Patent Baristas

The Court of Appeals for the Federal Circuit upheld a lower court ruling that Teva Pharmaceutical Industries Ltd. infringed two patents held by Pfizer Inc. for Celebrex, a non-steroidal anti-inflammatory drug (NSAID) used to treat osteoarthritis and rheumatoid arthritis. Pfizer v. Teva (07-1271).

Pfizer has three patents listed in the FDA’s Orange Book protecting its arthritis drug Celebrex (celecoxib), selective non-steroidal anti-inflammatory drug used to treat pain and inflammation. Pfizer sued Teva in 2004 after the company filed an Abbreviated New Drug Application (ANDA) filing for generic approval with the U.S. Food and Drug Administration. Because the patents covering celecoxib were listed in the Orange Book, Teva was required to certify that those patents were invalid or will not be infringed by the manufacture, use or sale of the new drug. Teva’s ANDA challenged the validity of the patents covering celecoxib.

Last year, the U.S. District Court for the Northern District of New Jersey ruled that all three of Pfizer’s Celebrex patents, U.S. Patent Nos. 5,466,823, 5,563,165, and 5,760,068, were valid and infringed by Teva’s ANDA filing. The district court also held that the asserted claims of the three patents were not invalid for a best mode violation and that the asserted claims of the ’068 patent were not invalid for obviousness-type double patenting. The court stopped Teva from selling its generic drug until until December 2015, when the ‘068 patent expires.

In a split decision, the Court of Appeals for the Federal Circuit held that one of the patents, the ‘068 patent, is invalid for double patenting in view of the earlier filed ‘165 patent.

Pfizer originally filed one patent application covering multiple inventions encompass a broad genus of non-steroidal anti-inflammatory compounds, compositions using those compounds, and methods of using those compositions. The claims of the patents include celecoxib—the active ingredient in Celebrex. During review of the application, the patent the patent examiner issued a restriction requirement, which required an election of the following inventions under 35 U.S.C. §121: <

1. Claims 1-20, compounds.
2. Claims 21-26, compositions.
3. Claims 27-37, methods of use.

In response, Pfizer chose to prosecute the generic compound claims and, within that genus, the single compound species celecoxib. The resulting compound claims ultimately issued as the ’823 patent. Subsequent to the restriction requirement but before the ’594 application issued, Pfizer filed a series of continuation applications claiming priority to the ’594 application and covering the non-elected subject matter which it had elected not to prosecute in the original ’594 application.

In particular, Pfizer filed a divisional application, which ultimately issued as the ’165 patent, that included the restricted-out composition claims, and a continuation-in-part application (“CIP”), which ultimately issued as the ’068 patent, that included the restricted-out method claims.

The issue in this case is that patent law prohibits getting more than one patent on the same invention — that is, you cannot get a second patent if it claims an invention that was disclosed or would have been obvious in light of the first patent. However, there is also a rule that says the first patent can’t be used against the second one if the second one is filed in response to the restriction requirement made in the earlier parent application.

35 U.S.C. § 121 provides a safe harbor to patents that issue on applications filed as a result of a restriction requirement:

A patent issuing on an application with respect to which a requirement for restriction under this section has been made, or on an application filed as a result of such a requirement, shall not be used as a reference either in the Patent and Trademark Office or in the courts against a divisional application or against the original application or any patent issued on either of them, if the divisional application is filed before the issuance of the patent on the other application.

In addition to the express requirements of section 121, the statute requires consonance: the applicant must maintain the line of demarcation between the independent and distinct inventions that prompted the restriction requirement. The court held that this safe harbor applies exclusively to divisional applications since a divisional application contains an identical disclosure to its parent application. This consonance requirement prevents an applicant from amending the claims in the divisional application in a way that would violate the originally imposed restriction requirement and thereby impermissibly extend the patent term as to that subject matter.

In the present case, Pfizer had filed a continuation-in-part application, which includes some portion of the original application but also introduces new matter. Teva argued that section 121 applies exclusively to divisional applications, and that because the ’068 patent issued on a CIP rather than on a divisional application, it does not fall within the terms of the statute.

Pfizer tried arguing that the terminology of the application did not matter but the appeals court pooh-poohed it:

There is no suggestion, however, in the legislative history of section 121 that the safe-harbor provision was, or needed to be, directed at anything but divisional applications. The commentary and materials published since section 121’s enactment similarly contain no suggestion that section 121 was meant to cover any applications other than divisionals. Although the legislative history reveals no reason why Congress drafted section 121 only to benefit divisional applications, there are certainly plausible reasons why Congress would have concluded that section 121 should be limited to divisional applications, and not include CIPs. The need for the protection only existed when a divisional application was filed as a result of the restriction.

Because the second application then was without the safe harbor, the court held that it was invalid for obviousness-type double patenting, a judicially created doctrine that prohibits someone from obtaining an extension of their patent rights by filing a later patent that are not patentably distinct from the first. The Appeals Court ruled in Teva’s favor that the patent covering the use in the treatment of inflammation was invalid.

The court ruled that two other patents covering the active ingredient in Celebrex are valid, enforceable and infringed by the Teva’s product. The decision will keep Teva from selling a generic counterpart in the U.S. until May 2014.

It is obviously good news for Pfizer tht they did not lose all of the patents, given that it is one of its biggest sellers with global sales of Celebrex totalling $2.3 billion a year, including $1.7 billion in the U.S. alone. However, the decision will cut Pfizer’s patent term by one and a half years.

The Intellectual Property Owners association (IPO) recently reported on the fifteen possible Judiciary Committee Amendments to S. 1145, that were circulated by the Judiciary Committee last week. IPO noted that the amendments do not address the most hotly debated portions of the bill. Meanwhile, IPO believes Senate leaders will attempt to pass the much-delayed, massive patent reform bill S. 1145 in April or May.

The PharmaBiotech IP Summit held on May 28-30 at the Ritz-Carlton Philadelphia will be addressing how this reform could impact IP practitioners within the pharmaceutical & biotech industries. A high level panel featuring John T. Li from Novartis, Gary Creason from AVEO Pharmaceuticals and Robert Hrubiec from Cephalon will kick off the summit and focus on understanding the reform efforts and what the patent office is attempting to do.

Other speakers include Kathleen Fonda, Legal Advisor Office Of Patent Legal Administration, USPTO, James Gould from Schering-Plough, Robert Hrubiec, VP Intellectual Property and Chief Patent Counsel, Cephalon, Lee Caffin, DVP Global IP Strategy for Abbott Laboratories, and Luisa Bigornia, Vice President Intellectual Property, BioMarin Pharmaceutical.

What:  PharmaBiotech IP USA 2008:  Protect Critical Patents and Drive Sustainable Growth Through IP-Driven Business Strategies. 

When:  28-30 May, 2008. 

Where:  Ritz-Carlton Philadelphia, PA.

Update:  Patent Baristas readers save 15% off registration to Pharmabiotech IP with code 13299.001XZ299.

For more information: www.pharmabiotech-ip.com
Email:  pharmabiotech-ip@wbresearch.com

Today is Pi Day 2008.  Pi, Greek letter (), is the symbol for the ratio of the circumference of a circle to its diameter. Pi = 3.1415926535… Pi Day is celebrated by math enthusiasts around the world on March 14th at 1:59 p.m.  (*As noted in the comments, this only works if you write the month in front of the day.)  The first theoretical calculation of a value of pi was by Archimedes of Syracuse (287-212 BC).  You can celebrate with a Pi-Ku.

thinkBiotech has some new books out on biotechnology.

The Patent Office held a Biotechnology/Chemical/Pharmaceutical Customer Partnership on March 12.  It included a presentation on the Patent Prosecution Highway and Enablement in Claims to Therapeutic Treatment.

The Collegiate Inventors Competition is now accepting entries for 2008.  The Competition promotes exploration in invention, science, engineering, technology, and other creative endeavors and provides college students to compete based on the originality and inventiveness of their new idea, process, or technology. One Undergraduate and one Graduate winner or team each receive $15,000. One Grand Prize winner or team receives $25,000.

Gmo Food for Thought Blog has a piece on the discovery of the plant gene that controls the amount of carbon dioxide absorbed and water released by a plant.  In practical terms, this means a plant that could both survive in severe drought conditions AND help fight global warming effects.

Since Spring is coming, I’ll mention that Husqvarna launched the world’s first automatic electric solar powered hybrid robotic lawn mower.

Finally, the baristas at Starbucks would like a $100 million tip back from the company. (Hat tip Blawgreview Ed.)

The big buzz around the IP world is that Rick Frenkel, the anonymous blogger of the Troll Tracker blog who just revealed his identity, along with his employer Cisco, have been sued for defamation by two attorneys from Texas, Eric Albritton and T. John Ward, Jr.

The lawsuit may be due to a posting over who filed what when in a lawsuit against Cisco for patent infringement. For Cisco, their response is apparently:

“The parties have mutually agreed to make no comment on the lawsuit in question at this time. That said, we would like to underscore that the comments made in the employee’s personal blog represented his own opinions and several of his comments are not consistent with Cisco’s views. We continue to have high regard for the judiciary of the Eastern District of Texas and confidence in the integrity of its judges.”

This story of mystery and intrigue can be followed at the Prior Art, by IP Law & Business writer Joe Mullin.

Earlier posts:

• Raymond Niro Responds to Patent Troll Tracker
• Bounty On The Blawger?

Also see:

• Legal Pad
• Prior Art
• Patently-O
• Securing Innovation
• peter zura’s 271 patent blog
• Case docket in Gregg County District Court
• Robert J. Ambrogi’s LawSites
• TechDirt
• Overlawyered
• WSJ Law Blog

The United States Patent and Trademark Office is moving ever onward with its proposed revision to the rules of practice pertaining to any claim using alternative language to claim one or more species. That is, if the claims use Markush or other forms of alternative language.

Markush claims, officially sanctioned since 1924, is a claim drafting technique using the phrase ‘‘selected from the group consisting of’’ followed by a closed listing of specific members of the group.  These types of claims allow an applicant to describe an invention where there is no available wording for the group. 

According to the USPTO, the search and examination of such claims consume a disproportionate amount of Office resources as compared to other types of claims.  I guess as opposed to claims that don’t use big words.

Specifically, the USPTO is complaining about applications claiming compounds by their chemical structure (read: they’re gunning for the Chemical and biotech arts).  The proposed rules would allow the Office to require new application for each listed item.

After publishing a notice proposing to revise the rules (Alternative Claims Notice of Proposed Rule Making), the Office received several comments/complaints concerning the impact of the proposed rules on small businesses and independent inventors.  So, the Office prepared an analysis on this proposed change to the rules of practice.

Description and estimate of the number of affected small entities:

Using the preceding definition of small entity, the Office screened these published applications for commonly used alternative language (e.g., ‘‘contains one selected from the group consisting of’’) and identified 20,824 small entity applications as containing alternative language and, therefore, as potentially affected by the proposed rule. The Office estimates that this represents approximately 31% of total applications containing alternative language.

As you could guess, a larger proportion of applications containing alternative language is concentrated in the biotechnology/chemical arts since those are the arts where there isn’t a good word to describe a group of related elements(43.4% small entity applications in the biotechnology/chemical arts and 15.8% electrical and mechanical arts).

Description of the projected reporting, recordkeeping and other compliance requirements of the proposed rules:

The proposed rule could potentially impact applicants in two ways:

First, it would require that a claim must be limited to a single invention. Consequently, if a submitted application contains a single claim that defines multiple independent and distinct inventions, then the examiner may apply an intra-claim restriction — applicants who want patent protection for the full scope of the initial application would have to file a divisional application for each additional invention defined in that original claim.

Second, the proposed rule allows examiners to require applicants to make amendments to simplify the presentation of claims.

The Office thinks that an applicant would need to file at most seven divisional applications following an examiner’s restriction requirement, “even if more were needed to seek patent protection for the full scope of the originally claimed inventions.” Basically, they decided on seven because stating the real cost would just sound bad and have decided that applicants don’t really need to pursue protection on “the full scope” of inventions.

Using this arbitrary point, the Office states that the cost of seven divisional applications would have present value of approximately $42,000. However, the Office’s analysis showed some applications would have required more than 100 divisional applications to maintain scope.

That is, their own estimates show it could cost $600,000 and that is an unrealistically low estimate for the costs. The Office’s own analysis states that the estimated cost for applications needing one divisional application and one amendment to correct the format of the claim(s) would run $14,287. Even for the seven divisional median they are touting, this puts the increased cost at over $100,000 per application. with very complex applications topping $1.4 million.

Oh, and if your considered a large entity, the Office has apparently decided that you can afford to fork over all the extra money so it really isn’t interested in hearing your whining.

To be fair, the Office did say it looked at alternatives but said that “none of these alternatives would accomplish the stated objectives of applicable statutes with a lesser economic impact on small entities,” e.g.,

1. Hiring more examiners: No can do.
2. Charging additional fees for applications containing claims using alternative language: Fun but no.
3. Limiting the number of species that may be presented in an application: You would just have to file all your applications sooner.
4. Exempting small entities (or take no action): No way.

If you want to (try to) make your voice heard, written comments must be received on or before April 9, 2008. No public hearing will be held.

• Comments on the analysis should be addressed to markush-irfa.comments@uspto.gov
• Comments on the proposed rules should be sent to markush.comments@uspto.gov.

Proposed rule, request for comment on initial regulatory flexibility analysis

See also:  USPTO to Limit Markush (Alternative) Claims: Serious Cost Increase in the Forecast

What happens when a brand name drug company asserts that a patent covers its drug and then pulls it out from the Orange Book? You fight to get it back in, that’s what.

In August, Teva Pharmaceuticals USA submitted a Citizen Petition pursuant to section 505 of the Food, Drug, and Cosmetic Act (FDCA) asking the FDA to do just that.

The FDA’s official Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book“) listed two patents as claiming Risperdal® tablets: U.S. Patent No. 4,804,663, which was set to expire on December 29, 2007, and U.S. Patent No. 5,158,952 (“the ‘952 patent”), which will expire on October 27, 2009.  Risperidone is an antipsychotic medication sold by Janssen Pharmaceutica (a subsidiary of Johnson & Johnson) under the trade-name Risperdal®.

Teva submitted an original Abbreviated New Drug Application (ANDA) seeking approval to market generic risperidone tablets. Because the Orange Book listed both the ‘663 and ‘952 patents for Risperdal® tablets, Teva was required to certify as to both patents.

Teva filed a certification under § 355(j)(2)(A)(vii)(III) (“Paragraph III certification”) as to the ‘663 patent, which is set to expire on December 29, 2007, and a certification under § 355(j)(2)(A)(vii)(IV) (“Paragraph IV certification”) as to the ‘952 patent, asserting that the patent was invalid or would not be infringed by Teva’s generic risperidone tablets.

Ordinarily, Teva would be entitled to 180 days of marketing exclusivity for its generic risperidone tablets as a result of its paragraph IV certification to the ‘952 patent. That’s because the ‘952 patent appeared in the official Orange Book when it originally filed – that meant that Teva was required to submit a certification to that patent at the time it submitted its ANDA for generic risperidone drug products. Teva then became the first company to submit a paragraph IV certification to any of the listed patents claiming Risperdal®.

On October 12, 2001, FDA notified Teva that it had “delisted” the ‘952 patent from the Orange Book (even though it continued to appear in the official Orange Book at that time) It also informed Teva that it would not accept Teva’s ANDA for filing unless Teva modified its patent certification to reflect that the ‘952 patent was no longer listed as claiming the reference drug product.

In November 2006, the D.C. Circuit ruled that the plain text of the FDCA prevented the FDA from effectuating the delisting of a patent following the submission of a paragraph IV certification as to that patent. Ranbaxy Laboratories Ltd. v. Leavitt, 469 F.3d 120, 125-26 (D.C. Cir. 2006). The court struck down the FDA’s practice because it “changed the incentive structure adopted by Congress,” by “depriving the generic applicant of a period of marketing exclusivity” after the generic manufacturer had expended significant resources in developing a non-infringing generic substitute and undertaken the risk of infringing the patent by filing a paragraph IV certification.

Teva then filed a Citizen’s Petition with the FDA arguing that the FDCA entitles Teva to a 180-day period of first-filer exclusivity for generic Risperdal® tablets since it was the first generic manufacturer to file an ANDA for generic risperidone tablets containing a paragraph IV certification as to the ‘952 patent.

Under 21 U.S.C. § 355(j)(5)(B)(iv) (2002), the earliest any subsequently-filed paragraph IV ANDA can be approved is “one hundred and eighty days after” Teva first commercially markets its generic risperidone tablets or the date of a court decision holding the ‘952 patent to be invalid or not infringed.

Teva argued that both FDA regulations and case law make clear that the agency does not adjudicate questions of patent law; instead, it plays only a ministerial role in maintaining the Orange Book. As a result, where a patent remains listed for a particular drug in the official Orange Book, a generic applicant has no choice but to believe that the NDA holder is continuing to assert that patent as claiming the listed drug.

Thus, at the time of its ANDA submission in August 2001, Teva was required to submit a certification to the ‘952 patent. Teva now wants its 180-exclusivity for these drug products.

The question here is whether or not a brand manufacturer can game the system by delisting a patent after the submission of a paragraph IV certification and without notice, forcing generic manufacturers to invest resources and assume the risk of patent litigation without any guarantee of the 180-day exclusivity reward.

The FDA wrote back a nice note to Teva:

We have carefully reviewed your Petition and have concluded that the ‘952 patent was delisted before Teva submitted ANDA 76-228 to FDA. For the reasons described in further detail in this Response, we deny your request that FDA relist the ‘952 patent. As Teva’s ANDA did not contain a paragraph IV certification for a listed patent, and Teva did not provide the required notice of such certification to the holder of the NDA for the reference listed drug and each owner of the listed patent, Teva would not be eligible for 180-day exclusivity pursuant to section 505(j)(5)(B)(iv) of the Act for its pending ANDA 76-228.

Like a game of Calvinball*, since the FDA had itself forced Teva to remove the paragraph IV certification or it wouldn’t accept the ANDA, the FDA now claims that Teva’s out of luck because it did, in fact, take out the certification.

Nice.

It probably wouldn’t take a law degree to guess that Teva has filed a lawsuit in federal court to try to get the Petition granted. Johnson & Johnson’s sales of antipsychotics in the U.S. were more than $2.7 billion last year with Risperdal accounting for a large part of that amount. A generic can make quite a bit in just 180 days.

Stay tuned.

Teva vs. FDA Complaint

[*Note: Under the Official Rules of Calvinball, Rule 1.2. states: “Any player may declare a new rule at any point in the game (Figure 1.2). The player may do this audibly or silently depending on what zone (Refer to Rule 1.5) the player is in.”]

Since the original decision in Ex Parte Bilski, the fate of U.S. application 08/833,892 has been a subject of great interest to the patent law community. Last month, the Federal Circuit, on its own initiative, issued an order granting an en banc hearing to the appeal of Bilski’s rejection by the patent office.

Since then, both the patent law community (see, e.g., here, here and here) and the mainstream media (e.g., here and here) have been all atwitter about the possibility of a major shift in patent law and the possible end of business method or software patents (or both). While the excitement is understandable, in this case I think it’s misplaced.

The Federal Circuit asked whether it should reconsider some of its patentable subject matter cases but I think it is unlikely to make any major changes it its existing jurisprudence. Further, to the extent that the Federal Circuit does make changes to its existing jurisprudence, I think it is unlikely that those changes will have much effect on the day to day business of getting patents. My reasons for this can be seen in the questions included in the Federal Circuit’s en banc order.

Question 1: Whether claim 1 of the 08/833,892 patent application claims patent-eligible subject matter under 35 U.S.C. § 101?

This is devoted to the narrow question of what to do with a particular claim in a particular patent. The Federal Circuit could answer this question in the negative by simply agreeing with the BPAI and leaving the broader picture of patent law untouched. While I think that’s unlikely to happen, this first question doesn’t indicate that the Federal Circuit is planning on doing away with business methods in general.

Question 2: What standard should govern in determining whether a process is patent-eligible subject matter under section 101?

This question, while broader than question 1, is focused on a particular class of patentable subject matter (processes), and is therefore unlikely to have much effect on the practice of “business method” patents. The BPAI’s original rejection of Bilski’s claims was based on the concept that the decisions which are generally recognized as opening the door to software and business method patents, State St. Bank & Trust Co. v. Signature Fin. Group and AT&T v. Excel Communications were limited to the “‘special case’ of transformation of data by a machine.”

Using that distinction, even if the Federal Circuit (contrary to statute) completely eliminates protection for process patents, clever attorneys can still get their “business method” patents past the 101 hurdle by casting them in the form of machines that manipulate data. Indeed, even Amazon’s notorious “1-Click” patent includes claims directed to machines, rather than being limited to process claims.

Question 3: Whether the claimed subject matter is not patent-eligible because it constitutes an abstract idea or mental process; when does a claim that contains both mental and physical steps create patent-eligible subject matter?

Like question 2, the answer to this question (whatever it is) is unlikely to have much practical effect because it is limited to process claims, and, moreover, to process claims which contain both physical and mental steps. However, as the state of the art in programming progresses, more and more steps which are today “mental” will eventually be performed by a machine, thereby allowing their inclusion in claims. Moreover, even if the Federal Circuit rules that any process including a step which could be performed by a human being is unpatentable, it still leaves open the “special case” of writing claims directed to the transformation of data by a machine, which keeps the door for business method and software patents wide open.

Question 4: Whether a method or process must result in a physical transformation of an article or be tied to a machine to be patent-eligible subject matter under section 101?

Like questions 2 and 3, regardless of the answer to this question, protection for “business method” type inventions will still be available as long as the invention can be described in terms of data processing. Further, even if that was not the case, requiring that a process be tied to a machine, or result in a physical transformation of an article would do no more than throw up formal barriers which would be easy to overcome.

For example, I can easily tie almost any process I write claims for to a computer, and it would be a trivial task to require that the computers make a physical change in an article (e.g., printing an invoice). Thus, I just don’t see the answer to question 4 really having any significant impact on my (or any other patent prosecutor’s) day to day practice.

Question 5: Whether it is appropriate to reconsider State Street Bank & Trust Co. v. Signature Financial Group, Inc., 149 F.3d 1368 (Fed. Cir. 1998), and AT&T Corp. v. Excel Communications, Inc., 172 F.3d 1352 (Fed. Cir. 1999), in this case and, if so, whether those cases should be overruled in any respect?

Unlike the previous four questions, this last question in the en banc order could result in a major shift in the landscape of patent law. However, even if the Federal Circuit completely overruled State Street and AT&T, at least for software patents, lawyers would be able to continue based on the Supreme Court’s case of Diamond v. Diehr which stated that when a claim containing a mathematical formula implements or applies the formula in a structure or process which, when considered as a whole, is performing a function which the patent laws were designed to protect (e. g., transforming or reducing an article to a different state or thing), then the claim satisfies 101’s requirements.

As long as that case is good law (and the Federal Circuit doesn’t have the power to overturn it) patent attorneys will be able to use it as shield to protect their software (and likely business method) claims from 101 rejections.

Today’s post comes from Guest Barista William Morriss, a registered patent attorney in Frost Brown Todd’s Cincinnati office and a Contributor to Ephemerallaw.

The U.S. Patent and Trademark Office (USPTO) has proposed making changes to the rules regarding when an invention involves biological material.  Often, these can’t be adequately described using just words.

As a way to supplement the written description of an invention, courts have sanctioned a procedure in which biological material may be deposited with an appropriate holding facility under conditions which ensure that the sample is properly maintained, and made available to others when appropriate.

For biological inventions, for which providing a description in written form is not practicable, one may nevertheless comply with the written description requirement by publicly depositing the biological material * * *. Such description is the quid pro quo of the patent system; the public must receive meaningful disclosure in exchange for being excluded from practicing the invention for a limited period of time. Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 970, 63 USPQ2d 1609, 1617 (Fed. Cir. 2002).

This is a requirement under 35 U.S.C. 112, first paragraph, which requires that an inventor must disclose the invention in such a manner that would allow the public to make and use it without undue experimentation. Internationally, the deposit of biological materials is governed by the Budapest Treaty.

The proposed rules would require:

(1) that any deposit of biological material be made before publication of a patent application; and

(2) that all restrictions on access to the deposited material imposed by the depositor be removed upon publication.

The proposed changes will provide that the public has access to biological materials referenced in the disclosure of a patent application to the same extent that access to the remainder of the disclosure is available. The public policy basis for allowing access to a referenced item is the same whether the item is another patent application or a deposited biological material.

The concern is that under the American Inventors Protection Act of 1999 (AIPA), patent applications publish eighteen months after the earliest priority date. In exchange for this disclosure, the AIPA also provided a provisional right under 35 U.S.C. 154(d) to obtain a reasonable royalty if the invention as claimed in the published patent application is substantially identical to the invention claimed in any patent that might issue and certain other conditions are met.

Only those patent application publications which provide an enabling disclosure of the claimed invention would be entitled to provisional rights under 35 U.S.C. 154(d). Although the AIPA allowed for certain applications to be published in redacted form, any redacted application was nevertheless required to contain a disclosure that would allow a person skilled in the art to make and use the subject matter of the claim.

The USPTO now states:

The proposed rule change brings the Office practice regarding biological deposits in line with the publication of patent applications under AIPA. Courts have consistently recognized that an applicant must have provided the Office with an enabling disclosure no later than the time an invention is disclosed to the public. Prior to publication of patent applications under the AIPA, disclosure occurred simultaneously with patent issuance. Thus, earlier court decisions held that deposits needed to be perfected at the time the patent became public, i.e., at the issue date.

In the era since Hawkins and Argoudelis were decided, Congress changed the law to require that most patent applications be published eighteen months after filing, and to grant provisional rights under certain conditions. Publication of patent applications under the AIPA means that the patent issue date is no longer ‘‘the time [the patent disclosure] is made public,’’ or the time when ‘‘the conditions of Rule 14 are met.’’

In part, Title 37 of the Code of Federal Regulations, is proposed to be amended as follows:

Section 1.804 is proposed to be amended to provide that if a biological material is necessary to preserve the availability of provisional rights under 35 U.S.C. 154(d), the deposit of the biological material must be made prior to filing an application or during the pendency of an application, provided that the deposit is made before technical preparations for publication of the application as a patent application publication have begun (see § 1.215(a)).

Section 1.808(a)(2) is proposed to be amended to provide that all restrictions imposed by the depositor will be irrevocably removed upon the earlier of publication of the application under § 1.211 and 35 U.S.C. 122(b) or grant of the patent, and to indicate that the rule applies regardless of whether the deposit was made to satisfy a statutory provision.

Section 1.808(b) is amended to add ‘‘before the patent is granted or’’ before ‘‘term of the patent.’’

Section 1.808(c) is amended to provide that the Office will, on request, certify that an application referring to the deposit has been filed, that the subject matter of that application involves the deposited biological material or the use thereof, that the application has been published or patented or is otherwise open to public inspection, and that the requesting party has a right to a sample of the biological material. This is the certification called for in Rule 11.3 of the Regulations Under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure. A form, BP/12, is provided on the World Intellectual Property Organization’s Internet Web site (http://www.wipo.int) for this purpose.

Section 1.809(e) is proposed to be amended to delete ‘‘before or with the payment of the issue fee (see § 1.312)’’ and to insert ‘‘(1) within a period of sixteen months after the date of filing of the application or, if the benefit of an earlier filing date is sought under 35 U.S.C. 119(e), 120, 121, or 365(c), within the later of four months of the actual filing date of the later-filed application and sixteen months from the filing date of the prior-filed application; and (2) before or with any request for early publication (§ 1.219).’’

Comments should be sent by e-mail addressed to AB99.Comments@uspto.gov. Comments may also be submitted by mail to: Mail Stop Comments— Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA, 22313–1450, or by fax to (571) 273–7754, marked to the attention of Kathleen Kahler Fonda. Written comments must be received on or before April 21, 2008. No public hearing will be held.

See all the details here.