2012

Patent Law Treaties Implementation Act of 2012

December 5, 2012PatentDennis Crouch

By Dennis Crouch

It appears that the Patent Law Treaties Implementation Act of 2012 will soon become law. The U.S. Senate passed the bill earlier this year (S. 3486) by a unanimous vote and this morning the House passed the identical version in a voice vote. President Obama is expected to sign the bill into law within the next two weeks.

The Bill provides the domestic legislation required to implement both: (1) The Hague Agreement Concerning International Registration of Industrial Designs ("Hague Agreement") and (2) The Patent Law Treaty ("PLT"). Both treaties were ratified by the Senate in 2007.

In discussing the pending bill last week, I wrote that the USPTO has lobbied for passage of this bill and provided the original draft legislation.

On the industrial design front, substantive elements of the changed law include (1) an extension of the design patent term by an additional year with the resulting term being fifteen years from issuance; (2) allowing applicants to include up to 100 different design inventions within a single international design application; and (3) creation of provisional rights as of the publication date of the international application. About 45 countries, including virtually all of Europe have signed-on to the Hague Agreement (Geneva Act).

A major change with regard to the patent law treaty is that the law would now allow for revival of unintentionally abandoned international applications.

Rader: Reviving the Doctrine of Equivalents

December 5, 2012PatentClaim ConstructionDennis Crouch

By Dennis Crouch

John Deere v. Bush Hog (Fed. Cir. 2012)

When I was a kid, we had a “John Deere Bush Hog” for mowing pasture land (AKA “bush hogging”). Several years later I learned that we really had a John Deere brand rotary cutter. The Bush Hog company also sells its own brand of rotary cutter. In this case, Deere sued Bush Hog for infringing its U.S. Patent No. 6,052,980. That patent claims a deck for a rotary cutter that is more easily cleanable.

One claim limitation required that an upper deck wall be sloped “rearwardly from said central portion into engagement with, and being secured to, said lower deck wall.” Apparently in the accused Bush Hog device, the upper deck wall does not directly contact the lower deck wall. As per usual, that infringement issue was posed as a claim construction question determined by the judge as a matter of law. Here, the district court judge ruled that the “into engagement with” limitation required direct contact and that there could therefore be no literal infringement of the claim. When pressed on the doctrine of equivalents, the district court revived the vitiation exception to the DOE and ruled that the claims could not be extend to cover no direct contact when they claim the exact opposite of direct contact.

On appeal, the Federal Circuit doubly rejected the district court opinion.

On claim construction, the court ruled that “engagement” between two metal sheets does not require direct contact, but may instead be facilitated through indirect contact. The court demonstrated this conclusion with reference to a drawing from the Deere patent where a filler plate (shown in blue) provides the engagement between the upper deck (yellow) and the lower deck (red).

On Vitiation of the Doctrine of Equivalents: Although dicta, Judge Rader continued his opinion a repudiation of the district court’s mistreatment of the vitiation doctrine. Of course, the doctrine is regularly mistreated because it is lacking in logical sense. The doctrine of equivalents allows a patentee to capture some amount of scope that goes beyond the literal scope of the claims as written. As a matter of course, this always involves rejecting the literal bounds created by one or more claim limitation. However, the doctrine of vitiation rises to stop a patentee from applying the DOE in a way that negates the meaning of one or more claim term. In his opinion, Chief Judge Rader attempts to cut through this knot and cautions against the programmatic use of the vitiation doctrine:

Courts should be cautious not to shortcut this inquiry by identifying a “binary” choice in which an element is either present or “not present.” Stated otherwise, the vitiation test cannot be satisfied by simply noting that an element is missing from the claimed structure or process because the doctrine of equivalents, by definition, recognizes that an element is missing that must be supplied by the equivalent substitute. If mere observation of a missing element could satisfy the vitiation requirement, this “exception” would swallow the rule. . . . [P]reserving the doctrine in its proper narrowed context requires a court to examine the fundamental question of whether there is a genuine factual issue that the accused device, while literally omitting a claim element, nonetheless incorporates an equivalent structure.

Chief Judge Rader goes on to explain how the suggested use of the DOE in this case likely does not vitiate the relevant claim terms.

In this case, the district court construed “contact” to require “direct contact,” and thus found that allowing “no direct contact” would vitiate the court’s construction. Yet, a reasonable jury could find that a small spacer connecting the upper and lower deck walls represents an insubstantial difference from direct contact. See TurboCare Div. of Demag Delaval Turbomachinery Corp. v. Gen. Elec. Co., 264 F.3d 1111, 1124 (Fed. Cir. 2001) (construing claim term “contact” to require “touching” but remanding question of whether “indirect contact” could be equivalent). Thus, the trial court erred by invoking the vitiation

Rader’s basic idea here an attempt to move away from the technical limitations that have pushed the DOE toward obscurity over the past several years. In his view, vitiation should not be seen as a technical doctrine but instead simply a tool for district courts to use when the claim language is so far from the asserted equivalent that no reasonable jury would find infringement.

On remand, the new claim construction breathes new life into Deere’s infringement case.

Solicitor General to the Supreme Court: Deny Cert. in Retractable Technologies

December 5, 2012PatentAIA Trials, Claim Construction, Federal Circuit En Banc, PGR, Supreme Court, Written DescriptionDennis Crouch

Guest Post by Andrew Dhuey

The U.S. Solicitor General has recommended that the Supreme Court deny certiorari in Retractable Technologies, Inc. v. Becton, Dickinson and Co. The key issues in Retractable concern i) the role of the specification in interpreting patent claim language and ii) the level of deference, if any, the Federal Circuit should give to trial court claim constructions. The SG's recommendation is a setback for those who hope the Court will address these two fundamental questions of patent law and procedure. In recent years, the Court has followed about 80% of the SG's recommendations that certiorari be denied. See, e.g., p. 276 of this 2009 George Mason Law Review article.

A Supreme Court decision in Retractable could fundamentally alter the way trial courts construe patent claims and how the Federal Circuit reviews claim constructions. If the Court decides to review the case, it might limit or overrule the Federal Circuit's en banc decisions in both Phillips v. AWH Corp. and Cybor Corp. v. FAS Techs., Inc. Or the Court might deny review and leave the status quo intact.

Pertinent Facts and Procedural History

Retractable Technologies, Inc. ("RTI") and Becton, Dickinson ("BD") manufacture retractable medical syringes that are designed to reduce the risk of needlestick injuries and infections to health care workers. RTI accuses BD of infringing U.S. Patents 5,632,733 and 7,351,224. The disputed issue of greatest precedential importance concerns the meaning of the claim term "body" as it is used in both patents to describe the structure of RTI's claimed retractable syringe. BD's accused syringe has a two-piece body, so the question of literal infringement hinges largely on whether "body" is limited to a one-piece structure.

Judge David Folsom (E.D. Tex.) sided with RTI on the construction of "body" as not being limited to a single-piece structure. Judge Folsom gave the construction short treatment in his claim construction order, adopting the reasoning and conclusion of his fellow Eastern District of Texas jurist, Leonard Davis, who construed the same term in related patents in earlier litigation RTI brought against New Medical Technologies.

In the earlier case, Judge Davis observed that the specifications of the patents-in-suit did suggest a one-piece structure limitation. Still, he opined, the claims themselves pointed in the opposite direction:

In sum, the Court finds that "body" . . . simply means "hollow outer structure that houses the syringe's components." . . . The only construction of "body" that is consistent with the . . . claim language is a structure that may be one or more pieces. This reading is consistent with the specification, despite some indications to the contrary.

A divided Federal Circuit panel reversed based on the district court's claim construction of "body". Circuit Judge Alan Lourie wrote the Court's opinion, joined by Senior Circuit Judge S. Jay Plager. The majority "agree[d] with BD that the claimed 'body' is limited to a one-piece structure in light of the specifications." Chief Judge Randall Rader dissented: "Because the language of the claims make clear that 'body' does not contain [a one-piece structural] limitation, and it is improper to import limitations from the specification into the claims, I respectfully dissent."

Judge Plager wrote a short concurrence to underscore the majority's position that claims must not be interpreted in ways that go beyond what the inventor disclosed:

However much desired by the claim drafters, who want claims that serve as business weapons and litigation threats … the claims cannot go beyond the actual invention that entitles the inventor to a patent. For that we look to the written description.

RTI petitioned for rehearing en banc, which the Court denied. Circuit Judge Kimberly Moore, joined by Chief Judge Rader, dissented from the denial of the petition. Judge Moore opined that the panel majority "attempt[ed] to rewrite the claims to better conform to what it discerns is the 'invention' of the patent instead of construing the language of the claim." This ran afoul of proper claim construction under Phillips, she contended, and it has happened with such frequency to warrant en banc review.

Judge Moore also suggested that the Court should reconsider Cybor en banc.

We have waited five years (since Amgen Inc. v. Hoechst Marion Roussel, Inc., 469 F.3d 1039 (Fed. Cir. 2006), where six judges claimed a willingness to review Cybor) for that ever-elusive perfect vehicle to review the issue of deference to the district court's claim construction. The Supreme Court held that claim construction was a "mongrel practice." Markman v. Westview Instruments, Inc., 517 U.S. 370, 378 (1996). As such it is clearly a mixed question of law and fact and deference should be given to the factual parts.

Circuit Judge Kathleen O'Malley also dissented from the denial of RTI's petition, but her concern was limited to the de novo standard of review mandated by Cybor.

The SG's Denial Recommendation

In response to RTI's petition for a writ of certiorari, the Supreme Court solicited the SG's views on whether to review the case. The SG recommended a denial of the petition, opining that "[n]either of the questions set forth in the petition for a writ of certiorari warrants review in this case."

On the first question concerning the role of the specification in interpreting patent claim language, the SG contends that there is general doctrinal agreement among Federal Circuit judges:

There is broad agreement among the judges on the Federal Circuit about the principles of law that govern that inquiry, and the Federal Circuit's claim-construction jurisprudence is fully consistent with this Court's precedents. Although different judges sometimes disagree about the proper interpretation of particular claim terms, that is simply the inevitable result of case-by-case adjudication, not a reason for this Court's intervention.

Regarding the second question about the standard of appellate review for claim constructions, the SG agreed that the issue might warrant review in a future case, but not this one:

In an appropriate case, this Court's intervention might be warranted to determine the appropriate standard of review when a district court makes subsidiary factual findings in the course of construing a disputed patent claim. The district court in this case, however, did not make any factual findings about the meaning of the term "body," the state of the relevant art, or any other matter…. Nor did the court consider any expert testimony, make any credibility determinations, or receive any documentary evidence. Rather, the district court's hearing consisted entirely of the oral argument of counsel regarding the claim language, the specification, and pertinent legal authorities…. Because the district court's claim-construction ruling did not depend on the resolution of any questions of fact, this case does not present the question whether a claim-construction ruling that is predicated on factual determinations should nevertheless be subject entirely to de novo appellate review.

RTI may now file a brief responding to the SG's recommendation. The Court will likely decide whether to grant or deny RTI's petition in one of its January conferences.

Andrew Dhuey is an appellate lawyer in Berkeley, California.

December 4, 2012PatentobviousnessDennis Crouch

I can now say with almost complete confidence that the USPTO will grant over 250,000 utility patents in calendar year 2012. This will obviously be a record. The prior record was set in 2011 with just under 225,000 utility patents.

Patent Exhaustion for GM Seeds

December 4, 2012PatentDennis Crouch

By Dennis Crouch

Bowman v. Monsanto (SCOTUS 2012) Download 11-796 ts

The farmer Vernon Bowman has filed his opening merits brief explaining his exhaustion defense against Monsanto's patent infringement charges. The case involves Monsanto's patented soybeans that have been genetically modified to be resistant to the broadleaf herbicide glyphosate, i.e., RoundUp Ready. U.S. Patent Nos. 5,352,605 and RE 39,247.

According to the statement of facts, Bowman purchased genetically modified soybeans on the commodity markets from a third party vender. It is assumed for the case that those seeds were grown and sold by farmers pursuant to a contract with Monsanto. As such, under traditional patent exhaustion principles, Monsanto's patents conferred no more control over the use, destruction, or distribution of those soybeans. This would have allowed Bowman to use the soybeans as feed or for biodiesel. However, Bowman chose to use the soybeans as seeds to grow a second generation of soybeans. Because soybeans self-fertilize, beans from the second and subsequent generations are genetically identical to the first generation and thus fit within the scope of Monsanto's patents. Although perhaps irrelevant to this case, Bowman admittedly purchased the commodity seeds with the hope that they were glyphosate resistant and then relied upon glyphosate resistance in the growing process. At the same time, he took pains to ensure that he was not violating any contract with Monsanto or pushing the grain dealer to violate such a contract.

Monsanto sued Bowman for patent infringement and won.

Exhaustion: Both the district court and the Court of Appeals for the Federal Circuit held that the exhaustion doctrine does not apply to new copies of a patented product created by the accused infringer. Monsanto sees its seed patents as akin to a book covered by copyright. When the publisher sells copies of the book, the copyright in those copies is exhausted — allowing the purchaser to resell or distribute the copies without reprisal. However, there is a major limitation to the exhaustion doctrine — copyright still protects against using the legitimate copy to make further unauthorized copies. For Monsanto, the fact that the patent is exhausted vis-à-vis a first generation of seeds says nothing about whether the patent is exhausted for the second or subsequent generation. Unlike the copyright laws, the patent law of exhaustion has not been codified, but the two doctrines are largely in step. The Supreme Court is currently considering a copyright exhaustion case, Kirtsaeng v. John Wiley & Sons, Inc. However, the outcome of that case is unlikely to impact Bowman's.

Monsanto also relies upon a property-law defense that limitations-on-use placed on the sale of patented goods operate as conditions that also bind subsequent purchasers. Here the original farmers were bound by contract not to replant the soybeans. Following the rule of derivative title, Monsanto argued (and the lower courts agreed) that "farmers could not convey to the grain dealers what they did not possess themselves." And further, that the grain dealers could only transfer to Bowman as much right as they possessed — that right being ownership of the soybeans without the right to use them as seed.

Pathway to Victory: Bowman's pathway to a Supreme Court victory seems to rest on two necessary holdings: (1) that the patent rights were fully exhausted in the seeds Bowman purchased and (2) that the exhaustion applies to subsequent generations of seeds. In my view, the first principle is will be easier to accomplish. The second is more difficult.

In Quanta Computer, Inc. v. LG Electronics, Inc., 553 U.S. 617 (2008), the Supreme Court confirmed that "[t]he longstanding doctrine of patent exhaustion provides that the initial authorized sale of a patented item terminates all patent rights to that item." The correct view is here is that a condition on use does not bind subsequent purchasers of personalty unless those buyers agree by contract to be so bound. This is the ordinary rule that courts follow involving personal property and I see no reason to change that rule based upon the fact that the personal property happens to be covered by a patent.

Subsequent Copies: The fact that a patented product is the subject of a legitimate sale that exhausts the patent rights does not give the purchaser the right to use that original as the source for generating subsequent copies. Rather, the creation of those additional copies will be deemed counterfeit and infringing. Bowman does not challenge these basic principles. Rather, Bowman argues that soybeans are different because they are self-replicating seeds. Bowman writes:

If patent rights in seeds sold in an authorized sale are exhausted, patent rights in seeds grown by lawful planting must be exhausted as well. Due to the self-replicating nature of the invention, subsequent generations of seeds are embodied in previous generations . . . because seeds will self-replicate by normal use.

The farmers that I know largely side with Bowman on the issues, but they would quarrel with the idea of self-replication. In fact, farmers do an incredible about of work to grow a commercially viable crop. At a minimum for a good crop, the seeds need to be planted in sufficiently fertilized soil, watered (hopefully by rain), weeded (perhaps with glyphosate), and harvested. The timing must be right to ensure sufficient light and heat, and the fields must be protected from invading wildlife. In this sense, Bowman's statement that "Roundup Ready® seeds have been engineered to include everything one needs to practice the invention" is disingenuous. In any event, it takes much more outside input to grow a second generation of soybeans than it does to distribute electronic copies of my copyrighted writings or deliver electronic copies of non-patent prior art to the USPTO. In fact, we teach in law school that the ease of replication is an important factor in understanding the role of intellectual property rights. In an e-mail, David Snively, executive vice president and general counsel for Monsanto agrees with this point, writing that the "patent system protects – and should protect – the rights to easily replicated technologies like herbicide-tolerant seeds, just as it does for those who invent computers or life-saving medicines."

Perhaps the self-replication difference is not about energy input, but more about the nature of the product (a living organism in the form of a seed) and the fact that living organisms reproduce as part of their natural life cycle. Monsanto added an important element to its soybeans (glyphosate resistance), but Monsanto started with an incredible life form with the ability to reproduce in our natural world. Monsanto did not change or enhance any of those reproductive abilities and its attempt to control reproduction is could be seen as akin to the improper tying arguments. The fact that Monsanto made a big claim (the seed itself) doesn't change the fact that its contribution is far less than 1% of the genetic material important for a soybean's life cycle.

Finally, the hook on the argument may be that self-replication is the "normal use" of a product. This market expectation is important and could win the day. In the brief, Bowman takes pains to establish that replanting is an important normal use of commodity seeds. It is unclear to me whether the court will buy this factual argument and would be an important gap that could be filled by an amicus filing.

Growing not Making: Bowman also suggests an interesting additional argument – that growing the seeds does not constitute "making" seeds under 35 U.S.C. § 271(a). Bowman writes:

The seeds at issue here will self-replicate or "sprout" unless stored in a controlled manner to prevent this natural occurrence. Humans can (and most often do) assist in the process of self-replication. For instance, Bowman planted Roundup Ready® seeds and treated them with glyphosate. This activity led in part to the creation of new soybeans having the patented Roundup Ready® trait. But it was the planted soybean, not Bowman, that "physically connected" all elements of the claimed invention into an "operable whole."

Referencing and quoting Deepsouth Packing Co. v. Laitram Corp., 406 U.S. 518 (1972). While important, this argument seemingly would not offer a complete win for Bowman because he may also be liable for using or selling the second generation.

One interesting rhetorical element of Bowman's brief is the way that it claims the middle ground by arguing that the court "should not create an exception to the traditional exhaustion doctrine for self-replicating technologies." (Bold in original). The starting point depends upon your perspective and I suspect that Monsanto will have a similar statement arguing that Bowman is asking for the exception.

Monsanto's brief of the merits is due January 16, 2013. Oral arguments and a decision will follow.

H.R. 6621: Proposed Modifications to the America Invents Act of 2011

December 3, 2012PatentAIA Trials, IPR, PGR, Trade SecretsDennis Crouch

On November 30, Rep. Lamar Smith introduced H.R. 6621, a Bill titled "To correct and improve certain provisions of the Leahy-Smith America Invents Act and title 35, United States Code". Because of its late introduction, the Bill would need to be passed and enacted before the new Congressional session begins in early January. The most likely outcome is that no action will be taken and the Bill will be reintroduced in 2013. A second viable alternative is that the language of the Bill will be included as part of a massive fiscal cliff resolution Bill. The Bill includes a number of interesting elements. In that case, there would be virtually no official debate on the Bill or its contents.

Killing pre-GATT applications: There are currently around 200 applications pending that were filed prior to the 1995 patent term changeover. Once issued, those applications will have a patent term of 17 years from the issuance date. If issued as patents, these applications will likely be disruptive to settled interests in various industries. H.R. 6621 would alter the rules for calculating patent term for any application still pending 1-year from the Bill's implementation date. For those applications, the patent term would be 20 years from filing — meaning that those patents will likely be expired. Because of their pre-URAA filing date, those applications would not be eligible for patent term adjustment. At this point, I am unsure how the change would impact applications whose issuance was delayed due to a US Government secrecy order. On 2012, the USPTO has issued 24 applications with pre-URAA filing dates. Of those, five were delayed due to secrecy orders. One example is Patent No US8,278,099 is interesting in that it claims a monoclonal antibody to human thrombopoietin and is owned by Genentech. Prosecution of that application was delayed for 10 years pending the outcome of an interference in a related case. The application makes clear that the claimed antibody could be either isolated from a human or else prepared by recombinant or synthetic methods. This breadth brings the claimed antibody within the ambit of the Myriad gene patent challenge. If isolated human genes are not patentable what about isolated human antibodies? But I digress.

Post-Grant Dead Zone: Once the AIA is fully implemented, an issued patent will be immediately challengeable through a post-grant review. Then, after a nine-month window, challenges will be available through inter partes review. However, the AIA has bit of an implementation issued because (1) post-grant reviews will only be available for patents issued on applications filed on or after March 16, 2013; (2) inter partes reviews are available for all patents, but only those that have been issued for at least 9-months; and (3) the old inter partes reexaminations are no longer available. This creates something of a dead zone in that for the next couple of years patents will not be challengeable through some inter partes system for the first 9-months. H.R. 6621 would eliminate that 9-month dead zone by allowing inter partes reviews to be filed at any time for applications with an effective filing date before March 16, 2013.

Delaying Inventor's Oath: Section 115(f) of the AIA indicates that an either an oath, substitute statement, or sufficient assignment must be submitted prior to the notice of allowance of a patent application. The amendment would push that deadline back to be "no later than the date on which the issue fee for the patent is paid."

Less Patent Term Adjustment: The current language of Section 154(b) suggests an applicant may begin accumulating PTA as of the filing date of an international PCT application that is later followed by a US national stage application. The proposed amendment would eliminate that option by clarifying that the PTA calculations only begin "commencement of the national stage under section 371 in an international application." The change also provides that the PTO calculate PTA with the issuance rather than at the notice of allowance. The amendment would also clarify that PTA challenges may only be filed in the Eastern District of Virginia.

US as International PCT Office: H.R. 6621 would eliminate 35 U.S.C. 373. That section currently limits who may file international PCT applications at the USPTO. Under current rules, at least one of the inventors or the assignee must be a resident or national of the United States of America.

Sharing Fees Between the Patent and Trademark Side: The AIA requires that, for the most part, fees collected on patents be used to cover "administrative costs of the Office relating to patents" while fees collected on the trademark side be used to cover "administrative costs of the Office relating to trademarks." H.R. 6621 would eliminate that restriction and thus allow patent fees to pay for trademark operations and vice versa.

Derivation Proceedings: The AIA eliminated the ongoing viability of interference proceedings (although some will be pending for years) but created a new beast known as a derivation proceeding. H.R. 6621 would clean up the language for initiated a derivation proceeding under 35 U.S.C. §135(a). I need to think some about the language to understand the substance. I have created a rough mark-up of this language. (/media/docs/2012/12/CompareNewOldDerivation.docx).

Noticeably absent from this bill are changes to clarify the new section 102 or to modify the estoppel provisions of post-grant oppositions. Still pending is the Patent Law Treaties Implementation Act of 2012 and the Saving High-Tech Innovators from Egregious Legal Disputes Act of 2012. In my estimation, the first still has a good chance of passing this term while the second does not.

Myriad at SCOTUS: Early Reaction

December 3, 2012PatentAIA Trials, PGRDennis Crouch

Eileen Kane: "There is a fair chance that the Court could side with the 2010 district court opinion, which found that the "claimed isolated DNA is not markedly different from native DNA as it exists in nature."
Kevin Noonan: "The decision [granting cert] is unsurprising in view of the (relative) specificity of the question presented and the overwhelmingly one-sided nature of the amicus briefing."
Rob Harrison: "It was a bit of a roller coaster day for US biotech Myriad Genetics as it share price plunged 9% on news that the US Supreme Court would be reviewing it '782 patent directed towards the BRACA1 and BRCA2 genes."
Julie Samuels: Myriad's Dangerous Patents and their Negative Impact on Women's Health
John Conley and Dan Vorhaus: "[A]ll we know for certain is that four justices (the minimum number needed to grant certiorari in any case) have something that they want to say about the matter."

Patents Encompassing a Human Organism

December 2, 2012PatentClaim Construction, Licenses, obviousness, USPTO DirectorDennis Crouch

by Dennis Crouch

Ex Parte Kamrava (PTAB 2012), APN 10/080,177 Download 10080177

Most Section 101 subject matter eligibility problems can be cured by integrating the ineligible subject matter with subject matter that is patent eligible. This works because the fact that an invention encompassing some ineligible material does not preclude patentability – as long as the invention also includes sufficient eligible subject matter. Following this theory, the Supreme Court in Diamond v. Diehr, 450 U.S. 175 (1981), agreed that a practical use of a mathematical formula was patentable even though the formula on its own would not have been subject matter eligible.

One exception to the cured-by-integration rule involves the patenting of human organisms. Generally speaking, a patent clam cannot encompasses a human organism and likewise, a claim encompassing an otherwise unpatentable human organism will not become patentable by integrating elements that are subject matter eligible. Following this rule, applicants typically carve-out offending portions of their claims. Thus, recently issued U.S. Patent No. 8,283,517 claims a "transgenic non-human animal" with certain genetic properties that result in alzheimer's-like brain plaques. Likewise, U.S. Patent No. 8,247,644 claims a "method for manufacturing a non-human animal" that is likely to develop a pulmonary tumor. The PTO sees these as subject matter eligible because they have disclaimed any coverage for human animals.

In Kamrava, the patent is generally directed toward a uterine catheter that can be used to deposit a fertilized embryo. Some of the claims also include the embryo as an element of the claim itself with "the catheter … further comprising an embryo in the distal portion." In its November 26, 2012 decision, the Patent Trials and Appeals Board (PTAB) concluded that those claims could not be patentable.

Focusing first on Section 101, the board noted that an embryo is subject matter ineligible because it is a part of the human body. Further, the combination of the ineligible subject matter with the eligible subject matter catheter offers no cure. "To allow one to sidestep 35 U.S.C. §101 by simply pairing in combination patent-ineligible subject matter with patent-eligible subject matter would impermissibly exalt claim strategy (form) over claimed subject matter (substance)." As a second ground of rejection, the Board raised the new Section 33(a) of the Leahy-Smith America Invents Act. That section prohibits the patenting of "a claim directed to or encompassing a human organism."

The PTAB's form-over-substance statement loses significant weight because, in the same paragraph, the Board note that the claims may become eligible by a simple amendment. As the Board notes, on remand to the examiner, applicant can rather easily cure the defect by claiming a catheter "adapted to hold the embryo" rather than claiming a catheter that includes the embryo. The U.S. does grant patents on non-human organisms, such as a genetically modified mouse, soybean, or bacterium. Canada denies patentability on multi-cellular organisms.

The issues presented here have obvious potential ties to the Myriad gene patent case. However, while most practitioners would agree with the idea that human organisms should not be patentable, the bar is much more divided on the question of the patentability of chemical compounds isolated from a human body, and almost all practitioners agree that methods of treating diseases in humans should be patentable. This case is likely most helpful for those supporting Myriad because it indicates that congress and the PTO have both considered the issue and have drawn a line that prohibits certain patents too closely tied to the core of humanity but allows for the patenting of genes.

The language of Section 33(a) was initially pushed by Representative Dave Weldon as a measure to support the sanctity of life. Although Weldon was out of Congress by the time the AIA passed, he spoke on the issue several times. Most poignantly, Weldon spoke on the issues in 2003 after receiving some initial criticism for his proposal.

[S]ome have continued to misrepresent my amendment by claiming it would also prohibit patent claims directed to methods to produce human organisms. Moreover, some incorrectly claim that my amendment would prohibit patents on claims directed to subject matter other than human organisms. This is simply untrue.

What I want to point out is that the U.S. Patent Office has already issued patents on genes, stem cells, animals with human genes, and a host of non-biologic products used by humans, but it has not issued patents on claims directed to human organisms, including human embryos and fetuses. My amendment would not affect the former, but would simply affirm the latter.

At the time, PTO Director James Rogan also submitted a letter to Congress indicating that the language was already "fully consistent with [current PTO] policy." (Note, parallel language has been regularly included in PTO appropriations bills that prohibit the PTO from spending money on issuing patents directed-to or encompassing human organisms.)

These issues will be interesting as we move forward with the gene patent debate. However, the history of patentability limitations suggest that, unless the Supreme Court takes a radical step in its decision, skilled patent attorneys will continue to be able to protect innovations through the patent system.

There is unlikely to be any successful appeal of this case to the Federal Circuit. Importantly, the applicant had not challenged the notion that an embryo is a human organism. Rather, the applicant argued that the examiner had erred in the claim construction and that the proper claim scope did not include the embryo. In addition, the applicant's patent attorneys at Blakeley Sokolof have withrdawn from the representation and Dr. Kamrava's medical license has been revoked.

Can the 271(e)(1) Safe Harbor Help DuPont Escape its $1 Billion Verdict?

December 1, 2012PatentLicensesDennis Crouch

Professor Holman has an interesting new post on his blog involving the ongoing battle between Monsanto, E.I. DuPont, and Pioneer HI-Bred. Earlier this year, a jury concluded that DuPont owed Monsanto $1 billion in reasonable royalty even though DuPont had only done research on its potential product and had never brought it to market.

In post verdict briefing, DuPont is raising an important question of the scope of the Hatch-Waxman Safe Harbor (271(e)(1)). That statute might be called a “fair use” statute in the way that it identifies a class of unauthorized uses of a patented invention and excuses those uses from infringement liability. In particular, the statute allows unlicensed use of a patented invention for purposes “reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.

Holman notes that the district court has issued a judgment rejecting the safe harbor for these GM foods. However, certain food additives do count as drugs under FDA rules. The interesting thought is that a greater regulatory scheme monitoring the use of genetically modified organisms would likely result in a broader safe harbor. In my view, the safe harbor is unlikely to apply because GMO foods have been classified in the GRAS category – Generally Regarded as Safe. Holman sees some potential that the Federal Circuit would arrive at the opposite conclusion.

Read: Holman, District Court Rejects Argument that Hatch-Waxman Safe Harbor Applies to Genetically Modified Crops at http://holmansbiotechipblog.blogspot.com/2012/11/district-court-rejects-argument-that.html.

Supreme Court has Granted Cert in the Myriad Case, Question: Are Human Genes Patentable

November 30, 2012PatentSupreme CourtDennis Crouch

by Dennis Crouch

From the get-go, case of AMP v. Myriad appeared to be on its way to the Supreme Court. That fate was furthered by District Court Judge Sweet’s sweeping 2010 ruling in the case. As written, that ruling would have invalidated essentially all gene patents. As predicted, the Federal Circuit reversed and followed its own prior precedent that isolated genes are patentable.

Now, the Supreme Court has granted the petition for writ of certiorari and will hear the case — limited to the single question: “Are human genes patentable?”

I’m sure there will be significant amicus support on both sides. A decision will probably not arrive until the end of the spring term.

Read more on the case.

Update on Supplemental Examination

November 30, 2012Patent, ReexaminationDennis Crouch

by Dennis Crouch

Supplemental Examination has been available as a post-grant option since September 16, 2012. I just received confirmation from the USPTO between Sept 16, 2012 and November 18, 2012, a total of four (4) request for Supplemental Examination have been filed, serial numbers 96/000,004 through 96/000,007.

I discussed the ‘007 application earlier. The remaining applications were apparently defective and thus have not yet been given a filing date.

Tags: Supplemental+Examination

Patent Prosecutors Licensing of Copyrights for Prior Art Submissions

November 29, 2012PatentDamages, LicensesDennis Crouch

By Dennis Crouch

CCC v. Oblon Spivak (license agreement)

The Copyright Clearance Center (CCC) is a collective agent for many copyright holders and serves as a one-stop-shop for folks to license copyrights for use. CCC offers licenses to many (perhaps most) of the academic publications (non-patent literature) submitted to the USPTO under the Rule 56 duty of disclosure. In recent years, CCC has implemented a buffet license approach that allows a business to use their entire catalog for a fixed negotiated price.

Until recently, few patent law firms have seen any copyright infringement risk associated non-patent prior art because the copies are most typically obtained from a licensed database and the submission to the PTO and file-copies are both likely fair use and therefore would not constitute copyright infringement. Thus, most firms have developed their its patent prosecution practices with an implicit belief that its prosecution related uses of scientific journal articles are noninfringing uses of the articles. In the spring of 2012, the publisher John Wiley began suing patent law firms – taking the contrary view that (1) making file copies; (2) sharing copies with clients; and (3) submitting copies to the USPTO each constitute actionable copyright infringement. These lawsuits are ongoing.

The CCC license would allow both internal copying and submitting copies to the USPTO, although it does not allow the sharing copies with clients. Of course, these actions were all previously thought to be fair use. Professor Jamie Boyle has an interesting essay from 2007 discussing the problems with this license. His main point is that once we start paying for fair use material it stops being fair use going forward and moves toward a “culture of permission” that, in his view, is normatively bad.

I contacted the CCC folks and received some information from CCC’s General Counsel Frederic Haber. The first point is that the Wiley articles that are the subject of the lawsuits are included within the license (still, the blanket license still does not include sharing articles outside of the firm). The second point is costs. CCC uses a model of basically charging on a per-professional-employee basis. For patent law firms, their current negotiated going rate is around $300 per year per registered attorney. The third point is that the form license includes a waiver of any unasserted claims of past infringement (with the caveat that the waiver only takes effect after one-year of license coverage). The fourth point is that the downside of losing a lawsuit is statutory damages.

Oblon is in a special case because the firm has the highest patent throughput of any firm in the country. Because of that, the firm would have likely been part of any upcoming second round of lawsuits. On that note, Oblon’s Managing Partner Brad Lytle writes that the “license allows us to go about our business and focus our efforts on protecting the intellectual property of our clients.” In other words, the license allows the firm to avoid the annoyance of a lawsuit. The question for firms and attorneys moving forward is (1) whether the fair use argument is sufficient and (2) whether your firm is small enough to fly under-the-radar. And, of course, there is the remaining problem that the license does not allow for the sharing of the articles with folks outside of the firm.

Update: A further communication from the folks at CCC indicates that, although “the repertory license is specifically designed for the internal use of the licensed organization”, “one exception to that general rule is that the licensee may provide individual copies (paper or electronic) to prospects, clients or customers of the licensee in response to requests from those outside people.”

Top 100 Law Blogs and the Law Blog Hall of Fame

November 29, 2012PatentDennis Crouch

By Dennis Crouch

I am happy to announce that Patently-O has once again been selected by the ABA Journal as one of the top 100 law blogs. This is the sixth year that the ABA has compiled this list and Patently-O is one of the handful of sites that have made the list each and every year. For the first time, the ABA Journal also created a "Hall of Fame" for law blogs and selected Patently-O as one of the ten introductory members. In my view, we've done an amazing job of improving the level of content and discussion over the past year. With the addition of Professors Rantanen and Hricik (on leave) and a number of other guest authors, Patently-O has more depth and breadth of coverage than ever before. MBHB has agreed to continue its exclusive sponsorship of the site. This means we can continue operating almost ad-free. And, hundreds of folks have found new jobs and connections through the Patently-O jobs site that is run by Ryan Swartz.

Although the ABA Journal top-100 list necessarily excludes a number of excellent IP law blog, the listed IP blogs are of a special caliber and I am honored that Patently-O is listed alongside. Other IP blogs on the list include:

Noonan & Zuhn's Patent Docs;
Gene Quinn's IPWatchDog;
Eric Goldman's Technology & Marketing Law Blog;
Groklaw now managed by Mark Webbink;
Hollywood Esq from the Hollywood Reporter; and
Rebecca Tushnet's 43(B)log

Congratulations to each of you! Blogging is really a community experience and I have a long connection with almost all of these listed blogs and their authors. I read Gene's impressive site (before it was a blog) even as a law student in Chicago. Gene also helped teach my patent bar review course (although I largely played hooky). I helped the Docs (Noonan and Zuhn) get started with their site while we were colleagues at MBHB. As he has been for many, Prof Goldman was instrumental in helping me find a job as a hopeful academic and then graciously welcoming me into the academy. Webbink and I continue to communicate regularly about ways to improve the patent system and both of us have the belief that broader participation and transparency will have important long term benefits. And, for several months each year I intensively read Prof. Tushnet's site (along with Prof Goldman's) as I teach my internet law course.

There is an ongoing popularity contest vote that Patently-O has won twice in the past. This year I have been discouraging folks from voting for Patently-O because there are so many other excellent IP blogs that also deserve to win.

Ranking company Cision just published its list that ranks Patently-O as No. 12 on the list of top law blog. BlogRank also just published its list that put Patently-O as No. 9 in its list of all law blogs. Professor Paul Caron rates Patently-O as No. 6 amongst faculty law blogs according to blog traffic. In his citation analysis, Professor Jay Brown ranks Patently-O as the third most cited law blog (in law journals).

I'll do a post soon on some of my favorite IP blogs, feel free to post your ideas in the comments.

Patent Term Adjustment

November 29, 2012PatentDennis Crouch

by Dennis Crouch

vast majority of newly issued patents are granted some amount of patent term adjustment (PTA) — often more than 18 months — added to the end of the patent to account for delays in the issuance of the patent. In the rececent case of Exelixis v. Kappos, the E.D.V.A. district court held that the PTO has been undercalculating PTA for (in my estimate) more than 10% of all recently issued patents. The PTO has not yet challenged that decision but it has also not taken action to correct its calculations.

The following survey is intended to get a feel for how the patent community is responding.

Patent Term Adjustment

November 29, 2012PatentJonathan Hummel

by Dennis Crouch

The following survey is intended to get a feel for how the patent community is responding.

Patent Term Adjustment

November 29, 2012PatentJonathan Hummel

by Dennis Crouch

The following survey is intended to get a feel for how the patent community is responding.

Federal-circuit-ism: Defining the relationship between the Federal Circuit and its Regional Sister Courts

November 28, 2012PatentSupreme CourtDennis Crouch

By Dennis Crouch

Revision Military, Inc. v. Balboa Manufacturing Co. (Fed. Cir. 2012)

In the US, federalism is the term that we generally use to highlight the complex relationship between state governments and the federal government. In patent litigation we might use the expanded term federal-circuit-ism to describe the Federal Circuit's relationship with both state courts and the regional circuit courts of appeal. Here, the Federal Circuit applied its principles of federal-circuit-ism to hold that preliminary injunctions in patent cases are patent specific and therefore require application of Federal Circuit law rather than the law of the relevant regional circuit court of appeal.

The Case: Revision's design patents are directed toward protective eyewear for hunting and other gun sports. Patent Nos. D. 537,098 and D. 620,039. Revision sued Balboa and requested a preliminary injunction to stop the ongoing alleged infringement. After a hearing, the district court sided with Balboa – holding that Revision had not provided a "clear and substantial" likelihood of success on the merits as required under the Second Circuit law of preliminary injunctive relief. The Federal Circuit has an easier standard for approving preliminary relief in patent cases – requiring only a preponderance of the evidence – and the lower court erred in not applying that standard.

The district court found that the patentee's infringement case lacked sufficient merit to meet the "clear and substantial" standard. On remand, the lower court will be asked to decide whether it meets the Federal Circuit's lower standard.

= = = = =

While the appellate court does a fine job of criticizing the district court judgment, one interesting optical mote in Judge Newman's written opinion is that it fails to mention the leading Supreme Court case on injunctive relief, eBay v. MercExchange. That case is important here. A major element of eBay is the Supreme Court's suggestion that the law of injunctive relief in patent cases should be the same law that is applied in other areas of law.

According to well-established principles of equity, a plaintiff seeking a permanent injunction must satisfy a four-factor test before a court may grant such relief. . . . These familiar principles apply with equal force to disputes arising under the Patent Act. As this Court has long recognized, "a major departure from the long tradition of equity practice should not be lightly implied." Nothing in the Patent Act indicates that Congress intended such a departure.

Federal Circuit precedent on applying its own law to preliminary injunction standards reaches back at least to Hybritech Inc. v. Abbott Labs., 849 F.2d 1446 (Fed. Cir. 1988). In that case, the Federal Circuit held that its own law (rather than that of a regional circuit) controls the grant or denial preliminary injunctions. In my view, eBay places this notion in serious question.

= = = = =

The second half of the opinion looks at the methodology for judging infringement. Here, the appellate court criticized the lower court's decision for unduly focusing on individual elements that "stand out as dissimilar" rather than how those differences would impact an ordinary observer considering the design as a whole and its similarity to the accused device and with reference to the closest prior art.

Colbert on the First Sale Doctrine

November 27, 2012PatentDennis Crouch

Colbert is once again on the mark.

The Colbert Report
Get More: Colbert Report Full Episodes,Political Humor & Satire Blog,Video Archive

USPTO Director Kappos will Leave in January 2013

November 26, 2012PatentUSPTO DirectorDennis Crouch

by Dennis Crouch

A source at the USPTO has confirmed that the David Kappos will step down from his post as USPTO Director in late January 2013 – concluding four years as the US Undersecretary of Commerce for Intellectual Property and the President's chief advisor on intellectual property matters. Kappos will be remembered for guiding the America Invents Act through Congress and an intense focus on practical implementation of the new provisions. Kappos has pushed a paradigm shift that focuses on mechanisms for improving patent quality by working with applicants rather than against applicants. This approach and his understanding of the business of patent law has allowed Kappos to remain well respected amongst patent attorneys and intellectual property professionals throughout a turbulent four year term.

In an effort to eliminate the patent prosecution backlog, Kappos has led the charge to greatly increase the number of patent examiners over the past two years. During this time, the number of examiners has swelled to over 8,000 – a more than 30% increase from two years before. A future concern will be legacy problems of overstaffing once the backlog has been sufficiently reduced.

USPTO Deputy Director Teresa Stanek Rea is in position to assume the role of acting Director. There is a strong likelihood that she will be nominated to more permanently fill the post.

Congratulations to Director Kappos. You will be missed.

Two Minute Survey:

Provisional Patent Applications as a Flash in the Pan: Many are Filed and Many are Abandoned

November 26, 2012PatentTrade SecretsDennis Crouch

By Dennis Crouch

Provisional patent application (PPA) filings continue to rise with over 160,000 filed in FY2012. Despite the relatively large number of filings, more than half of these applications are abandoned without ever reaching the non-provisional application stage. And, it appears that this rate-of-abandonment is growing. At the same time (and because of the growing absolute number of provisional filings), a larger percentage of non-provisional applications claim priority to a provisional filing than ever before.

The chart above shows the number of provisional patent applications filed each fiscal year for 1995-2012. 1995 is a partial year because provisional patent applications were created as an option as part of the 1995 GATT Uruguay Round implementation and only became available mid-year. Since then, over 1.7 million provisional applications have been filed. A provisional application is essentially a one-year place-holder offering no rights other than the filing-date priority claim. During that year, the USPTO ignores the application until the applicant takes some additional step – typically filing a non-provisional application or an international PCT application. At the end of the year, the provisional application is automatically abandoned. [But see, two year provisional].

By design, the vast majority of provisional patent applications are filed on US-originated inventions.

For most, provisional applications are seen as a low-cost mechanism for claiming a priority date and for delaying the eventual higher cost of drafting and filing a non-provisional application. Others (especially those in the pharmaceutical industry) use provisional applications as a way to shift the patent term back by one year.

The cost-savings is quite apparent once you consider the reality that most provisional applications are abandoned and never result in a non-provisional application. One problem with the cost-savings approach is that provisional applications only serve their purpose if they include a sufficient disclosure. In a small study of provisional applications, I found around 35% do not include even a single claim, and about 15% are essentially a stack of presentation materials.

The large number of abandoned provisional applications leads to several important results. First, the two-step filing process likely helps applicants do a better job of weeding out lower-quality inventions by the time examination begins. On the flip side, more weeding is probably necessary because the low cost and formality of provisional applications likely induce the filing of more weeds. Second, because the USPTO never makes-public the non-relied-upon applications, hundreds of thousands of patent applications are kept secret and their disclosures never made public. Although the information may still be useful for the applicant as a trade secret, the abandonment most likely means that the idea has been shelved and likely lost.