Patent Baristas

If an authority grants two patents for the same invention to the same applicant, that is double patenting. In most European states the law requires that one of the patents must cease.

Since it started, the European Patent Office (EPO) official view has been that it should not allow double patenting. The Guidelines for Examination explicitly state this. However, the governing European Patent Convention (EPC) makes no mention of double patenting.

A recent Technical Board of Appeal (TBA) decision, T 307/03, tried to find basis for the prohibition of double patenting in the EPC provision governing ownership of the invention.

The recent TBA decision T1423/07 rejects T 307/03 and confirms that the EPC gives no legal basis for any EPO prohibition of double patenting. The TBA decided there is nothing in the EPC explicitly prohibiting an applicant obtaining two patents for an invention, provided the applicant has a legitimate interest in doing so.

Consequences

This decision makes it more difficult for the EPO to refuse, on the grounds of double patenting, a divisional application to subject matter similar to that of the parent application.

However, the decision left open the possibility of refusing such an application if the applicant does not have ‘a legitimate interest’. We await the reaction of the EPO examiners with interest.

Please do not hesitate to contact us if you have any questions or if you would like further information.

Today’s post is by Guest Barista Matt Barton, a UK Chartered Patent Attorney and European Patent Attorney at Forresters in London.

After having some new faces join our firm, I’ve been thinking about the inherent difficulties of balancing work with the rest of life.  While I’ll leave the question of whether lawyers can achieve a work-life balance — or if many even want balance — for another day, I do think it’s useful to take stock of things as they are.  The school year is ending and summer is beginning.  For us, that means summer associates will be joining us soon and a whole new group of faces to learn.  It is also a good time to shed ourselves (and offices) of items that are cluttering up our lives.

After some time reflecting on all the things lawyers have to do, I can see that streamlining my life has held some valuable benefits.  Learning from a family of four that made the decision to minimize their possessions, declutter their home, and simplify their life, you can experience some of the same freedom.  Becoming Minimalist offers the most important lessons they have learned through the process in their new e-book: Simplify: 7 Guiding Principles to Help Anyone Declutter Their Home and Life.

From the Becoming Minimalist blog:

“Never continue in a job you don’t enjoy. If you’re happy in what you’re doing, you’ll like yourself, you’ll have inner peace. And if you have that, along with physical health, you’ll have more success than you could possibly have imagined.” – Roger Caras

Minimalism has many benefits. It gives freedom, time, and reduces stress. Minimalism also reduces the amount of money that is required for survival. And as a result, it allows the opportunity to choose a job not based solely on the amount of the paycheck.

To enjoy waking up in the morning, Becoming Minimalist notes to consider these 12 factors to look for in a job other than a paycheck:

1. It makes a positive difference. Choose a job that adds value to our world, that leaves it better than you found it, and genuinely helps other people.
2. You enjoy your co-workers. Given the fact that you will spend a large percentage of your day at work, be sure you enjoy the people around you. It is comforting to know that they support you, cheer for you, and work together as a team.
3. You feel appreciated and valued. A paycheck is nice, but that goes straight to the bank. On the other hand, appreciation is something that you carry in your soul every day. This appreciation can be communicated through respect, unexpected gifts, or just an old-fashioned “thank-you.”
4. You are trusted. It’s nice to know that somebody isn’t always looking over your shoulder. And that when you are given a task, you are given the freedom to complete it.
5. It is something you love to do. The old adage is completely true, “Find a job that you love and you’ll never have to work a day in your life.” Look for a job that keeps you motivated by its very nature, not solely by the paycheck – because that wears off real fast.
6. It fits your personality. Anyone who has ever taken a personality test knows that we all have unique personalities that thrive in certain environments. Some enjoy working with people, others enjoy completing tasks. Some like making the decisions, others don’t. Find a job that fits your sweet spot. And by the way, if you keep getting this one wrong, there are people who can help you with this step.
7. It challenges you to grow. Look for a job that will make you better. Whether through challenging assignments, educational opportunities, demanding excellence, or informal mentors, a job that forces you to grow beyond your current skill set will make you a better person and it, a better company.
8. The firm’s/company’s values align with yours. At the end of the day, your integrity is what matters most. Don’t compromise it every time you walk into the workplace. If you are at a job that requires you to suspend your personal convictions, you don’t need to be… nor should you be.
9. A flexible, results-oriented culture. A culture of flexibility suggests a results-driven focus. One that is more interested in you successfully completing your job with excellence than clocking in a set amount of work hours during a specified time of the day.
10. It values family. You value your family. Your job should too.
11. Brings balance to life. Work is not so bad when you love it. But if you are not allowed to explore other endeavors (play/hobbies/family) because of its demands, it is not healthy for your soul, life, or body. Find a job that allows you to enjoy your life outside of work too.
12. It brings you satisfaction. The ability to look back at your day, your year, or your life with satisfaction is more valuable than any number of digits in the bank.

Click here to visit Becoming Minimalist.

On March 29, 2010, the University of Utah and Myriad Genetics Inc. lost a U.S. court ruling over some of its patents for detecting inherited breast cancer related to the genes BRCA1 and BRCA2.  The 152-page decision, which addresses questions about whether human genes should be subject to patent protection, could have major ramifications for gene-related patents.

Earlier, the American Civil Liberties Union (ACLU), the Public Patent Foundation (PUBPAT), and a whole gaggle of others have filed a lawsuit challenging patents cover diagnostic tests for mutations along the genes, known as BRCA1 and BRCA2, which are responsible for most cases of hereditary breast and ovarian cancers.   Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, et al. (09 Civ. 4515)

Emphasizing that “purification of a product of nature, without more, cannot transform it into patentable subject matter” since the isolation or “purification of native DNA” did not alter the “essential characteristic- its nucleotide sequence…”, the Court held the composition of matter claims of the BRCA1 and BRCA2 patents did not meet the statutory requirements of 35 U.S.C. § 101 and were thus invalid.

The utility of purified BRCA1/2 DNA molecules as biotechnological tools relies on their ability to selectively bind to native or isolated BRCA1/2 DNA molecules, which is a function of the isolated DNA’s nucleotide sequence.

The decision mainly focused on the basic requirements of patentability set out by statute.  Section 101 of Title 35, United States Code, provides:

Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title.

While the court noted that the Supreme Court in Diamond v. Chakrabarty said that “Congress plainly contemplated that the patent laws would be given wide scope,” this broad reading of 101 and statutory patent eligibility is not without limits.  The court then looked at whether or not claims directed to isolated DNA containing naturally-occurring sequences fall within the products of nature exception to § 101.

Citing the Supreme Court:

There are many things well known and valuable in medicine or in the arts which may be extracted from divers[e] substances. But the extract is the same, no matter from what it has been taken. A process to obtain it from a subject from which it has never been taken may be the creature of invention, but the thing itself when obtained cannot be called a new manufacture.

Through a whole series of case law, the court frames the question in these other cases as one of novelty (a § 102 question), not of patentable subject matter (a § 101 question).

The question thus presented by Plaintiffs’ challenge to the composition claims is whether the isolated DNA claimed by Myriad possesses “markedly different characteristics” from a product of nature.

The central premise of Myriad’s argument that the claimed DNA is “markedly different” from DNA found in nature is the assertion that “[i]solated DNA molecules should be treated no differently than other chemical compounds for patent eligibility,” and that the alleged “difference in the structural and functional properties of isolated DNA” render the claimed DNA patentable subject matter.

The court distinguished the present invention from chemical inventions by making a big deal out of the “unique characteristics of DNA that differentiate it from other chemical compounds”:

As Myriad’s expert Dr. Joseph Straus observed: “Genes are of double nature: On the one hand, they are chemical substances or molecules. On the other hand, they are physical carriers of information, i.e., where the actual biological function of this information is coding for proteins. Thus, inherently genes are multifunctional.” This informational quality is unique among the chemical compounds found in our bodies, and it would be erroneous to view DNA as “no different[]” than other chemicals previously the subject of patents.

“[N]one of the structural and functional differences cited by Myriad between native BRCA1/2 DNA and the isolated BRCA1/2 DNA claimed in the patents-in-suit render the claimed DNA “markedly different.” This conclusion is driven by the overriding importance of DNA’s nucleotide sequence to both its natural biological function as well as the utility associated with DNA in its isolated form. The preservation of this defining characteristic of DNA in its native and isolated forms mandates the conclusion that the challenged composition claims are directed to unpatentable products of nature.

Were the isolated BRCAI/2 sequences different in any significant way, the entire point of their use – the production of BRCA1/2 proteins – would be undermined.

The court was adamant that the scientific challenges to the discovery had no bearing on the result:

The identification of the BRCA1 and BRCA2 gene sequences is unquestionably a valuable scientific achievement for which Myriad deserves recognition, but that is not the same as concluding that it is something for which they are entitled to a patent. Because the claimed isolated DNA is not markedly different from native DNA as it exists in nature, it constitutes unpatentable subject matter under 35 U.S.C. § 101.

But, if claims to DNA sequences are invalid under 101, what about claims for “analyzing” and “comparing”?  Myriad tried arguing that the claims incorporate a transformation step and therefore satisfy the “transformation” prong of the Bilski “machine or transformation” test. The court disagreed:

Myriad argues that just as the act of “determining” metabolite levels in Prometheus was found to involve the transformation of human blood, so too should “analyzing” or “comparing” BRCA1/2 gene sequences be construed to incorporate physically transformative steps (i.e. the isolation and sequencing of DNA) that would satisfy the Bilski “machine or transformation” test. Myriad further asserts that these transformations are “central to the purpose of the claims,” id. at 1347, because “Myriad’s method claims each require the transformation of a tissue or blood sample in order to isolate the patient’s DNA.”

The “isolation and sequencing of DNA from a human sample, even if incorporated into the method claims-in-suit, would represent nothing more than data- gathering steps to obtain the DNA sequence information on which to perform the claimed comparison or analysis. Moreover, in the absence of a specified method for isolating and sequencing DNA, u[a] requirement simply that data inputs be gathered – without specifying how – is a meaningless limit on a claim to an algorithm because every algorithm inherently requires the gathering of data inputs.”

A copy of the complaint is also available here: Myriad Decision (pdf)

From Don Chisum & Janice Mueller:

The Chisum Patent Academy will offer its second annual Intensive Patent Law Training Workshop at its offices in Seattle, Washington, on July 29-31, 2010. The workshop will focus on substantive patent law (patentability and enforcement) through analysis of critical Federal Circuit and Supreme Court decisions.  New material for the 2010 class will likely include business method patentability post-Bilski, written description requirement compliance post-Ariad, and the evolving landscape of inequitable conduct as reflected by the Federal Circuit’s recent grant of rehearing en banc in Therasense (see 2009 syllabus here).

The workshop is team-taught in seminar style (maximum of 10 students) by Donald Chisum, author of the treatise Chisum on Patents (LexisNexis), and Professor Janice Mueller, author of Patent Law, 3d Edition (Aspen 2009). Chisum and Mueller have a combined total of over 40 years experience teaching patent law. The workshop’s coverage is geared for junior patent attorneys, summer associates, engineers, scientists, paralegals, information specialists, and attorneys experienced in non-patent fields who desire an intensive introduction to patent law. Eighteen hours of CLE credit have been applied for.

For registration details, see here.

There is a new blog setting out information about patent goings-on in Europe.  According to the EPLAW Patent Blog, it  aims to be a top-quality, free, independent European blog on patent law, providing speedy access to patent judgments and patent information from various European jurisdictions.

In its coverage of the recent UK case, Neurim Pharmaceuticals (1991) Limited v. Comptroller-General of Patents, 6 May 2010, Case No. [2010] EWHC 976 (Pat), EPLAW Patent Blog details how the English High Court upheld a decision not to grant a supplementary protection certificate (SPC) for a product containing the active ingredient melatonin.  Article 3(d) provides that an SPC will only be granted if the authorisation granted to market the product as a medicinal product under article 3(b) is the first authorisation to that effect.

In this case, Neurim had filed an application for an SPC in September 2007, based on an authorisation to market melatonin for human use given in June 2007. The examiner had objected to Neurim’s SPC application because of a March 2001 authorisation for a veterinary medicinal product which contained melatonin as the active ingredient.

The judge followed the Court of Justice’s interpretation of Article 3(d) in Pharmacia, MIT and Yissum, holding that the authorization required under 3(b) is the first authorisation to place the product on the market as “any” medicinal product. A different indication of the product or the fact it is used for a different species, here the use for treatment of primary insomnia in humans as opposed to increasing the reproductive performance of sheep, were held to be irrelevant.

About EPLAW Patent Blog

The EPLAW Patent Blog aims to be a top-quality, free, independent European blog on patent law, providing speedy access to patent judgments and patent information from various European jurisdictions.

The blog intends to -over time- cover all relevant European national patent case law and news from all European jurisdictions. Also, the blog contains posts providing in-depth analysis of current developments. Of course, the blog provides a perfect platform for discussion.

The content of the blog is provided by an international team of patent specialists acting as editors/correspondents. Third party contributions are welcomed (although we do reserve the right to not publish all materials sent to us).

We think you’ll enjoy following this site as well.  (via Hal Wegner)

After the US Patent and Trademark Office denied a patent term extension under 35 U.S.C. §156, to Metvixia® — with an active ingredient methyl aminolevulinate hydrochloride — Photocure ASA sought a do-over in district court under the Administrative Procedure Act, 5 U.S.C. §702.

The district court held that the PTO’s ruling was “not in accordance with law,” and that the patent on MAL hydrochloride is subject to term extension. The USPTO Director David Kappos appealed claiming that the district court did not correctly define or apply the statutory terms “drug product” and “active ingredient.”  The US Court of Appeals for the Federal Circuit sided with the district court.  Photocure ASA v. Kappos (09-1393).

The Patent Term Extension statute was enacted in recognition of the long procedures associated with regulatory review of a new drug product, for the patent term continues to run although the product cannot be sold or used until authorized by the Food and Drug Administration. The statute was designed to restore a portion of the patent life lost during the period of regulatory review, in order to preserve the economic incentive for development of new therapeutic products.

35 U.S.C. §156(a):

The term of a patent which claims a product, a method of using a product, or a method of manufacturing a product shall be extended in accordance with this section . . . , if– (a)(4) the product has been subject to a regulatory review period before its commercial marketing or use; (a)(5)(A) except as provided in subparagraph (B) or (C) [not here relevant], the permission for the commercial marketing or use of the product after such regulatory review period is the first permitted commercial marketing or use of the product under the provision of law under which such regulatory review period occurred;

A product includes a new drug, antibiotic drug, or human biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act), . . . including any salt or ester of the active ingredient, as a single entity or in combination with another active ingredient.

Metvixia® is used in photochemotherapy or photodynamic therapy to treat actinic keratoses, which are precancerous cell growths on the skin. When the Metvixia® cream is applied to the skin, the MAL hydrochloride concentrates in the cells to be treated. The cells use MAL hydrochloride to form an excess amount of a naturally-occurring, light sensitive compound called protoporphyrin IX (“Pp”). On exposure to light, the Pp is activated and a chemical reaction ensues that kills the precancerous cells.

MAL hydrochloride was a new chemical compound, and was patented in U.S. Pat. No. 6,034,267 on the basis of its improved therapeutic properties as compared with the known compound aminolevulinic acid hydrochloride. MAL is the methyl ester of ALA. ALA hydrochloride had previously received FDA approval for the same therapeutic use. The specification of the ’267 patent discusses and exemplifies the biological and physiological advantages of the MAL product over the ALA product; MAL is characterized as “better able to penetrate skin and other tissues,” as a “better enhancer[] of Pp production than ALA,” and as providing “improved selectivity for the target tissue to be treated.” ’267 patent col. 4 l.59–col. 5 l.

The product containing MAL hydrochloride was a “new drug” in terms of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §321(p), and required full FDA approval. The clinical and other tests for demonstration of safety and efficacy of the MAL hydrochloride product consumed four and a half years. After FDA approval was received, Photocure applied for the statutory extension of the term of the ’267 patent. The PTO consulted with the FDA, in accordance with the Memorandum of Understanding, 52 Fed. Reg. 17,830 (FDA May 12, 1987). The FDA advised that MAL hydrochloride had received regulatory approval for the designated use. The FDA also pointed out that MAL hydrochloride is an ester of the previously FDA-approved ALA hydrochloride, and proposed that the requirements of §156(a)(5)(A) were not met.

The PTO then denied the requested term extension, stating that “active ingredient” in §156(f)(2) does not mean the product that was approved by the FDA, but rather means the “active moiety” of that product. The PTO held that MAL hydrochloride is the “same ‘product’” as ALA hydrochloride because the “underlying molecule” of MAL is ALA, and the PTO stated that “ALA is simply formulated differently in the two different drugs.” Final Decision Regarding Patent Term Extension Application Under 35 U.S.C. §156 For U.S. Patent No. 6,034,267 at 3, 5 (May 13, 2008). The PTO held that since a drug product containing ALA hydrochloride was previously approved by the FDA, the FDA’s marketing approval of the MAL hydrochloride product was not the first commercial marketing or use of that “product.”

Applying the provisions of the patent term extension statute, the district court considered the separate chemical composition, the separate patentability, and the separate FDA approval of MAL, and held that MAL hydrochloride is the active ingredient of a new drug product that required FDA approval, §156(f)(2)(A); that the MAL hydrochloride product was subject to a full regulatory review period before commercial marketing and use was permitted, §156(a)(4); that this review permitted the first commercial marketing and use of the MAL hydrochloride product, §156(a)(5)(A); and therefore that the statutory requirements for term extension were met.

The PTO argued that the statutory term “active ingredient” does not mean the product that is present in the approved drug, but only the “active moiety” of the product, that is, the part responsible for the pharmacological properties. However, the Federal Circuit said that MAL would meet the criteria for term extension since the pharmacological properties of MAL differ from those of ALA, supporting the separate patentability of the MAL product. MAL hydrochloride is a different chemical compound from ALA hydrochloride, and it is not disputed that they differ in their biological properties, warranting separate patenting and separate regulatory approval, although their chemical structure is similar. Thus the district court held that MAL hydrochloride and ALA hydrochloride are different “products” with different “active ingredients,” as the terms are used in §156, explaining that “a compound can only qualify as the ‘active ingredient’ of a drug if that compound itself is present in the drug,” citing Glaxo Operations UK Ltd. v. Quigg, 894 F.2d 392, 393 (Fed. Cir. 1990). Photocure, 622 F. Supp. 2d at 347.  In Glaxo, the Federal Circuit held that “product” in §156(a) means the product that is present in the drug for which federal approval was obtained.

The Federal Circuit said that the district court correctly applied 35 U.S.C. §156 and that the patent on MAL hydrochloride is subject to term extension.

The United States Patent and Trademark Office (USPTO) is increasing the availability of its patent electronic filing system, Electronic Filing System—Web (EFS-Web) by providing a new contingency option when the primary portal to EFS-Web has an unscheduled outage. Previously, the entire EFS-Web system is not available to the users during such an outage. The contingency option in EFS-Web will permit users to sign-on as unregistered EFS-Web users to file new applications, national stage submissions under the Patent Cooperation Treaty (PCT) submitted with the basic national fee necessary to enter the national stage, requests for reexamination, and certain petitions, during an unscheduled outage of the primary portal to EFS-Web.

EFS-Web Contingency Option

Effective immediately, the USPTO will provide EFS-Web Contingency Option to users to file new applications, national stage submissions under 35 U.S.C. 371, requests for reexamination, and certain petitions when the primary portal to EFS-Web is unavailable during an unscheduled outage. The USPTO will post a notification of any unscheduled outage of the primary portal to EFS-Web and provide the link to EFS-Web Contingency Option on the EFS-Web Internet page. The EFS-Web Contingency Option will have the same functionality as EFS-Web for unregistered e-filers.

It will permit users to sign on as unregistered EFS-Web users to file new applications, national stage submissions under 35 U.S.C. 371 submitted with the basic national fee necessary to enter the national stage, requests for reexamination, and certain petitions. However, other follow-on documents and fee payments filed after the initial submission of the application or reexamination request (e.g., amendments and replies to Office actions) cannot be filed using EFS-Web Contingency Option.

Specifically, EFS-Web Contingency Option will only permit users to electronically file the following items as unregistered EFS-Web users:

1. Provisional patent applications under 35 U.S.C. 111(b);
2. Nonprovisional utility patent applications under 35 U.S.C. 111(a) (including reissue utility patent applications);
3. Nonprovisional design patent applications under 35 U.S.C. 171 (including reissue design patent applications);
4. International applications under PCT Article 11 for filing in the United States Receiving Office;
5. National stage submissions under 35 U.S.C. 371 submitted with the basic national fee necessary to enter the national stage;
6. Requests for ex parte reexamination under 35 U.S.C. 302 for utility or design patents;
7. Requests for inter partes reexamination under 35 U.S.C. 311 for utility or design patents;
8. Petitions to make special based on age under 37 CFR 1.102(c) when filed as an e-petition using the EFS-Web SB130 form, for the automatic processing of the e-petition (for more information see here);
9. Petitions to accept an unintentionally delayed payment of maintenance fee under 37 CFR 1.378(c) when filed as an e-petition using the EFS-Web SB66 form, for the automatic processing of the e-petition (for more information see here); and
10. Petition to make special under the accelerated examination program (must be filed with a nonprovisional utility patent application under 35 U.S.C. 111(a)).

Documents filed via EFS-Web Contingency Option as part of the submissions listed above must meet the same file format requirements established for EFS-Web, e.g., file size and PDF embedded-font requirements. The same file validation performed in EFS-Web will be performed in EFS-Web Contingency Option. Similar to EFS-Web, EFS-Web Contingency Option will provide an Electronic Acknowledgement Receipt that establishes the date of receipt by the USPTO of an application or document submitted via EFS-Web Contingency Option. .

When the primary portal to EFS-Web is unavailable during an unscheduled outage, applicants may also file new applications, national stage submissions under 35 U.S.C. 371 submitted with the basic national fee necessary to enter the national stage, and reexamination requests, by hand-delivery to the USPTO, or ‘‘Express Mail’’ from the United States Postal Service (USPS) in accordance with 37 CFR 1.10, to establish the filing date or national stage entry date. See Revised Legal Framework for EFS-Web. New applications, national stage submissions under 35 U.S.C. 371 submitted with the basic national fee necessary to enter the national stage, and reexamination requests cannot be submitted by facsimile transmission, and certificate of mailing procedures under 37 CFR 1.8 do not apply to these items.

The EFS-Web Contingency Option does not permit follow-on fee payments and follow-on documents other than those listed above. Applicants may file the documents or fee payments by: (1) Facsimile transmission, (2) first class mail with a certificate of mailing in accordance with 37 CFR 1.8, (3) hand- delivery to the USPTO, or (4) ‘‘Express Mail’’ from USPS in accordance with 37 CFR 1.10. Documents that are required to establish the filing date of an application (e.g., a missing drawing figure or page of the specification) cannot be submitted by facsimile transmission, and certificate of mailing procedures under 37 CFR 1.8 do not apply to these documents.

Improperly Filed Follow-on Documents

As previously stated, EFS-Web Contingency Option and EFS-Web for unregistered e-filers permit users to sign on as unregistered EFS-Web users to file new applications, national stage submissions under 35 U.S.C. 371 submitted with the basic national fee necessary to enter the national stage, requests for reexamination and certain petitions. Unfortunately, EFS-Web Contingency and EFS-Web for unregistered e-filers have limited functionality, which do not permit users to file other follow-on documents and follow-on fee payments after the initial submission of the application or reexamination request (e.g., amendments and replies to Office actions). Accordingly, it will be improper for users to file follow-on documents as new applications.

See all the details in the USPTO Notice here.

Recently, the courts looked at the question of whether separate enantiomers can have “first commercial marketing or use” status for purposes of patent term extension under 35 U.S.C. § 156. The U.S. Patent and Trademark Office, after consulting with the FDA, had granted an extension for US Pat. No. 5,053,407, which is exclusively licensed to Ortho-McNeil Pharmaceutical and is directed to an enantiomer of a racemic compound.

Under the Hatch-Waxman Act, a patent term extension is permitted for a patent that claims a drug that required regulatory approval prior to being put on the market (the Drug Price Competition and Patent Term Restoration Act, codified in part at 35 U.S.C. § 156 et seq.).

The district court agreed with the positions of the Patent and Trademark Office and the FDA, and held that the statutory requirements for term extension were met for the ’407 patent. The court then prevented Lupin Pharmaceuticals from making and selling the drug during the extended term of the patent. Needless to say, Lupin was crestfallen and appealed but the US Court of Appeals for the Federal Circuit affirmed the district court’s judgment in Ortho-McNeil Pharma v. Lupin Pharma (09-1362).

The ’407 patent is for an antimicrobial compound having the common name levofloxacin. Levofloxacin is the levorotatory enantiomer (also designated the S(-) enantiomer) of the racemate ofloxacin, which is a known antimicrobial product. A racemate consists of equal amounts of spatial isomers called enantiomers, molecules that are mirror images of each other.

Due to their spatial orientation, enantiomers are optically active and are characterized by whether they rotate plane-polarized light clockwise (dextrorotatory) or counter-clockwise (levorotatory). Although enantiomers and their racemates have the same chemical composition, they may differ in their physical, chemical, or biological properties. It is often the case that one of the enantiomers possesses a substantially greater portion, if not all, of the biological activity of the racemic mixture. This raises the question of the status of separated enantiomers as “new drug products” and whether they can be “first commercial marketing or use” if the racemate has previously been granted market approval, pursuant to 35 U.S.C. § 156(a)(5)(A).

The inventors determined that levofloxacin has properties that are significantly superior to those of ofloxacin. The ’407 patent describes this synthesis, and presents data showing that levofloxacin is more effective as an antimicrobial agent, more rapidly available for biological effectiveness, and has lower acute toxicity and thus may be administered in higher doses than ofloxacin.

The PTO concluded that extension of the patent term was warranted, and the PTO and FDA collaborated in calculation of the applicable extension of 810 days, in accordance with §156(d)(2)(A). Lupin the tried to block the extension under 21 U.S.C. §355(j)(2)(A)(vii)(IV) (Paragraph IV certification).

The law, in 35 U.S.C. §156(a), states that:

The term of a patent which claims a product, a method of using a product, or a method of manufacturing a product shall be extended in accordance with this section . . . , if– . . . (a)(4) the product has been subject to a regulatory review period before its commercial marketing or use; (a)(5)(A) except as provided in subparagraph (B) or (C) [not here relevant], the permission for the commercial marketing or use of the product after such regulatory review period is the first permitted commercial marketing or use of the product under the provision of law under which such regulatory review period occurred; . . .

The term “drug product” means the active ingredient of (A) a new drug, antibiotic drug, or human biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act), . . . including any salt or ester of the active ingredient, as a single entity or in combination with another active ingredient.

The issue was whether this was the first permitted commercial marketing or use of levofloxacin, as required by 35 U.S.C. §156(a)(5)(A), for the racemate had previously been marketed. The district court held that the extension was in conformity with the practices of the PTO and the FDA with respect to enantiomers, and that the PTO’s determination that levofloxacin is a different “product” than the racemate ofloxacin must be afforded “great deference.”

Lupin argued that the PTO and the FDA incorrectly interpreted the statute as far as enantiomers are concerned. Lupin insisted that an enantiomer is half of its racemate, and thus that the enantiomer levofloxacin was an “active ingredient” or component of the previously marketed racemate ofloxacin. That is, the racemate was merely a composition containing two drugs: the R and the S enantiomers. Thus, levofloxacin is the same “drug product” as ofloxacin meaning that levofloxacin was not “the first permitted commercial marketing or use of the product” as required by §156(a)(5)(A).

Ortho countered that an enantiomer has consistently been recognized, by the FDA and the PTO, as a different “drug product” from its racemate. The FDA practices were explained by Dr. David Lin, a former acting Division Director in the FDA’s Division of New Drug Chemistry, declaring that “in each and every instance in which it has considered the question, the FDA has described a racemate as a single active ingredient, distinct from its enantiomers, and each enantiomer as a single active ingredient distinct from the other and from the racemate.”

Lupin tried arguing that the status of enantiomers with was legislatively changed in 2007, in the statute that changed the FDA policy concerning data exclusivity for new enantiomer products. 21 U.S.C. §355(u)(1) (Supp. II 2008). The new provision authorizes an applicant “for a non-racemic drug containing as an active ingredient (including any ester or salt of the active ingredient) a single enantiomer that is contained in a racemic drug approved in another application” to, under certain conditions, “elect to have the single enantiomer not be considered the same active ingredient as that contained in the approved racemic drug.” Lupin felt that by specifically allowing an applicant to “elect” this separate treatment for enantiomers, Congress expressed its understanding that enantiomers were the same active ingredient as the racemate for all other purposes, including patent term extension.

The Federal Circuit said it couldn’t find any support for this theory in the legislative record, or elsewhere and affirmed the district court’s ruling that the ’407 patent on levofloxacin was properly granted the statutory term extension, for the enantiomer is a different drug product from the racemate ofloxacin, and was subject to regulatory approval before it could be commercially marketed and used.

This case clarifies that separate enantiomers can obtain independent patent protection and be entitled to patent term extension for “first commercial marketing or use” as new drug products. However, the Federal Circuit has said that patents for separated enantiomers can be invalidated on obviousness grounds.  So, pharmaceutical companies that can show (very?) good reasons that separation of enantiomers was not obvious can look forward to a much longer patent term – for now.