethinking the Nature of Legal Services.

Evolving IP Marketplace

The Federal Trade Commission held the fourth in its series of hearings on the Evolving IP Marketplace. This set of hearings will explore the emergence of new business models in the market for intellectual property, strategies for buying, selling and licensing patents and the role of secondary markets. Discussions covered some of the recent changes in markets for intellectual property. Discussion included valuing and monetizing patents, strategies for buying and selling patents and the role of secondary markets for intellectual property.

Temporary Restraining Order Pulmicort

The US District Court for the District of New Jersey granted AstraZeneca’s request for a temporary restraining order, barring Apotex from selling a generic version of AstraZeneca’s Pulmicort Respules (budesonide inhalation suspension) until further order of the court. On 27 April 2009, the court will commence a hearing to determine whether the injunction should be continued.  Patents covering Pulmicort Respules expire in 2018 with pediatric exclusivity extending to 2019.

TRIPS, Pharmaceuticals and Manufacture for Export

This week’s IP Think Tank podcast has panelists Shamnad Basheer and Duncan Bucknell joined by Nicholas Gruen to follow up from a recent blog post and discuss Pharmaceutical patent extensions, TRIPS, Free Trade Agreements and Pharmaceutical Manufacture for Export.

Enter the Octomom

Nadya Suleman, often referred to as the Octomom after giving birth to octuplets through IVF despite living on welfare and already being a mother of six, has reportedly filed a pair of trademark filings with the USPTO on the term Octomom.  The applications, filed April 10th, are to gain rights to the term Octomom for selling disposable diapers and for ongoing television programs.

Unfortunately, another trademark application for Octomom had already been filed by Super Happy Fun Fun, a Texas-based corporation, which submitted its application March 12th, to use the name for computer game software, toys and action figures and wireless and mobile entertainment.

The company’s website shows a product called Fertile Myrtle (listed as formerly Octomom) for iPhone and iPod Touch. There is no indication why it is listed as “formerly Octomom” but the game is listed as “Simple and addictive game play. Press down on Fertyle Myrtle’s swollen belly, and another adorable bundle of joy will be brought into the world.”

In Takeda Pharma v. John J. Doll (08-1131), the US Court of Appeals for the Federal Circuit looked at an earlier District Court decision holding that later developments in the art may inform the “patentably distinct” determination for double patenting.

The Federal Circuit agreed but only to the extent that the subsequent developments predate the secondary application that triggers a double patenting rejection.

Takeda had obtained a number of patents claiming cephem compounds through a series of continuations, continuations-in-part, and divisional applications. Later, Takeda filed its application covering the process for making the cephem compounds claimed in the ’888 and ’606 product patents sixteen years after the 1974 priority date, and more than fourteen years after the filing of the ’888 product patent application.

The process patent issued as U.S. Patent No. 5,583,216 (the process patent) on December 10, 1996, claiming the sole process known and disclosed in the Japanese priority patent application, which led to the double patenting issue.

After two anonymous requests for reexamination, the examiner rejected the ’216 process patent claims as patentably indistinct over the ’606 product patent claims.  Takeda relied upon the declaration of Dr. Wuest disclosing an alternative process (displacement process) for making the cephem compounds claimed in the ’216 patent. Takeda appealed the rejection to the Board of Patent Appeals and Interferences, which dismissed Dr. Wuest’s declaration as “speculative” and upheld the examiner’s double patenting rejection.

In the District Court, Takeda presented the declaration of Dr. Duggan, which claimed that the process disclosed in U.S. Patent Nos. 6,552,186 (the Gerlach patent, published on Sept. 12, 2002, issued Apr. 22, 2003) and 7,071,329 (the Monguzzi patent, published June 2, 2005, issued July 4, 2006) provides a viable alternative, non-infringing process for making the certain cephem compounds claimed in the ’606 product patent.

Since the parties stipulated that “Method B” of the Duggan declaration described a materially distinct alternative process, the only issue was whether the alternative process—Method B, developed after the date of invention—could defeat the double patenting rejection.

The district court concluded that “subsequent developments in the art [are relevant to] determining whether alternative processes exist” when weighing patentable distinctions for double patenting.

Relying on Dr. Duggan’s disclosure of Method B (published in the Gerlach and Monguzi patents) the district court found that the product and process are “patentably distinct” and overturned the double patenting rejection.

Double patenting generally prevents a patentee from receiving two patents and extending the term of exclusivity for a single invention.  Statutory, or “same invention,” double patenting finds its origin in the statutory grant of “a patent” for any new and useful invention.  Non-statutory, or “obviousness-type,” double patenting is a judicially created doctrine designed to foreclose “claims in separate applications or patents that do not recite the ‘same’ invention, but nonetheless claim inventions so alike that granting both exclusive rights would effectively extend the life of patent protection.”

Here, the parties agreed that product and process claims are patentably distinct if multiple processes for creating a product exist at the time of the invention.  The question in this case is if later-developed alternative processes are relevant in the product-process “patentably distinct” inquiry.  The PTO determined that the date of invention governs the relevance of products and processes in the double patenting context.  The PTO didn’t cite statutory or case support for the “date of invention” approach other than analogizing to the patentability requirements of  §§ 112, 102, and 103.

The Federal Circuit sided with the District Court saying it was not persuaded by the PTO’s approach of the “date of invention” since it only raises other substantive questions such as: is the filing date the presumptive “date of invention”?

It also disagreed with the district court’s “doing away with blinders” approach, which would allow an applicant to come forward with any evidence that its product and process are patentably distinct, even if the alternative process is developed decades after the filing dates of the product and process applications. That is, the applicant can use the filing date as a shield, enjoying the earlier priority date in order to avoid prior art, and rely on later-developed alternative processes as a sword to defeat double patenting challenges.

This court is not persuaded by either approach. Neither approach addresses the policies underlying the double patenting doctrine. The secondary application (in this case, the process application of January 8, 1990) actually triggers the potential of an “unjustified extension of patent term.” When filing the secondary application, the applicant essentially avers that the product and process are “patentably distinct.” Thus, the relevant time frame for determining whether a product and process are “patentably distinct” should be at the filing date of the secondary application.

This approach allows an applicant to rely on some later-developed methods to show that the product and process are “patentably distinct,” even though the alternative processes for making that product may not have been known at the filing date of the primary application. This rule gives the applicant the benefit of future developments in the art. At the same time, however, it prevents the inequitable situation that arises when an applicant attempts to rely on developments occurring decades after the filing date of the secondary application.1

Therefore, the court remanded for further factual review.

Circuit Judge Schall dissented-in-part saying:

I agree with the majority that, in arguing against the claim of obviousness-type double patenting in the reexamination proceeding, Takeda should not be able to rely on the disclosures of the Gerlach and Monguzzi patents. However, I respectfully part company with the majority in its conclusion that Takeda should be able to rely on developments in the art up to January 8, 1990, the date of the filing of the ’216 process patent application. In my view, in arguing against the claim of obviousness-type double patenting, Takeda should not be able to rely on disclosures after the December 19, 1974 invention date.

I believe that tying the inquiry to the invention date is most commensurate with patent law as a whole and the policy goals relating to obviousness-type double patenting.

Deloitte has released a study, Avoiding no man’s land: Potential unintended consequences of follow-on biologics, that explores the debate on creating a regulatory pathway for the approval of follow-on biologics (FOBs, the biotech equivalent of generic pharmaceuticals). The study also outlines unintended effects of the Hatch-Waxman Act of 1984 and compares it with current proposed legislation.

The study notes that basic differences between the pharma industry in 1984 and the biotech industry in 2009 make it difficult to apply Hatch-Waxman as a model for FOBs legislation. According to the study, after 1984, patents protected innovators’ intellectual property and the data exclusivity period rarely came into effect.

At the heart of this debate
is one key issue: How
similar are the two
underlying industries?

In 1984, when the Hatch-Waxman generic drug legislation was enacted, the pharma industry was stable and mature.  Today the biotech industry is relatively young and complex and is highly reliant on risk capital. With follow-on biologics, Congress may need to consider a different set of rules to balance cost savings, patient safety, and economic incentives for future innovation.

Still, the essential debate has two main issues — patient safety and industry economics:

Patient Safety: What will constitute threshold “biosimilarity”? Specifically, what type and length of clinical trials will be required to establish that a new FOB is sufficiently similar to a currently approved and marketed “branded” biological drug, and thus permit the FOB a relatively quick path to market? Under what circumstances would a new FOB be considered “interchangeable” with a currently approved drug?

Industry Economics: How can new regulations most appropriately encourage competition while also maintaining sufficient economic incentives to foster scientific innovation? Specifically, what should be the appropriate period of time granted to a branded biological drug for protection of its underlying intellectual property prior to the approval and entry of an FOB?

Unintended Consequences

The  study outlines three of these unintended effects, and explores how this experience should be considered in current legislation:

• “Make Hay” effect: Once a drug is introduced to the market, an innovator has a short time to recoup its development costs — upwards of $1 billion over 12 years — before a competitor enters the market. Faced with patent protection of limited duration, innovator companies must maximize their revenues in the short period before generics are introduced. To do this, they generally raise prices and invest more in marketing the drug, tactics that run counter to Hatch-Waxman, the intent of which was to lower prices.
• “Blockbuster” effect: Facing increased drug development costs and a limited period of time before generics can compete, innovators typically focus only on those drugs that promise huge returns on investment. To recoup the amount of time and money an innovator spends on a new drug, experts have shown that to break even, a drug would have to achieve annual revenue of roughly $150 million, which is impossible unless a drug targets a large population, or charges a high price per treatment. This blockbuster effect has led pharma companies generally to focus development efforts on only the largest potential indications.
• “No Man’s Land” effect: As soon as a company receives a patent for a compound, the clock for commercialization begins ticking. Each year a patented drug spends in development is another year of lost revenue. If enough time elapses, there comes a point where the compound will never be able to earn sufficient return on investment. This could lead to promising compounds being dropped from development, including those for critical diseases like cancer, Parkinson’s, Alzheimer’s and others, because there is no way to fund the research once the compound has crossed into this “no man’s land.” Deloitte estimates this can occur within as little as one year of achieving a patent.

According to the study, the most serious of these unintended consequences may be the ‘no man’s land effect,’ which could substantially reduce the biotech industry’s ability to continue to develop innovative treatments for our most pressing diseases and medical conditions.

The blockbuster effect runs exactly
counter to the direction and
promise of the science of biotech.

According to the study, the economics of drug development essentially forces innovators to focus on drugs with the largest possible market potential – in this way, again, what was true for pharma innovators will be true for biotech innovators. But, this effect runs  counter to the promise of biotech, which has the potential to create  highly targeted therapies. In order for personalized medicine to become a reality, drug innovators will need a regulatory environment that allows a return on their investments in research and development.

Because of the structural differences between the pharmaceutical industry of 1984 and today’s biotech industry, Congress will need to act with care as it looks to create a regulatory path for FOBs.

Get the entire paper here.

To see if patenting DNA still has a place, see the Non-obviousness of DNA at Patent Docs.

Burn the ships, we’re here to stay
There’s no way we could go back
Now that we’ve come this far by faith
Burn the ships, we’ve passed the point of no return
Our life is here
So let the ships burn

~Burn the Ships (lyrics) by Steven Curtis Chapman and James Isaac Elliott

The phrase “Burn The Ships” comes from history when, in 1519, Spanish conquistador Hernán Cortés de Monroy y Pizarro (Hernando Cortez) landed in Mexico on the shores of the Yucatan intent on claiming the treasures of the Aztecs. Cortés was committed to his mission and his quest for riches is legendary. With just 500 soldiers and 100 sailors in 11 ships, Cortés set out to overtake the Aztec empire.

Knowing that they faced incredible odds, Cortés changed the game to do or die by ordering his men to “Burn the Ships”. That is, Cortés and his men burned their own ships saying that “if we are going home, we are going home in their ships”. Thus, providing ultimate motivation by giving themselves no way out. No fall back position. Cortés ultimately succeeded. Depending on how you view it, Cortés was either an awesome motivational leader or an insane megalomaniac who held little or no value in the lives and well being of his companions — or the Aztecs.

Now, a new book offers lessons for on the struggles between innovation and intellectual property called “Burning the Ships: Intellectual Property and the Transformation of Microsoft,” by Marshall Phelps and David Kline (John Wiley & Sons). “Burning the Ships” recounts Phelps’ behind-the-scenes account of how he overcame internal resistance and got Microsoft to embrace collaboration with other firms. The story details how Microsoft went from continually on the defensive — from anti-trust suits and IP litigation — to succeeding in the emerging era of “open innovation” by collaboration and cooperation.

Microsoft founder and Chairman Bill Gates (presumably like Cortez burning his ships at the shores of the New World) decided to embrace change and recruited Marshall Phelps who helped monetize IBM’s IP portfolio (another behemoth that thought might makes right).  Phelps, coming out of retirement, was put to task on a new “collaboration imperative” for leveraging intellectual property.  It shows that being the biggest doesn’t mean you don’t need others — like it or not.

The authors provide some behind-the-scenes look at what led up to Microsoft agreements with Novell, Toshiba and others — as well as agreements that didn’t go through such as with Red Hat, which decided not to reach an agreement after a year and a half of negotiations. The book details how difficult it was to reach an agreement over Linux without violating the licensing terms of the GNU open-source operating system.

There are plenty of lessons in this book for executives in every industry where accessing previously untapped intellectual property can open up new business opportunities. The irony is not lost on anyone that Phelps trumpets that Microsoft is a regular target for firms claiming Microsoft violates their IP rights, suggesting that Microsoft may be the one with an IP problem, not open source.

The bias shows through as the book describes how “the patent gold digging to on comic overtones.”  Yes, there is patent gold-digging but the lack of respect for intellectual property rights comes through when quoting Nathan Myhrvold, Microsoft’s CTO, decrying “So every time one of these companies came be to assert their patents against us, it would cost us money.  Sometimes 50 or 100 million dollars.  And that’s a lot of zeros to give away just because someone else has patents and you don’t.”  Waaaahhh.

Burning the Ships does show that collaboration is imperative, whether you like it or not.  It also distinctly points out that leadership starts at the top and that  company CEOs need to understand IP as a business strategy and not just a legal function.

While interesting in its glimpse inside the word’s largest software company’s inner workings, it feels a little contrived.  Many of the cited quotations come off sounding a lot like they were crafted by unimaginative marketing folks.  For example, Phelps writes about receiving a phone call from Gates while out golfing that goes like this:

“Hi, Marshall, this is Bill Gates.  I know that Brad [Smith] spoke with you yesterday about the offer.  But I just wanted to reinforce our hope that you’ll come to Microsoft and help us with this really big challenge that we’re facing.”

And then music played and children danced. Like Cortés, history is often written by the victors.

Burning the Ships: Intellectual Property and the Transformation of Microsoft is available from Amazon.

Marshall Phelps is Microsoft’s corporate vice president for intellectual property policy and strategy and is responsible for setting the global intellectual property strategies and policies for the company.  David Kline is a journalist, author, and intellectual property consultant who has earned acclaim for his best-selling book, Rembrandts in the Attic.

In In re Kubin (08-1184), the US Court of Appeals for the Federal Circuit held that the US Patent and Trademark Office’s Board of Patent Appeals and Interferences was correct to hold claims as unpatentably obvious when applicants use “conventional techniques” to make an invention.  This is bad news not just for biotech but for all arts.

In this case, the Board had rejected the claims of U.S. Patent Application Serial No. 09/667,859 as obvious under 35 U.S.C. § 103(a) and invalid under 35 U.S.C. § 112 ¶ 1 for lack of written description (Ex parte Kubin).

The application claims the isolation and sequencing of a human gene that encodes a particular domain of a protein, known as the Natural Killer Cell Activation Inducing Ligand (NAIL). Natural Killer cells express a number of surface molecules which, when stimulated, can activate cytotoxic mechanisms. NAIL is a specific receptor protein on the cell surface that plays a role in activating the NK cells.

The specification of the claimed invention recites an amino acid sequence of a NAIL polypeptide. The invention further isolates and sequences a polynucleotide that encodes a NAIL polypeptide. Moreover, the inventors allege discovery of a binding relationship between NAIL and a protein known as CD48, which causes an increase in cell cytotoxicity and in production of interferon.

Representative claim 73 is for the DNA that encodes the CD48-binding region of NAIL proteins:

73. An isolated nucleic acid molecule comprising a polynucleotide encoding a polypeptide at least 80% identical to amino acids 22-221 of SEQ ID NO:2, wherein the polypeptide binds CD48.

The applicants’ specification discloses nucleotide sequences for two polynucleotides: SEQ ID NO: 1 recites the specific coding sequence of NAIL, whereas SEQ ID NO: 3 recites the full NAIL gene, including upstream and downstream non-coding sequences. The specification also contemplates variants of NAIL that retain the same binding properties.

In rejecting the claims as invalid, the Board concluded that appellants were not entitled to their genus claim of DNA molecules encoding proteins 80% identical to SEQ ID NO:2:

Without a correlation between structure and function, the claim does little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement.

Regarding obviousness, the Board rejected the claims over the combined teachings of U.S. Patent No. 5,688,690 (Valiante) and Sambrook et al., Molecular Cloning: A Laboratory Manual.

Valiante discloses a receptor protein p38, which is present on virtually all human NK cells and can serve as an activation marker for cytotoxic NK cells. Valiante also discloses and claims a monoclonal antibody specific for p38 called mAB C1.7. The Board found that Valiante’s p38 protein is the same protein as NAIL.

The court said that Valiante teaches that “[t]he DNA and protein sequences for the receptor p38 may be obtained by resort to conventional methodologies known to one of skill in the art.” Additionally, the DNA sequence encoding the receptor can be obtained by the “panning” technique of screening a human NK cell library by eukaryotic expression cloning, of which several are known.

With regard to the amino acid sequence referred to as SEQ ID NO:2, the court agree with the Board that:

Because of NAIL’s important role in the human immune response, the Board further found that “one of ordinary skill in the art would have recognized the value of isolating NAIL cDNA, and would have been motivated to apply conventional methodologies, such as those disclosed in Sambrook and utilized in Valiante, to do so.”

Based on this, the Board turned to the Supreme Court’s decision in KSR and concluded that claim was “the product not of innovation but of ordinary skill and common sense,’ leading us to conclude NAIL cDNA is not patentable as it would have been obvious to isolate it.”

Seeing that the Board concluded that the method of isolating NAIL DNA was essentially the same as the methodologies and teachings of Valiante and Sambrook, the Federal Circuit really didn’t care about any similarities or differences in methods of deriving the NAIL DNA since the claim in question was for a gene sequence:

[T]his court determines that the Board had substantial evidence to conclude that appellants used conventional techniques, as taught in Valiante and Sambrook, to isolate a gene sequence for NAIL.

Thus, Kubin and Goodwin cannot represent to the public that their claimed gene sequence can be derived and isolated by “standard biochemical methods” discussed in a well-known manual on cloning techniques, while at the same time discounting the relevance of that very manual to the obviousness of their claims. For this reason as well, substantial evidence supports the Board’s factual finding that “[a]ppellants employed conventional methods, ‘such as those outlined in Sambrook,’ to isolate a cDNA encoding NAIL and determine the cDNA’s full nucleotide sequence (SEQ NOS: 1 & 3).”

Because this court sustains, under substantial evidence review, the Board’s finding that Valiante’s p38 is the same protein as appellant’s NAIL, Valiante’s teaching to obtain cDNA encoding p38 also necessarily teaches one to obtain cDNA of NAIL that exhibits the CD48 binding property.

The court also looked at the assessment of obviousness in the context of classical biotechnological inventions, specifically In re Deuel. In Deuel, the Federal Circuit reversed the Board’s conclusion that a prior art reference teaching a method of gene cloning, together with a reference disclosing a partial amino acid sequence of a protein, rendered DNA molecules encoding the protein obvious. The court also stated that “obvious to try” is not the test for obviousness.

The Federal Circuit then noted that the Supreme Court cast doubt on the viability of Deuel to the extent the Federal Circuit rejected an “obvious to try” test in KSR:

Under KSR, it’s now apparent “obvious to try” may be an appropriate test in more situations than we previously contemplated.

So, when is an invention that was obvious to try nevertheless nonobvious? To differentiate between proper and improper applications of “obvious to try,” this court outlined two classes of situations where “obvious to try” is erroneously equated with obviousness under § 103:

In the first class of cases, what would have been “obvious to try” would have been to vary all parameters or try each of numerous possible choices until one possibly arrived at a successful result, where the prior art gave either no indication of which parameters were critical or no direction as to which of many possible choices is likely to be successful (“where a defendant merely throws metaphorical darts at a board filled with combinatorial prior art possibilities”).

The second class of impermissible “obvious to try” situations occurs where what was “obvious to try” was to explore a new technology or general approach that seemed to be a promising field of experimentation, where the prior art gave only general guidance as to the particular form of the claimed invention or how to achieve it (“the improvement is more than the predictable use of prior art elements according to their established functions”).

The court then applied this to the current case:

The record shows that the prior art teaches a protein of interest, a motivation to isolate the gene coding for that protein, and illustrative instructions to use a monoclonal antibody specific to the protein for cloning this gene. Therefore, the claimed invention is “the product not of innovation but of ordinary skill and common sense.” KSR, 550 U.S. at 421. Or stated in the familiar terms of this court’s longstanding case law, the record shows that a skilled artisan would have had a resoundingly “reasonable expectation of success” in deriving the claimed invention in light of the teachings of the prior art. See O’Farrell, 853 F.2d at 904.

This court also declines to cabin KSR to the “predictable arts” (as opposed to the “unpredictable art” of biotechnology). In fact, this record shows that one of skill in this advanced art would find these claimed “results” profoundly “predictable.”

In light of the concrete, specific teachings of Sambrook and Valiante, artisans in this field, as found by the Board in its expertise, had every motivation to seek and every reasonable expectation of success in achieving the sequence of the claimed invention. In that sense, the claimed invention was reasonably expected in light of the prior art and “obvious to try.”

What is amazing about this decision is that complex discoveries — biotechnology or not — are almost always made through a complex and lengthy process using well-established and validated research methods.

PatentlyBIOtech points out the obvious problem in this case:

Would the Patent Office rather that Kubin hadn’t even tried? What about further discoveries that build upon Kubin’s gene? Are those also unpatentable if they are made with routine research tools and methods? What about a medicine that might one day be developed based on Kubin’s discovery? Is that also just the result of routine experimentation, undeserving of a patent?

While In Re Kubin seems like a case where hindsight will be used to club every biotech patent, Patent Docs felt that this is not the end of biotech patents:

Another reason the sky will not be falling on biotechnology patenting arises from the time in the history of biotechnology in which the decision was handed down.  Many (if not most) of the “known” genes in the art have been cloned and patented (or not) over the past 30 years of gene patenting, and many of these patents have expired or are nearing the ends of their terms.  … Turning to the present day, many (if not most) of the genes patented or that have been attempted to be patented were not known prior to their discovery (usually through homology comparisons) as a result of the Human Genome Project (HGP).  A fundamental pillar of the Court’s decision in Kubin was that p38 was known; that will not be the case for most of the genes identified since the late 1990’s.

This leaves a class of genes and gene patents “in the middle” — granted since (and perhaps because of) the Court’s decision in Deuel but prior to identification during the HGP effort.  Some of these, no doubt, have been made more open to an obviousness challenge since the Court’s decision in this case.  However, many (if not most) of these genes will be lacking some if not several of the factual underpinnings of the Kubin decision:  the existence of the protein encoded therein was not known, or there was not a commercially-available monoclonal antibody specific for the protein, or expression cloning was ineffective or unpredictable for that gene, or there was no express description in the art on how to isolate the gene, or there did not exist a cell or tissue source reliably expressing the protein.

The only thing that’s certain is that the Patent Office will begin hammering biotech patents on obviousness more than ever — starting immediately.