Patent Baristas

here at Patent Baristas, we get all giddy when a case comes down the pike involving protein synthesis and gene cloning vectors.  It doesn’t happen all that often and, when it does, we’re treated to BIO 101 introductions explaining how proteins are biomolecules that “are encoded by particular deoxyribonucleic acid (“DNA”) sequences known as genes.”

And so it is with Carnegie Mellon University and Three Rivers Biologicals v. Hoffmann-La Roche (07-1266).  After the district court deflated an infringement suit by Carnegie Mellon University and Three Rivers Biologicals holding that Hoffmann-La Roche et al. did not infringe the patents (and that certain claims were invalid for lack of written description anyway), Carnegie asked the Federal Circuit to intervene.

The patents, U.S. Patents 4,767,708, 5,126,270, and 6,017,745, relate to novel recombinant plasmids for the enhanced expression of an enzyme, to the preparation by gene cloning of the plasmids, to bacterial strains containing the plasmids, and to methods for the conditional control of the expression of the enzyme.

The enzyme of interest is DNA polymerase I (Pol I), which is encoded by the structural gene known as polA.  The prior art showed difficulties cloning polA into multicopy plasmids because the increase in expression of DNA polymerase I above the natural level of expression was found to be lethal to a host bacterium.  The claimed inventions overcome that problem by constructing a novel plasmid containing “the entire and undamaged polA gene coding region enzymatically excised from a DNA molecule,” which “contains essentially none of or at the most only a portion of the activity of its natural promoter.”

The patents disclose that severely damaging the natural polA promoter sequence constituted a “significant discovery of the present invention since it eliminates or greatly reduces the unregulated expression of Pol I, which would otherwise be lethal to the cell.”  By cloning the gene for DNA polymerase I into a vector along with a foreign promoter whose activity is conditionally controlled, one can obtain an amplified amount of DNA polymerase I.

The patents in suit share a common specification, and the claims are directed to recombinant plasmids that contain gene coding regions for the expression of DNA polymerase I from any bacterial source.  The accused product at issue in this appeal involves a recombinant plasmid referred to as pLSG5, which causes host cells to express an enzyme known as Thermus aquaticus (Taq) DNA polymerase.

During a claim construction hearing, the court construed the term “DNA polymerase” as requiring 3’-5’ exonuclease activity so Roche filed motions for summary judgment that some claims were invalid for lack of written description.   The district court agreed holding that there was no genuine issue of material fact as to whether the enzyme in the accused product possessed 3’-5’ exonuclease activity.  Because the undisputed evidence indicated that the accused products lacked that element, the court concluded that summary judgment of noninfringement of the ’708 patent was required.

The court also determined that the specification of the ’270 patent made clear that lethality was an essential feature of the invention and thus, the claims of the patent must contain that feature in order to comply with the written description requirement.  Because the claims omit the feature of lethality, the court concluded that those claims of the ’270 patent were invalid.

The court then concluded that while the claims of the ’708 patent claim recombinant plasmids “containing a cloned complete structural gene coding region from [any] bacterial sources for the expression of DNA polymerase I,” the ’638 application only described recombinant plasmids containing the encoding gene region for E. coli DNA polymerase I and thus failed to adequately support the generic claims of the ’708 patent.

Finally, the court determined that there was no genuine issue of material fact with regard to whether the ’745 patent complies with the written description requirement under 35 U.S.C. § 112 and granted Roche’s motion for summary judgment.

For good measure, Roche additionally asserted that the patents were unenforceable based on inequitable conduct, which is how patent trial lawyers say hello to each other in court.  The district court, however, said that Roche failed to present clear and convincing evidence that appellants committed inequitable conduct.

On appeal, Carnegie challenged the district court’s grant of summary judgment of invalidity and noninfringement of the asserted claims.

The written description requirement is as follows:

The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.

Thus, paragraph 1 of § 112 requires a written description of the invention as a requirement separate and distinct from the enablement requirement.  It has long been the case that a patentee “can lawfully claim only what he has invented and described, and if he claims more his patent is void.”  The written description serves a quid pro quo function “in which the public is given ‘meaningful disclosure in exchange for being excluded from practicing the invention for a limited period of time.’

To satisfy the written description requirement, the applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention.

Previously, the Federal Circuit has stated that “[a]n adequate written description of a DNA, such as the cDNA of the recombinant plasmids and microorganisms of the claimed invention, requires a precise definition, such as by structure, formula, chemical name, or physical properties, not a mere wish or plan for obtaining the claimed chemical invention.”  And further  that “[a] description of a genus of cDNAs may be achieved by means of a recitation of a representative number of cDNAs, defined by nucleotide sequence, falling within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus.”

Carnegie argued at the time of the invention, both DNA polymerase I and the polA gene were well known in the art.  Roche argued that the claims of the ’708 patent encompass more than the subject matter described in the specification and thus are invalid.

The Federal Circuit agreed with Roche:

The appealed claims of the ’708 patent are directed to recombinant plasmids that contain a DNA coding sequence that is broadly defined, and only by its function, viz., encoding DNA polymerase I.  Moreover, the generic claims are not limited to a single bacterial species, but broadly encompass coding sequences originating from any bacterial species.  Similarly, the appealed claims of the ’745 patent are broadly directed to recombinant plasmids that contain a DNA coding sequence, again, only defined by function, viz., encoding an enzyme with either DNA polymerase or nick-translation activity.  Those claims are also not limited to a single bacterial species, but cover all bacterial species.

The Guidelines for Examination of Patent Applications under the 35 U.S.C. § 112, ¶ 1, state:

The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species . . . by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.

A “representative number of species” means that the species which are adequately described are representative of the entire genus.  Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.

* * *

Satisfactory disclosure of a “representative number” depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features of the elements possessed by the members of the genus in view of the species disclosed.  For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus.

Driving a proverbial stake through the tiny hearts of Carnegie’s E. coli, the court held:

[A]lthough the written descriptions of the patents emphasize that the recombinant plasmids must be carefully constructed in order to overcome the lethality problem, particularly with regard to the promoter, the patents fail to disclose the nucleotide sequence or other descriptive features for a polA gene (including the promoter sequence) from any bacterial source other than E. coli.

We agree with the district court that the narrow disclosure of the E. coli polA gene is not representative of and fails to adequately support the entire claimed genus under Eli Lilly.  To satisfy the written description requirement in the case of a chemical or biotechnological genus, more than a statement of the genus is normally required.  One must show that one has possession, as described in the application, of sufficient species to show that he or she invented and disclosed the totality of the genus.  In light of the specifications’ disclosure concerning the careful construction of the claimed recombinant plasmids, such that the natural promoter of the polA gene is severely damaged or eliminated, and given the record evidence that the polA gene varied among the numerous bacterial species, as well as the absence of any polA gene sequence for any bacteria other than E. coli, we conclude that that requirement was not met here.

In a nonprecedential decision, the Court of Appeals for the Federal Circuit looked at the issue of whether there is an Article III case or controversy between a patentee drug company and a generic drug company in the context of the Hatch-Waxman Act.  Merck v. Apotex (07-1362).

Merck had sued Apotex for patent infringement when Apotex filed an Abbreviated New Drug Application (“ANDA”) with the FDA for a generic version of FOSAMAX®, which is used to treat and prevent osteoporosis.

Apotex cried patent invalidity and noninfringement.  So, Merck granted Apotex a covenant not to sue for infringement of all patents-in-suit and moved to dismiss all claims and counterclaims on the grounds that the case no longer presented an Article III case or controversy.

Unsatisfied, Apotex tried to amend its counterclaims to add a claim for a violation of the Sherman Antitrust Act, 15 U.S.C. § 2.  The district court said no.

Merck listed ten patents in the FDA’s Orange Book, including US Pat. Nos. 4,621,077; 5,358,941; 5,681,590; 5,849,726; 6,008,207; 6,090,410; 6,194,004; 5,994,329;2 6,015,801; and 6,225,294.  The ’077 patent covers alendronate sodium, the active ingredient.  Six of the listed patents cover various formulations for tablets.  The remaining three are directed to dosing schedules.

Merck’s ’077 patent expired on August 6, 2007.  However, Merck obtained an additional six-month period of regulatory exclusivity from the FDA in exchange for Merck’s submission of certain pediatric studies pursuant to 21 U.S.C. § 355a.  As a result, no generic drug company could obtain FDA approval for alendronate sodium until February 6, 2008.

Merck’s nine remaining Orange-Book-listed patents expire on dates ranging from 2012 to 2018.  Merck also obtained an additional six-month period of regulatory exclusivity beyond the patent terms of each of these remaining patents under 21 U.S.C. § 355a.

When Apotex filed an ANDA with the FDA to obtain approval for a generic version of FOSAMAX®, Apotex filed a Paragraph III certification stating that Apotex would not market its generic drug until six months after the expiration of the ’077 patent.  For Merck’s nine other Orange-Book-listed patents for FOSAMAX®, Apotex filed a Paragraph IV certification stating that the patents were invalid or not infringed by Apotex’s generic drug.  Merck promptly sued Apotex.

In its decision dismissing the case for lack of Article III jurisdiction, the district court found that Apotex’s alleged injury-in-fact—namely, delayed entry into the market— is not fairly traceable to any actions taken by Merck.  Moreover, the district court found that Merck’s grant of a covenant not to sue Apotex eliminated the controversy between the parties.

However, depending on the circumstances, a justiciable Article III controversy may continue to exist between a patentee drug company and a Paragraph IV ANDA filer in the context of the Hatch-Waxman Act even after the patentee drug company has granted the Paragraph IV ANDA filer a covenant not to sue.

In finding no case, the CAFC stated:

This case, however, has been rendered moot by two factual developments that were brought to this court’s attention after oral argument.  First, the FDA decided to treat the thirty-month stay on Apotex’s ANDA as dissolved once the district court dismissed this case.  Second, the first Paragraph IV filer (i.e., Teva) triggered its 180-day exclusivity period under 21 U.S.C. § 355(j)(5)(B)(iv) (2000) by marketing its generic drug on or about February 6, 2008.  As a result, Apotex no longer suffers a delay in entering the market under either the thirty-month stay provision or the 180-day exclusivity provision that is traceable to Merck and redressible by a court judgment

In the end, Apotex’s noninfringement and invalidity counterclaims were just plain moot.

The U.S. Court of Appeals for the Federal Circuit affirmed a district court decision that Apotex and Impax infringed on patents covering AstraZeneca’s heartburn drug Prilosec.  In re Omeprazole Patent Litigation (Astrazeneca v. Apotex Corp., Apotex and Impax; 07-1414, -1416, -1458, -1459).  This ruling comes on the heels of its earlier affirmation of a decision by the U.S. District Court for the Southern District of New York finding that Mylan and Esteve did not infringe on the same patents.

This is part of a consoldation of suits by AstraZeneca against a number of generic drug manufacturers for infringement of Astra’s patents, U.S. Patent No. 4,786,505 and U.S. Patent No. 4,853,230, covering formulations of omeprazole, the active ingredient in Prilosec, a drug designed to treat acid-related gastrointestinal disorders.  The companies were two of several firms to file ANDAs for the drug.

The district court consolidated several of the Prilosec cases and heard arguments in a 42-day bench trial. The court found for AstraZeneca, rejecting the defendants’ arguments for making the effective date of their ANDAs earlier than Oct. 20, 2007. The patents had expired April 20, 2007.

The patents relate to pharmaceutical preparations containing omeprazole, the active ingredient in Prilosec.  Omeprazole is a strong inhibitor of gastric acid secretion, but it is susceptible to degradation in acid-reacting and neutral media.  Its stability is also affected by moisture and organic solvents.

To increase the storage stability of a pharmaceutical dosage, alkaline reacting compounds (ARCs) may be added to the drug core.  The addition of an ARC, however, can compromise the enteric coating.

The inventors of the ’505 and ’230 patents solved that problem by adding an inert subcoating that rapidly disintegrates in water.  The subcoating increases storage stability and provides sufficient gastric acid resistance to prevent omeprazole from degrading in the stomach.  Once the dosage reaches the small intestine, the solubility of the subcoating allows for rapid release of the omeprazole in the drug core.

Impax argued that the district court lost jurisdiction over the case after the patents expired on April 20, 2007.  Impax argued that on that date the case became moot because Astra, having already dismissed its claims for damages, had no remaining claim for any possible relief to which it might be legally entitled.

The district court rejected that argument because the FDA had granted Astra an additional six-month period of market exclusivity after Astra had agreed to the FDA’s request that it perform pediatric testing of its product.  The court held that it had the authority to enforce Astra’s right to market exclusivity under the authority of section 271(e)(4)(A) and under its general equitable authority.

Section 271(e)(2)(A) makes it an act of infringement to file an application under section 505(j) of the Federal Food, Drug, and Cosmetic Act or described in section 505(b)(2) of such Act for a drug claimed in a patent or the use of which is claimed in a patent.

In most circumstances, the effective date in a district court’s order under section 271(e)(4)(A) will be the date of patent expiration, including any patent extensions.  In this case, however, Astra was entitled to an additional six-month period of market exclusivity (pediatric exclusivity) under the Food and Drug Administration Modernization Act of 1997.

The Act authorizes the FDA to make a written request to the holder of an approved new drug application (NDA) for the holder to perform pediatric studies.  If the NDA holder agrees and performs the pediatric studies, the period during which the FDA is barred from approving an ANDA filed by competing drug manufacturers is extended by six months.

The Federal Circuit sided with the district court:

Impax does not dispute that, if the district court had issued its decision before the patents expired, section 271(e)(4)(A) would have authorized the district court to order the effective date of Impax’s ANDA to be October 20, 2007, the date on which Astra’s period of market exclusivity expired.  Impax argues that once the patents expired, section 271(e)(4)(A) no longer provided a remedy because the patents’ expiration rendered the claim of infringement moot.  That argument simply assumes its conclusion; Impax offers no reason to suggest that section 271(e)(4)(A) provides no remedy after patent expiration other than to assert that no remedy is available after patent expiration.

Impax also challenged the district court’s findings with respect to the public-use bar under section 102(b).  Astra filed its applications for the ’505 and ’230 patents on April 20, 1987.  The critical date of the patents is therefore April 20, 1986.  Before that date, Astra commissioned four large clinical studies to determine the safety and efficacy of its formulation in order to obtain FDA approval.

Impax argued that the studies involved the public use of Astra’s claimed formulation.  The district court ruled against Impax on two grounds.  First, the court ruled that the studies constituted experimental uses, and therefore not public uses, of the claimed invention.  Second, the court ruled that the patented formulation was not ready for patenting until after the studies were completed.

The CAFC agreed with Impax that the district court misapplied this circuit’s law with respect to the experimental use exception since experimental use cannot negate a public use when it is shown that the invention was reduced to practice before the experimental use.

However, the CAFC affirmed the district court’s conclusion that the claims were not invalid under section 102(b) based on the court’s factual determination that the claimed formulation was not ready for patenting until after the clinical studies were completed.  That is, the claimed formulation was not reduced to practice before the clinical trials were completed.

In Pfaff, the Supreme Court described two ways for a party to show that an invention was ready for patenting before the critical date of section 102(b): “by proof of reduction to practice before the critical date; or by proof that prior to the critical date the inventor had prepared drawings or other descriptions of the invention that were sufficiently specific to enable a person skilled in the art to practice the invention.”

To demonstrate reduction to practice, a party must prove that the inventor (1) constructed an embodiment or performed a process that met all the limitations and (2) determined that the invention would work for its intended purpose.

Despite Impax arguing that it was known in 1979 that omeprazole could provide a safe and effective treatment, the CAFC shot down that theory:

The Astra scientists had long understood that omeprazole could provide a safe and effective treatment for certain gastrointestinal diseases.  The challenge they faced was developing a formulation to deliver omeprazole to the small intestine, a challenge that was made difficult by omeprazole’s sensitivity to acidic environments, such as the stomach.  Impax has not demonstrated that, without conducting the Phase III clinical tests, the inventors knew that the Phase III formulation would achieve the goals of long-term stability and in vivo stability such that it would be effective as a treatment for gastrointestinal disease.  We therefore find no clear error in the district court’s finding on this issue.

See also: AstraZeneca Suffers Reflux Over Generic Omeprazole

The American Conference Institute’s 10th Advanced Forum on Biotech Patents: Analysis, Insights and Strategies for New Challenges in Biotech Patent Practices will be held at the Royal Sonesta Hotel, Boston, MA, on September 15-16.

At the conference, I will be on a panel discussion with Michele Cimbala, of Sterne, Kessler, Goldstein & Fox,  entitled “Life on the Patent Tightrope: Updates on the Proposed Rules and Patent Reform.”

This looks to be a great conference on all the issues in biotech. The ACI Biotech Patent Conference is billed as the ONE place biotech patent practitioners come to learn and discuss the most recent and vital changes facing the industry today:

As a result of developments in the patent world as a whole, the majority of biotechnology companies and their patent agents and attorneys have been in a holding pattern of sorts for the past year, trying to position themselves and their clients in the best possible situation for whatever blows the industry takes … Keeping on top of all of these changes while still advancing the next stage of products from biotechnology has never been more crucial.

Topics include:

• How will the decision in Tafas v. Dudas impact patent practices and what you can expect in the future?
• KSR, In re Kubin, In re MedImmune, In re Duel and other crucial cases: how these court decisions are being interpreted and applied by the USPTO and the Board of Patent Appeals and Interference
• The status of Follow-On Biologics: the European Patent Office has already taken steps to introduce them into the marketplace.With growing demand for generic products in the US, can the FDA and USPTO be far behind?
• As the USPTO continues to implement international patenting approval programs in conjunction with other nations, how do you implement global patent goals and standards into your patent practice?
• The essential skills needed to develop and prosecute an effective patent while avoiding questions of inequitable conduct, overbroad patents, and more.

Speakers include the venerable Hal Wegner and Patent Docs‘ Kevin Noonan.  Register by calling 888.224.2480 or registering online.

Let me know if you are interested in attending, anyone who attends the conference as a referral from us is entitled to $200 off the registration price. Just drop me a line for the keycode. Otherwise, I look forward to seeing you in Boston.

The Senate Committee on Small Business & Entrepreneurship unanimously passed the SBIR/STTR Reauthorization Act of 2008 (S. 3362) to reauthorize the crucial Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs. The bipartisan bill is the result of months of deliberations among Committee members and includes a pivotal compromise that would allow limited investment in the SBIR program by majority-owned venture capital firms.

According to Senator Kerry, Chairman of the Committee on Small Business and Entrepreneurship, the government-wide program has generated more than 84,000 patents and millions of jobs.  The reauthorized SBIR and STTR programs will pump another $1 billion into our small business economy.

Federal agencies with an annual extramural research and development budget of over $100 million are required to allocate 2.5 percent of their extramural R&D dollars to the SBIR program. Currently, eleven agencies have SBIR programs. Approximately 1 in 4 SBIR projects will result in the sale of new commercial products or processes.

Historically, the SBIR program has provided critical financial support to biotech companies.  Of the 252 FDA-approved biologics, 32% of those companies received at least one SBIR/STTR award.

Specifically, the bill passed out of Committee:

• Reauthorizes the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs for 14 years, making the new sunset dates September 30, 2022, and September 30, 2023, respectively.
• Includes a compromise on the issue of the participation of companies majority owned and controlled by multiple venture capital companies in the SBIR program, allowing NIH to award up to 18 percent of its SBIR dollars to companies majority owned and controlled by multiple VCs and the other ten SBIR agencies to award up to 8 percent of their SBIR dollars to this class of firms. The affiliation rule and the 500 employee standard remain unchanged in this bill.
• Increases the SBIR allocation from 2.5 percent of SBIR agencies’ extramural research and development budgets to 3.5 percent over the course of 10 years, 0.1 percent per year, for all SBIR agencies except for the Department of Health and Human Services, home to the National Institutes of Health.
• Doubles the STTR allocation from 0.3 percent of STTR agencies’ extramural research and development budgets to 0.6 percent, over the course of 6 years, for all STTR agencies.
• Increases the award size guidelines for the SBIR and STTR programs from $100,000 to $150,000 for Phase I and from $750,000 to $1 million for Phase II. This is in line with the recommendation of the National Academy of Sciences.
• Attempts to increase geographic participation, particularly in rural states, by reauthorizing through 2014 and enhancing the Federal and State Technology Partnership (FAST) program and the Rural Outreach Program.
• Calls for better and streamlined data collection and assessment.
• Includes protections to address jumbo awards.

Venture capital companies have been pushing for changes to allow venture-backed companies compete for the money.  The compromise caps the percentages available.  There are provisions requiring each agency to track how many majority venture capital company proposals are received and the amount of venture capital a company has when it receives an award.

See more at the Committee on Small Business & Entrepreneurship

The U.S. Small Business Administration (SBA) is proposing to ratchet up the Small Business Innovation Research (SBIR) Program award threshold amounts to offset the effect of inflation since the amounts were last set in 1992.

Current threshold amounts are $100,000 for Phase I awards and $750,000 for Phase II awards. The SBA can adjust the award amounts once every 5 years and is proposing to increase the award amounts to $150,000 and $1,000,000, respectively.

Why does the government want to give away money?

The purpose of the SBIR program is to stimulate innovation in the economy through federally-funded research and development (R/R&D).

Eleven federal departments participate in the SBIR program; five departments participate in the Small Business Technology Transfer (STTR) program awarding $2 billion to small high-tech businesses.

According to the Federal Register, you can submit comments on the proposal here:

1. On-line at: Federal Rulemaking Portal;
2. Mail: Office of Technology, 409 Third Street, SW., Washington, DC 20416; or
3. Hand Delivery/Courier: Edsel Brown, Assistant Director, Office of Technology, 409 Third Street, SW., Washington, DC 20416.

Comments must be received on or before September 15, 2008

Wanna play double or nothing?

In what is probably the most clever use of state funds, Kentucky is now the only state in the nation with a start-to-finish matching funds program for high-tech small businesses that receive federal SBIR and STTR awards.

Kentucky-based SBIR and STTR grant recipients can apply for matching funds of up to $100,000 to support Phase 1 exploration of the technical merit or feasibility of an idea or technology. Phase 2 federal awards, which support full-scale research and development, would be matched by the commonwealth up to $500,000 in each year of the award. Phase 0 and Phase 00 funds are available to assist with preparing proposals for Phase 1 and Phase 2 grants, respectively.

Guidelines for the Kentucky program are posted at ThinkKentucky.

SBIR FAQs

Do you have to be a Phase I awardee in order to be considered for Phase II of a project?

Yes.

What is the small business size standard for purposes of the SBIR Program?

A small business concern is one which, including its affiliates, has a number of employees not exceeding 500.

Can a firm go directly to a Phase II award without having to compete for Phase I?

No.

Is a small US firm still eligible to compete for an SBIR award if it forms a 50-50 joint venture with a nonprofit or foreign firm?

No.

Are foreign-based firms eligible for SBIR awards?

To be eligible, a small business concern has to be independently owned and operated principal place of business is located in the US at least 51 percent owned by US citizens or lawfully admitted permanent resident aliens.

Are nonprofit concerns eligible for SBIR awards?

No.

May a portion of an SBIR award be subcontracted?

For Phase I, a minimum of two thirds of the research and/or analytical effort must be performed by the proposing firm, and for Phase II, a minimum of one-half of the research and/or analytical effort must be performed by the proposing firm.

Will innovations that have been patented or have patents pending be considered under SBIR?

No.

Are data rights protected and for what length of time?

Data rights are protected by agencies for a period of not less than 4 years from delivery of the last deliverable.

Gene Quinn, Jr., the force behind the Patent Briefs at the Practicing Law Institute, has struck out in a new venture.  Gene has now brought us a new patent blog, PatentFools.com.  PatentFools is described thusly:

The point of PatentFools is to try and identify wrongs, articulate positions, influence decision-makers and have some fun saving the world for generations to come. Essentially, we are fighting for truth, justice and the American way, not unlike Superman… well… very much unlike Superman if you are concerning yourself with the faster than a speeding bullet, more powerful than a locomotive and the ability to leap tall buildings with a single bound. We are, however, not affected by kryptonite, so at least we have that going for us, which is nice!

Why go for yet another patent discussion venue?  Well, according to Gene, while he will continue to write for PLI, there are some limitations on what he can write given the need for PLI, as a nonprofit, to keep its tax exempt status.

As an example of what to expect, Gene calls for the USPTO to withdraw its appeal of the permanent injunction enacted by a district court prohibiting the USPTO from putting the new rule changes into effect (Tafas v. Dudas).

The Court of Appeals for the Federal Circuit lowered any expectations the Patent Office and the Department of Justice had about getting the permanent injunction of the proposed claims and continuations rules overturned.

In Cooper v. Dudas, the Federal Circuit was asked to decide whether the the Patent Office had the authority to interpret the term “original application,” a term used in a section of the American Inventors Protection Act with respect to new provisions on filing for an inter partes reexamination of an issued patent.

The Federal Circuit reviewed the authority the Patent Office has to implement substantive changes to the law regarding patent applications:

We have also previously held that 35 U.S.C. § 2(b)(2) does not authorize the Patent Office to issue “substantive” rules. See Merck & Co. v. Kessler, 80 F.3d 1543, 1549-50 (Fed. Cir. 1996). “A rule is ‘substantive’ when it ‘effects a change in existing law or policy’ which ‘affect[s] individual rights and obligations.’” Animal Legal Def. Fund, 932 F.2d at 927 (quoting Cubanski v. Heckler, 781 F.2d 1421, 1426 (9th Cir.1986), vacated as moot sub nom., Bowen v. Kizer, 485 U.S. 386 (1988)). “In contrast, a rule which merely clarifies or explains existing law or regulations is ‘interpretative.’” Id.

Expressing the view that the USPTO stands virtually no chance that the Federal Circuit will overrule the permanent injunction stopping the implementation of the claims and continuations rules, Gene implores the Office to relent:

In fact, the Federal Circuit is not likely to even hear oral arguments in the GSK matter until late Fall 2008, which is after the next election.  Even if the Federal Circuit does hear the case late Fall 2008, no decision will be forthcoming until late Winter 2009 at the earliest, which means that by the time the Federal Circuit can agree with Judge Cacheris there will be a new President, a new Director of the Patent Office and a new Attorney General.  So why continue with a losing appeal?

Any fool could see the result.

See more here:  Tafas v. Dudas: The Continuation Wars

Bloggers May Need to Yield Equal Time

FCC Commissioner Robert McDowell (R) recently warned bloggers that the Commission’s decision to smack down Comcast  for hobbling Bit Torrent could lead the government to start “dictating content policy” by requiring blogs to give equal time to opposing views under the Fairness Doctrine.  We’re not sure if criticizing the U.S. Patent Office practices would count as political speech but, if so, Greg Aharonian will have a lot of catching up to do.

Genentech Wants Bigger Dowry

Playing coy, Genentech rebuffed an offer from Swiss pharma Roche to buy the remaining shares in the firm it does not already own for $43.7 billion.  Roche, which has been the majority owner of Genentech since 1990 and owns 55.9% of shares, offered $89 per share for the outstanding stock in July.  Roche Holding AG is expected to increase its offer for the rest of Genentech by 21 percent to $53 billion.

Mass.  Enacts Pharma/Device Code of Conduct

Massachusetts enacted Senate Bill 2863, which requires the Massachusetts Department of Public Health to establish a pharmaceutical and medical device marketing code of conduct, and imposes compliance and reporting requirements on pharmaceutical and medical device companies that employ a person to sell or market prescription drugs or medical devices in Massachusetts. (via FDA Law Blog)

It’s Dress-Down Day Everyday

Condé Nast Portfolio noted that there are fewer distinctions between industries and power levels when it comes to apparel as “pretty much everyone looks more like they belong in tech support than in a partners’ meeting.”  Why?  “In a world where profits are down, bankruptcies are rampant, and the most entrenched I-bankers are getting the heave-ho, you can’t afford to look as though you spared an extra second thinking about the cut of your Charvet shirt.”

Patent Office Wants More Money

USPTO announced a 5 percent inflation adjustment in its patent user fees, reflecting the increase in the Consumer Price Index for 12 months.  Fees will increase effective October 2, 2008.  The increase proposed for public comment in June was 4 percent, but recent CPI data apparently looked better with a 5 percent increase.

New Tricks For Your iPhone

iSmashPhone has 12 iPhone Tricks You Might Not Have Known like how to scroll to the top of a page in any application (by tapping on the “top bar”)  and how to type alternate characters (hold a letter for a pop-up of various versions of the character).  Now updated with 8 More iPhone Tricks You Might Not Know.

Doping For Gold

In the Olympic spirit, Wired presents 10 next-generation doping methods.  The next headaches for the World Anti-Doping Agency include popping hypoxia-inducible factor (HIF) to stimulate red blood cell production without EPO and manipulating genes to block naturally occurring muscle-growth inhibitors —  blocking the protein myostatin gave the mice up to 60 percent more lean muscle mass. Even more promising, Johns Hopkins’ Se-Jin Lee recently found that overproduction of one myostatin inhibitor pumps the mice up even more: up to 81 percent in females and 116 percent in males. Results of human clinical trials are pending so you might want to hold off on self-exerimentation.