Patent Docs

USPTO Issues Interim Guidance Regarding Mayo v. Prometheus

July 5, 2012

By Donald Zuhn —

On Tuesday, the U.S. Patent and Trademark Office issued a memorandum providing guidance for determining subject matter eligibility of process claims involving laws of nature in view of the Supreme Court's decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc. The memo, entitled "2012 Interim Procedure for Subject Matter Eligibility Analysis of Process Claims Involving Laws of Nature," was released some three and a half months following the Court's decision in Mayo, and sets forth an examination procedure that supersedes the preliminary guidance provided in the Office's March 21 memo on the Mayo decision (see "USPTO Issues Preliminary Guidance on Mayo v. Prometheus").

The Office notes that the examination procedure set forth in the memo is "an interim measure" intended "to provide instruction to examiners in technology areas impacted by the Mayo decision" while the Federal Circuit rehears the Association for Molecular Pathology v. Myriad Genetics and WildTangent v. Ultramercial cases. The Office also notes that "comprehensive updated guidance" will be issued following resolution of those cases, which the Office expects will "provide insight regarding the full reach of Bilski and Mayo."

The examination procedure set forth in the guidance memo consists of three "essential" inquiries:

1. Is the claimed invention directed to a process, defined as an act, or a series of acts or steps?

2. Does the claim focus on use of a law of nature, a natural phenomenon, or naturally occurring relation or correlation (collectively referred to as a natural principle herein)? (Is the natural principle a limiting feature of the claim?)

3. Does the claim include additional elements/steps or a combination of elements/steps that integrate the natural principle into the claimed invention such that the natural principle is practically applied, and are sufficient to ensure that the claim amounts to significantly more than the natural principle itself? (Is it more than a law of nature + the general instruction to simply "apply it"?)

According to the memo, these three inquiries are to be conducted "on the claim as a whole" after the claims have been reviewed "to determine the boundaries of patent protection sought by the applicant and to understand how the claims relate to and define what the applicant has indicated is the invention." In establishing the broadest reasonable interpretation of the claims when read in light of the specification and from the view of one of ordinary skill in the art, the memo states that:

Claim analysis begins by identifying and evaluating each claim limitation and then considering the claim as a whole. It is improper to dissect a claimed invention into discrete elements and then evaluate the elements in isolation because it is the combination of claim limitations functioning together that establish the boundaries of the invention and limit its scope.

Once the broadest reasonable interpretation of the claims has been determined, an examiner should proceed to the three inquiries.

The first inquiry is relatively straightforward — if an examiner determines that a claim is directed to a process (i.e., an act or series of acts or steps), then the examiner proceeds to the second inquiry. With respect to the second inquiry, the memo defines a natural principle as "the handiwork of nature [that] occurs without the hand of man," and provides three examples: the disinfecting property of sunlight; the relationship between blood glucose levels and diabetes; and a correlation that occurs naturally when a man-made product, such as a drug, interacts with a naturally occurring substance, such as blood. According to the memo, "a claim focuses on a natural principle when the natural principle is a limiting element or step." The memo notes that "a claim that recites a correlation used to make a diagnosis focuses on a natural principle and would require further analysis" under the third and final inquiry.

With respect to the third inquiry, the memo begins by stating that "[t]o show integration, the additional elements or steps must relate to the natural principle in a significant way to impose a meaningful limit on the claim scope," adding that "[t]he analysis turns on whether the claim has added enough to show a practical application." Such additional elements or steps will be deemed insufficient if they "simply amount to insignificant extra-solution activity that imposes no meaningful limit on the performance of the claimed invention." Thus:

[A] claim to diagnosing an infection that recites the step of correlating the presence of a certain bacterium in a person's blood with a particular type of bacterial infection with the additional step of recording the diagnosis on a chart would not be eligible because the step of recording the diagnosis on the chart is extra-solution activity that is unrelated to the correlation and does not integrate the correlation into the invention.

In contrast, the memo notes that:

Claims that do not include a natural principle as a limitation do not raise issues of subject matter eligibility under the law of nature exception. For example, a claim directed to simply administering a man-made drug that does not recite other steps or elements directed to use of a natural principle, such as a naturally occurring correlation, would be directed to eligible subject matter. Further, a claim that recites a novel drug or a new use of an existing drug, in combination with a natural principle, would be sufficiently specific to be eligible because the claim would amount to significantly more than the natural principle itself.

In conducting the third inquiry, the memo notes that the weighing factors outlined in the Office's "Interim Guidance for Determining Subject Matter Eligibility for Process Claims in View of Bilski v. Kappas" may assist in the analysis. The memo then sets forth a number of relevant factors that may be useful in completing the third inquiry. For example, the memo states that "[a] claim that covers known and unknown uses of a natural principle and can be performed through any existing or future-devised machinery, or even without any apparatus, would lack features that are sufficient for eligibility." The memo also indicates that "[a] particular machine or transformation recited in more than general terms may be sufficient to limit the application to just one of several possible machines or just one of several possible changes in state, such that the claim does not cover every substantial practical application of a natural principle." In contrast, the memo notes that "[a] machine or transformation that is merely nominally, insignificantly, or tangentially related to the steps or elements, e.g., data gathering or data storage, would not show integration." Lastly, the memo suggests that "[c]omplete absence of a machine-or-transformation in a claim signals the likelihood that the claim is directed to a natural principle and has not been instantiated (e.g., is disembodied or can be performed entirely in one's mind[])."

Following the description of relevant factors, the memo provides a sample analysis. The first two parts of this section discuss claims that were at issue in Diamond v. Diehr and Mayo, while the last three parts provide examples that practitioners and examiners may find to be more helpful. In a subsection entitled "Making A Rejection," the memo provides an exemplary claim:

Claim 1. A method of determining effective dosage of insulin to a patient, comprising the steps of administering a dose of insulin to a patient, testing the patient’s blood for the blood sugar level, and evaluating whether the insulin dosage is effective based on the blood sugar level.

The memo then applies the three inquiries to this claim, concluding that:

The claim does not pass Inquiry 3 because, although the additional steps integrate or make use of the correlation in the process by administering insulin in one step and testing for the correlation in another step, the steps are not sufficient to ensure that the claim amounts to significantly more than the correlation itself since every application of the correlation would require an administration of insulin and testing of blood to observe the relationship between insulin and blood glucose levels.

In the next subsection, entitled "Evaluating a Response," the memo notes that a "proper" response to a rejection based on failure to claim patent-eligible subject matter could involve the presentation by the applicant of "persuasive arguments that the additional steps add something significantly more to the claim than merely describing the natural principle," or a "showing that the steps are not routine, well-known or conventional." Returning to its disinfecting property of sunlight and blood glucose levels/diabetes examples, the memo states, with respect to the latter example, that:

A claim that sets forth the relationship between blood glucose levels and the incidence of diabetes would require additional steps that do significantly more to apply this principle than conventional blood sample testing or diagnostic activity based on recognizing a threshold blood glucose level. Such additional steps could involve a testing technique or treatment steps that would not be conventional or routine.

The last section of the memo provides an analysis of two sets of exemplary claims: one set directed to a method for treating a psychiatric behavioral disorder using sunlight (claim 1), white light (claim 2), or UV light (claim 3); and another set directed to a method of determining the increased likelihood of having or developing rheumatoid arthritis using an anti-IgM antibody (claim 1), providing a positive control (claim 2), using a specific IgM antibody (claim 3), or using two specific assays (claim 4). In the first example, the memo finds only claim 3 to be a patent-eligible practical application, stating that "the additional step of filtering the UV rays from the white light manipulates the white light; and the additional step of positioning the patient relates to the conditions under which the patient is exposed to the light." In the second example, the memo finds both claims 3 and 4 to be patent-eligible practical applications. With respect to claim 3, the memo notes that "use of the particularly claimed antibody does transform the claim to a patent-eligible practical application as it does not cover substantially all practical applications of the correlation because it is limited to those applications that use the antibody XYZ." As for claim 4, the memo points out that the claim "uses assays M and N, which are not routinely used together."
Study Finds That Foreign-Born Inventors Play Prominent Role at Top U.S. Patent-Producing Universities

July 4, 2012

By Donald Zuhn —

A study commissioned by the Partnership for a New American Economy, a bipartisan group of mayors from across the country and business leaders from all sectors of the economy seeking to raise awareness of the economic benefits of sensible immigration reform, shows that 76% of patents issued in 2011 to the top 10 patent-generating universities in the U.S. named a foreign-born inventor. The 30-page report, entitled "Patent Pending: How Immigrants Are Reinventing the American Economy," was released last month.

Partnership Co-Chair, New York Mayor Michael Bloomberg, noted that the study was "indisputable proof of the enormous contribution of immigrants in developing the new technologies and ideas needed to renew the U.S. economy and create American jobs," adding that "American universities are doing their part in attracting and educating the world's top minds, but our broken immigration laws continue to push them to our competitors." According to the report, the University of California led all other U.S. universities with respect to issued patents in 2011, securing 369. The top 10 patent-producing universities in 2011 is shown below:

The study also found that 54% of the patents issued to the top 10 universities named foreign inventors that were most likely to face visa hurdles, namely students, postdoctoral fellows, and staff researchers. With respect to pharmaceuticals, 79% of patents issued to the top universities named a foreign-born inventor. In a press release issued by the Partnership, American Enterprise Institute Fellow Nick Schulz noted that "[e]very graduate with an advanced degree working in a STEM-related field in the United States has been shown to create on average 2.62 additional jobs for native-born workers," and therefore asserted that "[s]ending those people away doesn't protect American jobs, it jeopardizes them."

The group noted that the study highlights the clear value foreign-born graduates bring to the U.S. economy, and offered recommendations for the U.S. to fix its immigration system and compete with countries such as South Korea, Switzerland, Spain, Italy, Germany, and the United Kingdom, which admit 60-80% of immigrants on economic needs (as opposed to the U.S., which admits only 7% of immigrants on economic needs). Among the group's recommendations are:

• Granting permanent residency (green cards) to foreign students who earn graduate degrees in STEM (science, technology, engineering and math) fields, where 99% of the patents naming a foreign-born inventor were issued.
• Creating a visa for foreign-born entrepreneurs having U.S. investors and wanting to start companies employing U.S. employees.
• Raising or removing the cap on H-1B visas, currently set at 65,000 (the group notes that the 2012 cap was hit in only 10 weeks).

More information regarding the study can be found here.
Sciele Pharma Inc. v. Lupin Ltd. (Fed. Cir. 2012)

July 3, 2012

By Andrew Williams —

On Monday, in Sciele Pharma Inc. v. Lupin Ltd., the Federal Circuit vacated a preliminary injunction against ANDA-filer Lupin that blocked its sale of generic Fortamet, and remanded the case to the District Court for the District of Delaware for further processing. In so doing, the Federal Circuit reiterated the holding of the Supreme Court in Microsoft v. i4i that, because issued patents enjoy a presumption of validity, the burden of proof for a challenger is clear and convincing evidence. The fact that a reference was before the Patent Office goes to the weight of the evidence, but the burden of proof never changes. As such, the Court explained, it may be harder to meet the clear and convincing burden when asserting invalidity contentions based on the same references and arguments considered by the Office. Nevertheless, the Federal Circuit found that Lupin had met the incredibly high burden of establishing that the District Court abused its discretion in issuing the injunction because it found that Lupin had raised a substantial question of invalidity — even though it was a question of obviousness based on two references considered by the Office.

The technology at issue in this case was an extended-release tablet of metaformin hydrochloride, marketed as Fortamet, which is an oral antihyperglycemic drug used in the management of type 2 diabetes. According to the lower court's decision, the advantage of the extended-release formulation is that the maximum concentration of the drug occurs at night when the body's glucose level is the highest. The sole patent at issue was U.S. Patent No. 6,866,866 (the "'866 patent"), which claimed dosage forms of controlled release metformin compositions with a mean time to maximum plasma concentration at 5.5 to 7.0-7.5 hours after oral administration. However, as politely noted by the Federal Circuit, there was a "quirk" in the prosecution history of this patent. The examiner had rejected some of the pending claims as obvious in light of WO 99/47125 ("Cheng") in view of U.S. Patent No. 3,845,770. The examiner indicated that Cheng suggested a T_max of 8 hours, and therefore rejected the claims which recited a T_max range of 5.5-7.5 hours (because it was too close to the 8 hours of Cheng). In response, the applicant cancelled claim 1, which recited this range, but maintained a claim reciting the narrower range of 5.5-7.0 hours, amending it from dependent to independent form. Nevertheless, the Examiner issued a notice of allowance for the original claims. The applicant attempted to rectify this mistake by alerting the examiner to the error, which resulted in a supplemental notice of allowance to the amended claims without the cancelled claims (such a claim 1). But, the '866 patent issued with a "surprise" — all of the original claims were printed in the patent, including canceled claim 1 with a T_max range of 5.5-7.5 hours, and original claim 3 with a T_max range of 5.5-7 hours.

The present action began when Lupin filed an ANDA to market generic Fortamet. Curiously, Sciele Pharma (now Shionogi Pharma) asserted both claims 1 and 3 (among others) — even though the patentees had twice cancelled claim 1. The litigation remained unresolved at the end of the 30-month stay, so the FDA approved Lupin's ANDA on June 29, 2011, and Lupin launched its ANDA product "at risk" on September 30, 2011. Shionogi moved for a preliminary injunction, which the District Court granted on December 6, 2011, noting that the presumption of validity creates a very steep requirement for the Lupin's validity challenge. The Federal Circuit vacated this injunction on February 6, 2012 because of the lower court's failure to address the merits of the obviousness argument. Eight days later, the District Court issued its Findings of Fact and Conclusions of Law.

Without repeating the other factors required for issuing a preliminary injunction, the lower court focused exclusively on Lupin's obviousness challenge, undertaking the approach as elucidated by the Supreme Court in Graham v. John Deere Co. The Court first determined the scope and content of the cited prior art and ascertained the differences between it and the claims at issue. The District Court did note that Lupin relied heavily on the Supreme Court's KSR decision, but pointed out "a fundamental factual difference" in the present case — the Patent Office had already considered Cheng and WO 99/47128 ("Timmins"), the two prior art references. As noted above, Cheng taught a formulation with a T_maxof 8 hours. Timmins, on the other hand, taught a new dosage form, but described a median T_max, not at mean T_max. And, an expert for Sciele declared that there was no way to ascertain the mean T_max given only the median and the range. Moreover, Timmins allegedly indicated that its new formulation provided no impact on bioavailability. To the contrary, the Court noted, the '866 patent explains that the bioavailability is improved with the claimed formulation. With regard to the level of skill in the art, Lupin pointed to statements made by the applicant in response to an enablement rejection during the prosecution history. However, as the lower court noted, enablement and obviousness have different standards, and statements with regard to one are not necessarily applicable to the other. Finally, the Court did not consider any objective evidence of nonobviousness because the only evidence presented was after the filing date of the '866 patent. Based on this analysis, the lower court again issued a preliminary injunction, and Lupin appealed.

The Federal Circuit first acknowledged that it was required to review a decision to grant a preliminary injunction for an abuse of discretion, which must be either from a clear error of judgment in weighing relevant factors or an exercise of discretion based on an error of law. The Federal Circuit next rejected Lupin's argument that the claims of the '866 patent were not entitled to the presumption of validity because Sciele was asserting claims that it acknowledged should not have been issued. However, the Court similarly rejected Sciele's assertion that the claims were entitled to a heightened standard because the references were considered by the examiner. Again, the Court pointed out that the burden of proof requires clear and convincing evidence, regardless of what happened during prosecution. Instead, what happens during prosecution can go to the weight of the evidence.

Nevertheless, the Federal Circuit did find that that Lupin had raised a substantial question of validity. The Court apparently found that the District Court's obviousness determination was flawed because it had misapplied KSR, most likely because it had relied too heavily on the fact that the two references were before the Office during prosecution. However, even though the lower court did note this "fundamental factual difference," and it did indicate that deference was owed to the Office, it still undertook the proper Graham analysis. Instead, the Federal Circuit reached a different conclusion regarding the teachings of Cheng and Timmins — finding that the Timmins-disclosed median T_max range could be converted to the claimed mean T_max range. The Court also found that the applicant's statements regarding enablement were evidence that the design choice to make the claimed extended release dosage would have been routine and obvious. In addition, the Federal Circuit noted that the benefits of an earlier extended release as touted by Timmons would have motivated one skilled in the art to modify Cheng to achieve a lower T_max range. The Federal Circuit concluded that Sciele failed to effectively rebut Lupin's arguments regarding what Timmins teaches, and how it could be used as motivation to modify Cheng.

Even though the Federal Circuit conducted what appeared to be a persuasive obviousness analysis, it is not clear that the analysis conducted at the District Court was so erroneous as to justify vacating the preliminary injunction. After all, Lupin faced an incredibly high hurdle — it needed to convince the Federal Circuit that the District Court abused its discretion in granting a preliminary injunction based, in part, on Lupin's failure to establish a substantial question of validity of an issued patent by clear and convincing evidence, in which both cited references were considered by the Office (which goes to the weight of the evidence). Instead, other than a few off-hand comments, the Court did not make much of the discrepancies between the issued claims and those that appear in the printed patent (and were asserted by Sciele). Nevertheless, Sciele's attorney was taken to task during the oral argument for its decision to assert claim 1 — even though it had acknowledged that this claim was cancelled during prosecution. It is tempting, therefore, to think that the Federal Circuit reached the decision that it did to correct this inequity. The problem, though, is that Sciele also asserted claim 3 against Lupin — a claim which always had the narrower T_max range of 5.5-7 hours. Nevertheless, even though the Federal Circuit's opinion provides a very plausible reason why Lupin might ultimately be successful in its obviousness allegation, such a substitution of judgment should not be appropriate under the abuse-of-discretion standard required to vacate a preliminary injunction. As a result, it is difficult not to question whether the Court was just looking for a justification to correct this perceived inequity.

Sciele Pharma Inc. v. Lupin Ltd. (Fed. Cir. 2012)
Panel: Circuit Judges Lourie, Prost, and Moore
Opinion by Circuit Judge Moore
USPTO to Open Three More Satellite Offices

July 2, 2012

By Donald Zuhn —

The U.S. Patent and Trademark Office announced today that it plans to open three more satellite offices in addition to the satellite office to be opened later this month in Detroit, MI. The additional offices will be located in Dallas, TX; Denver, CO; and in California's Silicon Valley. The announcement ends a process that began last November when the USPTO requested comments and information from stakeholders regarding potential cities and regions for future locations of the satellite offices (see "USPTO News Briefs," December 15, 2011). As a result of that request, the USPTO received more than 600 public comments. In addition to reviewing public comments, the Office also noted that "USPTO officials met with hundreds of state and local officials, congressional delegations, and policy leaders," and further, that "[t]he selection team developed a model to evaluate over 50 Metropolitan Statistical Areas based on the previously stated criteria to assess operational cost and feasibility, ability to improve patent quality, and ability to employ U.S. veterans." In selecting the satellite offices, the USPTO exercised its authority under to § 23 of the Leahy-Smith America Invents Act to establish three of more satellite offices in the United States by September 16, 2014, subject to available resources. Last December, the USPTO indicated that it would establish at least two more satellite offices. The USPTO also noted in today's statement that the Detroit satellite office would be opening on July 13, as the Office originally announced at the end of May (see "USPTO News Briefs," May 23, 2012).
News from Abroad: EU Patent Is Finally Born

July 2, 2012

By Devanand Crease —

After a gestation period of nearly 40 years, and amid the Eurozone crisis, the final form of the unitary European Union (EU) patent and unified patent litigation system was brought in existence on 29 June 2012. It was a troubled labour with much wrangling between the parent member states with some countries left out in the cold (Italy and Spain), and others obstinately digging their heels in and demanding concessions (United Kingdom). In the end, a working system for the grant and enforcement of a unitary EU patent was agreed upon and some key highlights are:

• The system will likely come into force in 2014-15 and pre-grant and opposition procedure will be substantially similar to the current EPO patent process.

• After grant of the EU patent, the previous financially burdensome validation process has been removed with official languages only of English, French, and German.

• Whilst infringement proceedings can be brought in any member state in the first instance (except Italy and Spain), the primary technical court dealing with appeals and all issues of patent validity will be the so-called Central Division. The Central Division will be headquartered in Paris, with specialist sections domiciled in London (for chemistry, including pharmaceuticals, and life sciences) and in Munich (for mechanical engineering).

• A single renewal fee will be paid covering the entire EU (except Spain and Italy).

The new EU Patent system will place patents on a similar footing with other pan-EU unitary IP rights such as trade marks and designs. There are likely to be a few further hiccups ahead, though, as the new agreement must be ratified by at least 13 member states before becoming law across the EU (again excepting Italy and Spain).

The legislation has had many critics over the past few months, particularly those concerned that the German style of dividing infringement and validity proceedings into separate cases tried in separate courts (termed 'bifurcation') would become commonplace across all of Europe. However, the classical EU compromise agreement that has been presented seems to mitigate some aspects of this, at least for the time-being. However, simply defaulting to an EU patent at the earliest opportunity may not be the best situation for non-EU applicants as the benefits of enforcing a unitary right should also be weighed against the drawbacks of central revocation.

It is certain, though, that this new patent right will be a powerful game changer in the European market and its effects cannot be ignored. The UK was particularly pleased with the outcome with its key life science industry benefitting from the location of the Central Division for chemical and life sciences litigation in London. This is also of major interest to US and Canadian based pharma companies as the UK is the only major common-law nation in Europe.

The next few years may prove to be volatile as patent owners learn to deal with the new system and discover whether it delivers improved competitiveness on the global stage for the EU.

Dr. Crease is a Partner at Keltie LLP in London, UK.

Graphic of member states of the European Union (above) by Ssolbergj, from the Wikipedia Commons under the Creative Commons license.
Court Report

July 1, 2012

By Sherri Oslick —

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.

Cumberland Pharmaceuticals Inc. v. Sagent Agila LLC et al.
1:12-cv-00825; filed June 26, 2012 in the District Court of Delaware

• Plaintiff: Cumberland Pharmaceuticals Inc.
• Defendants: Sagent Agila LLC; Sagent Pharmaceuticals Inc.

Infringement of U.S. Patent No. 8,148,356 ("Acetylcysteine Composition and Uses Therefor," issued April 3, 2012) following a Paragraph IV certification as part of Sagent's filing of an ANDA to manufacture a generic version of Cumberland's Acetadote® (N-acetylcysteine injection, used to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen). View the complaint here.

Galderma Laboratories, L.P. et al. v. Actavis Mid Atlantic LLC
3:12-cv-02038; filed June 26, 2012 in the Northern District of Texas

• Plaintiffs: Galderma Laboratories, L.P.; Galderma S.A.; Galderma Research & Development, S.N.C.
• Defendant: Actavis Mid Atlantic LLC

Infringement of U.S. Patent Nos. 7,820,186 ("Gel Composition for Once-Daily Treatment of Common Acne Comprising a Combination of Benzoyl Peroxide and Adapalene and/or Adapalene Salt," issued October 26, 2010), 7,964,202 ("Method for Treatment of Common Acne," issued June 21, 2011), 8,071,644 ("Combinations of Adapalene and Benzoyl Peroxide for Treating Acne Lesions," issued December 6, 2011), 8,080,537 (same title, issued December 26, 2011), 8,105,618 ("Dermatological/Cosmetic Gels Comprising At Least One Retinoid and/or Retinoid Salt and Benzoyl Peroxide," issued January 31, 2012), and 8,129,362 ("Combination/Association of Adapalene and Benzoyl Peroxide for Treating Acne Lesions," issued March 6, 2012) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Galderma's Epiduo® Gel (adapalene and benzoyl peroxide, used to treat acne vulgaris). View the complaint here.

Pfizer, Inc. et al. v. Mylan Pharmaceuticals Inc. et al.
1:12-cv-00106; filed June 26, 2012 in the Northern District of West Virginia

• Plaintiffs: Pfizer, Inc.; Wyeth LLC; Wyeth Pharmaceuticals, Inc.; PF Prism C.V.
• Defendants: Mylan Pharmaceuticals Inc.; Mylan Inc.

Pfizer Inc et al. v. Anchen Pharmaceuticals Inc et al.
2:12-cv-05535; filed June 25, 2012 in the Central District of California

• Plaintiffs: Pfizer Inc.; Wyeth LLC; Wyeth Pharmaceuticals Inc; PF Prims C.V.
• Defendants: Anchen Pharmaceuticals Inc.; Anchen Inc.

Pfizer Inc. et al. v. Watson Laboratories, Inc. Florida et al.
0:12-cv-61268; filed June 25, 2012 in the Southern District of Florida

• Plaintiffs: Pfizer Inc.; Wyeth LLC; Wyeth Pharmaceuticals Inc.; PF Prism C.V.
• Defendants: Watson Laboratories, Inc. Florida; Andrx Corp.; Watson Laboratories, Inc.; Watson Pharma, Inc.; Watson Pharmaceuticals, Inc.

Pfizer Inc. et al. v. Sandoz Inc.
3:12-cv-03880; filed June 25, 2012 in the District Court of New Jersey

• Plaintiffs: Pfizer Inc.; Wyeth LLC; Wyeth Pharmaceuticals Inc.; PF Prism C.V.
• Defendants: Sandoz Inc.

Pfizer Inc. et al. v. Zydus Pharmaceuticals (USA), Inc. et al.
3:12-cv-03893; filed June 25, 2012 in the District Court of New Jersey

• Plaintiffs: Pfizer Inc.; Wyeth LLC; Wyeth Pharmaceuticals Inc.; PF Prism C.V.
• Defendants: Zydus Pharmaceuticals (USA), Inc.; Cadila Healthcare Ltd.

Pfizer Inc. et al. v. Anchen Pharmaceuticals Inc. et al.
1:12-cv-00808; filed June 22, 2012 in the District Court of Delaware

• Plaintiffs: Pfizer Inc.; Wyeth LLC; Wyeth Pharmaceuticals Inc.; PF Prism C.V.
• Defendants: Anchen Pharmaceuticals Inc.; Anchen Inc.

Pfizer Inc. et al. v. Roxane Laboratories Inc. et al.
1:12-cv-00813; filed June 22, 2012 in the District Court of Delaware

• Plaintiffs: Pfizer Inc.; Wyeth LLC; Wyeth Pharmaceuticals Inc.; PF Prism C.V.
• Defendants: Roxane Laboratories Inc.; Boehringer Ingelheim Roxane Inc.

Pfizer Inc. et al. v. Apotex Inc. et al.
1:12-cv-00809; filed June 22, 2012 in the District Court of Delaware

• Plaintiffs: Pfizer Inc.; Wyeth LLC; Wyeth Pharmaceuticals Inc.; PF Prism C.V.
• Defendants: Apotex Inc.; Apotex Corp.

Pfizer Inc. et al. v. Sandoz Inc.
1:12-cv-00814; filed June 22, 2012 in the District Court of Delaware

• Plaintiffs: Pfizer Inc.; Wyeth LLC; Wyeth Pharmaceuticals Inc.; PF Prism C.V.
• Defendant: Sandoz Inc.

Pfizer Inc. et al. v. Breckenridge Pharmaceutical Inc. et al.
1:12-cv-00810; filed June 22, 2012 in the District Court of Delaware

• Plaintiffs: Pfizer Inc.; Wyeth LLC; Wyeth Pharmaceuticals Inc.; PF Prism C.V.
• Defendants: Breckenridge Pharmaceutical Inc.; Alembic Pharmaceuticals Ltd.; Alembic Ltd.

Pfizer Inc. et al. v. Teva Pharmaceuticals USA Inc. et al.
1:12-cv-00815; filed June 22, 2012 in the District Court of Delaware

• Plaintiffs: Pfizer Inc.; Wyeth LLC; Wyeth Pharmaceuticals Inc.; PF Prism C.V.
• Defendants: Teva Pharmaceuticals USA Inc.; Teva Pharmaceutical Industries Ltd.

Pfizer Inc. et al. v. Lupin Ltd. et al.
1:12-cv-00811; filed June 22, 2012 in the District Court of Delaware

• Plaintiffs: Pfizer Inc.; Wyeth LLC; Wyeth Pharmaceuticals Inc.; PF Prism C.V.
• Defendants: Lupin Ltd. ; Lupin Pharmaceuticals Inc.

Pfizer Inc. et al. v. Watson Laboratories Inc. Florida et al.
1:12-cv-00816; filed June 22, 2012 in the District Court of Delaware

• Plaintiffs: Pfizer Inc.; Wyeth LLC; Wyeth Pharmaceuticals Inc.; PF Prism C.V.
• Defendants: Watson Laboratories Inc. Florida; Andrx Corp.; Watson Laboratories Inc.; Watson Pharma Inc.; Watson Pharmaceuticals Inc.

Pfizer Inc. et al. v. Mylan Pharmaceuticals Inc. et al.
1:12-cv-00812; filed June 22, 2012 in the District Court of Delaware

• Plaintiffs: Pfizer Inc.; Wyeth LLC; Wyeth Pharmaceuticals Inc.; PF Prism C.V.
• Defendants: Mylan Pharmaceuticals Inc.; Mylan Inc.

Pfizer Inc. et al. v. Wockhardt Ltd. et al.
1:12-cv-00817; filed June 22, 2012 in the District Court of Delaware

• Plaintiffs: Pfizer Inc.; Wyeth LLC; Wyeth Pharmaceuticals Inc.; PF Prism C.V.
• Defendants: Wockhardt Ltd.; Wockhardt USA LLC

Pfizer Inc. et al. v. Zydus Pharmaceuticals USA Inc. et al.
1:12-cv-00818; filed June 22, 2012 in the District Court of Delaware

• Plaintiffs: Pfizer Inc.; Wyeth LLC; Wyeth Pharmaceuticals Inc.; PF Prism C.V.
• Defendants: Zydus Pharmaceuticals USA Inc.; Cadila Healthcare Ltd.

The complaints in these cases are substantially identical. Infringement of U.S. Patent No. 6,673,838 ("Succinate Salt of O-Desmethyl-Venlafaxine," issued January 6, 2004) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Pfizer's Pristiq® (desvenlafaxine, used to treat depression). View the Delaware Anchen complaint here.
Conference & CLE Calendar

July 1, 2012

July 11-13, 2012 – Fundamentals of Patent Prosecution 2012: A Boot Camp for Claim Drafting & Amendment Writing (Practising Law Institute) – San Francisco, CA

July 12, 2012 – Inducement to Infringe in Hatch-Waxman Litigation: Lessons from Bayer Schering v. Lupin and AstraZeneca v. Apotex for Pharma Patents (Strafford) – 1:00 – 2:30 pm (EDT)

July 17-19, 2012 – Product and Pipeline Enhancement for Generics*** (marcus evans) – Washington, DC

July 30-31, 2012 – Freedom to Operate*** (American Conference Institute) – Philadelphia, PA

July 30 to August 1, 2012 – Intensive Patent Law Seminar (Chisum Patent Academy) – Seattle, WA

August 2, 2012 – USPTO Post-Grant Proceedings: Meeting the New Requirements for Post-Grant and Inter Partes Reviews and Supplemental Examination (Strafford) – 1:00 – 2:30 pm (EDT)

September 9-11, 2012 – IPO Annual Meeting (Intellectual Property Owners Association) – San Antonio, TX

September 10-12, 2012 – Business of Biosimilars & Generic Drugs (Institute for International Research) – Boston, MA

***Patent Docs is a media partner of this conference or CLE
IPO Annual Meeting

June 29, 2012

The Intellectual Property Owners Association (IPO) will be holding its 40th Annual Meeting on September 9-11, 2012 in San Antonio, TX. Among the presentations being offered at the annual meeting are:

• Patent Case Law Update
• The America Invents Act – What Should Your Company or Client be Doing?
• IPO's Corporate IP Benchmarking Survey: A Trend Analysis
• International Issues in IP Transactions
• Invalidity Rates Around the World
• Emerging Market Strategies/Export Control
• Tips and Tactics for Drafting and Using Settlement Licenses in Litigation Post-ResQNet
• Trade Secret Protection: Trends, Developments and International Implications
• Ethics Session

In addition, Chief Judge Randall R. Rader of the U.S. Court of Appeals for the Federal Circuit will present the luncheon keynote on September 10.

A program for the meeting, including an agenda, descriptions of the scheduled sessions, and list of speakers, can be obtained here.

The registration fee for the meeting is $500 (government/academic), $950 (IPO members), or $1,450 (non-members). Those interested in registering for the meeting can do so here.
Affordable Care Act Survives Supreme Court Review Largely Unscathed, Clearing Way for Biosimilars

June 28, 2012

By James DeGiulio —

In a history-making decision, the Supreme Court today in National Federation of Independent Business v. Sebelius upheld the Patient Protection and Affordable Care Act (PPACA) as constitutional under the taxation clause of the Constitution. The individual mandate provision of the PPACA, which establishes the requirement that nearly all Americans secure "minimum essential" health insurance (26 U.S.C. § 5000A), has received most of the media attention. Lost in the political buzz surrounding this case, however, is the impact of the decision on U.S. regulatory and patent law. In contrast with the Court's decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., it was what the Supreme Court did not do today that provided the impact. Justice Ginsburg summarizes the surprising result in her concurring opinion: "In the end, the Affordable Health Care Act survives largely unscathed." While perhaps not as headline-worthy as the individual mandate provision, the survival of the Biologics Price Competition and Innovation Act (BPCIA), which created a new approval pathway in the U.S. for biosimilar products, is still big news to the biotech/pharma world. And it should be, for biologics totaled $112.93 billion in worldwide sales in 2011, which constituted a $5 billion, or 4.6 percent, increase over 2010 sales.

In the company of the individual mandate provision, the BPCIA could be considered a minimally controversial provision. None of the opinions expressed in this case discussed biologic drugs or biosimilars, and the BPCIA was barely acknowledged during oral argument, with Justice Bryer referring to it as "the biosimilar thing." Following oral argument on March 26-28, the general feeling was that the PPACA would be substantially modified by the Supreme Court, and because the PPACA lacks a severability clause, the bill in its entirety was at risk of being struck down. Should that have occurred, biosimilar producer representatives had indicated that they would lobby the President and Congress to move quickly to pass new biosimilars legislation. Under the current political regime this could take years, and several of the exclusivity periods may have been shortened in the process (see "President's Latest Budget Proposal Seeks Decrease of Data Exclusivity Period and Elimination of Pay-for-Delay Agreements"). During that time, the U.S. would have fallen even farther behind the rest of the world with biosimilars. Europe, in particular, has had a biosimilar pathway in place for nine years (since 2003), and has approved at least fourteen biosimilar products so far. If the uptake of biosimilars in Europe is any indication, there is plenty of incentive to enter the U.S. market as soon as possible. For example, Hospira's epoetin alfa (EPO) biosimilar Retacrit, used to treat anemia resulting from kidney failure and chemotherapy, is already in use in Europe and Australia, and worldwide EPO sales totaled $3.73 billion last year. Overall, the European biosimilars market generated revenues of approximately $172 million in 2010 and is expected to reach almost $4 billion by 2017. Despite these profit incentives, and despite the framework being in force for over two years already, no biosimilars have been approved in the U.S., and most indications are that none are close (as of February, the FDA had yet to receive its first ABLA application).

Today's Supreme Court decision erases any hesitation biosimilar producers may have had in using the BPCIA due to the uncertainty of its survival. With the biosimilars framework intact, efforts to shape the implementation of the pathway will certainly surge: the Biotechnology Industry Organization (BIO) has already issued a statement reconfirming its efforts to collaborate with the FDA on implementing the biosimilars pathway in such a way that will "ensure patient safety, expand patient access and competition, and provide necessary and fair incentives that will help spur continued biomedical breakthroughs." Biosimilar producers can now move forward full steam with their biosimilar products without fear of legislative overhaul and potential disruption of their FDA approval progress. The result is certainly a relief for biosimilar producers who have already invested resources in seeking biosimilar approval from the FDA. Pioneer biosimilar producers such as Sandoz and Hospira are already in Phase III human testing, and they have relied on the BPCIA to provide some clarity as to how biosimilars will be regulated in the U.S. The survival of the BPCIA is welcome news for biologics patient consumers as well, who hope to see lower prices in the near future on these important and typically costly drugs. How much lower the prices will fall is unclear, but by way of example, Hospira has predicted that upon a generic EPO entering the U.S. market, the initial discount would probably be about 35 percent or 40 percent below the reference product price.
Eli Lilly & Co. File Amicus Brief in AMP v. Myriad

June 27, 2012

By Kevin E. Noonan —

We are living in an age of retrenchment with regard to patent law, where thirty years of Federal Circuit precedent, from the court created by Congress to harmonize U.S. patent law to great public benefit, is being reconsidered by the inconstant, almost fickle attention of the U.S. Supreme Court. This has led (somewhat predictably) to a general questioning of patent law and its proper boundaries, evidenced no more clearly by Justice Breyer's ruminations in Mayo Collaborative Services v. Prometheus Laboratories, Inc. regarding what he perceives as the Janus-like qualities of patent protection:

Patent protection is, after all, a two-edged sword. On the one hand, the promise of exclusive rights provides monetary incentives that lead to creation, invention, and discovery. On the other hand, that very exclusivity can impede the flow of information that might permit, indeed spur, invention, by, for example, raising the price of using the patented ideas once created, requiring potential users to conduct costly and time-consuming searches of existing patents and pending patent applications, and requiring the negotiation of complex licensing arrangements.

While this analysis smacks more of Goldilocks than patent jurisprudence (and the opinion provides no rationale or evidence for the Justice's prejudice), it does illustrate the Pandora's box that is opened when Kant's admonition to "doubt everything" becomes the basis for decisions that make no precedent firm.

Another case that illustrates the point is, of course, the Myriad case, in which plaintiffs, many amici, and even the Department of Justice are perfectly willing to reverse thirty years of administrative and judicial precedent (not to mention squandering the untold amounts expended to obtain patent protection of DNA molecules) in a grand, Emily Latella-like gesture of "never mind" regarding gene patenting.

There is one claim at issue in the Myriad case that seems the "odd man out," and that is claim 20 of U.S. Patent No. 5,747,282:

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

Unlike the isolated DNA claims and the method claims for diagnosing/assessing a patient's genetic risk of cancer, claim 20 is directed to a screening method for identifying a compound with potential as a cancer therapeutic by having the property of reducing the growth rate of a cell containing an altered (presumably mutant and cancer-related) BRCA 1 gene and not altering the growth rate of a "normal" cell, i.e. one that does not contain an altered BRCA1 gene. Although not the product of a rigorous analysis, it is likely that there are at least as many claims of this nature in granted patents as there are claims to isolated DNA molecules.

And yet even this claim has been thrown into question and doubt, a doubt explored in an amicus curiae brief by Eli Lilly & Co. The brief, written by Robert Armitage and James Kelley, makes a bold request of the Federal Circuit: to create a "bright line" rule that claims to entirely mental processes "epitomize" patent-ineligible inventions. Further, the authors argue that a claim reciting multiple steps should be patent-ineligible if even only one of the steps is "entirely mental," and that if a claim like claim 20 does not preclude a step from being performed mentally it should be held patent-ineligible.

Their rationale for this calculus is as follows. Patent-eligibility should be used as a threshold filter that defines as being patent ineligible any claim that sets out one or more "mental steps." The brief defines a "mental step" as "a process step drafted in a sufficiently broad manner such that the step includes embodiments that can be carried out mentally" and more specifically "if no limitation in the step precludes the possibility of the human mind performing the step." This proscription is based as an "unavoidable corollary" on the "abstract idea" prong of the Supreme Court's patent-ineligibility precedents (albeit being an extension thereof), and on statements from the Court in both Bilski v. Kappos and Mayo v. Prometheus. The brief also argues that a multistep process is a "combination" invention "for which 35 U.S.C. §112(f) (formerly known as §112, 6th paragraph) dictates that each step of the combination must either explicitly set out one or more acts or be limited to the corresponding acts set forth in the specification of the patent."

Amici's detailed argument begins by recognizing the difficulties in consistently and rationally applying the Supreme Court's nebulous criteria for what it a "natural law, natural phenomenon or abstract idea." One "useful analytical kernel" the authors draw from the Supreme Court case law is that the Court abjures patenting for mental concepts (natural laws) expressed symbolically (explaining the penchant for cases as diverse in outcome as Diamond v. Chakrabarty and Mayo v. Prometheus to cite Einstein's equation relating mass and energy). This leads the authors to their position that it may be more analytically rigorous, and easier to apply, a "mental step" filter instead of the "tripartite test for exclusion" used by the Supreme Court. The policy rationale is that "[t]here can be little doubt that the patent laws were never intended to sanction patentability for inventions that are embodied specifically and exclusively in human thought, human thinking, or human thought processes," if only because infringement of such a claim would involve "no act, just thought." The brief cites In re Heritage, 150 F.2d 554, 556 (CCPA 1945), for the proposition that claims directed to "purely mental processes" are not patent eligible, and that the dissent in Diamond v. Diehr made a similar point, that there is a "mental step" exclusion from subject matter eligibility.

The brief further sets out a "poison species" and a "poison step" approach wherein the presence of even one step that can be characterized as a mental step is enough to bar patent eligibility for the claim. The "poison species" rule is derived from the requirements for novelty, non-obviousness, written description, and enablement, where even a single non-novel or obvious species falling within the scope of a claim, or a single undescribed or non-enabled species, renders a claim unpatentable. The same principles should apply to patent eligibility according to the brief authors. The brief argues that this position is consistent with the Mayo Court's admonition against using "artful claim drafting" to render a claim patent eligible (an admonition that seems to misapprehend the nature of patent claiming; see "Mayo Collaborative Services v. Prometheus Laboratories — What Should We Do? (or Can These Claims Be Saved?)"). In this regard, the brief identifies as "draftsman's machinations" claims written where the "mental step" is rendered patent eligible by the "trick of generically extending the reach of the claim to encompass embodiments to be performed by a machine, rather than the human mind." This immediately raises the question of when does the "trick" change from merely a quantitative difference (in speed of a calculation, or the number of variables involved) to something qualitative (i.e., something a machine can do that the human mind cannot — a patenting version of the Turing test). The brief recognizes that the "poison step" rule is contrary to longstanding precedent under 35 U.S.C. §§ 102 and 103, where the claims are considered as a whole and not cherry-picked step-by-step, but the Supreme Court's disregard for the niceties of the statutory distinctions make this less a disability in the argument than it might have been before the Mayo decision. Indeed, one purported benefit of the amici's approach is to "avoid[] the confusion caused by conflation of novelty, inventiveness, and patent-eligibility considerations evident in Supreme Court dicta. Mayo, 566 U.S. ___, 132 S. Ct. at 1299."

Much of the brief's argument is based on defining a process claim as being a "combination" claim as set forth in 35 U.S.C. § 112(f):

An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.

However, it is equally true that the patent statute defines the meaning of a "process" in 35 U.S.C. § 100(b):

The term "process" means process, art, or method, and includes a new use of a known process, machine, manufacture, composition of matter, or material.

On its face this definition is broader than the definition in § 112(f), a conclusion consistent with the interpretation that § 112(f) sets forth a way of claiming using "means for" or "steps for" achieving a result without specifying the means or steps expressly in the claims. The argument, particularly in Section E of the brief, is thus weakened by the implication that all method claims are governed by § 112(f).

The "mental steps" identified in the brief present in claim 20 include "determining the rate of growth of said host cell in the presence of said compound and the rate of growth of said host cell in the absence of said compound," "comparing the growth rate of said host cells" and (perhaps) "wherein a slower rate of growth of said host cell in the presence of said compound is indicative of a cancer therapeutic," and the brief thus concludes that the claims are ineligible for patenting.

The sweep of patent-ineligibility that would result from the Federal Circuit adopting such a bright line rule is breathtaking and suggests several verities highlighted by the Myriad appeal. The first is that human beings have a strong capacity for deriving theoretical constructs that produce paradoxical or inefficient results; medieval scholars really did seriously consider questions like "how many angels can dance on the head of a pin," despite the irrelevancy of the question to the modern mind. Here, the proposed bright line rule would make the analysis of patent eligibility easier by simply rendering most method claims patent ineligible (other than methods performed exclusively by machines). Another is that the desire to produce "bright line" rules by the Federal Circuit can be seen, as is argued frankly in Lilly's brief, as a reaction against the somewhat "less than pellucid" clarity of Supreme Court teachings in patent law (and the Supreme Court's rejection of the Federal Circuit's bright line rules can be seen as a reflection of its tendency to consider the "totality of the circumstances" without regard to creating legal certainty). It should also be appreciated that, like the medical amici in Mayo, Eli Lilly & Co. is not generally a "producer" of the types of inventions represented by claim 20 but a consumer. It has been predominantly universities and biotechnology companies that have identified the molecular targets for drug discovery and development and have sought anf obtained claims like claim 20, and these entities (non-practicing though they may be in some circumstances) represent a potental source of increased cost to future drug discovery that the Lilly brief's authors could not fail to recognize.

As was clearly evinced in the debates surrounding the Leahy-Smith America Invents Act, the types of questions presented by Mayo and Myriad elicit positions and responses that are political as well as legal in nature. Under the current circumstances, it should not be surprising that self-interest (enlightened or otherwise) will provide at least some motivation for positions advocated by amici as well as the parties involved. It will be up to the Federal Circuit and perhaps one day the Supreme Court to see past these partisan positions to define patent eligibility in a way that does not kill the innovation goose in an effort to save it from an uncertain and unsubstantiated risk from excessive patenting. With luck these courts will be up to the task.

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